Ob.Gyn. News

Approximately a third of older patients treated with thyroid hormones report the concurrent use of medications that can interfere with the accuracy of thyroid function tests, potentially compromising treatment decisions, new research shows.

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“We know from previous studies that thyroid hormone use is common in older adults and that there are a multitude of medications that can interfere with thyroid function tests in different ways,” senior author Maria Papaleontiou, MD, told Medscape Medical News.

“However, to our knowledge, the extent of concurrent use of thyroid hormone and interfering medications in older adults, age 65 years and older, has not been previously explored,” added Dr. Papaleontiou, of the Division of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor.

The findings were presented as a poster during virtual ENDO 2021, the Endocrine Society’s annual meeting.

Commenting on the study, Thanh Duc Hoang, DO, an endocrinologist with the Walter Reed National Military Medical Center, in Bethesda, Md., said: “It is important for clinicians to be aware of various interactions and interferences of medications affecting the accuracy of thyroid function tests.”

“If patients are not able to discontinue the medications shortly before the bloodwork, the clinicians may consider ordering different thyroid tests or assays that avoid the interferences,” he told Medscape Medical News.
 

32% of patients taking meds that could interfere with tests

In evaluating data on 538,137 patients treated with thyroid hormones from the Corporate Data Warehouse of the Veterans Health Administration, spanning 2004-2017, first author Rachel Beeson, MD, and colleagues with the University of Michigan found most patients in the study were men (96.5%), White (77.1%), and had two or more comorbidities (62.6%).

Of this total, 170,261 (31.6%) patients treated with thyroid hormones, over a median follow-up of 56 months, were taking at least one drug that could potentially interfere with thyroid function tests.

Among the drugs with potential thyroid test interference, about 28% of patients were taking prednisone or prednisolone, 8% were taking amiodarone, and 1.42% were taking phenytoin. Other reported drugs that could potentially interfere included carbamazepine (0.91%), phenobarbital (0.15%), lithium (0.40%), and tamoxifen (0.11%).

Multivariate analysis showed that characteristics associated with those most likely to have concurrent medication use included non-Whites (OR, 1.18 vs Whites), Hispanic ethnicity (OR 1.11 vs non-Hispanic), female sex (OR 1.12 vs males), and presence of comorbidities (eg, Charlson-Deyo comorbidity score ≥ 2, OR,  2.47 vs score of 0).

Meanwhile, older patients age 85 years and over had a lower likelihood of concurrent medications interfering with thyroid tests (OR, 0.47 vs age 65-74 years).

The findings are concerning given the wide use of levothyroxine to treat hypothyroidism, which is the most widely prescribed drug in the United States.

“Our findings not only highlight the complexity of thyroid hormone management in older adults in the context of polypharmacy and multimorbidity, but they also draw attention to vulnerable groups for this practice, which included female patients, non-Whites, patients of Hispanic ethnicity, and patients with comorbidities,” Dr. Papaleontiou said.
 

Nature of interference possibilities varies

Medications or supplements can interfere with thyroid function tests in a variety of ways, she explained. “Some medications could lead to a decrease in the absorption of levothyroxine, others may affect how well the pill dissolves.”

In addition, certain medications can affect the circulation of thyroid hormone in the blood and how it binds with proteins, or they can lead to decreasing thyroid hormone levels due to a variety of interactions.

And in contrast, “What is even more challenging is that some medications or supplements may appear to affect thyroid function based on lab tests when in reality they don’t actually affect thyroid function and may lead to dose adjustments unnecessarily,” Dr. Papaleontiou noted.
 

Recommendations to counter interference

Current recommendations to try to counter the effects of polypharmacy on thyroid treatment include advising patients to take thyroid hormones on an empty stomach at least 30-60 minutes prior to eating for optimal absorption.

If the patient is taking medications known to interfere with absorption of thyroid hormones, the recommendation is to space those out by at least 4 hours.

“The big challenge in older adults is that many of them do experience polypharmacy, being at risk for multiple drug-drug interactions,” Dr. Papaleontiou said.

“Physicians and patients should be vigilant and communicate closely every time there is initiation of a new medication or supplement to consider whether there may be interference.”

The authors have reported no relevant financial relationships. Dr. Hoang has reported being a speaker for Acella Pharmaceuticals.

A version of this article first appeared on Medscape.com.

Approximately a third of older patients treated with thyroid hormones report the concurrent use of medications that can interfere with the accuracy of thyroid function tests, potentially compromising treatment decisions, new research shows.

juststock/Thinkstock

“We know from previous studies that thyroid hormone use is common in older adults and that there are a multitude of medications that can interfere with thyroid function tests in different ways,” senior author Maria Papaleontiou, MD, told Medscape Medical News.

“However, to our knowledge, the extent of concurrent use of thyroid hormone and interfering medications in older adults, age 65 years and older, has not been previously explored,” added Dr. Papaleontiou, of the Division of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor.

The findings were presented as a poster during virtual ENDO 2021, the Endocrine Society’s annual meeting.

Commenting on the study, Thanh Duc Hoang, DO, an endocrinologist with the Walter Reed National Military Medical Center, in Bethesda, Md., said: “It is important for clinicians to be aware of various interactions and interferences of medications affecting the accuracy of thyroid function tests.”

“If patients are not able to discontinue the medications shortly before the bloodwork, the clinicians may consider ordering different thyroid tests or assays that avoid the interferences,” he told Medscape Medical News.
 

32% of patients taking meds that could interfere with tests

In evaluating data on 538,137 patients treated with thyroid hormones from the Corporate Data Warehouse of the Veterans Health Administration, spanning 2004-2017, first author Rachel Beeson, MD, and colleagues with the University of Michigan found most patients in the study were men (96.5%), White (77.1%), and had two or more comorbidities (62.6%).

Of this total, 170,261 (31.6%) patients treated with thyroid hormones, over a median follow-up of 56 months, were taking at least one drug that could potentially interfere with thyroid function tests.

Among the drugs with potential thyroid test interference, about 28% of patients were taking prednisone or prednisolone, 8% were taking amiodarone, and 1.42% were taking phenytoin. Other reported drugs that could potentially interfere included carbamazepine (0.91%), phenobarbital (0.15%), lithium (0.40%), and tamoxifen (0.11%).

Multivariate analysis showed that characteristics associated with those most likely to have concurrent medication use included non-Whites (OR, 1.18 vs Whites), Hispanic ethnicity (OR 1.11 vs non-Hispanic), female sex (OR 1.12 vs males), and presence of comorbidities (eg, Charlson-Deyo comorbidity score ≥ 2, OR,  2.47 vs score of 0).

Meanwhile, older patients age 85 years and over had a lower likelihood of concurrent medications interfering with thyroid tests (OR, 0.47 vs age 65-74 years).

The findings are concerning given the wide use of levothyroxine to treat hypothyroidism, which is the most widely prescribed drug in the United States.

“Our findings not only highlight the complexity of thyroid hormone management in older adults in the context of polypharmacy and multimorbidity, but they also draw attention to vulnerable groups for this practice, which included female patients, non-Whites, patients of Hispanic ethnicity, and patients with comorbidities,” Dr. Papaleontiou said.
 

Nature of interference possibilities varies

Medications or supplements can interfere with thyroid function tests in a variety of ways, she explained. “Some medications could lead to a decrease in the absorption of levothyroxine, others may affect how well the pill dissolves.”

In addition, certain medications can affect the circulation of thyroid hormone in the blood and how it binds with proteins, or they can lead to decreasing thyroid hormone levels due to a variety of interactions.

And in contrast, “What is even more challenging is that some medications or supplements may appear to affect thyroid function based on lab tests when in reality they don’t actually affect thyroid function and may lead to dose adjustments unnecessarily,” Dr. Papaleontiou noted.
 

Recommendations to counter interference

Current recommendations to try to counter the effects of polypharmacy on thyroid treatment include advising patients to take thyroid hormones on an empty stomach at least 30-60 minutes prior to eating for optimal absorption.

If the patient is taking medications known to interfere with absorption of thyroid hormones, the recommendation is to space those out by at least 4 hours.

“The big challenge in older adults is that many of them do experience polypharmacy, being at risk for multiple drug-drug interactions,” Dr. Papaleontiou said.

“Physicians and patients should be vigilant and communicate closely every time there is initiation of a new medication or supplement to consider whether there may be interference.”

The authors have reported no relevant financial relationships. Dr. Hoang has reported being a speaker for Acella Pharmaceuticals.

A version of this article first appeared on Medscape.com.

Approximately a third of older patients treated with thyroid hormones report the concurrent use of medications that can interfere with the accuracy of thyroid function tests, potentially compromising treatment decisions, new research shows.

juststock/Thinkstock

“We know from previous studies that thyroid hormone use is common in older adults and that there are a multitude of medications that can interfere with thyroid function tests in different ways,” senior author Maria Papaleontiou, MD, told Medscape Medical News.

“However, to our knowledge, the extent of concurrent use of thyroid hormone and interfering medications in older adults, age 65 years and older, has not been previously explored,” added Dr. Papaleontiou, of the Division of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor.

The findings were presented as a poster during virtual ENDO 2021, the Endocrine Society’s annual meeting.

Commenting on the study, Thanh Duc Hoang, DO, an endocrinologist with the Walter Reed National Military Medical Center, in Bethesda, Md., said: “It is important for clinicians to be aware of various interactions and interferences of medications affecting the accuracy of thyroid function tests.”

“If patients are not able to discontinue the medications shortly before the bloodwork, the clinicians may consider ordering different thyroid tests or assays that avoid the interferences,” he told Medscape Medical News.
 

32% of patients taking meds that could interfere with tests

In evaluating data on 538,137 patients treated with thyroid hormones from the Corporate Data Warehouse of the Veterans Health Administration, spanning 2004-2017, first author Rachel Beeson, MD, and colleagues with the University of Michigan found most patients in the study were men (96.5%), White (77.1%), and had two or more comorbidities (62.6%).

Of this total, 170,261 (31.6%) patients treated with thyroid hormones, over a median follow-up of 56 months, were taking at least one drug that could potentially interfere with thyroid function tests.

Among the drugs with potential thyroid test interference, about 28% of patients were taking prednisone or prednisolone, 8% were taking amiodarone, and 1.42% were taking phenytoin. Other reported drugs that could potentially interfere included carbamazepine (0.91%), phenobarbital (0.15%), lithium (0.40%), and tamoxifen (0.11%).

Multivariate analysis showed that characteristics associated with those most likely to have concurrent medication use included non-Whites (OR, 1.18 vs Whites), Hispanic ethnicity (OR 1.11 vs non-Hispanic), female sex (OR 1.12 vs males), and presence of comorbidities (eg, Charlson-Deyo comorbidity score ≥ 2, OR,  2.47 vs score of 0).

Meanwhile, older patients age 85 years and over had a lower likelihood of concurrent medications interfering with thyroid tests (OR, 0.47 vs age 65-74 years).

The findings are concerning given the wide use of levothyroxine to treat hypothyroidism, which is the most widely prescribed drug in the United States.

“Our findings not only highlight the complexity of thyroid hormone management in older adults in the context of polypharmacy and multimorbidity, but they also draw attention to vulnerable groups for this practice, which included female patients, non-Whites, patients of Hispanic ethnicity, and patients with comorbidities,” Dr. Papaleontiou said.
 

Nature of interference possibilities varies

Medications or supplements can interfere with thyroid function tests in a variety of ways, she explained. “Some medications could lead to a decrease in the absorption of levothyroxine, others may affect how well the pill dissolves.”

In addition, certain medications can affect the circulation of thyroid hormone in the blood and how it binds with proteins, or they can lead to decreasing thyroid hormone levels due to a variety of interactions.

And in contrast, “What is even more challenging is that some medications or supplements may appear to affect thyroid function based on lab tests when in reality they don’t actually affect thyroid function and may lead to dose adjustments unnecessarily,” Dr. Papaleontiou noted.
 

Recommendations to counter interference

Current recommendations to try to counter the effects of polypharmacy on thyroid treatment include advising patients to take thyroid hormones on an empty stomach at least 30-60 minutes prior to eating for optimal absorption.

If the patient is taking medications known to interfere with absorption of thyroid hormones, the recommendation is to space those out by at least 4 hours.

“The big challenge in older adults is that many of them do experience polypharmacy, being at risk for multiple drug-drug interactions,” Dr. Papaleontiou said.

“Physicians and patients should be vigilant and communicate closely every time there is initiation of a new medication or supplement to consider whether there may be interference.”

The authors have reported no relevant financial relationships. Dr. Hoang has reported being a speaker for Acella Pharmaceuticals.

A version of this article first appeared on Medscape.com.

Delaying surgery for up to 3 months had no adverse impact on overall survival in early-stage cervical cancer in a retrospective study of more than 4,700 women in the National Cancer Database.

The 5-year overall survival rate was 85.7% among women who had radical hysterectomy and lymphadenectomy within 4 weeks of diagnosis, 86.6% among those who had the same surgery 4-8 weeks after diagnosis, and 89.6% among those who had surgery 8-12 weeks after diagnosis (P = .12).

“For patients with clinical stage I cervical carcinoma undergoing radical hysterectomy, we found no evidence of a detrimental effect of waiting time (up to 12 weeks from diagnosis) on overall survival,” the study investigators reported in a poster at the Society of Gynecologic Oncology’s Virtual Annual Meeting on Women’s Cancer.

The investigators looked at the issue of surgical wait times because of surgery delays due to the COVID-19 pandemic, according to investigator Dimitrios Nasioudis, MD, of the University of Pennsylvania in Philadelphia.

“We wanted to see if there was a real impact in the survival of patients,” Dr. Nasioudis said in an interview. He added that “many times, there is a question of when to perform surgery,” especially when patients need medical optimization.

Dr. Nasioudis called the findings “reassuring” and said “waiting up to 3 or 4 months is reasonable.”

Still, the investigators plan to validate the results with more granular patient-level institutional data, he said. Given the limits of the database, there was no information on tumor relapse or cause of death and no central pathology review.
 

Study details

The study included 4,782 patients who underwent primary radical hysterectomy with lymphadenectomy. Patients had clinical stage I adenocarcinoma, squamous, or adenosquamous carcinoma of the cervix, with no history of another tumor or other cervical surgery.

The median time to surgery was 34 days across the study population. Patients were divided into three groups according to the timing of their surgery:

• Group 1 included 1,823 (38.1%) patients who had surgery less than 4 weeks from diagnosis.
• Group 2 included 2,207 (46.2%) patients who had surgery 4-8 weeks from diagnosis.
• Group 3 included 752 (15.7%) patients who had surgery 8-12 weeks from diagnosis.

Patients in group 1 had a higher rate of positive lymph nodes, compared with patients in groups 2 and 3 (18.4%, 15.6%, and 14.7%, respectively; P = .014). Patients in group 1 also had a higher incidence of lymphovascular space invasion (42.1%, 38.1%, and 33%; P = .007) and a higher rate of positive surgical margins (6.3%, 5.2%, and 3.9%; P = .047).

Group 1 patients “had more aggressive features,” which could explain why they had surgery within a month, Dr. Nasioudis said.

Patients in groups 3 and 2 were more likely to have government insurance, compared with patients in group 1 (35.6%, 31.6%, and 24.6%, respectively P < .001). Group 3 patients were more likely than those in groups 2 and 1 to have comorbidities (14.2%, 11.6%, and 10.5%; P = .29).

However, there were no survival differences between groups in a multivariate analysis controlling for confounders, which included tumor size, histology and extension, status of lymph nodes, receipt of radiotherapy, patient age, insurance, race, and comorbidities. Furthermore, in a stratified analysis based on tumor extent, the timing of surgery had no impact on survival.

Dr. Nasioudis said he suspects access to care was an issue for some women, and there were likely delays for medical optimization.

Access to gynecologic oncology services at the University of Pennsylvania is “pretty easy,” he said, so delays are usually related to medical optimization, but that’s not always the case in underserved areas of the United States.

There was no funding for this study, and the investigators didn’t have any disclosures.

[email protected]

Delaying surgery for up to 3 months had no adverse impact on overall survival in early-stage cervical cancer in a retrospective study of more than 4,700 women in the National Cancer Database.

The 5-year overall survival rate was 85.7% among women who had radical hysterectomy and lymphadenectomy within 4 weeks of diagnosis, 86.6% among those who had the same surgery 4-8 weeks after diagnosis, and 89.6% among those who had surgery 8-12 weeks after diagnosis (P = .12).

“For patients with clinical stage I cervical carcinoma undergoing radical hysterectomy, we found no evidence of a detrimental effect of waiting time (up to 12 weeks from diagnosis) on overall survival,” the study investigators reported in a poster at the Society of Gynecologic Oncology’s Virtual Annual Meeting on Women’s Cancer.

The investigators looked at the issue of surgical wait times because of surgery delays due to the COVID-19 pandemic, according to investigator Dimitrios Nasioudis, MD, of the University of Pennsylvania in Philadelphia.

“We wanted to see if there was a real impact in the survival of patients,” Dr. Nasioudis said in an interview. He added that “many times, there is a question of when to perform surgery,” especially when patients need medical optimization.

Dr. Nasioudis called the findings “reassuring” and said “waiting up to 3 or 4 months is reasonable.”

Still, the investigators plan to validate the results with more granular patient-level institutional data, he said. Given the limits of the database, there was no information on tumor relapse or cause of death and no central pathology review.
 

Study details

The study included 4,782 patients who underwent primary radical hysterectomy with lymphadenectomy. Patients had clinical stage I adenocarcinoma, squamous, or adenosquamous carcinoma of the cervix, with no history of another tumor or other cervical surgery.

The median time to surgery was 34 days across the study population. Patients were divided into three groups according to the timing of their surgery:

• Group 1 included 1,823 (38.1%) patients who had surgery less than 4 weeks from diagnosis.
• Group 2 included 2,207 (46.2%) patients who had surgery 4-8 weeks from diagnosis.
• Group 3 included 752 (15.7%) patients who had surgery 8-12 weeks from diagnosis.

Patients in group 1 had a higher rate of positive lymph nodes, compared with patients in groups 2 and 3 (18.4%, 15.6%, and 14.7%, respectively; P = .014). Patients in group 1 also had a higher incidence of lymphovascular space invasion (42.1%, 38.1%, and 33%; P = .007) and a higher rate of positive surgical margins (6.3%, 5.2%, and 3.9%; P = .047).

Group 1 patients “had more aggressive features,” which could explain why they had surgery within a month, Dr. Nasioudis said.

Patients in groups 3 and 2 were more likely to have government insurance, compared with patients in group 1 (35.6%, 31.6%, and 24.6%, respectively P < .001). Group 3 patients were more likely than those in groups 2 and 1 to have comorbidities (14.2%, 11.6%, and 10.5%; P = .29).

However, there were no survival differences between groups in a multivariate analysis controlling for confounders, which included tumor size, histology and extension, status of lymph nodes, receipt of radiotherapy, patient age, insurance, race, and comorbidities. Furthermore, in a stratified analysis based on tumor extent, the timing of surgery had no impact on survival.

Dr. Nasioudis said he suspects access to care was an issue for some women, and there were likely delays for medical optimization.

Access to gynecologic oncology services at the University of Pennsylvania is “pretty easy,” he said, so delays are usually related to medical optimization, but that’s not always the case in underserved areas of the United States.

There was no funding for this study, and the investigators didn’t have any disclosures.

[email protected]

Delaying surgery for up to 3 months had no adverse impact on overall survival in early-stage cervical cancer in a retrospective study of more than 4,700 women in the National Cancer Database.

The 5-year overall survival rate was 85.7% among women who had radical hysterectomy and lymphadenectomy within 4 weeks of diagnosis, 86.6% among those who had the same surgery 4-8 weeks after diagnosis, and 89.6% among those who had surgery 8-12 weeks after diagnosis (P = .12).

“For patients with clinical stage I cervical carcinoma undergoing radical hysterectomy, we found no evidence of a detrimental effect of waiting time (up to 12 weeks from diagnosis) on overall survival,” the study investigators reported in a poster at the Society of Gynecologic Oncology’s Virtual Annual Meeting on Women’s Cancer.

The investigators looked at the issue of surgical wait times because of surgery delays due to the COVID-19 pandemic, according to investigator Dimitrios Nasioudis, MD, of the University of Pennsylvania in Philadelphia.

“We wanted to see if there was a real impact in the survival of patients,” Dr. Nasioudis said in an interview. He added that “many times, there is a question of when to perform surgery,” especially when patients need medical optimization.

Dr. Nasioudis called the findings “reassuring” and said “waiting up to 3 or 4 months is reasonable.”

Still, the investigators plan to validate the results with more granular patient-level institutional data, he said. Given the limits of the database, there was no information on tumor relapse or cause of death and no central pathology review.
 

Study details

The study included 4,782 patients who underwent primary radical hysterectomy with lymphadenectomy. Patients had clinical stage I adenocarcinoma, squamous, or adenosquamous carcinoma of the cervix, with no history of another tumor or other cervical surgery.

The median time to surgery was 34 days across the study population. Patients were divided into three groups according to the timing of their surgery:

• Group 1 included 1,823 (38.1%) patients who had surgery less than 4 weeks from diagnosis.
• Group 2 included 2,207 (46.2%) patients who had surgery 4-8 weeks from diagnosis.
• Group 3 included 752 (15.7%) patients who had surgery 8-12 weeks from diagnosis.

Patients in group 1 had a higher rate of positive lymph nodes, compared with patients in groups 2 and 3 (18.4%, 15.6%, and 14.7%, respectively; P = .014). Patients in group 1 also had a higher incidence of lymphovascular space invasion (42.1%, 38.1%, and 33%; P = .007) and a higher rate of positive surgical margins (6.3%, 5.2%, and 3.9%; P = .047).

Group 1 patients “had more aggressive features,” which could explain why they had surgery within a month, Dr. Nasioudis said.

Patients in groups 3 and 2 were more likely to have government insurance, compared with patients in group 1 (35.6%, 31.6%, and 24.6%, respectively P < .001). Group 3 patients were more likely than those in groups 2 and 1 to have comorbidities (14.2%, 11.6%, and 10.5%; P = .29).

However, there were no survival differences between groups in a multivariate analysis controlling for confounders, which included tumor size, histology and extension, status of lymph nodes, receipt of radiotherapy, patient age, insurance, race, and comorbidities. Furthermore, in a stratified analysis based on tumor extent, the timing of surgery had no impact on survival.

Dr. Nasioudis said he suspects access to care was an issue for some women, and there were likely delays for medical optimization.

Access to gynecologic oncology services at the University of Pennsylvania is “pretty easy,” he said, so delays are usually related to medical optimization, but that’s not always the case in underserved areas of the United States.

There was no funding for this study, and the investigators didn’t have any disclosures.

[email protected]

The PARP inhibitor rucaparib significantly improved progression-free survival (PFS) compared with standard-of-care chemotherapy in women with BRCA-mutated, advanced, relapsed ovarian cancer in the phase 3 ARIEL4 study.

Investigator-assessed PFS in both an intention-to-treat (ITT) analysis and an efficacy analysis that excluded patients with BRCA reversion mutations was 7.4 months in the rucaparib arm, compared with 5.7 months in patients who received either platinum-based chemotherapy or weekly paclitaxel.

Among the 23 patients with BRCA reversion mutations, however, investigator-assessed PFS was 2.9 months with rucaparib and 5.5 months with chemotherapy.

Overall survival data were not mature at the time of data cutoff in September 2020.

“Although the numbers are very small, the results suggest that presence of a BRCA reversion mutation may predict a reduced benefit from rucaparib,” said Rebecca Kristeleit, MBChB, PhD, of Guy’s and St. Thomas’ NHS Foundation Trust in London.

She presented the findings from ARIEL4 at the Society of Gynecologic Oncology’s Virtual Annual Meeting on Women’s Cancer (Abstract 11479).

Invited discussant Ursula Matulonis, MD, of the Dana-Farber Cancer Institute in Boston, commented that the “BRCA reversion mutation data from ARIEL4 is intriguing. Strategies to overcome and better understand this type of resistance mechanism are needed.”
 

Study rationale and details

Rucaparib is approved as monotherapy for patients with BRCA-mutated, relapsed ovarian cancer who have received at least two prior lines of platinum-based chemotherapy. The approval was based on results of two phase 1/2 studies. ARIEL4 is a phase 3 confirmatory study, designed in consultation with both the U.S. Food and Drug Administration and the European Medicines Agency.

Women with relapsed, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer with deleterious germline or somatic BRCA mutations were eligible for enrollment in ARIEL4. The patients had to have received at least two lines of chemotherapy, including at least one platinum-based regimen, with no prior PARP inhibitor or single-agent paclitaxel treatment.

Overall, 95% of patients had epithelial ovarian cancer, 3% had fallopian tube cancer, and 2% had primary peritoneal cancer. About 90% of cancers were serous in histology. Most patients (84%) had germline BRCA mutations, 16% had somatic mutations, and the status was unknown in the remaining patients.

Patients were randomized on a 2:1 basis to receive rucaparib at 600 mg twice daily (n = 233) or chemotherapy (n = 116), stratified by platinum sensitivity status. Patients assigned to chemotherapy whose disease was considered platinum resistant or partially platinum sensitive were assigned to weekly paclitaxel. Patients with fully platinum-sensitive disease were assigned to platinum-based single-agent or doublet chemotherapy. Treatment cycles were 28 days.

On radiologically confirmed disease progression or unacceptable toxicity, patients assigned to chemotherapy had the option to cross over to the rucaparib arm. The follow-up portion of the study began 28 days after the last treatment dose, with visits every 8 weeks thereafter.

Baseline characteristics in the ITT population were similar between arms. There were 13 patients in the rucaparib arm and 10 in the chemotherapy arm who had BRCA reversion mutations and were excluded from the efficacy population.
 

Efficacy and safety

Investigator-assessed PFS in the efficacy population was a median of 7.4 months with rucaparib and 5.7 months with chemotherapy, translating to a hazard ratio (HR) of 0.64 (P = .001). In the ITT population, the respective median PFS intervals were identical, although with a slightly less favorable HR of 0.67 (P = .002). In the 23 patients with BRCA reversion mutations, the median PFS was worse with rucaparib, at 2.9 months, compared with 5.5 months for chemotherapy. This translated to a HR of 2.77, although the 95% confidence interval was wide and crossed 1, likely due to the small sample size.

Among patients who had measurable disease at baseline, the overall response rate in the efficacy population was 40.3% with rucaparib and 32.3% with chemotherapy, a difference that was not statistically significant (P = .13). The overall response data were similar in the ITT population (37.9% and 30.2%, respectively).

In the efficacy population, the duration of response was significantly longer in the rucaparib arm, at a median of 9.4 months versus 7.2 months (HR, 0.59; 95% CI, 0.36-0.98). The respective median response durations were identical in the ITT population, but the HR was 0.56 (95% CI, 0.34-0.93).

In both the efficacy and ITT populations, global health status was virtually identical and unchanged from baseline in both treatment arms through cycle 7.

Treatment-emergent adverse events (TEAEs) were more frequent with rucaparib. The most common TEAEs in the rucaparib and chemotherapy arms, respectively, were anemia/decreased hemoglobin (53.9% and 31.9%), nausea (53.4% and 31.9%), asthenia/fatigue (49.6% and 44.2%), ALT/AST increase (34.5% and 11.5%), and vomiting (34.1% and 16.8%).

In all, 8.2% of patients in the rucaparib arm and 12.4% of those in the chemotherapy arm discontinued therapy due to TEAEs.

Four patients in the rucaparib arm developed myelodysplastic syndrome or acute myeloid leukemia – one during treatment and three during follow-up. There were no cases of myelodysplastic syndrome or acute myeloid leukemia in patients who received chemotherapy.

“Data from ARIEL4 fits the paradigm that single-agent activity of PARP inhibitors in BRCA-mutated, recurrent ovarian cancer may be comparable to chemotherapy, and may, at times, be superior, depending on the study population, trial design, and treatment for control patients,” Dr. Matulonis said.

The study was funded by Clovis Oncology. Dr. Kristeleit disclosed relationships with Clovis, Roche, and Tesaro. Dr. Matulonis disclosed relationships with Novartis, Merck, and Immunogen.

The PARP inhibitor rucaparib significantly improved progression-free survival (PFS) compared with standard-of-care chemotherapy in women with BRCA-mutated, advanced, relapsed ovarian cancer in the phase 3 ARIEL4 study.

Investigator-assessed PFS in both an intention-to-treat (ITT) analysis and an efficacy analysis that excluded patients with BRCA reversion mutations was 7.4 months in the rucaparib arm, compared with 5.7 months in patients who received either platinum-based chemotherapy or weekly paclitaxel.

Among the 23 patients with BRCA reversion mutations, however, investigator-assessed PFS was 2.9 months with rucaparib and 5.5 months with chemotherapy.

Overall survival data were not mature at the time of data cutoff in September 2020.

“Although the numbers are very small, the results suggest that presence of a BRCA reversion mutation may predict a reduced benefit from rucaparib,” said Rebecca Kristeleit, MBChB, PhD, of Guy’s and St. Thomas’ NHS Foundation Trust in London.

She presented the findings from ARIEL4 at the Society of Gynecologic Oncology’s Virtual Annual Meeting on Women’s Cancer (Abstract 11479).

Invited discussant Ursula Matulonis, MD, of the Dana-Farber Cancer Institute in Boston, commented that the “BRCA reversion mutation data from ARIEL4 is intriguing. Strategies to overcome and better understand this type of resistance mechanism are needed.”
 

Study rationale and details

Rucaparib is approved as monotherapy for patients with BRCA-mutated, relapsed ovarian cancer who have received at least two prior lines of platinum-based chemotherapy. The approval was based on results of two phase 1/2 studies. ARIEL4 is a phase 3 confirmatory study, designed in consultation with both the U.S. Food and Drug Administration and the European Medicines Agency.

Women with relapsed, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer with deleterious germline or somatic BRCA mutations were eligible for enrollment in ARIEL4. The patients had to have received at least two lines of chemotherapy, including at least one platinum-based regimen, with no prior PARP inhibitor or single-agent paclitaxel treatment.

Overall, 95% of patients had epithelial ovarian cancer, 3% had fallopian tube cancer, and 2% had primary peritoneal cancer. About 90% of cancers were serous in histology. Most patients (84%) had germline BRCA mutations, 16% had somatic mutations, and the status was unknown in the remaining patients.

Patients were randomized on a 2:1 basis to receive rucaparib at 600 mg twice daily (n = 233) or chemotherapy (n = 116), stratified by platinum sensitivity status. Patients assigned to chemotherapy whose disease was considered platinum resistant or partially platinum sensitive were assigned to weekly paclitaxel. Patients with fully platinum-sensitive disease were assigned to platinum-based single-agent or doublet chemotherapy. Treatment cycles were 28 days.

On radiologically confirmed disease progression or unacceptable toxicity, patients assigned to chemotherapy had the option to cross over to the rucaparib arm. The follow-up portion of the study began 28 days after the last treatment dose, with visits every 8 weeks thereafter.

Baseline characteristics in the ITT population were similar between arms. There were 13 patients in the rucaparib arm and 10 in the chemotherapy arm who had BRCA reversion mutations and were excluded from the efficacy population.
 

Efficacy and safety

Investigator-assessed PFS in the efficacy population was a median of 7.4 months with rucaparib and 5.7 months with chemotherapy, translating to a hazard ratio (HR) of 0.64 (P = .001). In the ITT population, the respective median PFS intervals were identical, although with a slightly less favorable HR of 0.67 (P = .002). In the 23 patients with BRCA reversion mutations, the median PFS was worse with rucaparib, at 2.9 months, compared with 5.5 months for chemotherapy. This translated to a HR of 2.77, although the 95% confidence interval was wide and crossed 1, likely due to the small sample size.

Among patients who had measurable disease at baseline, the overall response rate in the efficacy population was 40.3% with rucaparib and 32.3% with chemotherapy, a difference that was not statistically significant (P = .13). The overall response data were similar in the ITT population (37.9% and 30.2%, respectively).

In the efficacy population, the duration of response was significantly longer in the rucaparib arm, at a median of 9.4 months versus 7.2 months (HR, 0.59; 95% CI, 0.36-0.98). The respective median response durations were identical in the ITT population, but the HR was 0.56 (95% CI, 0.34-0.93).

In both the efficacy and ITT populations, global health status was virtually identical and unchanged from baseline in both treatment arms through cycle 7.

Treatment-emergent adverse events (TEAEs) were more frequent with rucaparib. The most common TEAEs in the rucaparib and chemotherapy arms, respectively, were anemia/decreased hemoglobin (53.9% and 31.9%), nausea (53.4% and 31.9%), asthenia/fatigue (49.6% and 44.2%), ALT/AST increase (34.5% and 11.5%), and vomiting (34.1% and 16.8%).

In all, 8.2% of patients in the rucaparib arm and 12.4% of those in the chemotherapy arm discontinued therapy due to TEAEs.

Four patients in the rucaparib arm developed myelodysplastic syndrome or acute myeloid leukemia – one during treatment and three during follow-up. There were no cases of myelodysplastic syndrome or acute myeloid leukemia in patients who received chemotherapy.

“Data from ARIEL4 fits the paradigm that single-agent activity of PARP inhibitors in BRCA-mutated, recurrent ovarian cancer may be comparable to chemotherapy, and may, at times, be superior, depending on the study population, trial design, and treatment for control patients,” Dr. Matulonis said.

The study was funded by Clovis Oncology. Dr. Kristeleit disclosed relationships with Clovis, Roche, and Tesaro. Dr. Matulonis disclosed relationships with Novartis, Merck, and Immunogen.

The PARP inhibitor rucaparib significantly improved progression-free survival (PFS) compared with standard-of-care chemotherapy in women with BRCA-mutated, advanced, relapsed ovarian cancer in the phase 3 ARIEL4 study.

Investigator-assessed PFS in both an intention-to-treat (ITT) analysis and an efficacy analysis that excluded patients with BRCA reversion mutations was 7.4 months in the rucaparib arm, compared with 5.7 months in patients who received either platinum-based chemotherapy or weekly paclitaxel.

Among the 23 patients with BRCA reversion mutations, however, investigator-assessed PFS was 2.9 months with rucaparib and 5.5 months with chemotherapy.

Overall survival data were not mature at the time of data cutoff in September 2020.

“Although the numbers are very small, the results suggest that presence of a BRCA reversion mutation may predict a reduced benefit from rucaparib,” said Rebecca Kristeleit, MBChB, PhD, of Guy’s and St. Thomas’ NHS Foundation Trust in London.

She presented the findings from ARIEL4 at the Society of Gynecologic Oncology’s Virtual Annual Meeting on Women’s Cancer (Abstract 11479).

Invited discussant Ursula Matulonis, MD, of the Dana-Farber Cancer Institute in Boston, commented that the “BRCA reversion mutation data from ARIEL4 is intriguing. Strategies to overcome and better understand this type of resistance mechanism are needed.”
 

Study rationale and details

Rucaparib is approved as monotherapy for patients with BRCA-mutated, relapsed ovarian cancer who have received at least two prior lines of platinum-based chemotherapy. The approval was based on results of two phase 1/2 studies. ARIEL4 is a phase 3 confirmatory study, designed in consultation with both the U.S. Food and Drug Administration and the European Medicines Agency.

Women with relapsed, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer with deleterious germline or somatic BRCA mutations were eligible for enrollment in ARIEL4. The patients had to have received at least two lines of chemotherapy, including at least one platinum-based regimen, with no prior PARP inhibitor or single-agent paclitaxel treatment.

Overall, 95% of patients had epithelial ovarian cancer, 3% had fallopian tube cancer, and 2% had primary peritoneal cancer. About 90% of cancers were serous in histology. Most patients (84%) had germline BRCA mutations, 16% had somatic mutations, and the status was unknown in the remaining patients.

Patients were randomized on a 2:1 basis to receive rucaparib at 600 mg twice daily (n = 233) or chemotherapy (n = 116), stratified by platinum sensitivity status. Patients assigned to chemotherapy whose disease was considered platinum resistant or partially platinum sensitive were assigned to weekly paclitaxel. Patients with fully platinum-sensitive disease were assigned to platinum-based single-agent or doublet chemotherapy. Treatment cycles were 28 days.

On radiologically confirmed disease progression or unacceptable toxicity, patients assigned to chemotherapy had the option to cross over to the rucaparib arm. The follow-up portion of the study began 28 days after the last treatment dose, with visits every 8 weeks thereafter.

Baseline characteristics in the ITT population were similar between arms. There were 13 patients in the rucaparib arm and 10 in the chemotherapy arm who had BRCA reversion mutations and were excluded from the efficacy population.
 

Efficacy and safety

Investigator-assessed PFS in the efficacy population was a median of 7.4 months with rucaparib and 5.7 months with chemotherapy, translating to a hazard ratio (HR) of 0.64 (P = .001). In the ITT population, the respective median PFS intervals were identical, although with a slightly less favorable HR of 0.67 (P = .002). In the 23 patients with BRCA reversion mutations, the median PFS was worse with rucaparib, at 2.9 months, compared with 5.5 months for chemotherapy. This translated to a HR of 2.77, although the 95% confidence interval was wide and crossed 1, likely due to the small sample size.

Among patients who had measurable disease at baseline, the overall response rate in the efficacy population was 40.3% with rucaparib and 32.3% with chemotherapy, a difference that was not statistically significant (P = .13). The overall response data were similar in the ITT population (37.9% and 30.2%, respectively).

In the efficacy population, the duration of response was significantly longer in the rucaparib arm, at a median of 9.4 months versus 7.2 months (HR, 0.59; 95% CI, 0.36-0.98). The respective median response durations were identical in the ITT population, but the HR was 0.56 (95% CI, 0.34-0.93).

In both the efficacy and ITT populations, global health status was virtually identical and unchanged from baseline in both treatment arms through cycle 7.

Treatment-emergent adverse events (TEAEs) were more frequent with rucaparib. The most common TEAEs in the rucaparib and chemotherapy arms, respectively, were anemia/decreased hemoglobin (53.9% and 31.9%), nausea (53.4% and 31.9%), asthenia/fatigue (49.6% and 44.2%), ALT/AST increase (34.5% and 11.5%), and vomiting (34.1% and 16.8%).

In all, 8.2% of patients in the rucaparib arm and 12.4% of those in the chemotherapy arm discontinued therapy due to TEAEs.

Four patients in the rucaparib arm developed myelodysplastic syndrome or acute myeloid leukemia – one during treatment and three during follow-up. There were no cases of myelodysplastic syndrome or acute myeloid leukemia in patients who received chemotherapy.

“Data from ARIEL4 fits the paradigm that single-agent activity of PARP inhibitors in BRCA-mutated, recurrent ovarian cancer may be comparable to chemotherapy, and may, at times, be superior, depending on the study population, trial design, and treatment for control patients,” Dr. Matulonis said.

The study was funded by Clovis Oncology. Dr. Kristeleit disclosed relationships with Clovis, Roche, and Tesaro. Dr. Matulonis disclosed relationships with Novartis, Merck, and Immunogen.

Pregnant women can safely get vaccinated with the Pfizer-BioNTech and Moderna vaccines for COVID-19, surveillance data from the Centers for Disease Control and Prevention suggest.

More than 30,000 women who received these vaccines have reported pregnancies through the CDC’s V-Safe voluntary reporting system, and their rates of complications are not significantly different from those of unvaccinated pregnant women, said Tom Shimabukuro, MD, MPH, MBA, deputy director of the CDC Immunization Safety Office.

“Overall, the data are reassuring with respect to vaccine safety in pregnant women,” he told this news organization.

Dr. Shimabukuro presented the data during a March 1 meeting of the Advisory Committee on Immunization Practices, a group of health experts selected by the Secretary of the U.S. Department of Health & Human Services.

The CDC has included pregnancy along with other underlying conditions that qualify people to be offered vaccines in the third priority tier (Phase 1c).

“There is evidence that pregnant women who get COVID-19 are at increased risk of severe illness and complications from severe illness,” Dr. Shimabukuro explained. “And there is also evidence that pregnant persons who get COVID-19 may be at increased risk for adverse pregnancy outcomes.”

The American College of Obstetrics and Gynecology recommends that “COVID-19 vaccines should not be withheld from pregnant individuals.”

By contrast, the World Health Organization recommends the vaccines only for those pregnant women who are “at high risk of exposure to SARS-CoV-2 (for example, health workers) or who have comorbidities which add to their risk of severe disease.”

Not enough information was available from the pivotal trials of the Moderna and Pfizer vaccines to assess risk in pregnant women, according to these manufacturers. Pfizer has announced a follow-up trial of its vaccine in healthy pregnant women.

Analyzing surveillance data

To better assess whether the Pfizer or Moderna vaccines cause problems in pregnancy or childbirth, Dr. Shimabukuro and colleagues analyzed data from V-Safe and the Vaccine Adverse Event Reporting System (VAERS).

The CDC encourages providers to inform people they vaccinate about the V-Safe program. Participants can voluntarily enter their data through a website, and may receive follow-up text messages and phone calls from the CDC asking for additional information at various times after vaccination. It is not a systematic survey, and the sample is not necessarily representative of everyone who gets the vaccine, Dr. Shimabukuro noted.

At the time of the study, V-Safe recorded 55,220,364 reports from people who received at least one dose of the Pfizer or Moderna vaccine through Feb. 16. These included 30,494 pregnancies, of which 16,039 were in women who received the Pfizer vaccine and 14,455 in women who received the Moderna vaccine.

Analyzing data collected through Jan. 13, 2021, the researchers found that both local and systemic reactions were similar between pregnant and nonpregnant women aged 16-54 years.

Most women reported pain, and some reported swelling, redness, and itching at the injection site. Of systemic reactions, fatigue was the most common, followed by headache, myalgia, chills, nausea, and fever. The systemic reactions were more common with the second Pfizer dose; fatigue affected a majority of both pregnant and nonpregnant women. Data on the second Moderna dose were not available.

The CDC enrolled 1,815 pregnant women for additional follow-up, among whom there were 275 completed pregnancies and 232 live births.

Rates of outcomes “of interest” were no higher among these women than in the general population. 

In contrast to V-Safe, data from VAERS, comanaged by the CDC and U.S. Food and Drug Administration, are from spontaneous reports of adverse events. The sources for those reports are varied. “That could be the health care provider,” Dr. Shimabukuro said. “That could be the patient themselves. It could be a caregiver for children.”  

Just 154 VAERS reports through Feb. 16 concerned pregnant women, and of these, only 42 (27%) were for pregnancy-specific conditions, with the other 73% representing the types of adverse events reported for the general population of vaccinated people, such as headache and fatigue.

Of the 42 pregnancy-related events, there were 29 spontaneous abortions or miscarriages, with the remainder divided among 10 other pregnancy and neonatal conditions.

“When we looked at those outcomes and we compared the reporting rates, based on known background rates of these conditions, we did not see anything unexpected or concerning with respect to pregnancy or neonatal-specific conditions,” Dr. Shimabukuro said about the VAERS data.

The CDC did not collect data on fertility. “We’ve done a lot of work with other vaccines,” said Dr. Shimabukuro. “And just from a biological basis, we don’t have any evidence that vaccination, just in general, causes fertility problems.”

Also, Dr. Shimabukuro noted that the COVID-19 vaccine made by Janssen/Johnson & Johnson did not receive emergency authorization from the FDA in time to be included in the current report, but is being tracked for future reports.

Vaccination could benefit infants

In addition to the new safety data, experts continue to remind clinicians and the public that vaccination during pregnancy could benefit offspring. The unborn babies of pregnant women who receive the COVID-19 vaccine could be protected from the virus for the first several months of their lives, said White House COVID-19 czar Anthony Fauci, MD, at a briefing on March 10.

“We’ve seen this with many other vaccines,” Dr. Fauci said. “That’s a very good way you can get protection for the mother during pregnancy and also a transfer of protection for the infant, which will last a few months following the birth.”

Dr. Fauci also noted that the same vaccine platform used in Johnson & Johnson’s COVID-19 vaccine was successfully used for Ebola in pregnant women in Africa.

Dr. Shimabukuro has reported no relevant financial relationships.

Lindsay Kalter contributed to the reporting for this story.

A version of this article first appeared on Medscape.com.

Pregnant women can safely get vaccinated with the Pfizer-BioNTech and Moderna vaccines for COVID-19, surveillance data from the Centers for Disease Control and Prevention suggest.

More than 30,000 women who received these vaccines have reported pregnancies through the CDC’s V-Safe voluntary reporting system, and their rates of complications are not significantly different from those of unvaccinated pregnant women, said Tom Shimabukuro, MD, MPH, MBA, deputy director of the CDC Immunization Safety Office.

“Overall, the data are reassuring with respect to vaccine safety in pregnant women,” he told this news organization.

Dr. Shimabukuro presented the data during a March 1 meeting of the Advisory Committee on Immunization Practices, a group of health experts selected by the Secretary of the U.S. Department of Health & Human Services.

The CDC has included pregnancy along with other underlying conditions that qualify people to be offered vaccines in the third priority tier (Phase 1c).

“There is evidence that pregnant women who get COVID-19 are at increased risk of severe illness and complications from severe illness,” Dr. Shimabukuro explained. “And there is also evidence that pregnant persons who get COVID-19 may be at increased risk for adverse pregnancy outcomes.”

The American College of Obstetrics and Gynecology recommends that “COVID-19 vaccines should not be withheld from pregnant individuals.”

By contrast, the World Health Organization recommends the vaccines only for those pregnant women who are “at high risk of exposure to SARS-CoV-2 (for example, health workers) or who have comorbidities which add to their risk of severe disease.”

Not enough information was available from the pivotal trials of the Moderna and Pfizer vaccines to assess risk in pregnant women, according to these manufacturers. Pfizer has announced a follow-up trial of its vaccine in healthy pregnant women.

Analyzing surveillance data

To better assess whether the Pfizer or Moderna vaccines cause problems in pregnancy or childbirth, Dr. Shimabukuro and colleagues analyzed data from V-Safe and the Vaccine Adverse Event Reporting System (VAERS).

The CDC encourages providers to inform people they vaccinate about the V-Safe program. Participants can voluntarily enter their data through a website, and may receive follow-up text messages and phone calls from the CDC asking for additional information at various times after vaccination. It is not a systematic survey, and the sample is not necessarily representative of everyone who gets the vaccine, Dr. Shimabukuro noted.

At the time of the study, V-Safe recorded 55,220,364 reports from people who received at least one dose of the Pfizer or Moderna vaccine through Feb. 16. These included 30,494 pregnancies, of which 16,039 were in women who received the Pfizer vaccine and 14,455 in women who received the Moderna vaccine.

Analyzing data collected through Jan. 13, 2021, the researchers found that both local and systemic reactions were similar between pregnant and nonpregnant women aged 16-54 years.

Most women reported pain, and some reported swelling, redness, and itching at the injection site. Of systemic reactions, fatigue was the most common, followed by headache, myalgia, chills, nausea, and fever. The systemic reactions were more common with the second Pfizer dose; fatigue affected a majority of both pregnant and nonpregnant women. Data on the second Moderna dose were not available.

The CDC enrolled 1,815 pregnant women for additional follow-up, among whom there were 275 completed pregnancies and 232 live births.

Rates of outcomes “of interest” were no higher among these women than in the general population. 

In contrast to V-Safe, data from VAERS, comanaged by the CDC and U.S. Food and Drug Administration, are from spontaneous reports of adverse events. The sources for those reports are varied. “That could be the health care provider,” Dr. Shimabukuro said. “That could be the patient themselves. It could be a caregiver for children.”  

Just 154 VAERS reports through Feb. 16 concerned pregnant women, and of these, only 42 (27%) were for pregnancy-specific conditions, with the other 73% representing the types of adverse events reported for the general population of vaccinated people, such as headache and fatigue.

Of the 42 pregnancy-related events, there were 29 spontaneous abortions or miscarriages, with the remainder divided among 10 other pregnancy and neonatal conditions.

“When we looked at those outcomes and we compared the reporting rates, based on known background rates of these conditions, we did not see anything unexpected or concerning with respect to pregnancy or neonatal-specific conditions,” Dr. Shimabukuro said about the VAERS data.

The CDC did not collect data on fertility. “We’ve done a lot of work with other vaccines,” said Dr. Shimabukuro. “And just from a biological basis, we don’t have any evidence that vaccination, just in general, causes fertility problems.”

Also, Dr. Shimabukuro noted that the COVID-19 vaccine made by Janssen/Johnson & Johnson did not receive emergency authorization from the FDA in time to be included in the current report, but is being tracked for future reports.

Vaccination could benefit infants

In addition to the new safety data, experts continue to remind clinicians and the public that vaccination during pregnancy could benefit offspring. The unborn babies of pregnant women who receive the COVID-19 vaccine could be protected from the virus for the first several months of their lives, said White House COVID-19 czar Anthony Fauci, MD, at a briefing on March 10.

“We’ve seen this with many other vaccines,” Dr. Fauci said. “That’s a very good way you can get protection for the mother during pregnancy and also a transfer of protection for the infant, which will last a few months following the birth.”

Dr. Fauci also noted that the same vaccine platform used in Johnson & Johnson’s COVID-19 vaccine was successfully used for Ebola in pregnant women in Africa.

Dr. Shimabukuro has reported no relevant financial relationships.

Lindsay Kalter contributed to the reporting for this story.

A version of this article first appeared on Medscape.com.

Pregnant women can safely get vaccinated with the Pfizer-BioNTech and Moderna vaccines for COVID-19, surveillance data from the Centers for Disease Control and Prevention suggest.

More than 30,000 women who received these vaccines have reported pregnancies through the CDC’s V-Safe voluntary reporting system, and their rates of complications are not significantly different from those of unvaccinated pregnant women, said Tom Shimabukuro, MD, MPH, MBA, deputy director of the CDC Immunization Safety Office.

“Overall, the data are reassuring with respect to vaccine safety in pregnant women,” he told this news organization.

Dr. Shimabukuro presented the data during a March 1 meeting of the Advisory Committee on Immunization Practices, a group of health experts selected by the Secretary of the U.S. Department of Health & Human Services.

The CDC has included pregnancy along with other underlying conditions that qualify people to be offered vaccines in the third priority tier (Phase 1c).

“There is evidence that pregnant women who get COVID-19 are at increased risk of severe illness and complications from severe illness,” Dr. Shimabukuro explained. “And there is also evidence that pregnant persons who get COVID-19 may be at increased risk for adverse pregnancy outcomes.”

The American College of Obstetrics and Gynecology recommends that “COVID-19 vaccines should not be withheld from pregnant individuals.”

By contrast, the World Health Organization recommends the vaccines only for those pregnant women who are “at high risk of exposure to SARS-CoV-2 (for example, health workers) or who have comorbidities which add to their risk of severe disease.”

Not enough information was available from the pivotal trials of the Moderna and Pfizer vaccines to assess risk in pregnant women, according to these manufacturers. Pfizer has announced a follow-up trial of its vaccine in healthy pregnant women.

Analyzing surveillance data

To better assess whether the Pfizer or Moderna vaccines cause problems in pregnancy or childbirth, Dr. Shimabukuro and colleagues analyzed data from V-Safe and the Vaccine Adverse Event Reporting System (VAERS).

The CDC encourages providers to inform people they vaccinate about the V-Safe program. Participants can voluntarily enter their data through a website, and may receive follow-up text messages and phone calls from the CDC asking for additional information at various times after vaccination. It is not a systematic survey, and the sample is not necessarily representative of everyone who gets the vaccine, Dr. Shimabukuro noted.

At the time of the study, V-Safe recorded 55,220,364 reports from people who received at least one dose of the Pfizer or Moderna vaccine through Feb. 16. These included 30,494 pregnancies, of which 16,039 were in women who received the Pfizer vaccine and 14,455 in women who received the Moderna vaccine.

Analyzing data collected through Jan. 13, 2021, the researchers found that both local and systemic reactions were similar between pregnant and nonpregnant women aged 16-54 years.

Most women reported pain, and some reported swelling, redness, and itching at the injection site. Of systemic reactions, fatigue was the most common, followed by headache, myalgia, chills, nausea, and fever. The systemic reactions were more common with the second Pfizer dose; fatigue affected a majority of both pregnant and nonpregnant women. Data on the second Moderna dose were not available.

The CDC enrolled 1,815 pregnant women for additional follow-up, among whom there were 275 completed pregnancies and 232 live births.

Rates of outcomes “of interest” were no higher among these women than in the general population. 

In contrast to V-Safe, data from VAERS, comanaged by the CDC and U.S. Food and Drug Administration, are from spontaneous reports of adverse events. The sources for those reports are varied. “That could be the health care provider,” Dr. Shimabukuro said. “That could be the patient themselves. It could be a caregiver for children.”  

Just 154 VAERS reports through Feb. 16 concerned pregnant women, and of these, only 42 (27%) were for pregnancy-specific conditions, with the other 73% representing the types of adverse events reported for the general population of vaccinated people, such as headache and fatigue.

Of the 42 pregnancy-related events, there were 29 spontaneous abortions or miscarriages, with the remainder divided among 10 other pregnancy and neonatal conditions.

“When we looked at those outcomes and we compared the reporting rates, based on known background rates of these conditions, we did not see anything unexpected or concerning with respect to pregnancy or neonatal-specific conditions,” Dr. Shimabukuro said about the VAERS data.

The CDC did not collect data on fertility. “We’ve done a lot of work with other vaccines,” said Dr. Shimabukuro. “And just from a biological basis, we don’t have any evidence that vaccination, just in general, causes fertility problems.”

Also, Dr. Shimabukuro noted that the COVID-19 vaccine made by Janssen/Johnson & Johnson did not receive emergency authorization from the FDA in time to be included in the current report, but is being tracked for future reports.

Vaccination could benefit infants

In addition to the new safety data, experts continue to remind clinicians and the public that vaccination during pregnancy could benefit offspring. The unborn babies of pregnant women who receive the COVID-19 vaccine could be protected from the virus for the first several months of their lives, said White House COVID-19 czar Anthony Fauci, MD, at a briefing on March 10.

“We’ve seen this with many other vaccines,” Dr. Fauci said. “That’s a very good way you can get protection for the mother during pregnancy and also a transfer of protection for the infant, which will last a few months following the birth.”

Dr. Fauci also noted that the same vaccine platform used in Johnson & Johnson’s COVID-19 vaccine was successfully used for Ebola in pregnant women in Africa.

Dr. Shimabukuro has reported no relevant financial relationships.

Lindsay Kalter contributed to the reporting for this story.

A version of this article first appeared on Medscape.com.

Most breast cancer screening centers in the United States are not following national guidelines, say researchers reporting on a new analysis.

They assessed 606 centers and report that, among the centers that recommended a starting age for screening mammography, nearly 90% advised women to begin screening at age 40 years and to continue annually.

This contrasts with the current recommendations from the U.S. Preventive Services Task Force (USPSTF) on mammography screening, which stipulate starting at age 50 years and continuing every 2 years.

The new analysis was published online in JAMA Internal Medicine.

This may be doing “more harm than good,” warn the authors of an accompanying editorial.

“The recommendation for annual mammography in women younger than 50 years is, at best, confusing for patients and is likely to conflict with advice from their primary care physicians, which can create tension,” write Anand R. Habib, MD, MPhil; Deborah Grady, MD; and Rita F. Redberg, MD, all from the University of California, San Francisco.

“This recommendation can also produce unnecessary testing, invasive procedures, overdiagnosis, and anxiety among women who receive screening,” they write.

“Breast cancer centers with clear financial benefits from increased mammography rates may wish to reconsider offering recommendations that create greater referral volume but conflict with unbiased evidence-based USPSTF guidelines and have the potential to increase harms among women,” the editorialists add.

The age at which to start mammography screening has long been a contentious issue, with some experts and medical societies arguing that it should begin at 40.

The American College of Radiology, the Society of Breast Imaging, and the American Society of Breast Surgeons recommend that women start annual mammography screening at age 40.

The American Cancer Society’s guidelines recommend an initial screening mammogram between ages 45 and 55 and after that, screening every 1-2 years.

One expert who argues for starting at 40 years is Laurie Margolies, MD, chief of breast imaging, Mount Sinai Health System, and professor of radiology, Icahn School of Medicine at Mount Sinai, New York.

In a statement, she noted that 17% of all breast cancers are diagnosed in women in their 40s and that the majority of these women are not considered to be at high risk of developing the disease.

“Our own Mount Sinai research has shown that women with screen-detected breast cancers are less likely to need a mastectomy and are less likely to require chemotherapy or axillary node dissection,” Dr. Margolies said.

“Additionally, women who get regular breast cancer screening have a 47% lower risk of breast cancer death within 20 years of diagnosis than those not regularly screened. Skipping a mammogram can have lethal consequences,” she said.

Details of the analysis

The analysis of recommendations by breast cancer centers regarding screening mammography was carried out by Jennifer L. Marti, MD, from Weill Cornell Medicine, New York, and colleagues.

They examined 606 centers and found that 487 (80.4%) offered screening recommendations on their public websites.

Of 431 centers that recommended a starting age, 376 centers (87.2%) advised women to begin screening at age 40 years; 35 centers (8.1%) recommended beginning at age 45 years; and the remaining 20 centers (4.6%) recommended that screening begin at age 50 years.

A total of 429 centers recommended both a starting age and a screening interval. Of this group, 347 centers (80.9%) advised that annual screening begin at age 40 years. Only 16 centers (3.3%) recommended biennial mammography (as per the USPSTF guidelines). Almost three-quarters (72.7%, n = 354) recommended annual screening; 59 centers (12.1%) recommended annual or biennial screening; and 58 centers (11.9%) recommended a discussion with a physician.

The authors note that there were differences between centers according to National Cancer Institute designation, but these differences did not reach statistical significance.

Dr. Marti and coauthors, Dr. Habib and coauthors, and Dr. Margolies have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Most breast cancer screening centers in the United States are not following national guidelines, say researchers reporting on a new analysis.

They assessed 606 centers and report that, among the centers that recommended a starting age for screening mammography, nearly 90% advised women to begin screening at age 40 years and to continue annually.

This contrasts with the current recommendations from the U.S. Preventive Services Task Force (USPSTF) on mammography screening, which stipulate starting at age 50 years and continuing every 2 years.

The new analysis was published online in JAMA Internal Medicine.

This may be doing “more harm than good,” warn the authors of an accompanying editorial.

“The recommendation for annual mammography in women younger than 50 years is, at best, confusing for patients and is likely to conflict with advice from their primary care physicians, which can create tension,” write Anand R. Habib, MD, MPhil; Deborah Grady, MD; and Rita F. Redberg, MD, all from the University of California, San Francisco.

“This recommendation can also produce unnecessary testing, invasive procedures, overdiagnosis, and anxiety among women who receive screening,” they write.

“Breast cancer centers with clear financial benefits from increased mammography rates may wish to reconsider offering recommendations that create greater referral volume but conflict with unbiased evidence-based USPSTF guidelines and have the potential to increase harms among women,” the editorialists add.

The age at which to start mammography screening has long been a contentious issue, with some experts and medical societies arguing that it should begin at 40.

The American College of Radiology, the Society of Breast Imaging, and the American Society of Breast Surgeons recommend that women start annual mammography screening at age 40.

The American Cancer Society’s guidelines recommend an initial screening mammogram between ages 45 and 55 and after that, screening every 1-2 years.

One expert who argues for starting at 40 years is Laurie Margolies, MD, chief of breast imaging, Mount Sinai Health System, and professor of radiology, Icahn School of Medicine at Mount Sinai, New York.

In a statement, she noted that 17% of all breast cancers are diagnosed in women in their 40s and that the majority of these women are not considered to be at high risk of developing the disease.

“Our own Mount Sinai research has shown that women with screen-detected breast cancers are less likely to need a mastectomy and are less likely to require chemotherapy or axillary node dissection,” Dr. Margolies said.

“Additionally, women who get regular breast cancer screening have a 47% lower risk of breast cancer death within 20 years of diagnosis than those not regularly screened. Skipping a mammogram can have lethal consequences,” she said.

Details of the analysis

The analysis of recommendations by breast cancer centers regarding screening mammography was carried out by Jennifer L. Marti, MD, from Weill Cornell Medicine, New York, and colleagues.

They examined 606 centers and found that 487 (80.4%) offered screening recommendations on their public websites.

Of 431 centers that recommended a starting age, 376 centers (87.2%) advised women to begin screening at age 40 years; 35 centers (8.1%) recommended beginning at age 45 years; and the remaining 20 centers (4.6%) recommended that screening begin at age 50 years.

A total of 429 centers recommended both a starting age and a screening interval. Of this group, 347 centers (80.9%) advised that annual screening begin at age 40 years. Only 16 centers (3.3%) recommended biennial mammography (as per the USPSTF guidelines). Almost three-quarters (72.7%, n = 354) recommended annual screening; 59 centers (12.1%) recommended annual or biennial screening; and 58 centers (11.9%) recommended a discussion with a physician.

The authors note that there were differences between centers according to National Cancer Institute designation, but these differences did not reach statistical significance.

Dr. Marti and coauthors, Dr. Habib and coauthors, and Dr. Margolies have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Most breast cancer screening centers in the United States are not following national guidelines, say researchers reporting on a new analysis.

They assessed 606 centers and report that, among the centers that recommended a starting age for screening mammography, nearly 90% advised women to begin screening at age 40 years and to continue annually.

This contrasts with the current recommendations from the U.S. Preventive Services Task Force (USPSTF) on mammography screening, which stipulate starting at age 50 years and continuing every 2 years.

The new analysis was published online in JAMA Internal Medicine.

This may be doing “more harm than good,” warn the authors of an accompanying editorial.

“The recommendation for annual mammography in women younger than 50 years is, at best, confusing for patients and is likely to conflict with advice from their primary care physicians, which can create tension,” write Anand R. Habib, MD, MPhil; Deborah Grady, MD; and Rita F. Redberg, MD, all from the University of California, San Francisco.

“This recommendation can also produce unnecessary testing, invasive procedures, overdiagnosis, and anxiety among women who receive screening,” they write.

“Breast cancer centers with clear financial benefits from increased mammography rates may wish to reconsider offering recommendations that create greater referral volume but conflict with unbiased evidence-based USPSTF guidelines and have the potential to increase harms among women,” the editorialists add.

The age at which to start mammography screening has long been a contentious issue, with some experts and medical societies arguing that it should begin at 40.

The American College of Radiology, the Society of Breast Imaging, and the American Society of Breast Surgeons recommend that women start annual mammography screening at age 40.

The American Cancer Society’s guidelines recommend an initial screening mammogram between ages 45 and 55 and after that, screening every 1-2 years.

One expert who argues for starting at 40 years is Laurie Margolies, MD, chief of breast imaging, Mount Sinai Health System, and professor of radiology, Icahn School of Medicine at Mount Sinai, New York.

In a statement, she noted that 17% of all breast cancers are diagnosed in women in their 40s and that the majority of these women are not considered to be at high risk of developing the disease.

“Our own Mount Sinai research has shown that women with screen-detected breast cancers are less likely to need a mastectomy and are less likely to require chemotherapy or axillary node dissection,” Dr. Margolies said.

“Additionally, women who get regular breast cancer screening have a 47% lower risk of breast cancer death within 20 years of diagnosis than those not regularly screened. Skipping a mammogram can have lethal consequences,” she said.

Details of the analysis

The analysis of recommendations by breast cancer centers regarding screening mammography was carried out by Jennifer L. Marti, MD, from Weill Cornell Medicine, New York, and colleagues.

They examined 606 centers and found that 487 (80.4%) offered screening recommendations on their public websites.

Of 431 centers that recommended a starting age, 376 centers (87.2%) advised women to begin screening at age 40 years; 35 centers (8.1%) recommended beginning at age 45 years; and the remaining 20 centers (4.6%) recommended that screening begin at age 50 years.

A total of 429 centers recommended both a starting age and a screening interval. Of this group, 347 centers (80.9%) advised that annual screening begin at age 40 years. Only 16 centers (3.3%) recommended biennial mammography (as per the USPSTF guidelines). Almost three-quarters (72.7%, n = 354) recommended annual screening; 59 centers (12.1%) recommended annual or biennial screening; and 58 centers (11.9%) recommended a discussion with a physician.

The authors note that there were differences between centers according to National Cancer Institute designation, but these differences did not reach statistical significance.

Dr. Marti and coauthors, Dr. Habib and coauthors, and Dr. Margolies have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The National Resident Matching Program (NRMP) announced March 19 that this year’s Main Residency Match was the largest in its history.

A total of 38,106 positions were offered, up 850 spots (2.3%) from 2020. Of those, 35,194 were first-year (PGY-1) positions, which was 928 more than the previous year (2.7%). A record 5,915 programs were part of the Match, 88 more than 2020.

“The application and recruitment cycle was upended as a result of the pandemic, yet the results of the Match continue to demonstrate strong and consistent outcomes for participants,” Donna L. Lamb, DHSc, MBA, BSN, NRMP president and CEO, said in a new release.

The report comes amid a year of Zoom interview fatigue, canceled testing, and virus fears and work-arounds, which the NMRP has never had to wrestle with since it was established in 1952.

Despite challenges, fill rates increased across the board. Of the 38,106 total positions offered, 36,179 were filled, representing a 2.6% increase over 2020. Of the 35,194 first-year positions available, 33,535 were filled, representing a 2.9% increase.

Those rates drove the percentage of all positions filled to 94.9% (up from 94.6%) and the percentage of PGY-1 positions filled to 94.8% (also up from 94.6%). There were 1,927 unfilled positions, a decline of 71 (3.6%) from 2020.
 

Primary care results strong

Of the first-year positions offered, 17,649 (49.6%) were in family medicine, internal medicine, and pediatrics. That’s an increase of 514 positions (3%) over 2020.

Of first-year positions offered in 2021, 16,860 (95.5%) were filled. U.S. seniors took 11,013 (65.3%) of those slots; that represents a slight decline (0.3%) from 2020. Family medicine saw a gain of 63 U.S. MD seniors who matched, and internal medicine saw a gain of 93 U.S. DO seniors who matched.
 

Some specialties filled all positions

PGY-1 specialties with 30 positions or more that filled all available positions include dermatology, medicine – emergency medicine, medicine – pediatrics, neurologic surgery, otolaryngology, integrated plastic surgery, and vascular surgery.*

PGY-1 specialties with 30 positions or more that filled more than 90% with U.S. seniors include dermatology (100%), medicine – emergency medicine (93.6%), medicine – pediatrics (93.5%), otolaryngology (93.2%), orthopedic surgery (92.8%), and integrated plastic surgery (90.4%).*

PGY-1 specialties with at least 30 positions that filled less than 50% with U.S. seniors include pathology (41.4 %) and surgery–preliminary (28%).

The number of U.S. citizen international medical graduates who submitted rank-ordered lists was 5,295, an increase of 128 (2.5%) over 2020 and the highest in 6 years; 3,152 of them matched to first-year positions, down two PGY-1 matched applicants over last year.

Full data are available on the NRMP’s website.

Correction, 3/22/21: An earlier version of this article misstated the affected specialties.

A version of this article first appeared on Medscape.com.

The National Resident Matching Program (NRMP) announced March 19 that this year’s Main Residency Match was the largest in its history.

A total of 38,106 positions were offered, up 850 spots (2.3%) from 2020. Of those, 35,194 were first-year (PGY-1) positions, which was 928 more than the previous year (2.7%). A record 5,915 programs were part of the Match, 88 more than 2020.

“The application and recruitment cycle was upended as a result of the pandemic, yet the results of the Match continue to demonstrate strong and consistent outcomes for participants,” Donna L. Lamb, DHSc, MBA, BSN, NRMP president and CEO, said in a new release.

The report comes amid a year of Zoom interview fatigue, canceled testing, and virus fears and work-arounds, which the NMRP has never had to wrestle with since it was established in 1952.

Despite challenges, fill rates increased across the board. Of the 38,106 total positions offered, 36,179 were filled, representing a 2.6% increase over 2020. Of the 35,194 first-year positions available, 33,535 were filled, representing a 2.9% increase.

Those rates drove the percentage of all positions filled to 94.9% (up from 94.6%) and the percentage of PGY-1 positions filled to 94.8% (also up from 94.6%). There were 1,927 unfilled positions, a decline of 71 (3.6%) from 2020.
 

Primary care results strong

Of the first-year positions offered, 17,649 (49.6%) were in family medicine, internal medicine, and pediatrics. That’s an increase of 514 positions (3%) over 2020.

Of first-year positions offered in 2021, 16,860 (95.5%) were filled. U.S. seniors took 11,013 (65.3%) of those slots; that represents a slight decline (0.3%) from 2020. Family medicine saw a gain of 63 U.S. MD seniors who matched, and internal medicine saw a gain of 93 U.S. DO seniors who matched.
 

Some specialties filled all positions

PGY-1 specialties with 30 positions or more that filled all available positions include dermatology, medicine – emergency medicine, medicine – pediatrics, neurologic surgery, otolaryngology, integrated plastic surgery, and vascular surgery.*

PGY-1 specialties with 30 positions or more that filled more than 90% with U.S. seniors include dermatology (100%), medicine – emergency medicine (93.6%), medicine – pediatrics (93.5%), otolaryngology (93.2%), orthopedic surgery (92.8%), and integrated plastic surgery (90.4%).*

PGY-1 specialties with at least 30 positions that filled less than 50% with U.S. seniors include pathology (41.4 %) and surgery–preliminary (28%).

The number of U.S. citizen international medical graduates who submitted rank-ordered lists was 5,295, an increase of 128 (2.5%) over 2020 and the highest in 6 years; 3,152 of them matched to first-year positions, down two PGY-1 matched applicants over last year.

Full data are available on the NRMP’s website.

Correction, 3/22/21: An earlier version of this article misstated the affected specialties.

A version of this article first appeared on Medscape.com.

The National Resident Matching Program (NRMP) announced March 19 that this year’s Main Residency Match was the largest in its history.

A total of 38,106 positions were offered, up 850 spots (2.3%) from 2020. Of those, 35,194 were first-year (PGY-1) positions, which was 928 more than the previous year (2.7%). A record 5,915 programs were part of the Match, 88 more than 2020.

“The application and recruitment cycle was upended as a result of the pandemic, yet the results of the Match continue to demonstrate strong and consistent outcomes for participants,” Donna L. Lamb, DHSc, MBA, BSN, NRMP president and CEO, said in a new release.

The report comes amid a year of Zoom interview fatigue, canceled testing, and virus fears and work-arounds, which the NMRP has never had to wrestle with since it was established in 1952.

Despite challenges, fill rates increased across the board. Of the 38,106 total positions offered, 36,179 were filled, representing a 2.6% increase over 2020. Of the 35,194 first-year positions available, 33,535 were filled, representing a 2.9% increase.

Those rates drove the percentage of all positions filled to 94.9% (up from 94.6%) and the percentage of PGY-1 positions filled to 94.8% (also up from 94.6%). There were 1,927 unfilled positions, a decline of 71 (3.6%) from 2020.
 

Primary care results strong

Of the first-year positions offered, 17,649 (49.6%) were in family medicine, internal medicine, and pediatrics. That’s an increase of 514 positions (3%) over 2020.

Of first-year positions offered in 2021, 16,860 (95.5%) were filled. U.S. seniors took 11,013 (65.3%) of those slots; that represents a slight decline (0.3%) from 2020. Family medicine saw a gain of 63 U.S. MD seniors who matched, and internal medicine saw a gain of 93 U.S. DO seniors who matched.
 

Some specialties filled all positions

PGY-1 specialties with 30 positions or more that filled all available positions include dermatology, medicine – emergency medicine, medicine – pediatrics, neurologic surgery, otolaryngology, integrated plastic surgery, and vascular surgery.*

PGY-1 specialties with 30 positions or more that filled more than 90% with U.S. seniors include dermatology (100%), medicine – emergency medicine (93.6%), medicine – pediatrics (93.5%), otolaryngology (93.2%), orthopedic surgery (92.8%), and integrated plastic surgery (90.4%).*

PGY-1 specialties with at least 30 positions that filled less than 50% with U.S. seniors include pathology (41.4 %) and surgery–preliminary (28%).

The number of U.S. citizen international medical graduates who submitted rank-ordered lists was 5,295, an increase of 128 (2.5%) over 2020 and the highest in 6 years; 3,152 of them matched to first-year positions, down two PGY-1 matched applicants over last year.

Full data are available on the NRMP’s website.

Correction, 3/22/21: An earlier version of this article misstated the affected specialties.

A version of this article first appeared on Medscape.com.

In January, as Mississippi health officials planned for their incoming shipments of COVID-19 vaccine, they assessed the state’s most vulnerable: health care workers, of course, and elderly people in nursing homes. But among those who needed urgent protection from the virus ripping across the Magnolia State were 1 million Mississippians with obesity.

Obesity and weight-related illnesses have been deadly liabilities in the COVID era. A report released this month by the World Obesity Federation found that increased body weight is the second-greatest predictor of COVID-related hospitalization and death across the globe, trailing only old age as a risk factor.

As a fixture of life in the American South – home to 9 of the nation’s 12 heaviest states – obesity is playing a role not only in COVID outcomes, but in the calculus of the vaccination rollout. Mississippi was one of the first states to add a body mass index of 30 or more (a rough gauge of obesity tied to height and weight) to the list of qualifying medical conditions for a shot. About 40% of the state’s adults meet that definition, according to federal health survey data, and combined with the risk group already eligible for vaccination – residents 65 and older – that means fully half of Mississippi’s adults are entitled to vie for a restricted allotment of shots.

At least 29 states have green-lighted obesity for inclusion in the first phases of the vaccine rollout, according to KFF – a vast widening of eligibility that has the potential to overwhelm government efforts and heighten competition for scarce doses.

“We have a lifesaving intervention, and we don’t have enough of it,” said Jen Kates, PhD, director of global health and HIV policy for Kaiser Family Foundation. “Hard choices are being made about who should go first, and there is no right answer.”

The sheer prevalence of obesity in the nation – two in three Americans exceed what is considered a healthy weight – was a public health concern well before the pandemic. But COVID-19 dramatically fast-tracked the discussion from warnings about the long-term damage excess fat tissue can pose to heart, lung and metabolic functions to far more immediate threats.

In the United Kingdom, for example, overweight COVID patients were 67% more likely to require intensive care, and obese patients three times likelier, according to the World Obesity Federation report. A Centers for Disease Control and Prevention study released Monday found a similar trend among U.S. patients and noted that the risk of COVID-related hospitalization, ventilation and death increased with patients’ obesity level.

The counties that hug the southern Mississippi River are home to some of the most concentrated pockets of extreme obesity in the United States. Coronavirus infections began surging in Southern states early last summer, and hospitalizations rose in step.

Deaths in rural stretches of Arkansas, Louisiana, Mississippi, and Tennessee have been overshadowed by the sheer number of deaths in metropolitan areas like New York, Los Angeles, and Essex County, N.J. But as a share of the population, the coronavirus has been similarly unsparing in many Southern communities. In sparsely populated Claiborne County, Miss., on the floodplains of the Mississippi River, 30 residents – about 1 in 300 – had died as of early March. In East Feliciana Parish, La., north of Baton Rouge, with 106 deaths, about 1 in 180 had died by then.

“It’s just math. If the population is more obese and obesity clearly contributes to worse outcomes, then neighborhoods, cities, states and countries that are more obese will have a greater toll from COVID,” said Dr. James de Lemos, MD, a professor of internal medicine at UT Southwestern Medical Center in Dallas who led a study of hospitalized COVID patients published in the medical journal Circulation.

And, because in the U.S. obesity rates tend to be relatively high among African Americans and Latinos who are poor, with diminished access to health care, “it’s a triple whammy,” Dr. de Lemos said. “All these things intersect.”

Poverty and limited access to medical care are common features in the South, where residents like Michelle Antonyshyn, a former registered nurse and mother of seven in Salem, Ark., say they are afraid of the virus. Ms. Antonyshyn, 49, has obesity and debilitating pain in her knees and back, though she does not have high blood pressure or diabetes, two underlying conditions that federal health officials have determined are added risk factors for severe cases of COVID-19.

Still, she said, she “was very concerned just knowing that being obese puts you more at risk for bad outcomes such as being on a ventilator and death.” As a precaution, Ms. Antonyshyn said, she and her large brood locked down early and stopped attending church services in person, watching online instead.

“It’s not the same as having fellowship, but the risk for me was enough,” said Ms. Antonyshyn.

Governors throughout the South seem to recognize that weight can contribute to COVID-19 complications and have pushed for vaccine eligibility rules that prioritize obesity. But on the ground, local health officials are girding for having to tell newly eligible people who qualify as obese that there aren’t enough shots to go around.

In Port Gibson, Miss., Mheja Williams, MD, medical director of the Claiborne County Family Health Center, has been receiving barely enough doses to inoculate the health workers and oldest seniors in her county of 9,600. One week in early February, she received 100 doses.

Obesity and extreme obesity are endemic in Claiborne County, and health officials say the “normalization” of obesity means people often don’t register their weight as a risk factor, whether for COVID or other health issues. The risks are exacerbated by a general flouting of pandemic etiquette: Dr. Williams said that middle-aged and younger residents are not especially vigilant about physical distancing and that mask use is rare.

The rise of obesity in the United States is well documented over the past half-century, as the nation turned from a diet of fruits, vegetables and limited meats to one laden with ultra-processed foods and rich with salt, fat, sugar, and flavorings, along with copious amounts of meat, fast food, and soda. The U.S. has generally led the global obesity race, setting records as even toddlers and young children grew implausibly, dangerously overweight.

Well before COVID, obesity was a leading cause of preventable death in the United States. The National Institutes of Health declared it a disease in 1998, one that fosters heart disease, stroke, type 2 diabetes, and breast, colon, and other cancers.

Researchers say it is no coincidence that nations like the United States, the United Kingdom, and Italy, with relatively high obesity rates, have proved particularly vulnerable to the novel coronavirus.

They believe the virus may exploit underlying metabolic and physiological impairments that often exist in concert with obesity. Extra fat can lead to a cascade of metabolic disruptions, chronic systemic inflammation, and hormonal dysregulation that may thwart the body’s response to infection.

Other respiratory viruses, like influenza and SARS, which appeared in China in 2002, rely on cholesterol to spread enveloped RNA virus to neighboring cells, and researchers have proposed that a similar mechanism may play a role in the spread of the novel coronavirus.

There are also practical problems for coronavirus patients with obesity admitted to the hospital. They can be more difficult to intubate because of excess central weight pressing down on the diaphragm, making breathing with infected lungs even more difficult.

Physicians who specialize in treating patients with obesity say public health officials need to be more forthright and urgent in their messaging, telegraphing the risks of this COVID era.

“It should be explicit and direct,” said Fatima Stanford, MD, an obesity medicine specialist at Massachusetts General Hospital, Boston, and a Harvard Medical School instructor.

Dr. Stanford denounces the fat-shaming and bullying that people with obesity often experience. But telling patients – and the public – that obesity increases the risk of hospitalization and death is crucial, she said.

“I don’t think it’s stigmatizing,” she said. “If you tell them in that way, it’s not to scare you, it’s just giving information. Sometimes people are just unaware.”



KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

In January, as Mississippi health officials planned for their incoming shipments of COVID-19 vaccine, they assessed the state’s most vulnerable: health care workers, of course, and elderly people in nursing homes. But among those who needed urgent protection from the virus ripping across the Magnolia State were 1 million Mississippians with obesity.

Obesity and weight-related illnesses have been deadly liabilities in the COVID era. A report released this month by the World Obesity Federation found that increased body weight is the second-greatest predictor of COVID-related hospitalization and death across the globe, trailing only old age as a risk factor.

As a fixture of life in the American South – home to 9 of the nation’s 12 heaviest states – obesity is playing a role not only in COVID outcomes, but in the calculus of the vaccination rollout. Mississippi was one of the first states to add a body mass index of 30 or more (a rough gauge of obesity tied to height and weight) to the list of qualifying medical conditions for a shot. About 40% of the state’s adults meet that definition, according to federal health survey data, and combined with the risk group already eligible for vaccination – residents 65 and older – that means fully half of Mississippi’s adults are entitled to vie for a restricted allotment of shots.

At least 29 states have green-lighted obesity for inclusion in the first phases of the vaccine rollout, according to KFF – a vast widening of eligibility that has the potential to overwhelm government efforts and heighten competition for scarce doses.

“We have a lifesaving intervention, and we don’t have enough of it,” said Jen Kates, PhD, director of global health and HIV policy for Kaiser Family Foundation. “Hard choices are being made about who should go first, and there is no right answer.”

The sheer prevalence of obesity in the nation – two in three Americans exceed what is considered a healthy weight – was a public health concern well before the pandemic. But COVID-19 dramatically fast-tracked the discussion from warnings about the long-term damage excess fat tissue can pose to heart, lung and metabolic functions to far more immediate threats.

In the United Kingdom, for example, overweight COVID patients were 67% more likely to require intensive care, and obese patients three times likelier, according to the World Obesity Federation report. A Centers for Disease Control and Prevention study released Monday found a similar trend among U.S. patients and noted that the risk of COVID-related hospitalization, ventilation and death increased with patients’ obesity level.

The counties that hug the southern Mississippi River are home to some of the most concentrated pockets of extreme obesity in the United States. Coronavirus infections began surging in Southern states early last summer, and hospitalizations rose in step.

Deaths in rural stretches of Arkansas, Louisiana, Mississippi, and Tennessee have been overshadowed by the sheer number of deaths in metropolitan areas like New York, Los Angeles, and Essex County, N.J. But as a share of the population, the coronavirus has been similarly unsparing in many Southern communities. In sparsely populated Claiborne County, Miss., on the floodplains of the Mississippi River, 30 residents – about 1 in 300 – had died as of early March. In East Feliciana Parish, La., north of Baton Rouge, with 106 deaths, about 1 in 180 had died by then.

“It’s just math. If the population is more obese and obesity clearly contributes to worse outcomes, then neighborhoods, cities, states and countries that are more obese will have a greater toll from COVID,” said Dr. James de Lemos, MD, a professor of internal medicine at UT Southwestern Medical Center in Dallas who led a study of hospitalized COVID patients published in the medical journal Circulation.

And, because in the U.S. obesity rates tend to be relatively high among African Americans and Latinos who are poor, with diminished access to health care, “it’s a triple whammy,” Dr. de Lemos said. “All these things intersect.”

Poverty and limited access to medical care are common features in the South, where residents like Michelle Antonyshyn, a former registered nurse and mother of seven in Salem, Ark., say they are afraid of the virus. Ms. Antonyshyn, 49, has obesity and debilitating pain in her knees and back, though she does not have high blood pressure or diabetes, two underlying conditions that federal health officials have determined are added risk factors for severe cases of COVID-19.

Still, she said, she “was very concerned just knowing that being obese puts you more at risk for bad outcomes such as being on a ventilator and death.” As a precaution, Ms. Antonyshyn said, she and her large brood locked down early and stopped attending church services in person, watching online instead.

“It’s not the same as having fellowship, but the risk for me was enough,” said Ms. Antonyshyn.

Governors throughout the South seem to recognize that weight can contribute to COVID-19 complications and have pushed for vaccine eligibility rules that prioritize obesity. But on the ground, local health officials are girding for having to tell newly eligible people who qualify as obese that there aren’t enough shots to go around.

In Port Gibson, Miss., Mheja Williams, MD, medical director of the Claiborne County Family Health Center, has been receiving barely enough doses to inoculate the health workers and oldest seniors in her county of 9,600. One week in early February, she received 100 doses.

Obesity and extreme obesity are endemic in Claiborne County, and health officials say the “normalization” of obesity means people often don’t register their weight as a risk factor, whether for COVID or other health issues. The risks are exacerbated by a general flouting of pandemic etiquette: Dr. Williams said that middle-aged and younger residents are not especially vigilant about physical distancing and that mask use is rare.

The rise of obesity in the United States is well documented over the past half-century, as the nation turned from a diet of fruits, vegetables and limited meats to one laden with ultra-processed foods and rich with salt, fat, sugar, and flavorings, along with copious amounts of meat, fast food, and soda. The U.S. has generally led the global obesity race, setting records as even toddlers and young children grew implausibly, dangerously overweight.

Well before COVID, obesity was a leading cause of preventable death in the United States. The National Institutes of Health declared it a disease in 1998, one that fosters heart disease, stroke, type 2 diabetes, and breast, colon, and other cancers.

Researchers say it is no coincidence that nations like the United States, the United Kingdom, and Italy, with relatively high obesity rates, have proved particularly vulnerable to the novel coronavirus.

They believe the virus may exploit underlying metabolic and physiological impairments that often exist in concert with obesity. Extra fat can lead to a cascade of metabolic disruptions, chronic systemic inflammation, and hormonal dysregulation that may thwart the body’s response to infection.

Other respiratory viruses, like influenza and SARS, which appeared in China in 2002, rely on cholesterol to spread enveloped RNA virus to neighboring cells, and researchers have proposed that a similar mechanism may play a role in the spread of the novel coronavirus.

There are also practical problems for coronavirus patients with obesity admitted to the hospital. They can be more difficult to intubate because of excess central weight pressing down on the diaphragm, making breathing with infected lungs even more difficult.

Physicians who specialize in treating patients with obesity say public health officials need to be more forthright and urgent in their messaging, telegraphing the risks of this COVID era.

“It should be explicit and direct,” said Fatima Stanford, MD, an obesity medicine specialist at Massachusetts General Hospital, Boston, and a Harvard Medical School instructor.

Dr. Stanford denounces the fat-shaming and bullying that people with obesity often experience. But telling patients – and the public – that obesity increases the risk of hospitalization and death is crucial, she said.

“I don’t think it’s stigmatizing,” she said. “If you tell them in that way, it’s not to scare you, it’s just giving information. Sometimes people are just unaware.”



KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

In January, as Mississippi health officials planned for their incoming shipments of COVID-19 vaccine, they assessed the state’s most vulnerable: health care workers, of course, and elderly people in nursing homes. But among those who needed urgent protection from the virus ripping across the Magnolia State were 1 million Mississippians with obesity.

Obesity and weight-related illnesses have been deadly liabilities in the COVID era. A report released this month by the World Obesity Federation found that increased body weight is the second-greatest predictor of COVID-related hospitalization and death across the globe, trailing only old age as a risk factor.

As a fixture of life in the American South – home to 9 of the nation’s 12 heaviest states – obesity is playing a role not only in COVID outcomes, but in the calculus of the vaccination rollout. Mississippi was one of the first states to add a body mass index of 30 or more (a rough gauge of obesity tied to height and weight) to the list of qualifying medical conditions for a shot. About 40% of the state’s adults meet that definition, according to federal health survey data, and combined with the risk group already eligible for vaccination – residents 65 and older – that means fully half of Mississippi’s adults are entitled to vie for a restricted allotment of shots.

At least 29 states have green-lighted obesity for inclusion in the first phases of the vaccine rollout, according to KFF – a vast widening of eligibility that has the potential to overwhelm government efforts and heighten competition for scarce doses.

“We have a lifesaving intervention, and we don’t have enough of it,” said Jen Kates, PhD, director of global health and HIV policy for Kaiser Family Foundation. “Hard choices are being made about who should go first, and there is no right answer.”

The sheer prevalence of obesity in the nation – two in three Americans exceed what is considered a healthy weight – was a public health concern well before the pandemic. But COVID-19 dramatically fast-tracked the discussion from warnings about the long-term damage excess fat tissue can pose to heart, lung and metabolic functions to far more immediate threats.

In the United Kingdom, for example, overweight COVID patients were 67% more likely to require intensive care, and obese patients three times likelier, according to the World Obesity Federation report. A Centers for Disease Control and Prevention study released Monday found a similar trend among U.S. patients and noted that the risk of COVID-related hospitalization, ventilation and death increased with patients’ obesity level.

The counties that hug the southern Mississippi River are home to some of the most concentrated pockets of extreme obesity in the United States. Coronavirus infections began surging in Southern states early last summer, and hospitalizations rose in step.

Deaths in rural stretches of Arkansas, Louisiana, Mississippi, and Tennessee have been overshadowed by the sheer number of deaths in metropolitan areas like New York, Los Angeles, and Essex County, N.J. But as a share of the population, the coronavirus has been similarly unsparing in many Southern communities. In sparsely populated Claiborne County, Miss., on the floodplains of the Mississippi River, 30 residents – about 1 in 300 – had died as of early March. In East Feliciana Parish, La., north of Baton Rouge, with 106 deaths, about 1 in 180 had died by then.

“It’s just math. If the population is more obese and obesity clearly contributes to worse outcomes, then neighborhoods, cities, states and countries that are more obese will have a greater toll from COVID,” said Dr. James de Lemos, MD, a professor of internal medicine at UT Southwestern Medical Center in Dallas who led a study of hospitalized COVID patients published in the medical journal Circulation.

And, because in the U.S. obesity rates tend to be relatively high among African Americans and Latinos who are poor, with diminished access to health care, “it’s a triple whammy,” Dr. de Lemos said. “All these things intersect.”

Poverty and limited access to medical care are common features in the South, where residents like Michelle Antonyshyn, a former registered nurse and mother of seven in Salem, Ark., say they are afraid of the virus. Ms. Antonyshyn, 49, has obesity and debilitating pain in her knees and back, though she does not have high blood pressure or diabetes, two underlying conditions that federal health officials have determined are added risk factors for severe cases of COVID-19.

Still, she said, she “was very concerned just knowing that being obese puts you more at risk for bad outcomes such as being on a ventilator and death.” As a precaution, Ms. Antonyshyn said, she and her large brood locked down early and stopped attending church services in person, watching online instead.

“It’s not the same as having fellowship, but the risk for me was enough,” said Ms. Antonyshyn.

Governors throughout the South seem to recognize that weight can contribute to COVID-19 complications and have pushed for vaccine eligibility rules that prioritize obesity. But on the ground, local health officials are girding for having to tell newly eligible people who qualify as obese that there aren’t enough shots to go around.

In Port Gibson, Miss., Mheja Williams, MD, medical director of the Claiborne County Family Health Center, has been receiving barely enough doses to inoculate the health workers and oldest seniors in her county of 9,600. One week in early February, she received 100 doses.

Obesity and extreme obesity are endemic in Claiborne County, and health officials say the “normalization” of obesity means people often don’t register their weight as a risk factor, whether for COVID or other health issues. The risks are exacerbated by a general flouting of pandemic etiquette: Dr. Williams said that middle-aged and younger residents are not especially vigilant about physical distancing and that mask use is rare.

The rise of obesity in the United States is well documented over the past half-century, as the nation turned from a diet of fruits, vegetables and limited meats to one laden with ultra-processed foods and rich with salt, fat, sugar, and flavorings, along with copious amounts of meat, fast food, and soda. The U.S. has generally led the global obesity race, setting records as even toddlers and young children grew implausibly, dangerously overweight.

Well before COVID, obesity was a leading cause of preventable death in the United States. The National Institutes of Health declared it a disease in 1998, one that fosters heart disease, stroke, type 2 diabetes, and breast, colon, and other cancers.

Researchers say it is no coincidence that nations like the United States, the United Kingdom, and Italy, with relatively high obesity rates, have proved particularly vulnerable to the novel coronavirus.

They believe the virus may exploit underlying metabolic and physiological impairments that often exist in concert with obesity. Extra fat can lead to a cascade of metabolic disruptions, chronic systemic inflammation, and hormonal dysregulation that may thwart the body’s response to infection.

Other respiratory viruses, like influenza and SARS, which appeared in China in 2002, rely on cholesterol to spread enveloped RNA virus to neighboring cells, and researchers have proposed that a similar mechanism may play a role in the spread of the novel coronavirus.

There are also practical problems for coronavirus patients with obesity admitted to the hospital. They can be more difficult to intubate because of excess central weight pressing down on the diaphragm, making breathing with infected lungs even more difficult.

Physicians who specialize in treating patients with obesity say public health officials need to be more forthright and urgent in their messaging, telegraphing the risks of this COVID era.

“It should be explicit and direct,” said Fatima Stanford, MD, an obesity medicine specialist at Massachusetts General Hospital, Boston, and a Harvard Medical School instructor.

Dr. Stanford denounces the fat-shaming and bullying that people with obesity often experience. But telling patients – and the public – that obesity increases the risk of hospitalization and death is crucial, she said.

“I don’t think it’s stigmatizing,” she said. “If you tell them in that way, it’s not to scare you, it’s just giving information. Sometimes people are just unaware.”



KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

The first large study of its kind reveals that SARS-CoV-2 reinfections remain rare, although people older than 65 are at higher risk.

When researchers analyzed test results of 4 million people in Denmark, they found that less than 1% of those who tested positive experienced reinfection.

Initial infection was associated with about 80% protection overall against getting SARS-CoV-2 again. However, among those older than 65, the protection plummeted to 47%.

“Not everybody is protected against reinfection after a first infection. Older people are at higher risk of catching it again,” co–lead author Daniela Michlmayr, PhD, said in an interview. “Our findings emphasize the importance of policies to protect the elderly and of adhering to infection control measures and restrictions, even if previously infected with COVID-19.”
 

Verifying the need for vaccination

“The findings also highlight the need to vaccinate people who had COVID-19 before, as natural immunity to infection – especially among the elderly 65 and older – cannot be relied upon,” added Dr. Michlmayr, a researcher in the department of bacteria, parasites, and fungi at the Staten Serums Institut, Copenhagen.

The population-based observational study was published online March 17 in The Lancet.

“The findings make sense, as patients who are immunocompromised or of advanced age may not mount an immune response that is as long-lasting,” David Hirschwerk, MD, said in an interview. “It does underscore the importance of vaccination for people of more advanced age, even if they previously were infected with COVID.

“For those who were infected last spring and have not yet been vaccinated, this helps to support the value of still pursuing the vaccine,” added Dr. Hirschwerk, an infectious disease specialist at Northwell Health in Manhasset, N.Y.

Evidence on reinfection risk was limited prior to this study. “Little is known about protection against SARS-CoV-2 repeat infections, but two studies in the UK have found that immunity could last at least 5 to 6 months after infection,” the authors noted.

Along with co–lead author Christian Holm Hansen, PhD, Dr. Michlmayr and colleagues found that 2.11% of 525,339 individuals tested positive for SARS-CoV-2 during the first surge in Denmark from March to May 2020. Within this group, 0.65% tested positive during a second surge from September to December.

By the end of 2020, more than 10 million people had undergone free polymerase chain reaction testing by the Danish government or through the national TestDenmark program.

“My overall take is that it is great to have such a big dataset looking at this question,” E. John Wherry, PhD, said in an interview. The findings support “what we’ve seen in previous, smaller studies.”

Natural protection against reinfection of approximately 80% “is not as good as the vaccines, but not bad,” added Dr. Wherry, director of the Institute for Immunology at the University of Pennsylvania, Philadelphia.
 

Age alters immunity?

“Our finding that older people were more likely than younger people to test positive again if they had already tested positive could be explained by natural age-related changes in the immune system of older adults, also referred to as immune senescence,” the authors noted.

The investigators found no significant differences in reinfection rates between women and men.

As with the previous research, this study also indicates that an initial bout with SARS-CoV-2 infection appears to confer protection for at least 6 months. The researchers found no significant differences between people who were followed for 3-6 months and those followed for 7 months or longer.
 

Variants not included

To account for possible bias among people who got tested repeatedly, Dr. Michlmayr and colleagues performed a sensitivity analysis in a subgroup. They assessed reinfection rates among people who underwent testing frequently and routinely – nurses, doctors, social workers, and health care assistants – and found that 1.2% tested positive a second time during the second surge.

A limitation of the study was the inability to correlate symptoms with risk for reinfection. Also, the researchers did not account for SARS-CoV-2 variants, noting that “during the study period, such variants were not yet established in Denmark; although into 2021 this pattern is changing.”

Asked to speculate whether the results would be different had the study accounted for variants, Dr. Hirschwerk said, “It depends upon the variant, but certainly for the B.1.351 variant, there already has been data clearly demonstrating risk of reinfection with SARS-CoV-2 despite prior infection with the original strain of virus.”

The emergence of SARS-CoV-2 variants of concern that could escape natural and vaccine-related immunity “complicates matters further,” Rosemary J. Boyton, MBBS, and Daniel M. Altmann, PhD, both of Imperial College London, wrote in an accompanying comment in The Lancet.

“Emerging variants of concern might shift immunity below a protective margin, prompting the need for updated vaccines. Interestingly, vaccine responses even after single dose are substantially enhanced in individuals with a history of infection with SARS-CoV-2,” they added.

The current study confirms that “the hope of protective immunity through natural infections might not be within our reach, and a global vaccination program with high efficacy vaccines is the enduring solution,” Dr. Boyton and Dr. Altmann noted.

Cause for alarm?

Despite evidence that reinfection is relatively rare, “many will find the data reported by Hansen and colleagues about protection through natural infection relatively alarming,” Dr. Boyton and Dr. Altmann wrote in their commentary. The 80% protection rate from reinfection in general and the 47% rate among people aged 65 and older “are more concerning figures than offered by previous studies.”

Vaccines appear to provide better quality, quantity, and durability of protection against repeated infection – measured in terms of neutralizing antibodies and T cells – compared with previous infection with SARS-CoV-2, Dr. Boyton and Dr. Altmann wrote.
 

More research needed

The duration of natural protection against reinfection remains an unanswered question, the researchers noted, “because too little time has elapsed since the beginning of the pandemic.”

Future prospective and longitudinal cohort studies coupled with molecular surveillance are needed to characterize antibody titers and waning of protection against repeat infections, the authors noted. Furthermore, more answers are needed regarding how some virus variants might contribute to reinfection risk.

No funding for the study has been reported. Dr. Michlmayr, Dr. Hirschwerk, Dr. Wherry, Dr. Boyton, and Dr. Altmann have disclosed no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

The first large study of its kind reveals that SARS-CoV-2 reinfections remain rare, although people older than 65 are at higher risk.

When researchers analyzed test results of 4 million people in Denmark, they found that less than 1% of those who tested positive experienced reinfection.

Initial infection was associated with about 80% protection overall against getting SARS-CoV-2 again. However, among those older than 65, the protection plummeted to 47%.

“Not everybody is protected against reinfection after a first infection. Older people are at higher risk of catching it again,” co–lead author Daniela Michlmayr, PhD, said in an interview. “Our findings emphasize the importance of policies to protect the elderly and of adhering to infection control measures and restrictions, even if previously infected with COVID-19.”
 

Verifying the need for vaccination

“The findings also highlight the need to vaccinate people who had COVID-19 before, as natural immunity to infection – especially among the elderly 65 and older – cannot be relied upon,” added Dr. Michlmayr, a researcher in the department of bacteria, parasites, and fungi at the Staten Serums Institut, Copenhagen.

The population-based observational study was published online March 17 in The Lancet.

“The findings make sense, as patients who are immunocompromised or of advanced age may not mount an immune response that is as long-lasting,” David Hirschwerk, MD, said in an interview. “It does underscore the importance of vaccination for people of more advanced age, even if they previously were infected with COVID.

“For those who were infected last spring and have not yet been vaccinated, this helps to support the value of still pursuing the vaccine,” added Dr. Hirschwerk, an infectious disease specialist at Northwell Health in Manhasset, N.Y.

Evidence on reinfection risk was limited prior to this study. “Little is known about protection against SARS-CoV-2 repeat infections, but two studies in the UK have found that immunity could last at least 5 to 6 months after infection,” the authors noted.

Along with co–lead author Christian Holm Hansen, PhD, Dr. Michlmayr and colleagues found that 2.11% of 525,339 individuals tested positive for SARS-CoV-2 during the first surge in Denmark from March to May 2020. Within this group, 0.65% tested positive during a second surge from September to December.

By the end of 2020, more than 10 million people had undergone free polymerase chain reaction testing by the Danish government or through the national TestDenmark program.

“My overall take is that it is great to have such a big dataset looking at this question,” E. John Wherry, PhD, said in an interview. The findings support “what we’ve seen in previous, smaller studies.”

Natural protection against reinfection of approximately 80% “is not as good as the vaccines, but not bad,” added Dr. Wherry, director of the Institute for Immunology at the University of Pennsylvania, Philadelphia.
 

Age alters immunity?

“Our finding that older people were more likely than younger people to test positive again if they had already tested positive could be explained by natural age-related changes in the immune system of older adults, also referred to as immune senescence,” the authors noted.

The investigators found no significant differences in reinfection rates between women and men.

As with the previous research, this study also indicates that an initial bout with SARS-CoV-2 infection appears to confer protection for at least 6 months. The researchers found no significant differences between people who were followed for 3-6 months and those followed for 7 months or longer.
 

Variants not included

To account for possible bias among people who got tested repeatedly, Dr. Michlmayr and colleagues performed a sensitivity analysis in a subgroup. They assessed reinfection rates among people who underwent testing frequently and routinely – nurses, doctors, social workers, and health care assistants – and found that 1.2% tested positive a second time during the second surge.

A limitation of the study was the inability to correlate symptoms with risk for reinfection. Also, the researchers did not account for SARS-CoV-2 variants, noting that “during the study period, such variants were not yet established in Denmark; although into 2021 this pattern is changing.”

Asked to speculate whether the results would be different had the study accounted for variants, Dr. Hirschwerk said, “It depends upon the variant, but certainly for the B.1.351 variant, there already has been data clearly demonstrating risk of reinfection with SARS-CoV-2 despite prior infection with the original strain of virus.”

The emergence of SARS-CoV-2 variants of concern that could escape natural and vaccine-related immunity “complicates matters further,” Rosemary J. Boyton, MBBS, and Daniel M. Altmann, PhD, both of Imperial College London, wrote in an accompanying comment in The Lancet.

“Emerging variants of concern might shift immunity below a protective margin, prompting the need for updated vaccines. Interestingly, vaccine responses even after single dose are substantially enhanced in individuals with a history of infection with SARS-CoV-2,” they added.

The current study confirms that “the hope of protective immunity through natural infections might not be within our reach, and a global vaccination program with high efficacy vaccines is the enduring solution,” Dr. Boyton and Dr. Altmann noted.

Cause for alarm?

Despite evidence that reinfection is relatively rare, “many will find the data reported by Hansen and colleagues about protection through natural infection relatively alarming,” Dr. Boyton and Dr. Altmann wrote in their commentary. The 80% protection rate from reinfection in general and the 47% rate among people aged 65 and older “are more concerning figures than offered by previous studies.”

Vaccines appear to provide better quality, quantity, and durability of protection against repeated infection – measured in terms of neutralizing antibodies and T cells – compared with previous infection with SARS-CoV-2, Dr. Boyton and Dr. Altmann wrote.
 

More research needed

The duration of natural protection against reinfection remains an unanswered question, the researchers noted, “because too little time has elapsed since the beginning of the pandemic.”

Future prospective and longitudinal cohort studies coupled with molecular surveillance are needed to characterize antibody titers and waning of protection against repeat infections, the authors noted. Furthermore, more answers are needed regarding how some virus variants might contribute to reinfection risk.

No funding for the study has been reported. Dr. Michlmayr, Dr. Hirschwerk, Dr. Wherry, Dr. Boyton, and Dr. Altmann have disclosed no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

The first large study of its kind reveals that SARS-CoV-2 reinfections remain rare, although people older than 65 are at higher risk.

When researchers analyzed test results of 4 million people in Denmark, they found that less than 1% of those who tested positive experienced reinfection.

Initial infection was associated with about 80% protection overall against getting SARS-CoV-2 again. However, among those older than 65, the protection plummeted to 47%.

“Not everybody is protected against reinfection after a first infection. Older people are at higher risk of catching it again,” co–lead author Daniela Michlmayr, PhD, said in an interview. “Our findings emphasize the importance of policies to protect the elderly and of adhering to infection control measures and restrictions, even if previously infected with COVID-19.”
 

Verifying the need for vaccination

“The findings also highlight the need to vaccinate people who had COVID-19 before, as natural immunity to infection – especially among the elderly 65 and older – cannot be relied upon,” added Dr. Michlmayr, a researcher in the department of bacteria, parasites, and fungi at the Staten Serums Institut, Copenhagen.

The population-based observational study was published online March 17 in The Lancet.

“The findings make sense, as patients who are immunocompromised or of advanced age may not mount an immune response that is as long-lasting,” David Hirschwerk, MD, said in an interview. “It does underscore the importance of vaccination for people of more advanced age, even if they previously were infected with COVID.

“For those who were infected last spring and have not yet been vaccinated, this helps to support the value of still pursuing the vaccine,” added Dr. Hirschwerk, an infectious disease specialist at Northwell Health in Manhasset, N.Y.

Evidence on reinfection risk was limited prior to this study. “Little is known about protection against SARS-CoV-2 repeat infections, but two studies in the UK have found that immunity could last at least 5 to 6 months after infection,” the authors noted.

Along with co–lead author Christian Holm Hansen, PhD, Dr. Michlmayr and colleagues found that 2.11% of 525,339 individuals tested positive for SARS-CoV-2 during the first surge in Denmark from March to May 2020. Within this group, 0.65% tested positive during a second surge from September to December.

By the end of 2020, more than 10 million people had undergone free polymerase chain reaction testing by the Danish government or through the national TestDenmark program.

“My overall take is that it is great to have such a big dataset looking at this question,” E. John Wherry, PhD, said in an interview. The findings support “what we’ve seen in previous, smaller studies.”

Natural protection against reinfection of approximately 80% “is not as good as the vaccines, but not bad,” added Dr. Wherry, director of the Institute for Immunology at the University of Pennsylvania, Philadelphia.
 

Age alters immunity?

“Our finding that older people were more likely than younger people to test positive again if they had already tested positive could be explained by natural age-related changes in the immune system of older adults, also referred to as immune senescence,” the authors noted.

The investigators found no significant differences in reinfection rates between women and men.

As with the previous research, this study also indicates that an initial bout with SARS-CoV-2 infection appears to confer protection for at least 6 months. The researchers found no significant differences between people who were followed for 3-6 months and those followed for 7 months or longer.
 

Variants not included

To account for possible bias among people who got tested repeatedly, Dr. Michlmayr and colleagues performed a sensitivity analysis in a subgroup. They assessed reinfection rates among people who underwent testing frequently and routinely – nurses, doctors, social workers, and health care assistants – and found that 1.2% tested positive a second time during the second surge.

A limitation of the study was the inability to correlate symptoms with risk for reinfection. Also, the researchers did not account for SARS-CoV-2 variants, noting that “during the study period, such variants were not yet established in Denmark; although into 2021 this pattern is changing.”

Asked to speculate whether the results would be different had the study accounted for variants, Dr. Hirschwerk said, “It depends upon the variant, but certainly for the B.1.351 variant, there already has been data clearly demonstrating risk of reinfection with SARS-CoV-2 despite prior infection with the original strain of virus.”

The emergence of SARS-CoV-2 variants of concern that could escape natural and vaccine-related immunity “complicates matters further,” Rosemary J. Boyton, MBBS, and Daniel M. Altmann, PhD, both of Imperial College London, wrote in an accompanying comment in The Lancet.

“Emerging variants of concern might shift immunity below a protective margin, prompting the need for updated vaccines. Interestingly, vaccine responses even after single dose are substantially enhanced in individuals with a history of infection with SARS-CoV-2,” they added.

The current study confirms that “the hope of protective immunity through natural infections might not be within our reach, and a global vaccination program with high efficacy vaccines is the enduring solution,” Dr. Boyton and Dr. Altmann noted.

Cause for alarm?

Despite evidence that reinfection is relatively rare, “many will find the data reported by Hansen and colleagues about protection through natural infection relatively alarming,” Dr. Boyton and Dr. Altmann wrote in their commentary. The 80% protection rate from reinfection in general and the 47% rate among people aged 65 and older “are more concerning figures than offered by previous studies.”

Vaccines appear to provide better quality, quantity, and durability of protection against repeated infection – measured in terms of neutralizing antibodies and T cells – compared with previous infection with SARS-CoV-2, Dr. Boyton and Dr. Altmann wrote.
 

More research needed

The duration of natural protection against reinfection remains an unanswered question, the researchers noted, “because too little time has elapsed since the beginning of the pandemic.”

Future prospective and longitudinal cohort studies coupled with molecular surveillance are needed to characterize antibody titers and waning of protection against repeat infections, the authors noted. Furthermore, more answers are needed regarding how some virus variants might contribute to reinfection risk.

No funding for the study has been reported. Dr. Michlmayr, Dr. Hirschwerk, Dr. Wherry, Dr. Boyton, and Dr. Altmann have disclosed no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

A baby girl who was born 3 weeks after her mom got the first dose of the Moderna COVID-19 vaccine has antibodies against the coronavirus, according to a preprint paper published on the medRxiv server Feb. 5. The paper hasn’t yet been peer reviewed.

The mom, a health care worker in Florida, developed COVID-19 antibodies after she received the shot. Testing showed that the antibodies passed through the placenta to the baby.

“Maternal vaccination for influenza and TDaP have been well studied in terms of safety and efficacy for protection of the newborn by placental passage of antibodies,” Paul Gilbert, MD, and Chad Rudnick, MD, pediatricians and researchers at Florida Atlantic University, wrote in the paper.

Previous research has indicated that moms who have recovered from COVID-19 can deliver babies with antibodies, according to Insider, but this may be the first report that shows how vaccination during pregnancy can provide antibodies as well.

Dr. Gilbert and Dr. Rudnick said they were fortunate to connect with the mom in Boca Raton. She hadn’t contracted COVID-19 and was able to get the vaccine at the end of her pregnancy in January. When the baby was born, they were able to test the cord blood to look for antibodies specifically from the vaccine.

“We were very excited to see, once the test result came back, that the antibodies from the mom’s vaccine did in fact pass through the placenta to the newborn,” Dr. Rudnick told WPTV, an NBC affiliate in West Palm Beach.

“We knew that we were going to be potentially one of the first in the world to report it, and that opportunity probably only comes once in a career,” Dr. Gilbert told WPTV.

In the preprint, Dr. Gilbert and Dr. Rudnick said a “vigorous, healthy, full-term” baby was born, and the mom received the second dose of the Moderna vaccine during the postpartum period. The newborn received a normal “well-infant” evaluation and was breastfeeding.

The two doctors called for a “significant and urgent need” to research the safety and efficacy of COVID-19 vaccines during pregnancy. They also encouraged other researchers to create pregnancy and breastfeeding registries to study COVID-19 vaccines in pregnant and breastfeeding moms and newborns.

Dr. Gilbert and Dr. Rudnick are now preparing their research for publication and hope future studies will investigate the amount and length of antibody response in newborns.

“Total antibody measurements may be used to determine how long protection is expected, which may help to determine when the best time would be to begin vaccination,” they wrote.

A version of this article first appeared on Medscape.com.

A baby girl who was born 3 weeks after her mom got the first dose of the Moderna COVID-19 vaccine has antibodies against the coronavirus, according to a preprint paper published on the medRxiv server Feb. 5. The paper hasn’t yet been peer reviewed.

The mom, a health care worker in Florida, developed COVID-19 antibodies after she received the shot. Testing showed that the antibodies passed through the placenta to the baby.

“Maternal vaccination for influenza and TDaP have been well studied in terms of safety and efficacy for protection of the newborn by placental passage of antibodies,” Paul Gilbert, MD, and Chad Rudnick, MD, pediatricians and researchers at Florida Atlantic University, wrote in the paper.

Previous research has indicated that moms who have recovered from COVID-19 can deliver babies with antibodies, according to Insider, but this may be the first report that shows how vaccination during pregnancy can provide antibodies as well.

Dr. Gilbert and Dr. Rudnick said they were fortunate to connect with the mom in Boca Raton. She hadn’t contracted COVID-19 and was able to get the vaccine at the end of her pregnancy in January. When the baby was born, they were able to test the cord blood to look for antibodies specifically from the vaccine.

“We were very excited to see, once the test result came back, that the antibodies from the mom’s vaccine did in fact pass through the placenta to the newborn,” Dr. Rudnick told WPTV, an NBC affiliate in West Palm Beach.

“We knew that we were going to be potentially one of the first in the world to report it, and that opportunity probably only comes once in a career,” Dr. Gilbert told WPTV.

In the preprint, Dr. Gilbert and Dr. Rudnick said a “vigorous, healthy, full-term” baby was born, and the mom received the second dose of the Moderna vaccine during the postpartum period. The newborn received a normal “well-infant” evaluation and was breastfeeding.

The two doctors called for a “significant and urgent need” to research the safety and efficacy of COVID-19 vaccines during pregnancy. They also encouraged other researchers to create pregnancy and breastfeeding registries to study COVID-19 vaccines in pregnant and breastfeeding moms and newborns.

Dr. Gilbert and Dr. Rudnick are now preparing their research for publication and hope future studies will investigate the amount and length of antibody response in newborns.

“Total antibody measurements may be used to determine how long protection is expected, which may help to determine when the best time would be to begin vaccination,” they wrote.

A version of this article first appeared on Medscape.com.

A baby girl who was born 3 weeks after her mom got the first dose of the Moderna COVID-19 vaccine has antibodies against the coronavirus, according to a preprint paper published on the medRxiv server Feb. 5. The paper hasn’t yet been peer reviewed.

The mom, a health care worker in Florida, developed COVID-19 antibodies after she received the shot. Testing showed that the antibodies passed through the placenta to the baby.

“Maternal vaccination for influenza and TDaP have been well studied in terms of safety and efficacy for protection of the newborn by placental passage of antibodies,” Paul Gilbert, MD, and Chad Rudnick, MD, pediatricians and researchers at Florida Atlantic University, wrote in the paper.

Previous research has indicated that moms who have recovered from COVID-19 can deliver babies with antibodies, according to Insider, but this may be the first report that shows how vaccination during pregnancy can provide antibodies as well.

Dr. Gilbert and Dr. Rudnick said they were fortunate to connect with the mom in Boca Raton. She hadn’t contracted COVID-19 and was able to get the vaccine at the end of her pregnancy in January. When the baby was born, they were able to test the cord blood to look for antibodies specifically from the vaccine.

“We were very excited to see, once the test result came back, that the antibodies from the mom’s vaccine did in fact pass through the placenta to the newborn,” Dr. Rudnick told WPTV, an NBC affiliate in West Palm Beach.

“We knew that we were going to be potentially one of the first in the world to report it, and that opportunity probably only comes once in a career,” Dr. Gilbert told WPTV.

In the preprint, Dr. Gilbert and Dr. Rudnick said a “vigorous, healthy, full-term” baby was born, and the mom received the second dose of the Moderna vaccine during the postpartum period. The newborn received a normal “well-infant” evaluation and was breastfeeding.

The two doctors called for a “significant and urgent need” to research the safety and efficacy of COVID-19 vaccines during pregnancy. They also encouraged other researchers to create pregnancy and breastfeeding registries to study COVID-19 vaccines in pregnant and breastfeeding moms and newborns.

Dr. Gilbert and Dr. Rudnick are now preparing their research for publication and hope future studies will investigate the amount and length of antibody response in newborns.

“Total antibody measurements may be used to determine how long protection is expected, which may help to determine when the best time would be to begin vaccination,” they wrote.

A version of this article first appeared on Medscape.com.