MDedge Neurology

Rhythmic brain signals that help encode memories also appear to influence blood sugar levels and may regulate the timing of the release of hormones, early, pre-clinical research shows.

“Our study is the first to show how clusters of brain cell firing in the hippocampus may directly regulate metabolism,” senior author György Buzsáki, MD, PhD, professor, department of neuroscience and physiology, NYU Grossman School of Medicine and NYU Langone Health, said in a news release.

“Evidence suggests that the brain evolved, for reasons of efficiency, to use the same signals to achieve two very different functions in terms of memory and hormonal regulation,” added corresponding author David Tingley, PhD, a post-doctoral scholar in Dr. Buzsáki’s lab.

Additional research may also reveal devices or therapies that can adjust the brain signals to lower blood sugar and improve memory, the researchers say.

The study was published online August 11 in Nature.

It’s recently been discovered that populations of hippocampal neurons fire within milliseconds of each other in cycles. This firing pattern is called a “sharp wave ripple” for the shape it takes when captured graphically by electroencephalogram.

In their study, Dr. Buzsáki, Dr. Tingley, and colleagues observed that clusters of sharp wave ripples recorded from the hippocampus of rats were “reliably” and rapidly, followed by decreases in blood sugar concentrations in the animals.

“This correlation was not dependent on circadian, ultradian, or meal-triggered fluctuations; it could be mimicked with optogenetically induced ripples in the hippocampus, but not in the parietal cortex, and was attenuated to chance levels by pharmacogenetically suppressing activity of the lateral septum (LS), the major conduit between the hippocampus and hypothalamus,” the researchers report.

These observations suggest that hippocampal sharp wave ripples may regulate the timing of the release of hormones, possibly including insulin, by the pancreas and liver, as well as other hormones by the pituitary gland, the researchers note.

As sharp wave ripples mostly occur during non-rapid eye movement sleep, the impact of sleep disturbance on sharp wave ripples may provide a mechanistic link between poor sleep and high blood sugar levels seen in type 2 diabetes, they suggest.

“There are a couple of experimental studies showing that if you deprive a young healthy person from sleep [for 48 hours], their glucose tolerance resembles” that of a person with diabetes, Dr. Buzsáki noted in an interview.

Moving forward, the researchers will seek to extend their theory that several hormones could be affected by nightly sharp wave ripples.

The research was funded by National Institutes of Health. The authors have disclosed no relevant financial relationships.

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

Rhythmic brain signals that help encode memories also appear to influence blood sugar levels and may regulate the timing of the release of hormones, early, pre-clinical research shows.

“Our study is the first to show how clusters of brain cell firing in the hippocampus may directly regulate metabolism,” senior author György Buzsáki, MD, PhD, professor, department of neuroscience and physiology, NYU Grossman School of Medicine and NYU Langone Health, said in a news release.

“Evidence suggests that the brain evolved, for reasons of efficiency, to use the same signals to achieve two very different functions in terms of memory and hormonal regulation,” added corresponding author David Tingley, PhD, a post-doctoral scholar in Dr. Buzsáki’s lab.

Additional research may also reveal devices or therapies that can adjust the brain signals to lower blood sugar and improve memory, the researchers say.

The study was published online August 11 in Nature.

It’s recently been discovered that populations of hippocampal neurons fire within milliseconds of each other in cycles. This firing pattern is called a “sharp wave ripple” for the shape it takes when captured graphically by electroencephalogram.

In their study, Dr. Buzsáki, Dr. Tingley, and colleagues observed that clusters of sharp wave ripples recorded from the hippocampus of rats were “reliably” and rapidly, followed by decreases in blood sugar concentrations in the animals.

“This correlation was not dependent on circadian, ultradian, or meal-triggered fluctuations; it could be mimicked with optogenetically induced ripples in the hippocampus, but not in the parietal cortex, and was attenuated to chance levels by pharmacogenetically suppressing activity of the lateral septum (LS), the major conduit between the hippocampus and hypothalamus,” the researchers report.

These observations suggest that hippocampal sharp wave ripples may regulate the timing of the release of hormones, possibly including insulin, by the pancreas and liver, as well as other hormones by the pituitary gland, the researchers note.

As sharp wave ripples mostly occur during non-rapid eye movement sleep, the impact of sleep disturbance on sharp wave ripples may provide a mechanistic link between poor sleep and high blood sugar levels seen in type 2 diabetes, they suggest.

“There are a couple of experimental studies showing that if you deprive a young healthy person from sleep [for 48 hours], their glucose tolerance resembles” that of a person with diabetes, Dr. Buzsáki noted in an interview.

Moving forward, the researchers will seek to extend their theory that several hormones could be affected by nightly sharp wave ripples.

The research was funded by National Institutes of Health. The authors have disclosed no relevant financial relationships.

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

Rhythmic brain signals that help encode memories also appear to influence blood sugar levels and may regulate the timing of the release of hormones, early, pre-clinical research shows.

“Our study is the first to show how clusters of brain cell firing in the hippocampus may directly regulate metabolism,” senior author György Buzsáki, MD, PhD, professor, department of neuroscience and physiology, NYU Grossman School of Medicine and NYU Langone Health, said in a news release.

“Evidence suggests that the brain evolved, for reasons of efficiency, to use the same signals to achieve two very different functions in terms of memory and hormonal regulation,” added corresponding author David Tingley, PhD, a post-doctoral scholar in Dr. Buzsáki’s lab.

Additional research may also reveal devices or therapies that can adjust the brain signals to lower blood sugar and improve memory, the researchers say.

The study was published online August 11 in Nature.

It’s recently been discovered that populations of hippocampal neurons fire within milliseconds of each other in cycles. This firing pattern is called a “sharp wave ripple” for the shape it takes when captured graphically by electroencephalogram.

In their study, Dr. Buzsáki, Dr. Tingley, and colleagues observed that clusters of sharp wave ripples recorded from the hippocampus of rats were “reliably” and rapidly, followed by decreases in blood sugar concentrations in the animals.

“This correlation was not dependent on circadian, ultradian, or meal-triggered fluctuations; it could be mimicked with optogenetically induced ripples in the hippocampus, but not in the parietal cortex, and was attenuated to chance levels by pharmacogenetically suppressing activity of the lateral septum (LS), the major conduit between the hippocampus and hypothalamus,” the researchers report.

These observations suggest that hippocampal sharp wave ripples may regulate the timing of the release of hormones, possibly including insulin, by the pancreas and liver, as well as other hormones by the pituitary gland, the researchers note.

As sharp wave ripples mostly occur during non-rapid eye movement sleep, the impact of sleep disturbance on sharp wave ripples may provide a mechanistic link between poor sleep and high blood sugar levels seen in type 2 diabetes, they suggest.

“There are a couple of experimental studies showing that if you deprive a young healthy person from sleep [for 48 hours], their glucose tolerance resembles” that of a person with diabetes, Dr. Buzsáki noted in an interview.

Moving forward, the researchers will seek to extend their theory that several hormones could be affected by nightly sharp wave ripples.

The research was funded by National Institutes of Health. The authors have disclosed no relevant financial relationships.

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

The Food and Drug Administration has approved an oral solution of calcium, magnesium, potassium, and sodium oxybates (Xywav) for the treatment of idiopathic hypersomnia in adults, the company announced in a news release.

It marks the second approval for Xywav. The FDA approved it last year for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy as young as 7 years of age.

This recent approval is the first for a treatment for idiopathic hypersomnia.

“Idiopathic hypersomnia can have a significant impact on the social, educational, and occupational functioning of people living with the condition,” Diane Powell, board chair and CEO of the Hypersomnia Foundation, noted in the release.

This FDA approval “is a major milestone for the entire idiopathic hypersomnia community as Xywav becomes the first medicine approved to manage this chronic sleep disorder,” said Ms. Powell.

Low sodium oxybate product

Xywav is a novel oxybate product with a unique composition of cations. It contains 92% less sodium than sodium oxybate (Xyrem) at the recommended adult dosage range of 6 to 9 g, the company noted in a news release.

An estimated 37,000 people in the United States have been diagnosed with idiopathic hypersomnia, a neurologic sleep disorder characterized by chronic excessive daytime sleepiness.

Other symptoms of the disorder may include severe sleep inertia or sleep drunkenness (prolonged difficulty waking with frequent re-entries into sleep, confusion, and irritability), as well as prolonged, nonrestorative night-time sleep, cognitive impairment, and long and unrefreshing naps.

The approval was based on findings from a phase 3, double-blind, multicenter, placebo-controlled, randomized withdrawal study.

Results showed “statistically significant and clinically meaningful” differences compared with placebo in change in the primary endpoint of Epworth Sleepiness Scale score (P < .0001) and the secondary endpoints of Patient Global Impression of Change (P < .0001) and the Idiopathic Hypersomnia Severity Scale (P < .0001), the company reported.

The most common adverse reactions were nausea, headache, dizziness, anxiety, insomnia, decreased appetite, hyperhidrosis, vomiting, diarrhea, dry mouth, parasomnia, somnolence, fatigue, and tremor.

The novel agent can be administered once or twice nightly for the treatment of idiopathic hypersomnia in adults.

“To optimize response, a patient’s health care provider may consider prescribing a twice-nightly regimen in equally or unequally divided doses at bedtime and 2.5 to 4 hours later and gradually titrate Xywav so that a patient may receive an individualized dose and regimen based on efficacy and tolerability,” the company said.

Xywav carries a boxed warning because it is a central nervous system depressant and because there is potential for abuse and misuse. The drug is only available through a risk evaluation and mitigation strategy (REMS) program.

The company plans to make Xywav available to patients with idiopathic hypersomnia later this year following implementation of the REMS program.

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

The Food and Drug Administration has approved an oral solution of calcium, magnesium, potassium, and sodium oxybates (Xywav) for the treatment of idiopathic hypersomnia in adults, the company announced in a news release.

It marks the second approval for Xywav. The FDA approved it last year for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy as young as 7 years of age.

This recent approval is the first for a treatment for idiopathic hypersomnia.

“Idiopathic hypersomnia can have a significant impact on the social, educational, and occupational functioning of people living with the condition,” Diane Powell, board chair and CEO of the Hypersomnia Foundation, noted in the release.

This FDA approval “is a major milestone for the entire idiopathic hypersomnia community as Xywav becomes the first medicine approved to manage this chronic sleep disorder,” said Ms. Powell.

Low sodium oxybate product

Xywav is a novel oxybate product with a unique composition of cations. It contains 92% less sodium than sodium oxybate (Xyrem) at the recommended adult dosage range of 6 to 9 g, the company noted in a news release.

An estimated 37,000 people in the United States have been diagnosed with idiopathic hypersomnia, a neurologic sleep disorder characterized by chronic excessive daytime sleepiness.

Other symptoms of the disorder may include severe sleep inertia or sleep drunkenness (prolonged difficulty waking with frequent re-entries into sleep, confusion, and irritability), as well as prolonged, nonrestorative night-time sleep, cognitive impairment, and long and unrefreshing naps.

The approval was based on findings from a phase 3, double-blind, multicenter, placebo-controlled, randomized withdrawal study.

Results showed “statistically significant and clinically meaningful” differences compared with placebo in change in the primary endpoint of Epworth Sleepiness Scale score (P < .0001) and the secondary endpoints of Patient Global Impression of Change (P < .0001) and the Idiopathic Hypersomnia Severity Scale (P < .0001), the company reported.

The most common adverse reactions were nausea, headache, dizziness, anxiety, insomnia, decreased appetite, hyperhidrosis, vomiting, diarrhea, dry mouth, parasomnia, somnolence, fatigue, and tremor.

The novel agent can be administered once or twice nightly for the treatment of idiopathic hypersomnia in adults.

“To optimize response, a patient’s health care provider may consider prescribing a twice-nightly regimen in equally or unequally divided doses at bedtime and 2.5 to 4 hours later and gradually titrate Xywav so that a patient may receive an individualized dose and regimen based on efficacy and tolerability,” the company said.

Xywav carries a boxed warning because it is a central nervous system depressant and because there is potential for abuse and misuse. The drug is only available through a risk evaluation and mitigation strategy (REMS) program.

The company plans to make Xywav available to patients with idiopathic hypersomnia later this year following implementation of the REMS program.

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

The Food and Drug Administration has approved an oral solution of calcium, magnesium, potassium, and sodium oxybates (Xywav) for the treatment of idiopathic hypersomnia in adults, the company announced in a news release.

It marks the second approval for Xywav. The FDA approved it last year for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy as young as 7 years of age.

This recent approval is the first for a treatment for idiopathic hypersomnia.

“Idiopathic hypersomnia can have a significant impact on the social, educational, and occupational functioning of people living with the condition,” Diane Powell, board chair and CEO of the Hypersomnia Foundation, noted in the release.

This FDA approval “is a major milestone for the entire idiopathic hypersomnia community as Xywav becomes the first medicine approved to manage this chronic sleep disorder,” said Ms. Powell.

Low sodium oxybate product

Xywav is a novel oxybate product with a unique composition of cations. It contains 92% less sodium than sodium oxybate (Xyrem) at the recommended adult dosage range of 6 to 9 g, the company noted in a news release.

An estimated 37,000 people in the United States have been diagnosed with idiopathic hypersomnia, a neurologic sleep disorder characterized by chronic excessive daytime sleepiness.

Other symptoms of the disorder may include severe sleep inertia or sleep drunkenness (prolonged difficulty waking with frequent re-entries into sleep, confusion, and irritability), as well as prolonged, nonrestorative night-time sleep, cognitive impairment, and long and unrefreshing naps.

The approval was based on findings from a phase 3, double-blind, multicenter, placebo-controlled, randomized withdrawal study.

Results showed “statistically significant and clinically meaningful” differences compared with placebo in change in the primary endpoint of Epworth Sleepiness Scale score (P < .0001) and the secondary endpoints of Patient Global Impression of Change (P < .0001) and the Idiopathic Hypersomnia Severity Scale (P < .0001), the company reported.

The most common adverse reactions were nausea, headache, dizziness, anxiety, insomnia, decreased appetite, hyperhidrosis, vomiting, diarrhea, dry mouth, parasomnia, somnolence, fatigue, and tremor.

The novel agent can be administered once or twice nightly for the treatment of idiopathic hypersomnia in adults.

“To optimize response, a patient’s health care provider may consider prescribing a twice-nightly regimen in equally or unequally divided doses at bedtime and 2.5 to 4 hours later and gradually titrate Xywav so that a patient may receive an individualized dose and regimen based on efficacy and tolerability,” the company said.

Xywav carries a boxed warning because it is a central nervous system depressant and because there is potential for abuse and misuse. The drug is only available through a risk evaluation and mitigation strategy (REMS) program.

The company plans to make Xywav available to patients with idiopathic hypersomnia later this year following implementation of the REMS program.

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

Therapeutic levels of heparin can have widely varying effects on COVID-19 patients depending on the severity of their disease, according to a multiplatform clinical trial that analyzed patient data from three international trials.

NYU Langone Health

COVID-19 patients in the ICU, or at least receiving ICU-level care, derived no benefit from anticoagulation with heparin, while non–critically ill COVID-19 patients – those who were hospitalized but not receiving ICU-level care – on the same anticoagulation were less likely to progress to need respiratory or cardiovascular organ support despite a slightly heightened risk of bleeding events.

Reporting in two articles published online in the New England Journal of Medicine, authors of three international trials combined their data into one multiplatform trial that makes a strong case for prescribing therapeutic levels of heparin in hospitalized patients not receiving ICU-level care were non–critically ill and critically ill.

“I think this is going to be a game changer,” said Jeffrey S. Berger, MD, ACTIV-4a co–principal investigator and co–first author of the study of non–critically ill patients. “I think that using therapeutic-dose anticoagulation should improve outcomes in the tens of thousands of patients worldwide. I hope our data can have a global impact.”
 

Outcomes based on disease severity

The multiplatform trial analyzed data from the Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC); A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19 (ACTIV-4a); and Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP).

The trial evaluated 2,219 non–critically ill hospitalized patients, 1,181 of whom were randomized to therapeutic-dose anticoagulation; and 1,098 critically ill patients, 534 of whom were prescribed therapeutic levels of heparin.

In the critically ill patients, those on heparin were no more likely to get discharged or spend fewer days on respiratory or CV organ support – oxygen, mechanical ventilation, life support, vasopressors or inotropes – than were those on usual-care thromboprophylaxis. The investigators stopped the trial in both patient populations: in critically ill patients when it became obvious therapeutic-dose anticoagulation was having no impact; and in moderately ill patients when the trial met the prespecified criteria for the superiority of therapeutic-dose anticoagulation.

ICU patients on therapeutic-level heparin spent an average of 1 day free of organ support vs. 4 for patients on usual-care prophylactic antithrombotic drugs. The percentage of patients who survived to hospital discharge was similar in the therapeutic-level and usual-care critically ill patients: 62.7% and 64.5%, respectively. Major bleeding occurred in 3.8% and 2.8%, respectively. Demographic and clinical characteristics were similar between both patient groups.

However, in non–critically ill patients, therapeutic levels of heparin resulted in a marked improvement in outcomes. The researchers estimated that, for every 1,000 hospitalized patients with what they labeled moderate disease, an initial treatment with therapeutic-dose heparin resulted in 40 additional patients surviving compared to usual-care thromboprophylaxis.

The percentages of patients not needing organ support before hospital discharge was 80.2% on therapeutic-dose heparin and 76.4% on usual-care therapy. In terms of adjusted odds ratio, the anticoagulation group had a 27% improved chance of not needing daily organ support.

Those improvements came with an additional seven major bleeding events per 1,000 patients. That broke down to a rate of 1.9% in the therapeutic-dose and 0.9% in the usual-care patients.

As the Delta variant of COVID-19 spreads, Patrick R. Lawler, MD, MPH, principal investigator of the ATTACC trial, said there’s no reason these findings shouldn’t apply for all variants of the disease.

University of Toronto

Dr. Lawler, a physician-scientist at Peter Munk Cardiac Centre at Toronto General Hospital, noted that the multiplatform study did not account for disease variant. “Ongoing clinical trials are tracking the variant patients have or the variants that are most prevalent in an area at that time,” he said. “It may be easier in future trials to look at that question.”
 

Explaining heparin’s varying effects

The study did not specifically sort out why moderately ill patients fared better on heparin than their critically ill counterparts, but Dr. Lawler speculated on possible reasons. “One might be that the extent of illness severity is too extreme in the ICU-level population for heparin to have a beneficial extent,” he said.

He acknowledged that higher rates of macrovascular thrombosis, such as venous thromboembolism, in ICU patients would suggest that heparin would have a greater beneficial effect, but, he added, “it may also suggest how advanced that process is, and perhaps heparin is not adequate to reverse the course at that point given relatively extensive thrombosis and associate organ failure.”

As clinicians have gained experience dealing with COVID-19, they’ve learned that infected patients carry a high burden of macro- and microthrombosis, Dr. Berger said, which may explain why critically ill patients didn’t respond as well to therapeutic levels of heparin. “I think the cat is out of the bag; patients who are severe are too ill to benefit,” he said. “I would think there’s too much microthrombosis that is already in their bodies.”

However, this doesn’t completely rule out therapeutic levels of heparin in critically ill COVID-19 patients. There are some scenarios where it’s needed, said Dr. Berger, associate professor of medicine and surgery and director of the Center for the Prevention of Cardiovascular Disease at New York University Langone Health. “Anyone who has a known clot already, like a known macrothrombosis in their leg or lung, needs to be on full-dose heparin,” he said.

That rationale can help reconcile the different outcomes in the critically and non–critically ill COVID-19 patients, wrote Hugo ten Cate, MD, PhD, of Maastricht University in the Netherlands, wrote in an accompanying editorial. But differences in the study populations may also explain the divergent outcomes, Dr. ten Cate noted.

The studies suggest that critically ill patients may need hon-heparin antithrombotic approaches “or even profibrinolytic strategies,” Dr. Cate wrote, and that the safety and effectiveness of thromboprophylaxis “remains an important question.” Nonetheless, he added, treating physicians must deal with the bleeding risk when using heparin or low-molecular-weight heparin in moderately ill COVID-19 patients.

Deepak L. Bhatt MD, MPH, of Brigham and Women’s Hospital Heart & Vascular Center, Boston, said in an interview that reconciling the two studies was “a bit challenging,” because effective therapies tend to have a greater impact in sicker patients.

“Of course, with antithrombotic therapies, bleeding side effects can sometimes overwhelm benefits in patients who are at high risk of both bleeding and ischemic complications, though that does not seem to be the explanation here,” Dr. Bhatt said. “I do think we need more data to clarify exactly which COVID patients benefit from various antithrombotic regimens, and fortunately, there are other ongoing studies, some of which will report relatively soon.”

He concurred with Dr. Berger that patients who need anticoagulation should receive it “apart from their COVID status,” Dr. Bhatt said. “Sick, hospitalized patients with or without COVID should receive appropriate prophylactic doses of anticoagulation.” However, he added, “Whether we should routinely go beyond that in COVID-positive inpatients, I think we need more data.”

The ATTACC platform received grants from the Canadian Institutes of Health Research and several other research foundations. The ACTIV-4a platform received funding from the National Heart, Lung, and Blood Institute. REMAP-CAP received funding from the European Union and several international research foundations, as well as Amgen and Eisai.

Dr. Lawler had no relationships to disclose. Dr. Berger disclosed receiving grants from the NHLBI, and financial relationships with AstraZeneca, Janssen, and Amgen outside the submitted work. Dr. ten Cate reported relationships with Alveron, Coagulation Profile, Portola/Alexion, Bayer, Pfizer, Stago, Leo Pharma, Daiichi, and Gilead/Galapagos. Dr. Bhatt is chair of the data safety and monitoring board of the FREEDOM COVID anticoagulation clinical trial.

Therapeutic levels of heparin can have widely varying effects on COVID-19 patients depending on the severity of their disease, according to a multiplatform clinical trial that analyzed patient data from three international trials.

NYU Langone Health

COVID-19 patients in the ICU, or at least receiving ICU-level care, derived no benefit from anticoagulation with heparin, while non–critically ill COVID-19 patients – those who were hospitalized but not receiving ICU-level care – on the same anticoagulation were less likely to progress to need respiratory or cardiovascular organ support despite a slightly heightened risk of bleeding events.

Reporting in two articles published online in the New England Journal of Medicine, authors of three international trials combined their data into one multiplatform trial that makes a strong case for prescribing therapeutic levels of heparin in hospitalized patients not receiving ICU-level care were non–critically ill and critically ill.

“I think this is going to be a game changer,” said Jeffrey S. Berger, MD, ACTIV-4a co–principal investigator and co–first author of the study of non–critically ill patients. “I think that using therapeutic-dose anticoagulation should improve outcomes in the tens of thousands of patients worldwide. I hope our data can have a global impact.”
 

Outcomes based on disease severity

The multiplatform trial analyzed data from the Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC); A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19 (ACTIV-4a); and Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP).

The trial evaluated 2,219 non–critically ill hospitalized patients, 1,181 of whom were randomized to therapeutic-dose anticoagulation; and 1,098 critically ill patients, 534 of whom were prescribed therapeutic levels of heparin.

In the critically ill patients, those on heparin were no more likely to get discharged or spend fewer days on respiratory or CV organ support – oxygen, mechanical ventilation, life support, vasopressors or inotropes – than were those on usual-care thromboprophylaxis. The investigators stopped the trial in both patient populations: in critically ill patients when it became obvious therapeutic-dose anticoagulation was having no impact; and in moderately ill patients when the trial met the prespecified criteria for the superiority of therapeutic-dose anticoagulation.

ICU patients on therapeutic-level heparin spent an average of 1 day free of organ support vs. 4 for patients on usual-care prophylactic antithrombotic drugs. The percentage of patients who survived to hospital discharge was similar in the therapeutic-level and usual-care critically ill patients: 62.7% and 64.5%, respectively. Major bleeding occurred in 3.8% and 2.8%, respectively. Demographic and clinical characteristics were similar between both patient groups.

However, in non–critically ill patients, therapeutic levels of heparin resulted in a marked improvement in outcomes. The researchers estimated that, for every 1,000 hospitalized patients with what they labeled moderate disease, an initial treatment with therapeutic-dose heparin resulted in 40 additional patients surviving compared to usual-care thromboprophylaxis.

The percentages of patients not needing organ support before hospital discharge was 80.2% on therapeutic-dose heparin and 76.4% on usual-care therapy. In terms of adjusted odds ratio, the anticoagulation group had a 27% improved chance of not needing daily organ support.

Those improvements came with an additional seven major bleeding events per 1,000 patients. That broke down to a rate of 1.9% in the therapeutic-dose and 0.9% in the usual-care patients.

As the Delta variant of COVID-19 spreads, Patrick R. Lawler, MD, MPH, principal investigator of the ATTACC trial, said there’s no reason these findings shouldn’t apply for all variants of the disease.

University of Toronto

Dr. Lawler, a physician-scientist at Peter Munk Cardiac Centre at Toronto General Hospital, noted that the multiplatform study did not account for disease variant. “Ongoing clinical trials are tracking the variant patients have or the variants that are most prevalent in an area at that time,” he said. “It may be easier in future trials to look at that question.”
 

Explaining heparin’s varying effects

The study did not specifically sort out why moderately ill patients fared better on heparin than their critically ill counterparts, but Dr. Lawler speculated on possible reasons. “One might be that the extent of illness severity is too extreme in the ICU-level population for heparin to have a beneficial extent,” he said.

He acknowledged that higher rates of macrovascular thrombosis, such as venous thromboembolism, in ICU patients would suggest that heparin would have a greater beneficial effect, but, he added, “it may also suggest how advanced that process is, and perhaps heparin is not adequate to reverse the course at that point given relatively extensive thrombosis and associate organ failure.”

As clinicians have gained experience dealing with COVID-19, they’ve learned that infected patients carry a high burden of macro- and microthrombosis, Dr. Berger said, which may explain why critically ill patients didn’t respond as well to therapeutic levels of heparin. “I think the cat is out of the bag; patients who are severe are too ill to benefit,” he said. “I would think there’s too much microthrombosis that is already in their bodies.”

However, this doesn’t completely rule out therapeutic levels of heparin in critically ill COVID-19 patients. There are some scenarios where it’s needed, said Dr. Berger, associate professor of medicine and surgery and director of the Center for the Prevention of Cardiovascular Disease at New York University Langone Health. “Anyone who has a known clot already, like a known macrothrombosis in their leg or lung, needs to be on full-dose heparin,” he said.

That rationale can help reconcile the different outcomes in the critically and non–critically ill COVID-19 patients, wrote Hugo ten Cate, MD, PhD, of Maastricht University in the Netherlands, wrote in an accompanying editorial. But differences in the study populations may also explain the divergent outcomes, Dr. ten Cate noted.

The studies suggest that critically ill patients may need hon-heparin antithrombotic approaches “or even profibrinolytic strategies,” Dr. Cate wrote, and that the safety and effectiveness of thromboprophylaxis “remains an important question.” Nonetheless, he added, treating physicians must deal with the bleeding risk when using heparin or low-molecular-weight heparin in moderately ill COVID-19 patients.

Deepak L. Bhatt MD, MPH, of Brigham and Women’s Hospital Heart & Vascular Center, Boston, said in an interview that reconciling the two studies was “a bit challenging,” because effective therapies tend to have a greater impact in sicker patients.

“Of course, with antithrombotic therapies, bleeding side effects can sometimes overwhelm benefits in patients who are at high risk of both bleeding and ischemic complications, though that does not seem to be the explanation here,” Dr. Bhatt said. “I do think we need more data to clarify exactly which COVID patients benefit from various antithrombotic regimens, and fortunately, there are other ongoing studies, some of which will report relatively soon.”

He concurred with Dr. Berger that patients who need anticoagulation should receive it “apart from their COVID status,” Dr. Bhatt said. “Sick, hospitalized patients with or without COVID should receive appropriate prophylactic doses of anticoagulation.” However, he added, “Whether we should routinely go beyond that in COVID-positive inpatients, I think we need more data.”

The ATTACC platform received grants from the Canadian Institutes of Health Research and several other research foundations. The ACTIV-4a platform received funding from the National Heart, Lung, and Blood Institute. REMAP-CAP received funding from the European Union and several international research foundations, as well as Amgen and Eisai.

Dr. Lawler had no relationships to disclose. Dr. Berger disclosed receiving grants from the NHLBI, and financial relationships with AstraZeneca, Janssen, and Amgen outside the submitted work. Dr. ten Cate reported relationships with Alveron, Coagulation Profile, Portola/Alexion, Bayer, Pfizer, Stago, Leo Pharma, Daiichi, and Gilead/Galapagos. Dr. Bhatt is chair of the data safety and monitoring board of the FREEDOM COVID anticoagulation clinical trial.

Therapeutic levels of heparin can have widely varying effects on COVID-19 patients depending on the severity of their disease, according to a multiplatform clinical trial that analyzed patient data from three international trials.

NYU Langone Health

COVID-19 patients in the ICU, or at least receiving ICU-level care, derived no benefit from anticoagulation with heparin, while non–critically ill COVID-19 patients – those who were hospitalized but not receiving ICU-level care – on the same anticoagulation were less likely to progress to need respiratory or cardiovascular organ support despite a slightly heightened risk of bleeding events.

Reporting in two articles published online in the New England Journal of Medicine, authors of three international trials combined their data into one multiplatform trial that makes a strong case for prescribing therapeutic levels of heparin in hospitalized patients not receiving ICU-level care were non–critically ill and critically ill.

“I think this is going to be a game changer,” said Jeffrey S. Berger, MD, ACTIV-4a co–principal investigator and co–first author of the study of non–critically ill patients. “I think that using therapeutic-dose anticoagulation should improve outcomes in the tens of thousands of patients worldwide. I hope our data can have a global impact.”
 

Outcomes based on disease severity

The multiplatform trial analyzed data from the Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC); A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19 (ACTIV-4a); and Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP).

The trial evaluated 2,219 non–critically ill hospitalized patients, 1,181 of whom were randomized to therapeutic-dose anticoagulation; and 1,098 critically ill patients, 534 of whom were prescribed therapeutic levels of heparin.

In the critically ill patients, those on heparin were no more likely to get discharged or spend fewer days on respiratory or CV organ support – oxygen, mechanical ventilation, life support, vasopressors or inotropes – than were those on usual-care thromboprophylaxis. The investigators stopped the trial in both patient populations: in critically ill patients when it became obvious therapeutic-dose anticoagulation was having no impact; and in moderately ill patients when the trial met the prespecified criteria for the superiority of therapeutic-dose anticoagulation.

ICU patients on therapeutic-level heparin spent an average of 1 day free of organ support vs. 4 for patients on usual-care prophylactic antithrombotic drugs. The percentage of patients who survived to hospital discharge was similar in the therapeutic-level and usual-care critically ill patients: 62.7% and 64.5%, respectively. Major bleeding occurred in 3.8% and 2.8%, respectively. Demographic and clinical characteristics were similar between both patient groups.

However, in non–critically ill patients, therapeutic levels of heparin resulted in a marked improvement in outcomes. The researchers estimated that, for every 1,000 hospitalized patients with what they labeled moderate disease, an initial treatment with therapeutic-dose heparin resulted in 40 additional patients surviving compared to usual-care thromboprophylaxis.

The percentages of patients not needing organ support before hospital discharge was 80.2% on therapeutic-dose heparin and 76.4% on usual-care therapy. In terms of adjusted odds ratio, the anticoagulation group had a 27% improved chance of not needing daily organ support.

Those improvements came with an additional seven major bleeding events per 1,000 patients. That broke down to a rate of 1.9% in the therapeutic-dose and 0.9% in the usual-care patients.

As the Delta variant of COVID-19 spreads, Patrick R. Lawler, MD, MPH, principal investigator of the ATTACC trial, said there’s no reason these findings shouldn’t apply for all variants of the disease.

University of Toronto

Dr. Lawler, a physician-scientist at Peter Munk Cardiac Centre at Toronto General Hospital, noted that the multiplatform study did not account for disease variant. “Ongoing clinical trials are tracking the variant patients have or the variants that are most prevalent in an area at that time,” he said. “It may be easier in future trials to look at that question.”
 

Explaining heparin’s varying effects

The study did not specifically sort out why moderately ill patients fared better on heparin than their critically ill counterparts, but Dr. Lawler speculated on possible reasons. “One might be that the extent of illness severity is too extreme in the ICU-level population for heparin to have a beneficial extent,” he said.

He acknowledged that higher rates of macrovascular thrombosis, such as venous thromboembolism, in ICU patients would suggest that heparin would have a greater beneficial effect, but, he added, “it may also suggest how advanced that process is, and perhaps heparin is not adequate to reverse the course at that point given relatively extensive thrombosis and associate organ failure.”

As clinicians have gained experience dealing with COVID-19, they’ve learned that infected patients carry a high burden of macro- and microthrombosis, Dr. Berger said, which may explain why critically ill patients didn’t respond as well to therapeutic levels of heparin. “I think the cat is out of the bag; patients who are severe are too ill to benefit,” he said. “I would think there’s too much microthrombosis that is already in their bodies.”

However, this doesn’t completely rule out therapeutic levels of heparin in critically ill COVID-19 patients. There are some scenarios where it’s needed, said Dr. Berger, associate professor of medicine and surgery and director of the Center for the Prevention of Cardiovascular Disease at New York University Langone Health. “Anyone who has a known clot already, like a known macrothrombosis in their leg or lung, needs to be on full-dose heparin,” he said.

That rationale can help reconcile the different outcomes in the critically and non–critically ill COVID-19 patients, wrote Hugo ten Cate, MD, PhD, of Maastricht University in the Netherlands, wrote in an accompanying editorial. But differences in the study populations may also explain the divergent outcomes, Dr. ten Cate noted.

The studies suggest that critically ill patients may need hon-heparin antithrombotic approaches “or even profibrinolytic strategies,” Dr. Cate wrote, and that the safety and effectiveness of thromboprophylaxis “remains an important question.” Nonetheless, he added, treating physicians must deal with the bleeding risk when using heparin or low-molecular-weight heparin in moderately ill COVID-19 patients.

Deepak L. Bhatt MD, MPH, of Brigham and Women’s Hospital Heart & Vascular Center, Boston, said in an interview that reconciling the two studies was “a bit challenging,” because effective therapies tend to have a greater impact in sicker patients.

“Of course, with antithrombotic therapies, bleeding side effects can sometimes overwhelm benefits in patients who are at high risk of both bleeding and ischemic complications, though that does not seem to be the explanation here,” Dr. Bhatt said. “I do think we need more data to clarify exactly which COVID patients benefit from various antithrombotic regimens, and fortunately, there are other ongoing studies, some of which will report relatively soon.”

He concurred with Dr. Berger that patients who need anticoagulation should receive it “apart from their COVID status,” Dr. Bhatt said. “Sick, hospitalized patients with or without COVID should receive appropriate prophylactic doses of anticoagulation.” However, he added, “Whether we should routinely go beyond that in COVID-positive inpatients, I think we need more data.”

The ATTACC platform received grants from the Canadian Institutes of Health Research and several other research foundations. The ACTIV-4a platform received funding from the National Heart, Lung, and Blood Institute. REMAP-CAP received funding from the European Union and several international research foundations, as well as Amgen and Eisai.

Dr. Lawler had no relationships to disclose. Dr. Berger disclosed receiving grants from the NHLBI, and financial relationships with AstraZeneca, Janssen, and Amgen outside the submitted work. Dr. ten Cate reported relationships with Alveron, Coagulation Profile, Portola/Alexion, Bayer, Pfizer, Stago, Leo Pharma, Daiichi, and Gilead/Galapagos. Dr. Bhatt is chair of the data safety and monitoring board of the FREEDOM COVID anticoagulation clinical trial.

In a large study of community-based stroke survivors in Canada, researchers found those meeting guideline-recommended levels of physical activity had a significantly lower risk for death from any cause, with a greater than 50% reduction in risk.

Lead study author Raed A. Joundi, MD, DPhil, of the University of Calgary (Alta.), said he expected results to show exercise was beneficial, but was surprised by the magnitude of the association between physical activity and lower mortality risk.

The impact of physical activity also differed significantly by age; those younger than 75 had a 79% reduction in mortality risk, compared with 32% in those age 75 and older.

“This is even after adjusting for factors such heart disease, respiratory conditions, smoking, and other functional limitations,” said Dr. Joundi.

The study was published online Aug. 11 in the journal Neurology.

For this analysis, the researchers used data on a cohort of people across Canada (excluding the province of Quebec) over 3-9 years. The 895 patients with prior stroke averaged 72 years of age, while the 97,805 in the control group had an average age of 63.

Weekly physical activity averages were evaluated using the self-reporting Canadian Community Health Survey, which was linked with administrative databases to evaluate the association of physical activity with long-term risk for mortality among stroke survivors, compared with controls.

Physical activity was measured in metabolic equivalents (METs); meeting minimum physical activity guidelines was defined as 10 MET-hours/week.

During the study period, more stroke patients than controls died (24.7% vs. 5.7%). However, those who met the physical activity guideline recommendations of 10 MET-hours/week had a lower mortality, both in the stroke survivor group (14.6% vs. 33.2%; adjusted hazard ratio, 0.46; 95% confidence interval, 0.29-0.73) and among control participants (3.6% vs. 7.9%; aHR 0.69; 95% CI, 0.62-0.76).  

The largest absolute and relative reduction in mortality was among stroke respondents younger than 75 (10.5% vs. 29%; aHR, 0.21; 95% CI, 0.10-0.43), the researchers note.

There was a significant interaction with age for the stroke patients but not the control group.

“The greatest reduction in mortality was seen between 0 and 10 METs per week … so the main point is that something is better than nothing,” said Dr. Joundi.
 

Exercise guidelines for the future

Although current guidelines recommend physical activity in stroke survivors, investigators noted that these are largely based on studies in the general population. Therefore, the aim of this research was to get a better understanding of the role of physical activity in the health of stroke survivors in the community, which could ultimately be used to design improved public health campaigns and physical activity interventions.

Given that this is a large study of stroke survivors in the community, Dr. Joundi hopes the results will influence future activity guidelines for those who have suffered a stroke.

“We found a log-linear relationship between physical activity and mortality such that 10 MET-hours/week was associated with large reductions in mortality with most benefit achieved by 20 MET-hours/week,” the authors concluded. “These thresholds could be considered for use in future guidelines for stroke.”

Clinical trials are underway to provide evidence for the implementation of exercise programs after stroke, they add, and offering physical activity programs to stroke survivors in the community “is an increasing priority in the U.S., Canada, and Europe.”

“People are at higher risk of death early on after a stroke but also months and years later, so if we can identify a relatively low-cost and easy intervention like physical activity to improve health and reduce the risk of death for stroke survivors it would be important,” Dr. Joundi said.
 

Key barriers

Paul George, MD, PhD, a stroke and vascular neurologist at Stanford (Calif.) University, said findings such as these further strengthen the argument that physical exercise is important after stroke.

“Because the study looked specifically at stroke patients, it can provide further guidance on physical activity recommendations that we provide to our patients following stroke,” said Dr. George, who was not associated with the study. 

Going forward, he said, more research is needed to identify specifically what is preventing stroke patients from exercising more. What is required, he said, is “future research to determine the key barriers to physical activity following stroke and methods to reduce these will also be important to increasing physical activity in stroke survivors.”

Dr. Joundi said determining how to tailor exercise recommendations to meet the wide range of capabilities of stroke survivors will be another key factor.

“Stroke survivors may have some disabilities, so we need to be able to engage them at an [exercise] level that’s possible for them,” he said.

The study did not include stroke survivors living in long-term care homes.

The study had no targeted funding. Coauthor Eric E. Smith, MD, MPH, reports royalties from UpToDate, and consulting fees from Alnylam, Biogen, and Javelin. Dr. Joundi and the other coauthors have disclosed no relevant financial relationships.

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

In a large study of community-based stroke survivors in Canada, researchers found those meeting guideline-recommended levels of physical activity had a significantly lower risk for death from any cause, with a greater than 50% reduction in risk.

Lead study author Raed A. Joundi, MD, DPhil, of the University of Calgary (Alta.), said he expected results to show exercise was beneficial, but was surprised by the magnitude of the association between physical activity and lower mortality risk.

The impact of physical activity also differed significantly by age; those younger than 75 had a 79% reduction in mortality risk, compared with 32% in those age 75 and older.

“This is even after adjusting for factors such heart disease, respiratory conditions, smoking, and other functional limitations,” said Dr. Joundi.

The study was published online Aug. 11 in the journal Neurology.

For this analysis, the researchers used data on a cohort of people across Canada (excluding the province of Quebec) over 3-9 years. The 895 patients with prior stroke averaged 72 years of age, while the 97,805 in the control group had an average age of 63.

Weekly physical activity averages were evaluated using the self-reporting Canadian Community Health Survey, which was linked with administrative databases to evaluate the association of physical activity with long-term risk for mortality among stroke survivors, compared with controls.

Physical activity was measured in metabolic equivalents (METs); meeting minimum physical activity guidelines was defined as 10 MET-hours/week.

During the study period, more stroke patients than controls died (24.7% vs. 5.7%). However, those who met the physical activity guideline recommendations of 10 MET-hours/week had a lower mortality, both in the stroke survivor group (14.6% vs. 33.2%; adjusted hazard ratio, 0.46; 95% confidence interval, 0.29-0.73) and among control participants (3.6% vs. 7.9%; aHR 0.69; 95% CI, 0.62-0.76).  

The largest absolute and relative reduction in mortality was among stroke respondents younger than 75 (10.5% vs. 29%; aHR, 0.21; 95% CI, 0.10-0.43), the researchers note.

There was a significant interaction with age for the stroke patients but not the control group.

“The greatest reduction in mortality was seen between 0 and 10 METs per week … so the main point is that something is better than nothing,” said Dr. Joundi.
 

Exercise guidelines for the future

Although current guidelines recommend physical activity in stroke survivors, investigators noted that these are largely based on studies in the general population. Therefore, the aim of this research was to get a better understanding of the role of physical activity in the health of stroke survivors in the community, which could ultimately be used to design improved public health campaigns and physical activity interventions.

Given that this is a large study of stroke survivors in the community, Dr. Joundi hopes the results will influence future activity guidelines for those who have suffered a stroke.

“We found a log-linear relationship between physical activity and mortality such that 10 MET-hours/week was associated with large reductions in mortality with most benefit achieved by 20 MET-hours/week,” the authors concluded. “These thresholds could be considered for use in future guidelines for stroke.”

Clinical trials are underway to provide evidence for the implementation of exercise programs after stroke, they add, and offering physical activity programs to stroke survivors in the community “is an increasing priority in the U.S., Canada, and Europe.”

“People are at higher risk of death early on after a stroke but also months and years later, so if we can identify a relatively low-cost and easy intervention like physical activity to improve health and reduce the risk of death for stroke survivors it would be important,” Dr. Joundi said.
 

Key barriers

Paul George, MD, PhD, a stroke and vascular neurologist at Stanford (Calif.) University, said findings such as these further strengthen the argument that physical exercise is important after stroke.

“Because the study looked specifically at stroke patients, it can provide further guidance on physical activity recommendations that we provide to our patients following stroke,” said Dr. George, who was not associated with the study. 

Going forward, he said, more research is needed to identify specifically what is preventing stroke patients from exercising more. What is required, he said, is “future research to determine the key barriers to physical activity following stroke and methods to reduce these will also be important to increasing physical activity in stroke survivors.”

Dr. Joundi said determining how to tailor exercise recommendations to meet the wide range of capabilities of stroke survivors will be another key factor.

“Stroke survivors may have some disabilities, so we need to be able to engage them at an [exercise] level that’s possible for them,” he said.

The study did not include stroke survivors living in long-term care homes.

The study had no targeted funding. Coauthor Eric E. Smith, MD, MPH, reports royalties from UpToDate, and consulting fees from Alnylam, Biogen, and Javelin. Dr. Joundi and the other coauthors have disclosed no relevant financial relationships.

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

In a large study of community-based stroke survivors in Canada, researchers found those meeting guideline-recommended levels of physical activity had a significantly lower risk for death from any cause, with a greater than 50% reduction in risk.

Lead study author Raed A. Joundi, MD, DPhil, of the University of Calgary (Alta.), said he expected results to show exercise was beneficial, but was surprised by the magnitude of the association between physical activity and lower mortality risk.

The impact of physical activity also differed significantly by age; those younger than 75 had a 79% reduction in mortality risk, compared with 32% in those age 75 and older.

“This is even after adjusting for factors such heart disease, respiratory conditions, smoking, and other functional limitations,” said Dr. Joundi.

The study was published online Aug. 11 in the journal Neurology.

For this analysis, the researchers used data on a cohort of people across Canada (excluding the province of Quebec) over 3-9 years. The 895 patients with prior stroke averaged 72 years of age, while the 97,805 in the control group had an average age of 63.

Weekly physical activity averages were evaluated using the self-reporting Canadian Community Health Survey, which was linked with administrative databases to evaluate the association of physical activity with long-term risk for mortality among stroke survivors, compared with controls.

Physical activity was measured in metabolic equivalents (METs); meeting minimum physical activity guidelines was defined as 10 MET-hours/week.

During the study period, more stroke patients than controls died (24.7% vs. 5.7%). However, those who met the physical activity guideline recommendations of 10 MET-hours/week had a lower mortality, both in the stroke survivor group (14.6% vs. 33.2%; adjusted hazard ratio, 0.46; 95% confidence interval, 0.29-0.73) and among control participants (3.6% vs. 7.9%; aHR 0.69; 95% CI, 0.62-0.76).  

The largest absolute and relative reduction in mortality was among stroke respondents younger than 75 (10.5% vs. 29%; aHR, 0.21; 95% CI, 0.10-0.43), the researchers note.

There was a significant interaction with age for the stroke patients but not the control group.

“The greatest reduction in mortality was seen between 0 and 10 METs per week … so the main point is that something is better than nothing,” said Dr. Joundi.
 

Exercise guidelines for the future

Although current guidelines recommend physical activity in stroke survivors, investigators noted that these are largely based on studies in the general population. Therefore, the aim of this research was to get a better understanding of the role of physical activity in the health of stroke survivors in the community, which could ultimately be used to design improved public health campaigns and physical activity interventions.

Given that this is a large study of stroke survivors in the community, Dr. Joundi hopes the results will influence future activity guidelines for those who have suffered a stroke.

“We found a log-linear relationship between physical activity and mortality such that 10 MET-hours/week was associated with large reductions in mortality with most benefit achieved by 20 MET-hours/week,” the authors concluded. “These thresholds could be considered for use in future guidelines for stroke.”

Clinical trials are underway to provide evidence for the implementation of exercise programs after stroke, they add, and offering physical activity programs to stroke survivors in the community “is an increasing priority in the U.S., Canada, and Europe.”

“People are at higher risk of death early on after a stroke but also months and years later, so if we can identify a relatively low-cost and easy intervention like physical activity to improve health and reduce the risk of death for stroke survivors it would be important,” Dr. Joundi said.
 

Key barriers

Paul George, MD, PhD, a stroke and vascular neurologist at Stanford (Calif.) University, said findings such as these further strengthen the argument that physical exercise is important after stroke.

“Because the study looked specifically at stroke patients, it can provide further guidance on physical activity recommendations that we provide to our patients following stroke,” said Dr. George, who was not associated with the study. 

Going forward, he said, more research is needed to identify specifically what is preventing stroke patients from exercising more. What is required, he said, is “future research to determine the key barriers to physical activity following stroke and methods to reduce these will also be important to increasing physical activity in stroke survivors.”

Dr. Joundi said determining how to tailor exercise recommendations to meet the wide range of capabilities of stroke survivors will be another key factor.

“Stroke survivors may have some disabilities, so we need to be able to engage them at an [exercise] level that’s possible for them,” he said.

The study did not include stroke survivors living in long-term care homes.

The study had no targeted funding. Coauthor Eric E. Smith, MD, MPH, reports royalties from UpToDate, and consulting fees from Alnylam, Biogen, and Javelin. Dr. Joundi and the other coauthors have disclosed no relevant financial relationships.

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

The FDA has authorized a third dose of either the Pfizer or Moderna COVID-19 vaccines for people with compromised immune systems.

The decision, which came late on Aug. 12, was not unexpected and a Centers for Disease Control and Prevention (CDC) panel meeting Aug. 13 is expected to approve directions to doctors and health care providers on who should receive the booster shot.

“The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease. After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines,” acting FDA Commissioner Janet Woodcock, MD, said in a statement.

Those eligible for a third dose include solid organ transplant recipients, those undergoing cancer treatments, and people with autoimmune diseases that suppress their immune systems.

Meanwhile, White House officials said Aug. 12 they “have supply and are prepared” to give all U.S. residents COVID-19 boosters -- which, as of now, are likely to be authorized first only for immunocompromised people.

“We believe sooner or later you will need a booster,” Anthony Fauci, MD, said at a news briefing Aug. 12. “Right now, we are evaluating this on a day-by-day, week-by-week, month-by-month basis.”

He added: “Right at this moment, apart from the immunocompromised -- elderly or not elderly -- people do not need a booster.” But, he said, “We’re preparing for the eventuality of doing that.”

White House COVID-19 Response Coordinator Jeff Zients said officials “have supply and are prepared” to at some point provide widespread access to boosters.

The immunocompromised population is very small -- less than 3% of adults, said CDC Director Rochelle Walensky, MD.

Meanwhile, COVID-19 rates continue to rise. Dr. Walensky reported that the 7-day average of daily cases is 132,384 -- an increase of 24% from the previous week. Average daily hospitalizations are up 31%, at 9,700, and deaths are up to 452 -- an increase of 22%.

In the past week, Florida has had more COVID-19 cases than the 30 states with the lowest case rates combined, Mr. Zients said. Florida and Texas alone have accounted for nearly 40% of new hospitalizations across the country.


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

The FDA has authorized a third dose of either the Pfizer or Moderna COVID-19 vaccines for people with compromised immune systems.

The decision, which came late on Aug. 12, was not unexpected and a Centers for Disease Control and Prevention (CDC) panel meeting Aug. 13 is expected to approve directions to doctors and health care providers on who should receive the booster shot.

“The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease. After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines,” acting FDA Commissioner Janet Woodcock, MD, said in a statement.

Those eligible for a third dose include solid organ transplant recipients, those undergoing cancer treatments, and people with autoimmune diseases that suppress their immune systems.

Meanwhile, White House officials said Aug. 12 they “have supply and are prepared” to give all U.S. residents COVID-19 boosters -- which, as of now, are likely to be authorized first only for immunocompromised people.

“We believe sooner or later you will need a booster,” Anthony Fauci, MD, said at a news briefing Aug. 12. “Right now, we are evaluating this on a day-by-day, week-by-week, month-by-month basis.”

He added: “Right at this moment, apart from the immunocompromised -- elderly or not elderly -- people do not need a booster.” But, he said, “We’re preparing for the eventuality of doing that.”

White House COVID-19 Response Coordinator Jeff Zients said officials “have supply and are prepared” to at some point provide widespread access to boosters.

The immunocompromised population is very small -- less than 3% of adults, said CDC Director Rochelle Walensky, MD.

Meanwhile, COVID-19 rates continue to rise. Dr. Walensky reported that the 7-day average of daily cases is 132,384 -- an increase of 24% from the previous week. Average daily hospitalizations are up 31%, at 9,700, and deaths are up to 452 -- an increase of 22%.

In the past week, Florida has had more COVID-19 cases than the 30 states with the lowest case rates combined, Mr. Zients said. Florida and Texas alone have accounted for nearly 40% of new hospitalizations across the country.


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

The FDA has authorized a third dose of either the Pfizer or Moderna COVID-19 vaccines for people with compromised immune systems.

The decision, which came late on Aug. 12, was not unexpected and a Centers for Disease Control and Prevention (CDC) panel meeting Aug. 13 is expected to approve directions to doctors and health care providers on who should receive the booster shot.

“The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease. After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines,” acting FDA Commissioner Janet Woodcock, MD, said in a statement.

Those eligible for a third dose include solid organ transplant recipients, those undergoing cancer treatments, and people with autoimmune diseases that suppress their immune systems.

Meanwhile, White House officials said Aug. 12 they “have supply and are prepared” to give all U.S. residents COVID-19 boosters -- which, as of now, are likely to be authorized first only for immunocompromised people.

“We believe sooner or later you will need a booster,” Anthony Fauci, MD, said at a news briefing Aug. 12. “Right now, we are evaluating this on a day-by-day, week-by-week, month-by-month basis.”

He added: “Right at this moment, apart from the immunocompromised -- elderly or not elderly -- people do not need a booster.” But, he said, “We’re preparing for the eventuality of doing that.”

White House COVID-19 Response Coordinator Jeff Zients said officials “have supply and are prepared” to at some point provide widespread access to boosters.

The immunocompromised population is very small -- less than 3% of adults, said CDC Director Rochelle Walensky, MD.

Meanwhile, COVID-19 rates continue to rise. Dr. Walensky reported that the 7-day average of daily cases is 132,384 -- an increase of 24% from the previous week. Average daily hospitalizations are up 31%, at 9,700, and deaths are up to 452 -- an increase of 22%.

In the past week, Florida has had more COVID-19 cases than the 30 states with the lowest case rates combined, Mr. Zients said. Florida and Texas alone have accounted for nearly 40% of new hospitalizations across the country.


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

Although a novel investigational drug that combines dextromethorphan and bupropion (AXS-05, Axsome Therapeutics) met its primary and key secondary endpoints in a phase 2 trial of patients with treatment-resistant depression (TRD), the U.S. Food and Drug Administration has voiced some concerns.

In the MERIT study, AXS-05 significantly delayed time to depression relapse compared with placebo (primary endpoint) – with no relapses observed for at least 6 months. It also significantly prevented depression relapse (secondary endpoint), the company said in a news release announcing the topline results.

The drug has been granted breakthrough therapy designations by the FDA for the treatment of major depressive disorder (MDD) and agitation associated with Alzheimer’s disease.

In addition, the agency is currently reviewing a new drug application (NDA) for AXS-05 for the treatment of MDD, with a target action date of August 22.

However, Axsome stated that the FDA has identified “deficiencies that preclude labeling discussions at this time.”

The company is “attempting to learn the nature of these deficiencies with the goal of addressing them,” Herriot Tabuteau, MD, chief executive officer of Axsome, said in a statement.

However, Dr. Tabuteau acknowledged that this development “may lead to a delay in the potential approval of AXS-05.”
 

‘Well tolerated’

A total of 44 adults with TRD were enrolled into the MERIT study from the long-term, open-label phase 3 trial of AXS-05.

All patients were in stable remission after treatment with AXS-05 and were randomly assigned to continued treatment with AXS-05 (45 mg dextromethorphan/105 mg bupropion twice daily) or to switch to placebo.

Compared with placebo, AXS-05 significantly delayed time to depression relapse (P = .002) and prevented depression relapse (P = .004).

The novel drug was also well tolerated, with no treatment-emergent adverse events reported in more than one participant in the AXS-05 group, the company said.

One patient treated with AXS-05 did experience gout and bacteremia, but these incidents were deemed unrelated to the medication.

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

Although a novel investigational drug that combines dextromethorphan and bupropion (AXS-05, Axsome Therapeutics) met its primary and key secondary endpoints in a phase 2 trial of patients with treatment-resistant depression (TRD), the U.S. Food and Drug Administration has voiced some concerns.

In the MERIT study, AXS-05 significantly delayed time to depression relapse compared with placebo (primary endpoint) – with no relapses observed for at least 6 months. It also significantly prevented depression relapse (secondary endpoint), the company said in a news release announcing the topline results.

The drug has been granted breakthrough therapy designations by the FDA for the treatment of major depressive disorder (MDD) and agitation associated with Alzheimer’s disease.

In addition, the agency is currently reviewing a new drug application (NDA) for AXS-05 for the treatment of MDD, with a target action date of August 22.

However, Axsome stated that the FDA has identified “deficiencies that preclude labeling discussions at this time.”

The company is “attempting to learn the nature of these deficiencies with the goal of addressing them,” Herriot Tabuteau, MD, chief executive officer of Axsome, said in a statement.

However, Dr. Tabuteau acknowledged that this development “may lead to a delay in the potential approval of AXS-05.”
 

‘Well tolerated’

A total of 44 adults with TRD were enrolled into the MERIT study from the long-term, open-label phase 3 trial of AXS-05.

All patients were in stable remission after treatment with AXS-05 and were randomly assigned to continued treatment with AXS-05 (45 mg dextromethorphan/105 mg bupropion twice daily) or to switch to placebo.

Compared with placebo, AXS-05 significantly delayed time to depression relapse (P = .002) and prevented depression relapse (P = .004).

The novel drug was also well tolerated, with no treatment-emergent adverse events reported in more than one participant in the AXS-05 group, the company said.

One patient treated with AXS-05 did experience gout and bacteremia, but these incidents were deemed unrelated to the medication.

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

Although a novel investigational drug that combines dextromethorphan and bupropion (AXS-05, Axsome Therapeutics) met its primary and key secondary endpoints in a phase 2 trial of patients with treatment-resistant depression (TRD), the U.S. Food and Drug Administration has voiced some concerns.

In the MERIT study, AXS-05 significantly delayed time to depression relapse compared with placebo (primary endpoint) – with no relapses observed for at least 6 months. It also significantly prevented depression relapse (secondary endpoint), the company said in a news release announcing the topline results.

The drug has been granted breakthrough therapy designations by the FDA for the treatment of major depressive disorder (MDD) and agitation associated with Alzheimer’s disease.

In addition, the agency is currently reviewing a new drug application (NDA) for AXS-05 for the treatment of MDD, with a target action date of August 22.

However, Axsome stated that the FDA has identified “deficiencies that preclude labeling discussions at this time.”

The company is “attempting to learn the nature of these deficiencies with the goal of addressing them,” Herriot Tabuteau, MD, chief executive officer of Axsome, said in a statement.

However, Dr. Tabuteau acknowledged that this development “may lead to a delay in the potential approval of AXS-05.”
 

‘Well tolerated’

A total of 44 adults with TRD were enrolled into the MERIT study from the long-term, open-label phase 3 trial of AXS-05.

All patients were in stable remission after treatment with AXS-05 and were randomly assigned to continued treatment with AXS-05 (45 mg dextromethorphan/105 mg bupropion twice daily) or to switch to placebo.

Compared with placebo, AXS-05 significantly delayed time to depression relapse (P = .002) and prevented depression relapse (P = .004).

The novel drug was also well tolerated, with no treatment-emergent adverse events reported in more than one participant in the AXS-05 group, the company said.

One patient treated with AXS-05 did experience gout and bacteremia, but these incidents were deemed unrelated to the medication.

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

A nurse in Germany is suspected of giving saline solution rather than the COVID-19 vaccine to more than 8,500 people at a vaccination center this year.

Those who may be affected are being informed about their possible vulnerability to the coronavirus and will be offered COVID-19 shots, according to CBS News.

“I’m totally shocked by the incident,” Sven Ambrosy, a district administrator of Friesland, wrote in a Facebook post on Aug. 10.

“The district of Friesland will do everything possible to ensure that the affected people receive their vaccination protection as soon as possible,” he said.

In late April, a former Red Cross employee who worked at the Roffhausen Vaccination Center in Friesland, a district in Germany’s northern state of Lower Saxony, told a colleague that she filled six syringes with saline instead of the Pfizer vaccine, according to police reports. The nurse said she dropped a vial containing the vaccine while preparing syringes and tried to cover it up.

The nurse was immediately fired, and local authorities conducted antibody tests on more than 100 people who visited the vaccination center on April 21. Since it was impossible to trace who received the saline shots, everyone who visited the center that day was invited to receive a follow-up shot.

But during a police investigation, authorities found evidence that more people were affected. The case now involves 8,557 vaccinations given between March 5 and April 20 at specific times.

Now, authorities are contacting those who were affected by phone or email to schedule new vaccination appointments. They’ve established a dedicated information phone line as well, according to NPR.

Saline solution is harmless, but most people who received shots in Germany during that time were older adults, who are more likely to have severe COVID-19 if infected, according to Reuters.

The nurse has remained silent about the allegations of her giving saline rather than a vaccine to thousands of people, CBS News reported. And it’s unclear whether there have been any arrests or charges related to the case, according to Reuters.

The nurse hasn’t been named publicly, and the motive hasn’t been shared, NPR reported, though the nurse had purportedly expressed skepticism about COVID-19 vaccines in social media posts.

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

A nurse in Germany is suspected of giving saline solution rather than the COVID-19 vaccine to more than 8,500 people at a vaccination center this year.

Those who may be affected are being informed about their possible vulnerability to the coronavirus and will be offered COVID-19 shots, according to CBS News.

“I’m totally shocked by the incident,” Sven Ambrosy, a district administrator of Friesland, wrote in a Facebook post on Aug. 10.

“The district of Friesland will do everything possible to ensure that the affected people receive their vaccination protection as soon as possible,” he said.

In late April, a former Red Cross employee who worked at the Roffhausen Vaccination Center in Friesland, a district in Germany’s northern state of Lower Saxony, told a colleague that she filled six syringes with saline instead of the Pfizer vaccine, according to police reports. The nurse said she dropped a vial containing the vaccine while preparing syringes and tried to cover it up.

The nurse was immediately fired, and local authorities conducted antibody tests on more than 100 people who visited the vaccination center on April 21. Since it was impossible to trace who received the saline shots, everyone who visited the center that day was invited to receive a follow-up shot.

But during a police investigation, authorities found evidence that more people were affected. The case now involves 8,557 vaccinations given between March 5 and April 20 at specific times.

Now, authorities are contacting those who were affected by phone or email to schedule new vaccination appointments. They’ve established a dedicated information phone line as well, according to NPR.

Saline solution is harmless, but most people who received shots in Germany during that time were older adults, who are more likely to have severe COVID-19 if infected, according to Reuters.

The nurse has remained silent about the allegations of her giving saline rather than a vaccine to thousands of people, CBS News reported. And it’s unclear whether there have been any arrests or charges related to the case, according to Reuters.

The nurse hasn’t been named publicly, and the motive hasn’t been shared, NPR reported, though the nurse had purportedly expressed skepticism about COVID-19 vaccines in social media posts.

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

A nurse in Germany is suspected of giving saline solution rather than the COVID-19 vaccine to more than 8,500 people at a vaccination center this year.

Those who may be affected are being informed about their possible vulnerability to the coronavirus and will be offered COVID-19 shots, according to CBS News.

“I’m totally shocked by the incident,” Sven Ambrosy, a district administrator of Friesland, wrote in a Facebook post on Aug. 10.

“The district of Friesland will do everything possible to ensure that the affected people receive their vaccination protection as soon as possible,” he said.

In late April, a former Red Cross employee who worked at the Roffhausen Vaccination Center in Friesland, a district in Germany’s northern state of Lower Saxony, told a colleague that she filled six syringes with saline instead of the Pfizer vaccine, according to police reports. The nurse said she dropped a vial containing the vaccine while preparing syringes and tried to cover it up.

The nurse was immediately fired, and local authorities conducted antibody tests on more than 100 people who visited the vaccination center on April 21. Since it was impossible to trace who received the saline shots, everyone who visited the center that day was invited to receive a follow-up shot.

But during a police investigation, authorities found evidence that more people were affected. The case now involves 8,557 vaccinations given between March 5 and April 20 at specific times.

Now, authorities are contacting those who were affected by phone or email to schedule new vaccination appointments. They’ve established a dedicated information phone line as well, according to NPR.

Saline solution is harmless, but most people who received shots in Germany during that time were older adults, who are more likely to have severe COVID-19 if infected, according to Reuters.

The nurse has remained silent about the allegations of her giving saline rather than a vaccine to thousands of people, CBS News reported. And it’s unclear whether there have been any arrests or charges related to the case, according to Reuters.

The nurse hasn’t been named publicly, and the motive hasn’t been shared, NPR reported, though the nurse had purportedly expressed skepticism about COVID-19 vaccines in social media posts.

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

The state of Mississippi is out of intensive care unit beds. The University of Mississippi Medical Center in Jackson – the state’s largest health system – is converting part of a parking garage into a field hospital to make more room.

Andriy Onufriyenko

“Hospitals are full from Memphis to Gulfport, Natchez to Meridian. Everything’s full,” said Alan Jones, MD, the hospital’s COVID-19 response leader, in a press briefing Aug. 11.

The state has requested the help of a federal disaster medical assistance team of physicians, nurses, respiratory therapists, pharmacists, and paramedics to staff the extra beds. The goal is to open the field hospital on Aug. 13.

Arkansas hospitals have as little as eight ICU beds left to serve a population of 3 million people. Alabama isn’t far behind.

As of Aug. 10, several large metro Atlanta hospitals were diverting patients because they were full.

Hospitals in Alabama, Florida, Tennessee, and Texas are canceling elective surgeries, as they are flooded with COVID patients.  

Florida has ordered more ventilators from the federal government. Some hospitals in that state have so many patients on high-flow medical oxygen that it is taxing the building supply lines.

“Most hospitals were not designed for this type of volume distribution in their facilities,” said Mary Mayhew, president of the Florida Hospital Association.

That’s when they can get it. Oxygen deliveries have been disrupted because of a shortage of drivers who are trained to transport it.

“Any disruption in the timing of a delivery can be hugely problematic because of the volume of oxygen they’re going through,” Ms. Mayhew said.
 

Hospitals ‘under great stress’

In a setting where most Americans now have access to safe and highly effective vaccines, hospitals in the Southeast are once again under siege from COVID-19.

Over the month of June, the number of COVID patients in Florida hospitals soared from 2,000 to 10,000. Ms. Mayhew says it took twice as long during the last surge for the state to reach those numbers. And they’re still climbing. The state had 15,000 hospitalized COVID patients as of Aug. 11.

COVID hospitalizations tripled in 3 weeks in South Carolina, said state epidemiologist Linda Bell, MD, in a news conference Aug. 11.

“These hospitals are under great stress,” says Eric Toner, MD, a senior scientist at the Johns Hopkins Center for Health Security in Baltimore

The Delta variant has swept through the unvaccinated South with such veracity that hospitals in the region are unable to keep up. Patients with non-COVID health conditions are in jeopardy too.

Lee Owens, age 56, said he was supposed to have triple bypass surgery on Aug. 12 at St. Thomas West Hospital in Nashville, Tenn. Three of the arteries around his heart are 100%, 90%, and 70% blocked. Mr. Owens said the hospital called him Aug. 10 to postpone his surgery because they’ve cut back elective procedures to just one each day because the ICU beds there are full.

“I’m okay with having to wait a few days (my family isn’t!), especially if there are people worse than me, but so much anger at the reason,” he said. “These idiots that refused health care are now taking up my slot for heart surgery. It’s really aggravating.”

Anjali Bright, a spokesperson for St. Thomas West, provided a statement to this news organization saying they are not suspending elective procedures, but they are reviewing those “requiring an inpatient stay on a case-by-case basis.”

She emphasized, though, that “we will never delay care if the patient’s status changes to ‘urgent.’ ”

“Because of how infectious this variant is, this has the potential to be so much worse than what we saw in January,” said Donald Williamson, MD, president of the Alabama Hospital Association.

Dr. Williamson said they have modeled three possible scenarios for spread in the state, which ranks dead last in the United States for vaccination, with just 35% of its population fully protected. If the Delta variant spreads as it did in the United Kingdom, Alabama could see it hospitalize up to 3,000 people. 

“That’s the best scenario,” he said.

If it sweeps through the state as it did in India, Alabama is looking at up to 4,500 patients hospitalized, a number that would require more beds and more staff to care for patients.

Then, there is what Dr. Williamson calls his “nightmare scenario.” If the entire state begins to see transmission rates as high as they’re currently seeing in coastal Mobile and Baldwin counties, that could mean up to 8,000 people in the hospital.

“If we see R-naughts of 5-8 statewide, we’re in real trouble,” he said. The R-naught is the basic rate of reproduction, and it means that each infected person would go on to infect 5-8 others. Dr. Williamson said the federal government would have to send them more staff to handle that kind of a surge.
 

‘Sense of betrayal’

Unlike the surges of last winter and spring, which sent hospitals scrambling for beds and supplies, the biggest pain point for hospitals now is staffing.

In Mississippi, where 200 patients are parked in emergency departments waiting for available and staffed ICU beds, the state is facing Delta with 2,000 fewer registered nurses than it had during its winter surge. 

Some have left because of stress and burnout. Others have taken higher-paying jobs with travel nursing companies. To stop the exodus, hospitals are offering better pay, easier schedules, and sign-on and stay-on bonuses.

Doctors say the incentives are nice, but they don’t help with the anguish and anger many feel after months of battling COVID.

“There’s a big sense of betrayal,” said Sarah Nafziger, MD, vice president of clinical support services at the University of Alabama at Birmingham Hospital. “Our staff and health care workers, in general, feel like we’ve been betrayed by the community.”

“We have a vaccine, which is the key to ending this pandemic and people just refuse to take it, and so I think we’re very frustrated. We feel that our communities have let us down by not taking advantage of the vaccine,” Dr. Nafziger said. “It’s just baffling to me and it’s broken my heart every single day.”

Dr. Nafziger said she met with several surgeons at UAB on Aug. 11 and began making decisions about which surgeries would need to be canceled the following week. “We’re talking about cancer surgery. We’re talking about heart surgery. We’re talking about things that are critical to people.”

Compounding the staffing problems, about half of hospital workers in Alabama are still unvaccinated. Dr. Williamson says they’re now starting to see these unvaccinated health care workers come down with COVID too. He says that will exacerbate their surge even further as health care workers become too sick to help care for patients and some will end up needing hospital beds themselves.

At the University of Mississippi Medical Center, 70 hospital employees and another 20 clinic employees are now being quarantined or have COVID, Dr. Jones said.

“The situation is bleak for Mississippi hospitals,” said Timothy Moore, president and CEO of the Mississippi Hospital Association. He said he doesn’t expect it to get better anytime soon.

Mississippi has more patients hospitalized now than at any other point in the pandemic, said Thomas Dobbs, MD, MPH, the state epidemiologist.

“If we look at the rapidity of this rise, it’s really kind of terrifying and awe-inspiring,” Dr. Dobbs said in a news conference Aug. 11.

Schools are just starting back, and, in many parts of the South, districts are operating under a patchwork of policies – some require masks, while others have made them voluntary. Physicians say they are bracing for what these half measures could mean for pediatric cases and community transmission.

The only sure way for people to help themselves and their hospitals and schools, experts said, is vaccination.

“State data show that in this latest COVID surge, 97% of new COVID-19 infections, 89% of hospitalizations, and 82% of deaths occur in unvaccinated residents,” Mr. Moore said.

“To relieve pressure on hospitals, we need Mississippians – even those who have previously had COVID – to get vaccinated and wear a mask in public. The Delta variant is highly contagious and we need to do all we can to stop the spread,” he said.

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

The state of Mississippi is out of intensive care unit beds. The University of Mississippi Medical Center in Jackson – the state’s largest health system – is converting part of a parking garage into a field hospital to make more room.

Andriy Onufriyenko

“Hospitals are full from Memphis to Gulfport, Natchez to Meridian. Everything’s full,” said Alan Jones, MD, the hospital’s COVID-19 response leader, in a press briefing Aug. 11.

The state has requested the help of a federal disaster medical assistance team of physicians, nurses, respiratory therapists, pharmacists, and paramedics to staff the extra beds. The goal is to open the field hospital on Aug. 13.

Arkansas hospitals have as little as eight ICU beds left to serve a population of 3 million people. Alabama isn’t far behind.

As of Aug. 10, several large metro Atlanta hospitals were diverting patients because they were full.

Hospitals in Alabama, Florida, Tennessee, and Texas are canceling elective surgeries, as they are flooded with COVID patients.  

Florida has ordered more ventilators from the federal government. Some hospitals in that state have so many patients on high-flow medical oxygen that it is taxing the building supply lines.

“Most hospitals were not designed for this type of volume distribution in their facilities,” said Mary Mayhew, president of the Florida Hospital Association.

That’s when they can get it. Oxygen deliveries have been disrupted because of a shortage of drivers who are trained to transport it.

“Any disruption in the timing of a delivery can be hugely problematic because of the volume of oxygen they’re going through,” Ms. Mayhew said.
 

Hospitals ‘under great stress’

In a setting where most Americans now have access to safe and highly effective vaccines, hospitals in the Southeast are once again under siege from COVID-19.

Over the month of June, the number of COVID patients in Florida hospitals soared from 2,000 to 10,000. Ms. Mayhew says it took twice as long during the last surge for the state to reach those numbers. And they’re still climbing. The state had 15,000 hospitalized COVID patients as of Aug. 11.

COVID hospitalizations tripled in 3 weeks in South Carolina, said state epidemiologist Linda Bell, MD, in a news conference Aug. 11.

“These hospitals are under great stress,” says Eric Toner, MD, a senior scientist at the Johns Hopkins Center for Health Security in Baltimore

The Delta variant has swept through the unvaccinated South with such veracity that hospitals in the region are unable to keep up. Patients with non-COVID health conditions are in jeopardy too.

Lee Owens, age 56, said he was supposed to have triple bypass surgery on Aug. 12 at St. Thomas West Hospital in Nashville, Tenn. Three of the arteries around his heart are 100%, 90%, and 70% blocked. Mr. Owens said the hospital called him Aug. 10 to postpone his surgery because they’ve cut back elective procedures to just one each day because the ICU beds there are full.

“I’m okay with having to wait a few days (my family isn’t!), especially if there are people worse than me, but so much anger at the reason,” he said. “These idiots that refused health care are now taking up my slot for heart surgery. It’s really aggravating.”

Anjali Bright, a spokesperson for St. Thomas West, provided a statement to this news organization saying they are not suspending elective procedures, but they are reviewing those “requiring an inpatient stay on a case-by-case basis.”

She emphasized, though, that “we will never delay care if the patient’s status changes to ‘urgent.’ ”

“Because of how infectious this variant is, this has the potential to be so much worse than what we saw in January,” said Donald Williamson, MD, president of the Alabama Hospital Association.

Dr. Williamson said they have modeled three possible scenarios for spread in the state, which ranks dead last in the United States for vaccination, with just 35% of its population fully protected. If the Delta variant spreads as it did in the United Kingdom, Alabama could see it hospitalize up to 3,000 people. 

“That’s the best scenario,” he said.

If it sweeps through the state as it did in India, Alabama is looking at up to 4,500 patients hospitalized, a number that would require more beds and more staff to care for patients.

Then, there is what Dr. Williamson calls his “nightmare scenario.” If the entire state begins to see transmission rates as high as they’re currently seeing in coastal Mobile and Baldwin counties, that could mean up to 8,000 people in the hospital.

“If we see R-naughts of 5-8 statewide, we’re in real trouble,” he said. The R-naught is the basic rate of reproduction, and it means that each infected person would go on to infect 5-8 others. Dr. Williamson said the federal government would have to send them more staff to handle that kind of a surge.
 

‘Sense of betrayal’

Unlike the surges of last winter and spring, which sent hospitals scrambling for beds and supplies, the biggest pain point for hospitals now is staffing.

In Mississippi, where 200 patients are parked in emergency departments waiting for available and staffed ICU beds, the state is facing Delta with 2,000 fewer registered nurses than it had during its winter surge. 

Some have left because of stress and burnout. Others have taken higher-paying jobs with travel nursing companies. To stop the exodus, hospitals are offering better pay, easier schedules, and sign-on and stay-on bonuses.

Doctors say the incentives are nice, but they don’t help with the anguish and anger many feel after months of battling COVID.

“There’s a big sense of betrayal,” said Sarah Nafziger, MD, vice president of clinical support services at the University of Alabama at Birmingham Hospital. “Our staff and health care workers, in general, feel like we’ve been betrayed by the community.”

“We have a vaccine, which is the key to ending this pandemic and people just refuse to take it, and so I think we’re very frustrated. We feel that our communities have let us down by not taking advantage of the vaccine,” Dr. Nafziger said. “It’s just baffling to me and it’s broken my heart every single day.”

Dr. Nafziger said she met with several surgeons at UAB on Aug. 11 and began making decisions about which surgeries would need to be canceled the following week. “We’re talking about cancer surgery. We’re talking about heart surgery. We’re talking about things that are critical to people.”

Compounding the staffing problems, about half of hospital workers in Alabama are still unvaccinated. Dr. Williamson says they’re now starting to see these unvaccinated health care workers come down with COVID too. He says that will exacerbate their surge even further as health care workers become too sick to help care for patients and some will end up needing hospital beds themselves.

At the University of Mississippi Medical Center, 70 hospital employees and another 20 clinic employees are now being quarantined or have COVID, Dr. Jones said.

“The situation is bleak for Mississippi hospitals,” said Timothy Moore, president and CEO of the Mississippi Hospital Association. He said he doesn’t expect it to get better anytime soon.

Mississippi has more patients hospitalized now than at any other point in the pandemic, said Thomas Dobbs, MD, MPH, the state epidemiologist.

“If we look at the rapidity of this rise, it’s really kind of terrifying and awe-inspiring,” Dr. Dobbs said in a news conference Aug. 11.

Schools are just starting back, and, in many parts of the South, districts are operating under a patchwork of policies – some require masks, while others have made them voluntary. Physicians say they are bracing for what these half measures could mean for pediatric cases and community transmission.

The only sure way for people to help themselves and their hospitals and schools, experts said, is vaccination.

“State data show that in this latest COVID surge, 97% of new COVID-19 infections, 89% of hospitalizations, and 82% of deaths occur in unvaccinated residents,” Mr. Moore said.

“To relieve pressure on hospitals, we need Mississippians – even those who have previously had COVID – to get vaccinated and wear a mask in public. The Delta variant is highly contagious and we need to do all we can to stop the spread,” he said.

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

The state of Mississippi is out of intensive care unit beds. The University of Mississippi Medical Center in Jackson – the state’s largest health system – is converting part of a parking garage into a field hospital to make more room.

Andriy Onufriyenko

“Hospitals are full from Memphis to Gulfport, Natchez to Meridian. Everything’s full,” said Alan Jones, MD, the hospital’s COVID-19 response leader, in a press briefing Aug. 11.

The state has requested the help of a federal disaster medical assistance team of physicians, nurses, respiratory therapists, pharmacists, and paramedics to staff the extra beds. The goal is to open the field hospital on Aug. 13.

Arkansas hospitals have as little as eight ICU beds left to serve a population of 3 million people. Alabama isn’t far behind.

As of Aug. 10, several large metro Atlanta hospitals were diverting patients because they were full.

Hospitals in Alabama, Florida, Tennessee, and Texas are canceling elective surgeries, as they are flooded with COVID patients.  

Florida has ordered more ventilators from the federal government. Some hospitals in that state have so many patients on high-flow medical oxygen that it is taxing the building supply lines.

“Most hospitals were not designed for this type of volume distribution in their facilities,” said Mary Mayhew, president of the Florida Hospital Association.

That’s when they can get it. Oxygen deliveries have been disrupted because of a shortage of drivers who are trained to transport it.

“Any disruption in the timing of a delivery can be hugely problematic because of the volume of oxygen they’re going through,” Ms. Mayhew said.
 

Hospitals ‘under great stress’

In a setting where most Americans now have access to safe and highly effective vaccines, hospitals in the Southeast are once again under siege from COVID-19.

Over the month of June, the number of COVID patients in Florida hospitals soared from 2,000 to 10,000. Ms. Mayhew says it took twice as long during the last surge for the state to reach those numbers. And they’re still climbing. The state had 15,000 hospitalized COVID patients as of Aug. 11.

COVID hospitalizations tripled in 3 weeks in South Carolina, said state epidemiologist Linda Bell, MD, in a news conference Aug. 11.

“These hospitals are under great stress,” says Eric Toner, MD, a senior scientist at the Johns Hopkins Center for Health Security in Baltimore

The Delta variant has swept through the unvaccinated South with such veracity that hospitals in the region are unable to keep up. Patients with non-COVID health conditions are in jeopardy too.

Lee Owens, age 56, said he was supposed to have triple bypass surgery on Aug. 12 at St. Thomas West Hospital in Nashville, Tenn. Three of the arteries around his heart are 100%, 90%, and 70% blocked. Mr. Owens said the hospital called him Aug. 10 to postpone his surgery because they’ve cut back elective procedures to just one each day because the ICU beds there are full.

“I’m okay with having to wait a few days (my family isn’t!), especially if there are people worse than me, but so much anger at the reason,” he said. “These idiots that refused health care are now taking up my slot for heart surgery. It’s really aggravating.”

Anjali Bright, a spokesperson for St. Thomas West, provided a statement to this news organization saying they are not suspending elective procedures, but they are reviewing those “requiring an inpatient stay on a case-by-case basis.”

She emphasized, though, that “we will never delay care if the patient’s status changes to ‘urgent.’ ”

“Because of how infectious this variant is, this has the potential to be so much worse than what we saw in January,” said Donald Williamson, MD, president of the Alabama Hospital Association.

Dr. Williamson said they have modeled three possible scenarios for spread in the state, which ranks dead last in the United States for vaccination, with just 35% of its population fully protected. If the Delta variant spreads as it did in the United Kingdom, Alabama could see it hospitalize up to 3,000 people. 

“That’s the best scenario,” he said.

If it sweeps through the state as it did in India, Alabama is looking at up to 4,500 patients hospitalized, a number that would require more beds and more staff to care for patients.

Then, there is what Dr. Williamson calls his “nightmare scenario.” If the entire state begins to see transmission rates as high as they’re currently seeing in coastal Mobile and Baldwin counties, that could mean up to 8,000 people in the hospital.

“If we see R-naughts of 5-8 statewide, we’re in real trouble,” he said. The R-naught is the basic rate of reproduction, and it means that each infected person would go on to infect 5-8 others. Dr. Williamson said the federal government would have to send them more staff to handle that kind of a surge.
 

‘Sense of betrayal’

Unlike the surges of last winter and spring, which sent hospitals scrambling for beds and supplies, the biggest pain point for hospitals now is staffing.

In Mississippi, where 200 patients are parked in emergency departments waiting for available and staffed ICU beds, the state is facing Delta with 2,000 fewer registered nurses than it had during its winter surge. 

Some have left because of stress and burnout. Others have taken higher-paying jobs with travel nursing companies. To stop the exodus, hospitals are offering better pay, easier schedules, and sign-on and stay-on bonuses.

Doctors say the incentives are nice, but they don’t help with the anguish and anger many feel after months of battling COVID.

“There’s a big sense of betrayal,” said Sarah Nafziger, MD, vice president of clinical support services at the University of Alabama at Birmingham Hospital. “Our staff and health care workers, in general, feel like we’ve been betrayed by the community.”

“We have a vaccine, which is the key to ending this pandemic and people just refuse to take it, and so I think we’re very frustrated. We feel that our communities have let us down by not taking advantage of the vaccine,” Dr. Nafziger said. “It’s just baffling to me and it’s broken my heart every single day.”

Dr. Nafziger said she met with several surgeons at UAB on Aug. 11 and began making decisions about which surgeries would need to be canceled the following week. “We’re talking about cancer surgery. We’re talking about heart surgery. We’re talking about things that are critical to people.”

Compounding the staffing problems, about half of hospital workers in Alabama are still unvaccinated. Dr. Williamson says they’re now starting to see these unvaccinated health care workers come down with COVID too. He says that will exacerbate their surge even further as health care workers become too sick to help care for patients and some will end up needing hospital beds themselves.

At the University of Mississippi Medical Center, 70 hospital employees and another 20 clinic employees are now being quarantined or have COVID, Dr. Jones said.

“The situation is bleak for Mississippi hospitals,” said Timothy Moore, president and CEO of the Mississippi Hospital Association. He said he doesn’t expect it to get better anytime soon.

Mississippi has more patients hospitalized now than at any other point in the pandemic, said Thomas Dobbs, MD, MPH, the state epidemiologist.

“If we look at the rapidity of this rise, it’s really kind of terrifying and awe-inspiring,” Dr. Dobbs said in a news conference Aug. 11.

Schools are just starting back, and, in many parts of the South, districts are operating under a patchwork of policies – some require masks, while others have made them voluntary. Physicians say they are bracing for what these half measures could mean for pediatric cases and community transmission.

The only sure way for people to help themselves and their hospitals and schools, experts said, is vaccination.

“State data show that in this latest COVID surge, 97% of new COVID-19 infections, 89% of hospitalizations, and 82% of deaths occur in unvaccinated residents,” Mr. Moore said.

“To relieve pressure on hospitals, we need Mississippians – even those who have previously had COVID – to get vaccinated and wear a mask in public. The Delta variant is highly contagious and we need to do all we can to stop the spread,” he said.

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

The COVID-19 pandemic has fueled a growing demand for nurse practitioners (NPs), while demand for primary care physicians has cooled, according to Merritt Hawkins’ annual review of physician and advanced practitioner recruiting trends.

This marks the first time in the review’s 28-year history that NPs have topped the list of the most recruited practitioners, according to the medical search firm. In the 27 prior years, physicians held the top spot. For the previous 14 years, the No. 1 position was held by family physicians.

“COVID-19 and other market forces are changing the dynamics of physician and advanced practitioner recruiting. NPs are coming into their own in a market that puts a premium on easy access to care and cost containment,” Tom Florence, president of Merritt Hawkins, said in a statement.
 

Primary care ‘recruiting frenzy’ over

Mr. Florence said primary care physicians remain a “vital part of team-based care and will be increasingly responsible for coordinating the care of older patients with multiple chronic conditions. But the recruiting frenzy in primary care is over.”

Merritt Hawkins says that overall COVID-19 has had a “severely inhibiting” effect on demand for physicians. The number of searches the company conducted dropped 25%, compared with 2020, and many hospitals and medical groups shut down or lost money during the pandemic.

But the drop-off in demand for physicians is likely to be temporary because the underlying dynamics driving physician supply and demand remain in place, according to the report. These include a growing and aging population, a limited supply of newly trained physicians, and an aging physician workforce.

COVID-19 will not permanently change these market conditions, and demand for physicians already is rebounding, the company said.

The 2021 review of physician and advanced practitioner recruiting is based on a representative sample of 2,458 permanent search engagements that Merritt Hawkins/AMN Healthcare’s physician staffing companies conducted or were in the process of conducting during the 12-month period from April 1, 2020, to March 31, 2021.

Among the key findings:

• 18% of Merritt Hawkins’ recruiting searches were for advanced practitioners, including NPs, physician assistants (PAs), and certified registered nurse anesthetists, up from 13% in the 2020 review. This represents the highest percentage in the 28 years the review has been conducted.
• About two-thirds (64%) of Merritt Hawkins’ search engagements were for physician specialists, including radiologists, psychiatrists, gastroenterologists, and others, “highlighting the robust demand for specialty physicians.”
• In 2021, 18% of Merritt Hawkins’ search engagements were for primary care physicians, down from 20% in 2020 and 22% in 2019, “signaling a relative decline in demand for primary care doctors.”
• Psychiatrists placed fourth on the list of most requested search engagements, a sign of continued strong demand for mental health professionals that is likely to accelerate because of COVID-19.

Starting salaries take a pandemic hit

Owing to the reduced demand for practitioners, starting salaries decreased for many types of health care professions, with the exception of NPs and PAs.

Average starting salaries for NPs showed strong growth, increasing 12% year over year, from $125,000 to $140,000. The average starting salaries for PAs also showed strong growth, increasing by 14% year over year, from $112,000 to $128,000.

Among physicians, interventional cardiologists were offered the highest average starting salaries, at $611,000, followed by orthopedic surgeons, at $546,000. Pediatricians were offered the lowest average starting salaries, at $236,000.

Merritt Hawkins said only 3% of their search engagements were for solo practice or partnership settings, “underscoring the decline of physician private practice.”

Roughly two-thirds (67%) of Merritt Hawkins’ search engagements were in communities of 100,000 people or more, indicating that demand for physicians and advanced practitioners is not limited to small or rural communities.

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

The COVID-19 pandemic has fueled a growing demand for nurse practitioners (NPs), while demand for primary care physicians has cooled, according to Merritt Hawkins’ annual review of physician and advanced practitioner recruiting trends.

This marks the first time in the review’s 28-year history that NPs have topped the list of the most recruited practitioners, according to the medical search firm. In the 27 prior years, physicians held the top spot. For the previous 14 years, the No. 1 position was held by family physicians.

“COVID-19 and other market forces are changing the dynamics of physician and advanced practitioner recruiting. NPs are coming into their own in a market that puts a premium on easy access to care and cost containment,” Tom Florence, president of Merritt Hawkins, said in a statement.
 

Primary care ‘recruiting frenzy’ over

Mr. Florence said primary care physicians remain a “vital part of team-based care and will be increasingly responsible for coordinating the care of older patients with multiple chronic conditions. But the recruiting frenzy in primary care is over.”

Merritt Hawkins says that overall COVID-19 has had a “severely inhibiting” effect on demand for physicians. The number of searches the company conducted dropped 25%, compared with 2020, and many hospitals and medical groups shut down or lost money during the pandemic.

But the drop-off in demand for physicians is likely to be temporary because the underlying dynamics driving physician supply and demand remain in place, according to the report. These include a growing and aging population, a limited supply of newly trained physicians, and an aging physician workforce.

COVID-19 will not permanently change these market conditions, and demand for physicians already is rebounding, the company said.

The 2021 review of physician and advanced practitioner recruiting is based on a representative sample of 2,458 permanent search engagements that Merritt Hawkins/AMN Healthcare’s physician staffing companies conducted or were in the process of conducting during the 12-month period from April 1, 2020, to March 31, 2021.

Among the key findings:

• 18% of Merritt Hawkins’ recruiting searches were for advanced practitioners, including NPs, physician assistants (PAs), and certified registered nurse anesthetists, up from 13% in the 2020 review. This represents the highest percentage in the 28 years the review has been conducted.
• About two-thirds (64%) of Merritt Hawkins’ search engagements were for physician specialists, including radiologists, psychiatrists, gastroenterologists, and others, “highlighting the robust demand for specialty physicians.”
• In 2021, 18% of Merritt Hawkins’ search engagements were for primary care physicians, down from 20% in 2020 and 22% in 2019, “signaling a relative decline in demand for primary care doctors.”
• Psychiatrists placed fourth on the list of most requested search engagements, a sign of continued strong demand for mental health professionals that is likely to accelerate because of COVID-19.

Starting salaries take a pandemic hit

Owing to the reduced demand for practitioners, starting salaries decreased for many types of health care professions, with the exception of NPs and PAs.

Average starting salaries for NPs showed strong growth, increasing 12% year over year, from $125,000 to $140,000. The average starting salaries for PAs also showed strong growth, increasing by 14% year over year, from $112,000 to $128,000.

Among physicians, interventional cardiologists were offered the highest average starting salaries, at $611,000, followed by orthopedic surgeons, at $546,000. Pediatricians were offered the lowest average starting salaries, at $236,000.

Merritt Hawkins said only 3% of their search engagements were for solo practice or partnership settings, “underscoring the decline of physician private practice.”

Roughly two-thirds (67%) of Merritt Hawkins’ search engagements were in communities of 100,000 people or more, indicating that demand for physicians and advanced practitioners is not limited to small or rural communities.

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

The COVID-19 pandemic has fueled a growing demand for nurse practitioners (NPs), while demand for primary care physicians has cooled, according to Merritt Hawkins’ annual review of physician and advanced practitioner recruiting trends.

This marks the first time in the review’s 28-year history that NPs have topped the list of the most recruited practitioners, according to the medical search firm. In the 27 prior years, physicians held the top spot. For the previous 14 years, the No. 1 position was held by family physicians.

“COVID-19 and other market forces are changing the dynamics of physician and advanced practitioner recruiting. NPs are coming into their own in a market that puts a premium on easy access to care and cost containment,” Tom Florence, president of Merritt Hawkins, said in a statement.
 

Primary care ‘recruiting frenzy’ over

Mr. Florence said primary care physicians remain a “vital part of team-based care and will be increasingly responsible for coordinating the care of older patients with multiple chronic conditions. But the recruiting frenzy in primary care is over.”

Merritt Hawkins says that overall COVID-19 has had a “severely inhibiting” effect on demand for physicians. The number of searches the company conducted dropped 25%, compared with 2020, and many hospitals and medical groups shut down or lost money during the pandemic.

But the drop-off in demand for physicians is likely to be temporary because the underlying dynamics driving physician supply and demand remain in place, according to the report. These include a growing and aging population, a limited supply of newly trained physicians, and an aging physician workforce.

COVID-19 will not permanently change these market conditions, and demand for physicians already is rebounding, the company said.

The 2021 review of physician and advanced practitioner recruiting is based on a representative sample of 2,458 permanent search engagements that Merritt Hawkins/AMN Healthcare’s physician staffing companies conducted or were in the process of conducting during the 12-month period from April 1, 2020, to March 31, 2021.

Among the key findings:

• 18% of Merritt Hawkins’ recruiting searches were for advanced practitioners, including NPs, physician assistants (PAs), and certified registered nurse anesthetists, up from 13% in the 2020 review. This represents the highest percentage in the 28 years the review has been conducted.
• About two-thirds (64%) of Merritt Hawkins’ search engagements were for physician specialists, including radiologists, psychiatrists, gastroenterologists, and others, “highlighting the robust demand for specialty physicians.”
• In 2021, 18% of Merritt Hawkins’ search engagements were for primary care physicians, down from 20% in 2020 and 22% in 2019, “signaling a relative decline in demand for primary care doctors.”
• Psychiatrists placed fourth on the list of most requested search engagements, a sign of continued strong demand for mental health professionals that is likely to accelerate because of COVID-19.

Starting salaries take a pandemic hit

Owing to the reduced demand for practitioners, starting salaries decreased for many types of health care professions, with the exception of NPs and PAs.

Average starting salaries for NPs showed strong growth, increasing 12% year over year, from $125,000 to $140,000. The average starting salaries for PAs also showed strong growth, increasing by 14% year over year, from $112,000 to $128,000.

Among physicians, interventional cardiologists were offered the highest average starting salaries, at $611,000, followed by orthopedic surgeons, at $546,000. Pediatricians were offered the lowest average starting salaries, at $236,000.

Merritt Hawkins said only 3% of their search engagements were for solo practice or partnership settings, “underscoring the decline of physician private practice.”

Roughly two-thirds (67%) of Merritt Hawkins’ search engagements were in communities of 100,000 people or more, indicating that demand for physicians and advanced practitioners is not limited to small or rural communities.

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

The U.S. Food and Drug Administration (FDA) could green-light a booster dose of the COVID-19 mRNA vaccines for people with weakened immune systems within the next two days, according to multiple media reports.

The agency, along with the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health, is working through the details of how booster doses for this population would work, and could authorize a third dose of both the Pfizer and Moderna vaccines as early as Aug. 12, Politico reports.

About 2.7% of adults in the United States are immunocompromised, according to the CDC. This group includes people who have cancer, have received solid organ or stem cell transplants, have genetic conditions that weaken the immune function, have HIV, or are people with health conditions that require treatment with medications that turn down immune function, such as rheumatoid arthritis. 

Immune function also wanes with age, so the FDA could consider boosters for the elderly.

New research shows that between one-third and one-half of immunocompromised patients who didn’t develop detectable levels of virus-fighting antibodies after two doses of a COVID vaccine will respond to a third dose. 

A committee of independent experts that advises the CDC on the use of vaccines in the United States had previously signaled its support for giving boosters to those who are immunocompromised, but noted that it couldn’t officially recommend the strategy until the FDA had updated its emergency-use authorization for the shots or granted them a full biologics license, or “full approval.”

It’s unclear which mechanism the FDA might use, or exactly who will be eligible for the shots.

The United States would follow other nations such as Israel, France, the United Kingdom, and Germany in planning for or authorizing boosters for some vulnerable individuals.

The World Health Organization (WHO) has voiced strong opposition to the use of boosters in wealthy countries while much of the world still doesn’t have access to these lifesaving therapies. The WHO has asked wealthy nations to hold off on giving boosters until at least the end of September to give more people the opportunity to get a first dose.

The CDC’s Advisory Committee on Immunization Practices (ACIP) meets again on Aug. 13 and is expected to discuss booster doses for this population of patients. The ACIP officially makes recommendations on the use of vaccines to the nation’s doctors.

The committee’s recommendation ensures that a vaccine will be covered by public and private insurers. Statutory vaccination requirements are also made based on the ACIP’s recommendations.

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

The U.S. Food and Drug Administration (FDA) could green-light a booster dose of the COVID-19 mRNA vaccines for people with weakened immune systems within the next two days, according to multiple media reports.

The agency, along with the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health, is working through the details of how booster doses for this population would work, and could authorize a third dose of both the Pfizer and Moderna vaccines as early as Aug. 12, Politico reports.

About 2.7% of adults in the United States are immunocompromised, according to the CDC. This group includes people who have cancer, have received solid organ or stem cell transplants, have genetic conditions that weaken the immune function, have HIV, or are people with health conditions that require treatment with medications that turn down immune function, such as rheumatoid arthritis. 

Immune function also wanes with age, so the FDA could consider boosters for the elderly.

New research shows that between one-third and one-half of immunocompromised patients who didn’t develop detectable levels of virus-fighting antibodies after two doses of a COVID vaccine will respond to a third dose. 

A committee of independent experts that advises the CDC on the use of vaccines in the United States had previously signaled its support for giving boosters to those who are immunocompromised, but noted that it couldn’t officially recommend the strategy until the FDA had updated its emergency-use authorization for the shots or granted them a full biologics license, or “full approval.”

It’s unclear which mechanism the FDA might use, or exactly who will be eligible for the shots.

The United States would follow other nations such as Israel, France, the United Kingdom, and Germany in planning for or authorizing boosters for some vulnerable individuals.

The World Health Organization (WHO) has voiced strong opposition to the use of boosters in wealthy countries while much of the world still doesn’t have access to these lifesaving therapies. The WHO has asked wealthy nations to hold off on giving boosters until at least the end of September to give more people the opportunity to get a first dose.

The CDC’s Advisory Committee on Immunization Practices (ACIP) meets again on Aug. 13 and is expected to discuss booster doses for this population of patients. The ACIP officially makes recommendations on the use of vaccines to the nation’s doctors.

The committee’s recommendation ensures that a vaccine will be covered by public and private insurers. Statutory vaccination requirements are also made based on the ACIP’s recommendations.

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

The U.S. Food and Drug Administration (FDA) could green-light a booster dose of the COVID-19 mRNA vaccines for people with weakened immune systems within the next two days, according to multiple media reports.

The agency, along with the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health, is working through the details of how booster doses for this population would work, and could authorize a third dose of both the Pfizer and Moderna vaccines as early as Aug. 12, Politico reports.

About 2.7% of adults in the United States are immunocompromised, according to the CDC. This group includes people who have cancer, have received solid organ or stem cell transplants, have genetic conditions that weaken the immune function, have HIV, or are people with health conditions that require treatment with medications that turn down immune function, such as rheumatoid arthritis. 

Immune function also wanes with age, so the FDA could consider boosters for the elderly.

New research shows that between one-third and one-half of immunocompromised patients who didn’t develop detectable levels of virus-fighting antibodies after two doses of a COVID vaccine will respond to a third dose. 

A committee of independent experts that advises the CDC on the use of vaccines in the United States had previously signaled its support for giving boosters to those who are immunocompromised, but noted that it couldn’t officially recommend the strategy until the FDA had updated its emergency-use authorization for the shots or granted them a full biologics license, or “full approval.”

It’s unclear which mechanism the FDA might use, or exactly who will be eligible for the shots.

The United States would follow other nations such as Israel, France, the United Kingdom, and Germany in planning for or authorizing boosters for some vulnerable individuals.

The World Health Organization (WHO) has voiced strong opposition to the use of boosters in wealthy countries while much of the world still doesn’t have access to these lifesaving therapies. The WHO has asked wealthy nations to hold off on giving boosters until at least the end of September to give more people the opportunity to get a first dose.

The CDC’s Advisory Committee on Immunization Practices (ACIP) meets again on Aug. 13 and is expected to discuss booster doses for this population of patients. The ACIP officially makes recommendations on the use of vaccines to the nation’s doctors.

The committee’s recommendation ensures that a vaccine will be covered by public and private insurers. Statutory vaccination requirements are also made based on the ACIP’s recommendations.

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