Practice Alert

Two pneumococcal vaccines are licensed for use in the United States: the 13-valent pneumococcal conjugate vaccine (PCV13 [Prevnar 13, Wyeth]) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23 [Pneumovax, Merck]). The recommendations for using these vaccines in adults ages ≥ 19 years are arguably among the most complicated and confusing of all vaccine recommendations made by the Advisory Committee on Immunization Practices (ACIP).

In June 2019, things got even more complicated with ACIP’s unusual decision to change the previous recommendation on the routine use of PCV13 in adults ≥ 65 years. The new recommendation states that PCV13 should be used in immunocompetent older adults only after individual clinical decision making. The recommendation for routine use of PPSV23 remains unchanged. This Practice Alert explains the reasoning behind this change and its practical implications.

How we got to where we are now

Nearly 20 years ago, PCV was introduced into the child immunization schedule in the United States as a 7-valent vaccine (PCV7). In 2010, it was modified to include 13 antigens. And in 2012, the use of PCV13 was expanded to include adults with immunocompromising conditions.¹ In 2014, PCV13 was recommended as an addition to PPSV23 for adults ≥ 65 years.² However, with this recommendation, ACIP noted that the incidence of invasive pneumococcal disease in the elderly had been declining since the introduction of PCV7 use in children in the year 2000 (FIGURE 1³), presumably due to the decreased transmission of pneumococcal infections from children to older adults.

Because it was unclear in 2014 how much added benefit PCV13 would offer older adults, ACIP voted to restudy the issue after 4 years. At the June 2019 ACIP meeting, the results of an interim analysis were presented. ACIP concluded that routine use of PCV13 in immunocompetent adults ≥ 65 years adds little population-wide public health benefit given the vaccine’s routine use among children and immunocompromised adults (FIGURE 2³).

ACIP had 3 options in formulating its recommendations.

• Recommend the vaccine for routine use universally or among designated high-risk groups.
• Do not recommend the vaccine.
• Recommend the vaccine only for specific patients after individualized clinical decision making.

The last option—the one ACIP decided on—applies when a safe and immunogenic vaccine has been approved by the Food and Drug Administration and may be beneficial for (or desired by) individuals even though it does not meet criteria for routine universal or targeted use.

Practical issues

ACIP recommendations for the use of PCV13 and PPSV23 in adults vary according to 3 categories of health status: immunocompetent patients with underlying medical conditions; those with functional or anatomic asplenia; and immunocompromised individuals (TABLE¹). Those in the latter 2 categories should receive both PCV13 and PPSV23 and be revaccinated once with PPSV23 before the age of 65 (given 5 years after the first dose). For immunocompetent individuals with underlying medical conditions, only those with cerebral spinal fluid leaks or cochlear implants should receive both PCV13 and PPSV23, although revaccination with PPSV23 before the age of 65 is not recommended.

Continue to: Prior to the recent change...

Prior to the recent change, ACIP recommended both PCV13 and PPSV23 for those ≥ 65 years. Now, PCV13 is not recommended routinely for immunocompetent adults ≥ 65 years; however, individuals in this age group who have chronic underlying medical conditions may receive PCV13 after consulting with their physician. PPSV23 is still recommended for all adults in this age group. Recommendations for those with immunocompromising conditions are also unchanged.

3 sentences summarize change in ­vaccine intervals. Another source of confusion is the recommended intervals in administering the 2 vaccines when both are indicated. The current guidance has been simplified and can be summarized in 3 sentences⁴:

• When both PCV13 and PPSV23 are indicated, give PCV13 before PPSV23.
• For patients ≥ 65 years, separate the vaccines by 12 months or more—­regardless of which vaccine is administered first.
• For patients who are 19 to 64 years of age, separate the vaccines by ≥ 8 weeks.

Advice on repeating the PPSV23 vaccine also can be summarized in 3 sentences¹:

• When a repeat PPSV23 dose is indicated, give it at least 5 years after the first dose.
• Administer no more than 2 doses before age 65.
• For an individual older than 65, only 1 dose should be administered and it should be done at least 5 years after a previous PPSV23 dose.

Two pneumococcal vaccines are licensed for use in the United States: the 13-valent pneumococcal conjugate vaccine (PCV13 [Prevnar 13, Wyeth]) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23 [Pneumovax, Merck]). The recommendations for using these vaccines in adults ages ≥ 19 years are arguably among the most complicated and confusing of all vaccine recommendations made by the Advisory Committee on Immunization Practices (ACIP).

In June 2019, things got even more complicated with ACIP’s unusual decision to change the previous recommendation on the routine use of PCV13 in adults ≥ 65 years. The new recommendation states that PCV13 should be used in immunocompetent older adults only after individual clinical decision making. The recommendation for routine use of PPSV23 remains unchanged. This Practice Alert explains the reasoning behind this change and its practical implications.

How we got to where we are now

Nearly 20 years ago, PCV was introduced into the child immunization schedule in the United States as a 7-valent vaccine (PCV7). In 2010, it was modified to include 13 antigens. And in 2012, the use of PCV13 was expanded to include adults with immunocompromising conditions.¹ In 2014, PCV13 was recommended as an addition to PPSV23 for adults ≥ 65 years.² However, with this recommendation, ACIP noted that the incidence of invasive pneumococcal disease in the elderly had been declining since the introduction of PCV7 use in children in the year 2000 (FIGURE 1³), presumably due to the decreased transmission of pneumococcal infections from children to older adults.

Because it was unclear in 2014 how much added benefit PCV13 would offer older adults, ACIP voted to restudy the issue after 4 years. At the June 2019 ACIP meeting, the results of an interim analysis were presented. ACIP concluded that routine use of PCV13 in immunocompetent adults ≥ 65 years adds little population-wide public health benefit given the vaccine’s routine use among children and immunocompromised adults (FIGURE 2³).

ACIP had 3 options in formulating its recommendations.

• Recommend the vaccine for routine use universally or among designated high-risk groups.
• Do not recommend the vaccine.
• Recommend the vaccine only for specific patients after individualized clinical decision making.

The last option—the one ACIP decided on—applies when a safe and immunogenic vaccine has been approved by the Food and Drug Administration and may be beneficial for (or desired by) individuals even though it does not meet criteria for routine universal or targeted use.

Practical issues

ACIP recommendations for the use of PCV13 and PPSV23 in adults vary according to 3 categories of health status: immunocompetent patients with underlying medical conditions; those with functional or anatomic asplenia; and immunocompromised individuals (TABLE¹). Those in the latter 2 categories should receive both PCV13 and PPSV23 and be revaccinated once with PPSV23 before the age of 65 (given 5 years after the first dose). For immunocompetent individuals with underlying medical conditions, only those with cerebral spinal fluid leaks or cochlear implants should receive both PCV13 and PPSV23, although revaccination with PPSV23 before the age of 65 is not recommended.

Continue to: Prior to the recent change...

Prior to the recent change, ACIP recommended both PCV13 and PPSV23 for those ≥ 65 years. Now, PCV13 is not recommended routinely for immunocompetent adults ≥ 65 years; however, individuals in this age group who have chronic underlying medical conditions may receive PCV13 after consulting with their physician. PPSV23 is still recommended for all adults in this age group. Recommendations for those with immunocompromising conditions are also unchanged.

3 sentences summarize change in ­vaccine intervals. Another source of confusion is the recommended intervals in administering the 2 vaccines when both are indicated. The current guidance has been simplified and can be summarized in 3 sentences⁴:

• When both PCV13 and PPSV23 are indicated, give PCV13 before PPSV23.
• For patients ≥ 65 years, separate the vaccines by 12 months or more—­regardless of which vaccine is administered first.
• For patients who are 19 to 64 years of age, separate the vaccines by ≥ 8 weeks.

Advice on repeating the PPSV23 vaccine also can be summarized in 3 sentences¹:

• When a repeat PPSV23 dose is indicated, give it at least 5 years after the first dose.
• Administer no more than 2 doses before age 65.
• For an individual older than 65, only 1 dose should be administered and it should be done at least 5 years after a previous PPSV23 dose.

Two pneumococcal vaccines are licensed for use in the United States: the 13-valent pneumococcal conjugate vaccine (PCV13 [Prevnar 13, Wyeth]) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23 [Pneumovax, Merck]). The recommendations for using these vaccines in adults ages ≥ 19 years are arguably among the most complicated and confusing of all vaccine recommendations made by the Advisory Committee on Immunization Practices (ACIP).

In June 2019, things got even more complicated with ACIP’s unusual decision to change the previous recommendation on the routine use of PCV13 in adults ≥ 65 years. The new recommendation states that PCV13 should be used in immunocompetent older adults only after individual clinical decision making. The recommendation for routine use of PPSV23 remains unchanged. This Practice Alert explains the reasoning behind this change and its practical implications.

How we got to where we are now

Nearly 20 years ago, PCV was introduced into the child immunization schedule in the United States as a 7-valent vaccine (PCV7). In 2010, it was modified to include 13 antigens. And in 2012, the use of PCV13 was expanded to include adults with immunocompromising conditions.¹ In 2014, PCV13 was recommended as an addition to PPSV23 for adults ≥ 65 years.² However, with this recommendation, ACIP noted that the incidence of invasive pneumococcal disease in the elderly had been declining since the introduction of PCV7 use in children in the year 2000 (FIGURE 1³), presumably due to the decreased transmission of pneumococcal infections from children to older adults.

Because it was unclear in 2014 how much added benefit PCV13 would offer older adults, ACIP voted to restudy the issue after 4 years. At the June 2019 ACIP meeting, the results of an interim analysis were presented. ACIP concluded that routine use of PCV13 in immunocompetent adults ≥ 65 years adds little population-wide public health benefit given the vaccine’s routine use among children and immunocompromised adults (FIGURE 2³).

ACIP had 3 options in formulating its recommendations.

• Recommend the vaccine for routine use universally or among designated high-risk groups.
• Do not recommend the vaccine.
• Recommend the vaccine only for specific patients after individualized clinical decision making.

The last option—the one ACIP decided on—applies when a safe and immunogenic vaccine has been approved by the Food and Drug Administration and may be beneficial for (or desired by) individuals even though it does not meet criteria for routine universal or targeted use.

Practical issues

ACIP recommendations for the use of PCV13 and PPSV23 in adults vary according to 3 categories of health status: immunocompetent patients with underlying medical conditions; those with functional or anatomic asplenia; and immunocompromised individuals (TABLE¹). Those in the latter 2 categories should receive both PCV13 and PPSV23 and be revaccinated once with PPSV23 before the age of 65 (given 5 years after the first dose). For immunocompetent individuals with underlying medical conditions, only those with cerebral spinal fluid leaks or cochlear implants should receive both PCV13 and PPSV23, although revaccination with PPSV23 before the age of 65 is not recommended.

Continue to: Prior to the recent change...

Prior to the recent change, ACIP recommended both PCV13 and PPSV23 for those ≥ 65 years. Now, PCV13 is not recommended routinely for immunocompetent adults ≥ 65 years; however, individuals in this age group who have chronic underlying medical conditions may receive PCV13 after consulting with their physician. PPSV23 is still recommended for all adults in this age group. Recommendations for those with immunocompromising conditions are also unchanged.

3 sentences summarize change in ­vaccine intervals. Another source of confusion is the recommended intervals in administering the 2 vaccines when both are indicated. The current guidance has been simplified and can be summarized in 3 sentences⁴:

• When both PCV13 and PPSV23 are indicated, give PCV13 before PPSV23.
• For patients ≥ 65 years, separate the vaccines by 12 months or more—­regardless of which vaccine is administered first.
• For patients who are 19 to 64 years of age, separate the vaccines by ≥ 8 weeks.

Advice on repeating the PPSV23 vaccine also can be summarized in 3 sentences¹:

• When a repeat PPSV23 dose is indicated, give it at least 5 years after the first dose.
• Administer no more than 2 doses before age 65.
• For an individual older than 65, only 1 dose should be administered and it should be done at least 5 years after a previous PPSV23 dose.

2018-2019 season retrospective

Last year’s influenza season was longer than usual. Infections, as measured by the percentage of outpatient visits due to influenza-like illness, increased in early November 2018, peaked in early February to mid-March of 2019, and remained above baseline levels through mid-May.^1,2 Ninety six percent of influenza-positive samples were influenza A,¹ and 57% of those were H1N1.² In the second half of the season, H3N2 became the predominant circulating virus and there was a genetic shift in this strain that caused a decrease in the effectiveness of influenza vaccines ­(FIGURE).¹ The influenza-confirmed hospitalization rate was 65.3/100,000, with the highest rate (221.7/100,000) occurring among those 65 years of age and older.² Of those hospitalized with influenza, 93% of adults and 55% of children had an underlying medical condition and 29% of women of childbearing age were pregnant.²

Morbidity and mortality from influenza during the 2018-2019 influenza season were moderate compared with previous years. Pneumonia and influenza mortality reached close to 8% of all deaths during the peak of the season (considered a modest peak), but stayed above the epidemic threshold for 10 weeks.² There were 119 pediatric deaths.¹ Overall, in the United States, there were an estimated 37 to 43 million influenza-related illnesses, 17 to 20 million flu-related medical visits, 531,000 to 647,000 flu-related hospitalizations, and 36,400 to 61,200 deaths.¹

Influenza viral resistance to oseltamivir remained very low throughout the season for both A and B viruses.²

Vaccine effectiveness was subpar

The effectiveness of influenza vaccine last season was disappointing. When assessed using laboratory-confirmed medically attended influenza, the vaccine was 29% effective; when assessed by age group, the confidence intervals included 0 in ages 9 to 17 years and 50 years and older.³ In the age group 6 months to 8 years, the vaccine was 49% effective.³ The vaccine was not effective against the predominant H3N2 strain circulating. It was 25% effective in preventing hospitalization, with a lack of benefit seen in individuals ages 18 to 49 years and those 65 and older.³

Vaccination was associated with increased rates of hospitalizations from infections cause by H3N2. It is not known if this finding was due to chance, unstable results from small numbers, an unknown bias, or some biological cause not yet understood. This is a topic of ongoing research.

Effectiveness in preventing pediatric hospitalizations was estimated at 31%, again with no effectiveness against H3N2.³ The estimate of vaccine effectiveness in the United States was similar to that in Canada.²

While these results are much lower than desired, influenza vaccine did prevent an estimated 40,000 to 90,000 hospitalizations and decreased influenza-like illnesses by 44%.³

Continue to: A look at vaccine safety

Numerous studies of influenza vaccine safety were presented at the June 2019 meeting of the Advisory Committee on Immunization Practices (ACIP).⁴ These studies included assessments using the Vaccine Adverse Events Reporting System; the Vaccine Safety Datalink (VSD), which conducts ongoing rapid analysis of adverse events throughout the influenza season; and Food and Drug Administration (FDA)-sponsored studies of Medicare patients. These vaccine safety monitoring systems have been described in a prior Practice Alert.⁵

The effectiveness of the influenza vaccine last season was disappointing. When assessed using laboratory-confirmed medically attended influenza, the vaccine was 29% effective.

Possible vaccine reactions studied included Guillain-Barre Syndrome (GBS), anaphylaxis, encephalitis, Bell’s palsy, febrile seizures, and pregnancy-related adverse events such as miscarriage and congenital anomalies. While preliminary safety signals were detected for anaphylaxis, Bell’s palsy, febrile seizures, and GBS, a more in-depth investigation found no association of any adverse events with vaccination except for febrile seizures, with an attributable risk of 4.24/100,000 doses in children ages 6 to 23 months and 1.8/100,000 in those ages 24 to 59 months.⁴ The incidence of febrile seizures was similar to that of previous seasons and primarily occurred when the vaccine was administered in conjunction with another vaccine. A preliminary FDA analysis found a small elevated risk of GBS with high-dose trivalent inactivated vaccine, with an attributable risk of 0.98 per million doses, but this was not confirmed by the VSD analysis.⁴

What you need to know about the upcoming season

ACIP recommendations on influenza vaccines for 2019 to 2020 are essentially unchanged from last year.⁶ All individuals ages 6 months and older, who do not have a contraindication, should receive a flu vaccine in the fall of 2019. The composition of this season’s vaccine contains new H1N1 and H3N2 variants to more closely match the circulating strains. ACIP has updated or clarified 4 logistical issues in this year’s recommendations:

1. Four inactivated-influenza vaccines are now available for children ages 6 to 35 months. Dose volumes are not the same for all 4 (TABLE).⁷
2. Vaccination is now encouraged for September or later for those requiring only 1 dose of vaccine. Earlier administration can result in waning immunity by the end of the flu season, especially in older adults.⁷
3. Children ages 6 months to 8 years may require 2 doses if they haven’t received any previous influenza vaccine, and the second dose should be given even if the child turns 9 between doses 1 and 2.⁷
4. One adjuvanted influenza vaccine containing MF59—the trivalent inactivated influenza vaccine, Fluad—is approved for those ages 65 years and older. One note of caution is that licensed vaccines for other conditions also contain new nonaluminum adjuvants and there are few data on the safety and effectiveness of simultaneous or sequential administration of Fluad with the 2 novel nonaluminum adjuvant-containing vaccines. These vaccines are the recombinant zoster subunit vaccine (Shingrix), which contains the liposome-based adjuvant ASO1, and the recombinant hepatitis B surface antigen vaccine (Heplisav-B), which contains cytosine phosphoguanine oligodeoxynucleotide. Given the lack of data and the availability of other influenza vaccine options, ACIP advises that selecting a nonadjuvanted influenza vaccine may be the best option when an older adult needs both an influenza vaccine and either Shingrix or Heplisav-B. However, do not delay giving any vaccine if a specific alternate product is unavailable.⁷

All recommendations concerning the use of influenza vaccine for the 2019-2020 influenza season and a listing of all available influenza vaccine products can be found on the ACIP Web site (cdc.gov/vaccines/acip/index.html) or in the Morbidity and Mortality Weekly Report.⁸

2018-2019 season retrospective

Last year’s influenza season was longer than usual. Infections, as measured by the percentage of outpatient visits due to influenza-like illness, increased in early November 2018, peaked in early February to mid-March of 2019, and remained above baseline levels through mid-May.^1,2 Ninety six percent of influenza-positive samples were influenza A,¹ and 57% of those were H1N1.² In the second half of the season, H3N2 became the predominant circulating virus and there was a genetic shift in this strain that caused a decrease in the effectiveness of influenza vaccines ­(FIGURE).¹ The influenza-confirmed hospitalization rate was 65.3/100,000, with the highest rate (221.7/100,000) occurring among those 65 years of age and older.² Of those hospitalized with influenza, 93% of adults and 55% of children had an underlying medical condition and 29% of women of childbearing age were pregnant.²

Morbidity and mortality from influenza during the 2018-2019 influenza season were moderate compared with previous years. Pneumonia and influenza mortality reached close to 8% of all deaths during the peak of the season (considered a modest peak), but stayed above the epidemic threshold for 10 weeks.² There were 119 pediatric deaths.¹ Overall, in the United States, there were an estimated 37 to 43 million influenza-related illnesses, 17 to 20 million flu-related medical visits, 531,000 to 647,000 flu-related hospitalizations, and 36,400 to 61,200 deaths.¹

Influenza viral resistance to oseltamivir remained very low throughout the season for both A and B viruses.²

Vaccine effectiveness was subpar

The effectiveness of influenza vaccine last season was disappointing. When assessed using laboratory-confirmed medically attended influenza, the vaccine was 29% effective; when assessed by age group, the confidence intervals included 0 in ages 9 to 17 years and 50 years and older.³ In the age group 6 months to 8 years, the vaccine was 49% effective.³ The vaccine was not effective against the predominant H3N2 strain circulating. It was 25% effective in preventing hospitalization, with a lack of benefit seen in individuals ages 18 to 49 years and those 65 and older.³

Vaccination was associated with increased rates of hospitalizations from infections cause by H3N2. It is not known if this finding was due to chance, unstable results from small numbers, an unknown bias, or some biological cause not yet understood. This is a topic of ongoing research.

Effectiveness in preventing pediatric hospitalizations was estimated at 31%, again with no effectiveness against H3N2.³ The estimate of vaccine effectiveness in the United States was similar to that in Canada.²

While these results are much lower than desired, influenza vaccine did prevent an estimated 40,000 to 90,000 hospitalizations and decreased influenza-like illnesses by 44%.³

Continue to: A look at vaccine safety

Numerous studies of influenza vaccine safety were presented at the June 2019 meeting of the Advisory Committee on Immunization Practices (ACIP).⁴ These studies included assessments using the Vaccine Adverse Events Reporting System; the Vaccine Safety Datalink (VSD), which conducts ongoing rapid analysis of adverse events throughout the influenza season; and Food and Drug Administration (FDA)-sponsored studies of Medicare patients. These vaccine safety monitoring systems have been described in a prior Practice Alert.⁵

The effectiveness of the influenza vaccine last season was disappointing. When assessed using laboratory-confirmed medically attended influenza, the vaccine was 29% effective.

Possible vaccine reactions studied included Guillain-Barre Syndrome (GBS), anaphylaxis, encephalitis, Bell’s palsy, febrile seizures, and pregnancy-related adverse events such as miscarriage and congenital anomalies. While preliminary safety signals were detected for anaphylaxis, Bell’s palsy, febrile seizures, and GBS, a more in-depth investigation found no association of any adverse events with vaccination except for febrile seizures, with an attributable risk of 4.24/100,000 doses in children ages 6 to 23 months and 1.8/100,000 in those ages 24 to 59 months.⁴ The incidence of febrile seizures was similar to that of previous seasons and primarily occurred when the vaccine was administered in conjunction with another vaccine. A preliminary FDA analysis found a small elevated risk of GBS with high-dose trivalent inactivated vaccine, with an attributable risk of 0.98 per million doses, but this was not confirmed by the VSD analysis.⁴

What you need to know about the upcoming season

ACIP recommendations on influenza vaccines for 2019 to 2020 are essentially unchanged from last year.⁶ All individuals ages 6 months and older, who do not have a contraindication, should receive a flu vaccine in the fall of 2019. The composition of this season’s vaccine contains new H1N1 and H3N2 variants to more closely match the circulating strains. ACIP has updated or clarified 4 logistical issues in this year’s recommendations:

1. Four inactivated-influenza vaccines are now available for children ages 6 to 35 months. Dose volumes are not the same for all 4 (TABLE).⁷
2. Vaccination is now encouraged for September or later for those requiring only 1 dose of vaccine. Earlier administration can result in waning immunity by the end of the flu season, especially in older adults.⁷
3. Children ages 6 months to 8 years may require 2 doses if they haven’t received any previous influenza vaccine, and the second dose should be given even if the child turns 9 between doses 1 and 2.⁷
4. One adjuvanted influenza vaccine containing MF59—the trivalent inactivated influenza vaccine, Fluad—is approved for those ages 65 years and older. One note of caution is that licensed vaccines for other conditions also contain new nonaluminum adjuvants and there are few data on the safety and effectiveness of simultaneous or sequential administration of Fluad with the 2 novel nonaluminum adjuvant-containing vaccines. These vaccines are the recombinant zoster subunit vaccine (Shingrix), which contains the liposome-based adjuvant ASO1, and the recombinant hepatitis B surface antigen vaccine (Heplisav-B), which contains cytosine phosphoguanine oligodeoxynucleotide. Given the lack of data and the availability of other influenza vaccine options, ACIP advises that selecting a nonadjuvanted influenza vaccine may be the best option when an older adult needs both an influenza vaccine and either Shingrix or Heplisav-B. However, do not delay giving any vaccine if a specific alternate product is unavailable.⁷

All recommendations concerning the use of influenza vaccine for the 2019-2020 influenza season and a listing of all available influenza vaccine products can be found on the ACIP Web site (cdc.gov/vaccines/acip/index.html) or in the Morbidity and Mortality Weekly Report.⁸

2018-2019 season retrospective

Last year’s influenza season was longer than usual. Infections, as measured by the percentage of outpatient visits due to influenza-like illness, increased in early November 2018, peaked in early February to mid-March of 2019, and remained above baseline levels through mid-May.^1,2 Ninety six percent of influenza-positive samples were influenza A,¹ and 57% of those were H1N1.² In the second half of the season, H3N2 became the predominant circulating virus and there was a genetic shift in this strain that caused a decrease in the effectiveness of influenza vaccines ­(FIGURE).¹ The influenza-confirmed hospitalization rate was 65.3/100,000, with the highest rate (221.7/100,000) occurring among those 65 years of age and older.² Of those hospitalized with influenza, 93% of adults and 55% of children had an underlying medical condition and 29% of women of childbearing age were pregnant.²

Morbidity and mortality from influenza during the 2018-2019 influenza season were moderate compared with previous years. Pneumonia and influenza mortality reached close to 8% of all deaths during the peak of the season (considered a modest peak), but stayed above the epidemic threshold for 10 weeks.² There were 119 pediatric deaths.¹ Overall, in the United States, there were an estimated 37 to 43 million influenza-related illnesses, 17 to 20 million flu-related medical visits, 531,000 to 647,000 flu-related hospitalizations, and 36,400 to 61,200 deaths.¹

Influenza viral resistance to oseltamivir remained very low throughout the season for both A and B viruses.²

Vaccine effectiveness was subpar

The effectiveness of influenza vaccine last season was disappointing. When assessed using laboratory-confirmed medically attended influenza, the vaccine was 29% effective; when assessed by age group, the confidence intervals included 0 in ages 9 to 17 years and 50 years and older.³ In the age group 6 months to 8 years, the vaccine was 49% effective.³ The vaccine was not effective against the predominant H3N2 strain circulating. It was 25% effective in preventing hospitalization, with a lack of benefit seen in individuals ages 18 to 49 years and those 65 and older.³

Vaccination was associated with increased rates of hospitalizations from infections cause by H3N2. It is not known if this finding was due to chance, unstable results from small numbers, an unknown bias, or some biological cause not yet understood. This is a topic of ongoing research.

Effectiveness in preventing pediatric hospitalizations was estimated at 31%, again with no effectiveness against H3N2.³ The estimate of vaccine effectiveness in the United States was similar to that in Canada.²

While these results are much lower than desired, influenza vaccine did prevent an estimated 40,000 to 90,000 hospitalizations and decreased influenza-like illnesses by 44%.³

Continue to: A look at vaccine safety

Numerous studies of influenza vaccine safety were presented at the June 2019 meeting of the Advisory Committee on Immunization Practices (ACIP).⁴ These studies included assessments using the Vaccine Adverse Events Reporting System; the Vaccine Safety Datalink (VSD), which conducts ongoing rapid analysis of adverse events throughout the influenza season; and Food and Drug Administration (FDA)-sponsored studies of Medicare patients. These vaccine safety monitoring systems have been described in a prior Practice Alert.⁵

The effectiveness of the influenza vaccine last season was disappointing. When assessed using laboratory-confirmed medically attended influenza, the vaccine was 29% effective.

Possible vaccine reactions studied included Guillain-Barre Syndrome (GBS), anaphylaxis, encephalitis, Bell’s palsy, febrile seizures, and pregnancy-related adverse events such as miscarriage and congenital anomalies. While preliminary safety signals were detected for anaphylaxis, Bell’s palsy, febrile seizures, and GBS, a more in-depth investigation found no association of any adverse events with vaccination except for febrile seizures, with an attributable risk of 4.24/100,000 doses in children ages 6 to 23 months and 1.8/100,000 in those ages 24 to 59 months.⁴ The incidence of febrile seizures was similar to that of previous seasons and primarily occurred when the vaccine was administered in conjunction with another vaccine. A preliminary FDA analysis found a small elevated risk of GBS with high-dose trivalent inactivated vaccine, with an attributable risk of 0.98 per million doses, but this was not confirmed by the VSD analysis.⁴

What you need to know about the upcoming season

ACIP recommendations on influenza vaccines for 2019 to 2020 are essentially unchanged from last year.⁶ All individuals ages 6 months and older, who do not have a contraindication, should receive a flu vaccine in the fall of 2019. The composition of this season’s vaccine contains new H1N1 and H3N2 variants to more closely match the circulating strains. ACIP has updated or clarified 4 logistical issues in this year’s recommendations:

1. Four inactivated-influenza vaccines are now available for children ages 6 to 35 months. Dose volumes are not the same for all 4 (TABLE).⁷
2. Vaccination is now encouraged for September or later for those requiring only 1 dose of vaccine. Earlier administration can result in waning immunity by the end of the flu season, especially in older adults.⁷
3. Children ages 6 months to 8 years may require 2 doses if they haven’t received any previous influenza vaccine, and the second dose should be given even if the child turns 9 between doses 1 and 2.⁷
4. One adjuvanted influenza vaccine containing MF59—the trivalent inactivated influenza vaccine, Fluad—is approved for those ages 65 years and older. One note of caution is that licensed vaccines for other conditions also contain new nonaluminum adjuvants and there are few data on the safety and effectiveness of simultaneous or sequential administration of Fluad with the 2 novel nonaluminum adjuvant-containing vaccines. These vaccines are the recombinant zoster subunit vaccine (Shingrix), which contains the liposome-based adjuvant ASO1, and the recombinant hepatitis B surface antigen vaccine (Heplisav-B), which contains cytosine phosphoguanine oligodeoxynucleotide. Given the lack of data and the availability of other influenza vaccine options, ACIP advises that selecting a nonadjuvanted influenza vaccine may be the best option when an older adult needs both an influenza vaccine and either Shingrix or Heplisav-B. However, do not delay giving any vaccine if a specific alternate product is unavailable.⁷

All recommendations concerning the use of influenza vaccine for the 2019-2020 influenza season and a listing of all available influenza vaccine products can be found on the ACIP Web site (cdc.gov/vaccines/acip/index.html) or in the Morbidity and Mortality Weekly Report.⁸

The current increase in measles cases in the United States has sharpened the focus on antivaccine activities. While the percentage of US children who are fully vaccinated remains high (≥ 94%), the number of un- or undervaccinated children has been growing¹ because of nonmedical exemptions from school vaccine requirements due to concerns about vaccine safety and an underappreciation of the benefits of vaccines. Family physicians need to be conversant with several important aspects of this matter, including the magnitude of benefits provided by childhood vaccines, as well as the systems already in place for

• assessing vaccine effectiveness and safety,
• making recommendations on the use of vaccines,
• monitoring safety after vaccine approval, and
• compensating those affected by rare but serious vaccine-related adverse events (AEs).

Familiarity with these issues will allow for informed discussions with parents who are vaccine hesitant and with those who have read or heard inaccurate information.

The benefits of vaccines are indisputable

In 1999, the Centers for Disease Control and Prevention (CDC) published a list of 9 selected childhood infectious diseases and compared their incidences before and after immunization was available.² Each of these infections causes morbidity, sequelae, and mortality at predictable rates depending on the infectious agent. The comparisons were dramatic: Measles, with a baseline annual morbidity of 503,282 cases, fell to just 89 cases; poliomyelitis decreased from 16,316 to 0; and Haemophilus influenzae type b declined from 20,000 to 54. In a 2014 analysis, the CDC stated that “among 78.6 million children born during 1994–2013, routine childhood immunization was estimated to prevent 322 million illnesses (averaging 4.1 illnesses per child) and 21 million hospitalizations (0.27 per child) over the course of their lifetimes and avert 732,000 premature deaths from vaccine-preventable illnesses” (TABLE).³

It is not unusual to hear a vaccine opponent say that childhood infectious diseases are not serious and that it is better for a child to contract the infection and let the immune system fight it naturally. Measles is often used as an example. This argument ignores some important aspects of vaccine benefits.

It is true in the United States that the average child who contracts measles will recover from it and not suffer immediate or long-term effects. However, it is also true that measles has a hospitalization rate of about 20% and a death rate of between 1/500 and 1/1000 cases.⁴ Mortality is much higher in developing countries. Prior to widespread use of measles vaccine, hundreds of thousands of cases of measles occurred each year. That translated into hundreds of preventable child deaths per year. An individual case does not tell the full story about the public health impact of infectious illnesses.

In addition, there are often unappreciated sequelae from child infections, such as shingles occurring years after resolution of a chickenpox infection. There are also societal consequences of child infections, such as deafness from congenital rubella and intergenerational transfer of infectious agents to family members at risk for serious consequences (influenza from a child to a grandparent). Finally, infected children pose a risk to those who cannot be vaccinated because of immune deficiencies and other medical conditions.

A multilayered US system monitors vaccine safety

Responsibility for assuring the safety of vaccines lies with the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research and with the CDC’s Immunization Safety Office (ISO). The FDA is responsible for the initial assessment of the effectiveness and safety of new vaccines and for ongoing monitoring of the manufacturing facilities where vaccines are produced. After FDA approval, safety is monitored using a multilayered system that includes the Vaccine Adverse Event Reporting System (VAERS), the Vaccine Safety Datalink (VSD) system, the Clinical Immunization Safety Assessment (CISA) Project, and periodic reviews by the National Academy of Medicine (NAM), previously the Institute of Medicine. In addition, there is a large number of studies published each year by the nation’s—and world’s—medical research community on vaccine effectiveness and safety.

Continue to: VAERS

VAERS (https://vaers.hhs.gov/) is a passive reporting system that allows patients, physicians, and other health care providers to record suspected vaccine-related adverse events.⁵ It was created in 1990 and is run by the FDA and the CDC. It is not intended to be a comprehensive or definitive list of proven vaccine-related harms. As a passive reporting system, it is subject to both over- and underreporting, and the data from it are often misinterpreted and used incorrectly by vaccine opponents—eg, wrongly declaring that VAERS reports of possible AEs are proven cases. It provides a sentinel system that is monitored for indications of possible serious AEs linked to a particular vaccine. When a suspected interaction is detected, it is investigated by the VSD system.

VSD is a collaboration of the CDC’s ISO and 8 geographically distributed health care organizations with complete electronic patient medical information on their members. VSD conducts studies when a question about vaccine safety arises, when new vaccines are licensed, or when there are new vaccine recommendations. A description of VSD sites, the research methods used, and a list of publications describing study results can be found at https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html#organizations. If the VSD system finds a link between serious AEs and a particular vaccine, this association is reported to the Advisory Committee on Immunization Practices (ACIP) for consideration in changing recommendations regarding that vaccine. This happens only rarely.

It is true that the average American child who contracts measles will recover from it and not suffer long-term effects. However, it is also true that measles has a death rate of between 1/500 and 1/1000 cases.

CISA was established in 2001 as a network of vaccine safety experts at 7 academic medical centers who collaborate with the CDC’s ISO. CISA conducts studies on specific questions related to vaccine safety and provides a consultation service to clinicians and researchers who have questions about vaccine safety. A description of the CISA sites, past publications on vaccine safety, and ongoing research priorities can be found at https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.html.

NAM (https://nam.edu/) conducts periodic reviews of vaccine safety and vaccine-caused AEs. The most recent was published in 2012 and looked at possible AEs of 8 vaccines containing 12 different antigens.⁶ The literature search for this review found more than 12,000 articles, which speaks to the volume of scientific work on vaccine safety. These NAM reports document the rarity of severe AEs to vaccines and are used with other information to construct the table for the Vaccine Injury Compensation Program (VICP), which is described below.

Are vaccines killing children?

Vaccine opponents frequently claim that vaccines cause much more harm than is documented, including the deaths of children. A vaccine opponent made this claim in my state (Arizona) at a legislative committee hearing even though our state child mortality review committee has been investigating all child deaths for decades and has never attributed a death to a vaccine.

Continue to: One study conducted...

One study conducted using the VSD system from January 1, 2005, to December 31, 2011, identified 1100 deaths occurring within 12 months of any vaccination among 2,189,504 VSD enrollees ages 9 to 26 years.⁷ They found that the risk of death in this age group was not increased during the 30 days after vaccination, and no deaths were found to be causally associated with vaccination. Deaths among children do occur and, due to the number of vaccines administered, some deaths will occur within a short time period after a vaccine. This temporal association does not prove the death was vaccine-caused, but vaccine opponents have claimed that it does.

The vaccine injury compensation system

In 1986, the federal government established a no-fault system—the National Vaccine Injury Compensation Program (VICP)—to compensate those who suffer a serious AE from a vaccine covered by the program. This system is administered by the Health Resources and Services Administration (HRSA) in the Department of Health and Human Services (DHHS). HRSA maintains a table of proven AEs of specific vaccines, based in part on the NAM report mentioned earlier. Petitions for compensation—with proof of an AE following the administration of a vaccine that is included on the HRSA table—are accepted and remunerated if the AE lasted > 6 months or resulted in hospitalization. Petitions that allege AEs following administration of a vaccine not included on the table are nevertheless reviewed by the staff of HRSA, who can still recommend compensation based on the medical evidence. If HRSA declines the petition, the petitioner can appeal the case in the US Court of Federal Claims, which makes the final decision on a petition’s validity and, if warranted, the type and amount of compensation.

From 2006 to 2017, > 3.4 billion doses of vaccines covered by VICP were distributed in the United States.⁸ During this period, 6293 petitions were adjudicated by the court; 4311 were compensated.⁸ For every 1 million doses of vaccine distributed, 1 individual was compensated. Seventy percent of these compensations were awarded to petitioners despite a lack of clear evidence that the patient’s condition was caused by a vaccine.⁸ The rate of compensation for conditions proven to be caused by a vaccine was 1/3.33 million.⁸

The VICP pays for attorney fees, in some cases even if the petition is denied, but does not allow contingency fees. Since the beginning of the program, more than $4 billion has been awarded.⁸ The program is funded by a 75-cent tax on each vaccine antigen. Because serious AEs are so rare, the trust fund established to administer the VICP finances has a surplus of about $6 billion.

The Advisory Committee on Immunization Practices

After a vaccine is approved for use by the FDA, ACIP makes recommendations for its use in the US civilian population.^9,10 ACIP, created in 1964, was chartered as a federal advisory committee to provide expert external advice to the Director of the CDC and the Secretary of DHHS on the use of vaccines. ACIP also provides guidance on the use of other biologicals, antibiotics, and antivirals for treatment and prevention of vaccine-preventable infections.

Continue to: As an official...

As an official federal advisory committee governed by the Federal Advisory Committee Act, ACIP operates under strict requirements for public notification of meetings, allowing for written and oral public comment at its meetings, and timely publication of minutes. ACIP meeting minutes are posted soon after each meeting, along with draft recommendations. ACIP meeting agendas and slide presentations are available on the ACIP Web site (https://www.cdc.gov/vaccines/acip/index.html).

ACIP consists of 15 members serving overlapping 4-year terms, appointed by the Secretary of DHHS from a list of candidates proposed by the CDC. One member is a consumer representative; the other members have expertise in vaccinology, immunology, pediatrics, internal medicine, infectious diseases, preventive medicine, and public health. In the CDC, staff support for ACIP is provided by the National Center for Immunization and Respiratory Diseases, Office of Infectious Diseases.

Infected children pose a risk to those who cannot be vaccinated because of immune deficiencies and other medical conditions.

ACIP holds 2-day meetings 3 times a year. Much of the work occurs between meetings, by work groups via phone conferences. Work groups are chaired by an ACIP member and staffed by one or more CDC programmatic, content-expert professionals. Membership of the work groups consists of at least 2 ACIP members, representatives from relevant professional clinical and public health organizations, and other individuals with specific expertise. Work groups propose recommendations to ACIP, which can adopt, revise, or reject them.

When formulating recommendations for a particular vaccine, ACIP considers the burden of disease prevented, the effectiveness and safety of the vaccine, cost effectiveness, and practical and logistical issues of implementing recommendations. ACIP also receives frequent reports from ISO regarding the safety of vaccines previously approved. Since 2011, ACIP has used a standardized, modified GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) system to assess the evidence regarding effectiveness and safety of new vaccines and an evidence-to-recommendation framework to transparently explain how it arrives at recommendations.^11,12

We can recommend vaccines with confidence

In the United States, we have a secure supply of safe vaccines, a transparent method of making vaccine recommendations, a robust system to monitor vaccine safety, and an efficient system to compensate those who experience a rare, serious adverse reaction to a vaccine. The US public health system has achieved a marked reduction in morbidity and mortality from childhood infectious diseases, mostly because of vaccines. Many people today have not experienced or seen children with these once-common childhood infections and may not appreciate the seriousness of childhood infectious diseases or the full value of vaccines. As family physicians, we can help address this problem and recommend vaccines to our patients with confidence.

The current increase in measles cases in the United States has sharpened the focus on antivaccine activities. While the percentage of US children who are fully vaccinated remains high (≥ 94%), the number of un- or undervaccinated children has been growing¹ because of nonmedical exemptions from school vaccine requirements due to concerns about vaccine safety and an underappreciation of the benefits of vaccines. Family physicians need to be conversant with several important aspects of this matter, including the magnitude of benefits provided by childhood vaccines, as well as the systems already in place for

• assessing vaccine effectiveness and safety,
• making recommendations on the use of vaccines,
• monitoring safety after vaccine approval, and
• compensating those affected by rare but serious vaccine-related adverse events (AEs).

Familiarity with these issues will allow for informed discussions with parents who are vaccine hesitant and with those who have read or heard inaccurate information.

The benefits of vaccines are indisputable

In 1999, the Centers for Disease Control and Prevention (CDC) published a list of 9 selected childhood infectious diseases and compared their incidences before and after immunization was available.² Each of these infections causes morbidity, sequelae, and mortality at predictable rates depending on the infectious agent. The comparisons were dramatic: Measles, with a baseline annual morbidity of 503,282 cases, fell to just 89 cases; poliomyelitis decreased from 16,316 to 0; and Haemophilus influenzae type b declined from 20,000 to 54. In a 2014 analysis, the CDC stated that “among 78.6 million children born during 1994–2013, routine childhood immunization was estimated to prevent 322 million illnesses (averaging 4.1 illnesses per child) and 21 million hospitalizations (0.27 per child) over the course of their lifetimes and avert 732,000 premature deaths from vaccine-preventable illnesses” (TABLE).³

It is not unusual to hear a vaccine opponent say that childhood infectious diseases are not serious and that it is better for a child to contract the infection and let the immune system fight it naturally. Measles is often used as an example. This argument ignores some important aspects of vaccine benefits.

It is true in the United States that the average child who contracts measles will recover from it and not suffer immediate or long-term effects. However, it is also true that measles has a hospitalization rate of about 20% and a death rate of between 1/500 and 1/1000 cases.⁴ Mortality is much higher in developing countries. Prior to widespread use of measles vaccine, hundreds of thousands of cases of measles occurred each year. That translated into hundreds of preventable child deaths per year. An individual case does not tell the full story about the public health impact of infectious illnesses.

In addition, there are often unappreciated sequelae from child infections, such as shingles occurring years after resolution of a chickenpox infection. There are also societal consequences of child infections, such as deafness from congenital rubella and intergenerational transfer of infectious agents to family members at risk for serious consequences (influenza from a child to a grandparent). Finally, infected children pose a risk to those who cannot be vaccinated because of immune deficiencies and other medical conditions.

A multilayered US system monitors vaccine safety

Responsibility for assuring the safety of vaccines lies with the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research and with the CDC’s Immunization Safety Office (ISO). The FDA is responsible for the initial assessment of the effectiveness and safety of new vaccines and for ongoing monitoring of the manufacturing facilities where vaccines are produced. After FDA approval, safety is monitored using a multilayered system that includes the Vaccine Adverse Event Reporting System (VAERS), the Vaccine Safety Datalink (VSD) system, the Clinical Immunization Safety Assessment (CISA) Project, and periodic reviews by the National Academy of Medicine (NAM), previously the Institute of Medicine. In addition, there is a large number of studies published each year by the nation’s—and world’s—medical research community on vaccine effectiveness and safety.

Continue to: VAERS

VAERS (https://vaers.hhs.gov/) is a passive reporting system that allows patients, physicians, and other health care providers to record suspected vaccine-related adverse events.⁵ It was created in 1990 and is run by the FDA and the CDC. It is not intended to be a comprehensive or definitive list of proven vaccine-related harms. As a passive reporting system, it is subject to both over- and underreporting, and the data from it are often misinterpreted and used incorrectly by vaccine opponents—eg, wrongly declaring that VAERS reports of possible AEs are proven cases. It provides a sentinel system that is monitored for indications of possible serious AEs linked to a particular vaccine. When a suspected interaction is detected, it is investigated by the VSD system.

VSD is a collaboration of the CDC’s ISO and 8 geographically distributed health care organizations with complete electronic patient medical information on their members. VSD conducts studies when a question about vaccine safety arises, when new vaccines are licensed, or when there are new vaccine recommendations. A description of VSD sites, the research methods used, and a list of publications describing study results can be found at https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html#organizations. If the VSD system finds a link between serious AEs and a particular vaccine, this association is reported to the Advisory Committee on Immunization Practices (ACIP) for consideration in changing recommendations regarding that vaccine. This happens only rarely.

It is true that the average American child who contracts measles will recover from it and not suffer long-term effects. However, it is also true that measles has a death rate of between 1/500 and 1/1000 cases.

CISA was established in 2001 as a network of vaccine safety experts at 7 academic medical centers who collaborate with the CDC’s ISO. CISA conducts studies on specific questions related to vaccine safety and provides a consultation service to clinicians and researchers who have questions about vaccine safety. A description of the CISA sites, past publications on vaccine safety, and ongoing research priorities can be found at https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.html.

NAM (https://nam.edu/) conducts periodic reviews of vaccine safety and vaccine-caused AEs. The most recent was published in 2012 and looked at possible AEs of 8 vaccines containing 12 different antigens.⁶ The literature search for this review found more than 12,000 articles, which speaks to the volume of scientific work on vaccine safety. These NAM reports document the rarity of severe AEs to vaccines and are used with other information to construct the table for the Vaccine Injury Compensation Program (VICP), which is described below.

Are vaccines killing children?

Vaccine opponents frequently claim that vaccines cause much more harm than is documented, including the deaths of children. A vaccine opponent made this claim in my state (Arizona) at a legislative committee hearing even though our state child mortality review committee has been investigating all child deaths for decades and has never attributed a death to a vaccine.

Continue to: One study conducted...

One study conducted using the VSD system from January 1, 2005, to December 31, 2011, identified 1100 deaths occurring within 12 months of any vaccination among 2,189,504 VSD enrollees ages 9 to 26 years.⁷ They found that the risk of death in this age group was not increased during the 30 days after vaccination, and no deaths were found to be causally associated with vaccination. Deaths among children do occur and, due to the number of vaccines administered, some deaths will occur within a short time period after a vaccine. This temporal association does not prove the death was vaccine-caused, but vaccine opponents have claimed that it does.

The vaccine injury compensation system

In 1986, the federal government established a no-fault system—the National Vaccine Injury Compensation Program (VICP)—to compensate those who suffer a serious AE from a vaccine covered by the program. This system is administered by the Health Resources and Services Administration (HRSA) in the Department of Health and Human Services (DHHS). HRSA maintains a table of proven AEs of specific vaccines, based in part on the NAM report mentioned earlier. Petitions for compensation—with proof of an AE following the administration of a vaccine that is included on the HRSA table—are accepted and remunerated if the AE lasted > 6 months or resulted in hospitalization. Petitions that allege AEs following administration of a vaccine not included on the table are nevertheless reviewed by the staff of HRSA, who can still recommend compensation based on the medical evidence. If HRSA declines the petition, the petitioner can appeal the case in the US Court of Federal Claims, which makes the final decision on a petition’s validity and, if warranted, the type and amount of compensation.

From 2006 to 2017, > 3.4 billion doses of vaccines covered by VICP were distributed in the United States.⁸ During this period, 6293 petitions were adjudicated by the court; 4311 were compensated.⁸ For every 1 million doses of vaccine distributed, 1 individual was compensated. Seventy percent of these compensations were awarded to petitioners despite a lack of clear evidence that the patient’s condition was caused by a vaccine.⁸ The rate of compensation for conditions proven to be caused by a vaccine was 1/3.33 million.⁸

The VICP pays for attorney fees, in some cases even if the petition is denied, but does not allow contingency fees. Since the beginning of the program, more than $4 billion has been awarded.⁸ The program is funded by a 75-cent tax on each vaccine antigen. Because serious AEs are so rare, the trust fund established to administer the VICP finances has a surplus of about $6 billion.

The Advisory Committee on Immunization Practices

After a vaccine is approved for use by the FDA, ACIP makes recommendations for its use in the US civilian population.^9,10 ACIP, created in 1964, was chartered as a federal advisory committee to provide expert external advice to the Director of the CDC and the Secretary of DHHS on the use of vaccines. ACIP also provides guidance on the use of other biologicals, antibiotics, and antivirals for treatment and prevention of vaccine-preventable infections.

Continue to: As an official...

As an official federal advisory committee governed by the Federal Advisory Committee Act, ACIP operates under strict requirements for public notification of meetings, allowing for written and oral public comment at its meetings, and timely publication of minutes. ACIP meeting minutes are posted soon after each meeting, along with draft recommendations. ACIP meeting agendas and slide presentations are available on the ACIP Web site (https://www.cdc.gov/vaccines/acip/index.html).

ACIP consists of 15 members serving overlapping 4-year terms, appointed by the Secretary of DHHS from a list of candidates proposed by the CDC. One member is a consumer representative; the other members have expertise in vaccinology, immunology, pediatrics, internal medicine, infectious diseases, preventive medicine, and public health. In the CDC, staff support for ACIP is provided by the National Center for Immunization and Respiratory Diseases, Office of Infectious Diseases.

Infected children pose a risk to those who cannot be vaccinated because of immune deficiencies and other medical conditions.

ACIP holds 2-day meetings 3 times a year. Much of the work occurs between meetings, by work groups via phone conferences. Work groups are chaired by an ACIP member and staffed by one or more CDC programmatic, content-expert professionals. Membership of the work groups consists of at least 2 ACIP members, representatives from relevant professional clinical and public health organizations, and other individuals with specific expertise. Work groups propose recommendations to ACIP, which can adopt, revise, or reject them.

When formulating recommendations for a particular vaccine, ACIP considers the burden of disease prevented, the effectiveness and safety of the vaccine, cost effectiveness, and practical and logistical issues of implementing recommendations. ACIP also receives frequent reports from ISO regarding the safety of vaccines previously approved. Since 2011, ACIP has used a standardized, modified GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) system to assess the evidence regarding effectiveness and safety of new vaccines and an evidence-to-recommendation framework to transparently explain how it arrives at recommendations.^11,12

We can recommend vaccines with confidence

In the United States, we have a secure supply of safe vaccines, a transparent method of making vaccine recommendations, a robust system to monitor vaccine safety, and an efficient system to compensate those who experience a rare, serious adverse reaction to a vaccine. The US public health system has achieved a marked reduction in morbidity and mortality from childhood infectious diseases, mostly because of vaccines. Many people today have not experienced or seen children with these once-common childhood infections and may not appreciate the seriousness of childhood infectious diseases or the full value of vaccines. As family physicians, we can help address this problem and recommend vaccines to our patients with confidence.

The current increase in measles cases in the United States has sharpened the focus on antivaccine activities. While the percentage of US children who are fully vaccinated remains high (≥ 94%), the number of un- or undervaccinated children has been growing¹ because of nonmedical exemptions from school vaccine requirements due to concerns about vaccine safety and an underappreciation of the benefits of vaccines. Family physicians need to be conversant with several important aspects of this matter, including the magnitude of benefits provided by childhood vaccines, as well as the systems already in place for

• assessing vaccine effectiveness and safety,
• making recommendations on the use of vaccines,
• monitoring safety after vaccine approval, and
• compensating those affected by rare but serious vaccine-related adverse events (AEs).

Familiarity with these issues will allow for informed discussions with parents who are vaccine hesitant and with those who have read or heard inaccurate information.

The benefits of vaccines are indisputable

In 1999, the Centers for Disease Control and Prevention (CDC) published a list of 9 selected childhood infectious diseases and compared their incidences before and after immunization was available.² Each of these infections causes morbidity, sequelae, and mortality at predictable rates depending on the infectious agent. The comparisons were dramatic: Measles, with a baseline annual morbidity of 503,282 cases, fell to just 89 cases; poliomyelitis decreased from 16,316 to 0; and Haemophilus influenzae type b declined from 20,000 to 54. In a 2014 analysis, the CDC stated that “among 78.6 million children born during 1994–2013, routine childhood immunization was estimated to prevent 322 million illnesses (averaging 4.1 illnesses per child) and 21 million hospitalizations (0.27 per child) over the course of their lifetimes and avert 732,000 premature deaths from vaccine-preventable illnesses” (TABLE).³

It is not unusual to hear a vaccine opponent say that childhood infectious diseases are not serious and that it is better for a child to contract the infection and let the immune system fight it naturally. Measles is often used as an example. This argument ignores some important aspects of vaccine benefits.

It is true in the United States that the average child who contracts measles will recover from it and not suffer immediate or long-term effects. However, it is also true that measles has a hospitalization rate of about 20% and a death rate of between 1/500 and 1/1000 cases.⁴ Mortality is much higher in developing countries. Prior to widespread use of measles vaccine, hundreds of thousands of cases of measles occurred each year. That translated into hundreds of preventable child deaths per year. An individual case does not tell the full story about the public health impact of infectious illnesses.

In addition, there are often unappreciated sequelae from child infections, such as shingles occurring years after resolution of a chickenpox infection. There are also societal consequences of child infections, such as deafness from congenital rubella and intergenerational transfer of infectious agents to family members at risk for serious consequences (influenza from a child to a grandparent). Finally, infected children pose a risk to those who cannot be vaccinated because of immune deficiencies and other medical conditions.

A multilayered US system monitors vaccine safety

Responsibility for assuring the safety of vaccines lies with the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research and with the CDC’s Immunization Safety Office (ISO). The FDA is responsible for the initial assessment of the effectiveness and safety of new vaccines and for ongoing monitoring of the manufacturing facilities where vaccines are produced. After FDA approval, safety is monitored using a multilayered system that includes the Vaccine Adverse Event Reporting System (VAERS), the Vaccine Safety Datalink (VSD) system, the Clinical Immunization Safety Assessment (CISA) Project, and periodic reviews by the National Academy of Medicine (NAM), previously the Institute of Medicine. In addition, there is a large number of studies published each year by the nation’s—and world’s—medical research community on vaccine effectiveness and safety.

Continue to: VAERS

VAERS (https://vaers.hhs.gov/) is a passive reporting system that allows patients, physicians, and other health care providers to record suspected vaccine-related adverse events.⁵ It was created in 1990 and is run by the FDA and the CDC. It is not intended to be a comprehensive or definitive list of proven vaccine-related harms. As a passive reporting system, it is subject to both over- and underreporting, and the data from it are often misinterpreted and used incorrectly by vaccine opponents—eg, wrongly declaring that VAERS reports of possible AEs are proven cases. It provides a sentinel system that is monitored for indications of possible serious AEs linked to a particular vaccine. When a suspected interaction is detected, it is investigated by the VSD system.

VSD is a collaboration of the CDC’s ISO and 8 geographically distributed health care organizations with complete electronic patient medical information on their members. VSD conducts studies when a question about vaccine safety arises, when new vaccines are licensed, or when there are new vaccine recommendations. A description of VSD sites, the research methods used, and a list of publications describing study results can be found at https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html#organizations. If the VSD system finds a link between serious AEs and a particular vaccine, this association is reported to the Advisory Committee on Immunization Practices (ACIP) for consideration in changing recommendations regarding that vaccine. This happens only rarely.

It is true that the average American child who contracts measles will recover from it and not suffer long-term effects. However, it is also true that measles has a death rate of between 1/500 and 1/1000 cases.

CISA was established in 2001 as a network of vaccine safety experts at 7 academic medical centers who collaborate with the CDC’s ISO. CISA conducts studies on specific questions related to vaccine safety and provides a consultation service to clinicians and researchers who have questions about vaccine safety. A description of the CISA sites, past publications on vaccine safety, and ongoing research priorities can be found at https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.html.

NAM (https://nam.edu/) conducts periodic reviews of vaccine safety and vaccine-caused AEs. The most recent was published in 2012 and looked at possible AEs of 8 vaccines containing 12 different antigens.⁶ The literature search for this review found more than 12,000 articles, which speaks to the volume of scientific work on vaccine safety. These NAM reports document the rarity of severe AEs to vaccines and are used with other information to construct the table for the Vaccine Injury Compensation Program (VICP), which is described below.

Are vaccines killing children?

Vaccine opponents frequently claim that vaccines cause much more harm than is documented, including the deaths of children. A vaccine opponent made this claim in my state (Arizona) at a legislative committee hearing even though our state child mortality review committee has been investigating all child deaths for decades and has never attributed a death to a vaccine.

Continue to: One study conducted...

One study conducted using the VSD system from January 1, 2005, to December 31, 2011, identified 1100 deaths occurring within 12 months of any vaccination among 2,189,504 VSD enrollees ages 9 to 26 years.⁷ They found that the risk of death in this age group was not increased during the 30 days after vaccination, and no deaths were found to be causally associated with vaccination. Deaths among children do occur and, due to the number of vaccines administered, some deaths will occur within a short time period after a vaccine. This temporal association does not prove the death was vaccine-caused, but vaccine opponents have claimed that it does.

The vaccine injury compensation system

In 1986, the federal government established a no-fault system—the National Vaccine Injury Compensation Program (VICP)—to compensate those who suffer a serious AE from a vaccine covered by the program. This system is administered by the Health Resources and Services Administration (HRSA) in the Department of Health and Human Services (DHHS). HRSA maintains a table of proven AEs of specific vaccines, based in part on the NAM report mentioned earlier. Petitions for compensation—with proof of an AE following the administration of a vaccine that is included on the HRSA table—are accepted and remunerated if the AE lasted > 6 months or resulted in hospitalization. Petitions that allege AEs following administration of a vaccine not included on the table are nevertheless reviewed by the staff of HRSA, who can still recommend compensation based on the medical evidence. If HRSA declines the petition, the petitioner can appeal the case in the US Court of Federal Claims, which makes the final decision on a petition’s validity and, if warranted, the type and amount of compensation.

From 2006 to 2017, > 3.4 billion doses of vaccines covered by VICP were distributed in the United States.⁸ During this period, 6293 petitions were adjudicated by the court; 4311 were compensated.⁸ For every 1 million doses of vaccine distributed, 1 individual was compensated. Seventy percent of these compensations were awarded to petitioners despite a lack of clear evidence that the patient’s condition was caused by a vaccine.⁸ The rate of compensation for conditions proven to be caused by a vaccine was 1/3.33 million.⁸

The VICP pays for attorney fees, in some cases even if the petition is denied, but does not allow contingency fees. Since the beginning of the program, more than $4 billion has been awarded.⁸ The program is funded by a 75-cent tax on each vaccine antigen. Because serious AEs are so rare, the trust fund established to administer the VICP finances has a surplus of about $6 billion.

The Advisory Committee on Immunization Practices

After a vaccine is approved for use by the FDA, ACIP makes recommendations for its use in the US civilian population.^9,10 ACIP, created in 1964, was chartered as a federal advisory committee to provide expert external advice to the Director of the CDC and the Secretary of DHHS on the use of vaccines. ACIP also provides guidance on the use of other biologicals, antibiotics, and antivirals for treatment and prevention of vaccine-preventable infections.

Continue to: As an official...

As an official federal advisory committee governed by the Federal Advisory Committee Act, ACIP operates under strict requirements for public notification of meetings, allowing for written and oral public comment at its meetings, and timely publication of minutes. ACIP meeting minutes are posted soon after each meeting, along with draft recommendations. ACIP meeting agendas and slide presentations are available on the ACIP Web site (https://www.cdc.gov/vaccines/acip/index.html).

ACIP consists of 15 members serving overlapping 4-year terms, appointed by the Secretary of DHHS from a list of candidates proposed by the CDC. One member is a consumer representative; the other members have expertise in vaccinology, immunology, pediatrics, internal medicine, infectious diseases, preventive medicine, and public health. In the CDC, staff support for ACIP is provided by the National Center for Immunization and Respiratory Diseases, Office of Infectious Diseases.

Infected children pose a risk to those who cannot be vaccinated because of immune deficiencies and other medical conditions.

ACIP holds 2-day meetings 3 times a year. Much of the work occurs between meetings, by work groups via phone conferences. Work groups are chaired by an ACIP member and staffed by one or more CDC programmatic, content-expert professionals. Membership of the work groups consists of at least 2 ACIP members, representatives from relevant professional clinical and public health organizations, and other individuals with specific expertise. Work groups propose recommendations to ACIP, which can adopt, revise, or reject them.

When formulating recommendations for a particular vaccine, ACIP considers the burden of disease prevented, the effectiveness and safety of the vaccine, cost effectiveness, and practical and logistical issues of implementing recommendations. ACIP also receives frequent reports from ISO regarding the safety of vaccines previously approved. Since 2011, ACIP has used a standardized, modified GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) system to assess the evidence regarding effectiveness and safety of new vaccines and an evidence-to-recommendation framework to transparently explain how it arrives at recommendations.^11,12

We can recommend vaccines with confidence

In the United States, we have a secure supply of safe vaccines, a transparent method of making vaccine recommendations, a robust system to monitor vaccine safety, and an efficient system to compensate those who experience a rare, serious adverse reaction to a vaccine. The US public health system has achieved a marked reduction in morbidity and mortality from childhood infectious diseases, mostly because of vaccines. Many people today have not experienced or seen children with these once-common childhood infections and may not appreciate the seriousness of childhood infectious diseases or the full value of vaccines. As family physicians, we can help address this problem and recommend vaccines to our patients with confidence.

Over the past year through early 2019, the US Preventive Services Task Force made 34 recommendations on 19 different topics. Twenty-six were reaffirmations of recommendations made in previous years (TABLE 1¹); the Task Force attempts to reassess topics every 7 years. Two new topics were addressed with 2 new recommendations, and 6 previous recommendations were revised or reversed (TABLE 2^2-9).

This Practice Alert discusses the new and the changed recommendations. (In 2018, the Practice Alert podcast series covered screening for ovarian cancer [April], prostate cancer [June], and cervical cancer [October], and EKG screening for cardiovascular disease [November].) All current Task Force recommendations are available on the USPSTF Web site.¹

New topics

Perinatal depression prevention

The Task Force recommends that clinicians counsel pregnant women and women in the first year postpartum who are at increased risk for perinatal depression, or refer for such services. The recommendation applies to those who are not diagnosed with depression but are at increased risk.

Perinatal depression can negatively affect both mother and child in several ways and occurs at a rate close to 9% during pregnancy and 37% during the first year postpartum.² The interventions studied by the Task Force included cognitive behavioral therapy and interpersonal therapy; most sessions were initiated in the second trimester of pregnancy and varied in number of sessions and intensity. The Task Force includes the following in the list of risks that should prompt a referral: a history of depression, current depressive symptoms that fall short of that needed for a depression diagnosis, low income, adolescent or single parenthood, recent intimate partner violence, elevated anxiety symptoms, physical or sexual abuse, or a history of significant negative life events. (See “Postpartum anxiety: More common than you think,” in the April issue.)

Atrial fibrillation

The Task Force found insufficient evidence to recommend for or against the use of electrocardiography (EKG) to screen for atrial fibrillation (AF).³ Atrial fibrillation is common, affecting 3% of men and 2% of women between the ages of 65 and 69 years, and it increases in prevalence with age.⁴ It is a major risk factor for stroke, although it is commonly first diagnosed after a stroke. Treatment with anticoagulant therapy reduces the incidence of stroke in patients with symptomatic AF, but this treatment is associated with the risk of major bleeding. The problem in screening for AF with EKG is that it is associated with misdiagnosis, over-treatment, and further testing. The Task Force could not find any direct evidence of the totality of benefits and harms of screening asymptomatic adults with EKG, and it raised the possibility that benefit with less harm might be achieved by screening with pulse palpation and heart auscultation, followed by EKG testing of those with an irregular pulse.

Revisions of previous recommendations

Cervical cancer screening

The Task Force continues to recommend screening for cervical cancer in women 21 to 65 years of age.⁵ The major change in the current recommendation is for women ages 30 to 65 years. For this group, the Task Force now recommends screening every 5 years with high-risk human papillomavirus (hrHPV) testing alone as a possible alternative to screening every 3 years with cytology alone. They also halfheartedly endorse co-testing as an option, even though it may result in more tests and procedures compared with either cytology or hrHPV testing alone, with equal effectiveness. For women ages 21 to 29 years, cervical cytology alone every 3 years is still the only recommended regimen.

Skin cancer prevention

The Task Force made 2 revisions to the 2012 recommendation on preventing skin cancer through behavioral counseling to avoid ultraviolet (UV) radiation.⁶ These recommendations continue to focus on those with fair skin. The first revision: The earliest age at which children (through their guardians) can benefit from counseling on UV avoidance has been lowered from age 10 years to 6 months. The second revision: Some adults older than age 24 can also benefit from such counseling if they have fair skin and other skin cancer risks such as using tanning beds, having a history of sunburns or previous skin cancer, having an increased number of nevi (moles) and atypical nevi, having human immunodeficiency virus (HIV) infection, having received an organ transplant, or having a family history of skin cancer.

Continue to: Those at risk...

Those at risk can reduce their chances of skin cancer by using broad-spectrum sunscreens and sun-protective clothing, and by avoiding sun exposure and indoor tanning beds.

Fall prevention

In a reversal of its 2012 recommendation, the Task Force now recommends against the use of vitamin D supplementation to prevent falls in community-dwelling adults 65 years or older.⁷ In a reanalysis of previous studies on this topic, along with new evidence, the Task Force concluded that vitamin D supplementation offers no benefit for preventing falls in adults who are not vitamin D deficient.

Screening for scoliosis in adolescents

In 2004 the USPSTF recommended against screening for idiopathic scoliosis in children and adolescents 10 to 18 years of age. In its most recent review, the Task Force continued to find no direct evidence of the benefit of screening and inadequate evidence on the long-term benefits of reduction in spinal curvature through exercise, surgery, and bracing. However, following a reanalysis of the potential harms of these treatments and the use of a new analytic framework, the Task Force concluded it is not possible at this time to assess the balance of benefits and harms of screening.⁸

Prostate cancer screening

In its most controversial action, the Task Force reversed its 2012 recommendation against routine prostate-specific antigen–based screening for prostate cancer in men ages 55 to 69 years and now lists this as a “C” recommendation.⁹ The potential benefits of screening include preventing 1.3 deaths from prostate cancer per 1000 men screened over 13 years and approximately 3 cases of metastatic prostate cancer. However, no trials have found a reduction in all-cause mortality from screening. Contrast that with the known harms of screening: 15% false positive results over 10 years; 1% hospitalization rate among those undergoing a prostate biopsy; over-diagnosis and resultant treatment of 20% to 50% of men diagnosed with prostate cancer through screening; and incontinence and erectile dysfunction in 20% and 67%, respectively, of men following prostatectomy.⁹

Evidence is insufficient to recommend for or against the use of electrocardiography in screening for atrial fibrillation.

Based on these outcomes, the Task Force “does not recommend screening for prostate cancer unless men express a preference for screening after being informed of and understanding the benefits and risks.”⁹ The Task Force continues to recommend against screening men ages 70 years and older.

Continue to: The change in this recommendation...

The change in this recommendation and its wording present dilemmas for family physicians: whether to discuss potential screening with all men ages 55 to 69; to selectively discuss it with those at high risk (principally African Americans and those with a strong family history of prostate cancer); or to address the issue only if a patient asks about it. In addition, if a man requests screening, how often should it be performed? Most clinical trials have found equal benefit from testing less frequently than every year, with fewer harms. The Task Force provided little or no guidance on these issues.

Final advice: D recommendations

The Task Force reaffirmed that 7 services have either no benefit or cause more harm than benefit (TABLE 1¹). Family physicians should be familiar with these services, as well as all Task Force D recommendations, and avoid recommending them or providing them. High quality preventive care involves both providing services of proven benefit and avoiding those that do not.

Over the past year through early 2019, the US Preventive Services Task Force made 34 recommendations on 19 different topics. Twenty-six were reaffirmations of recommendations made in previous years (TABLE 1¹); the Task Force attempts to reassess topics every 7 years. Two new topics were addressed with 2 new recommendations, and 6 previous recommendations were revised or reversed (TABLE 2^2-9).

This Practice Alert discusses the new and the changed recommendations. (In 2018, the Practice Alert podcast series covered screening for ovarian cancer [April], prostate cancer [June], and cervical cancer [October], and EKG screening for cardiovascular disease [November].) All current Task Force recommendations are available on the USPSTF Web site.¹

New topics

Perinatal depression prevention

The Task Force recommends that clinicians counsel pregnant women and women in the first year postpartum who are at increased risk for perinatal depression, or refer for such services. The recommendation applies to those who are not diagnosed with depression but are at increased risk.

Perinatal depression can negatively affect both mother and child in several ways and occurs at a rate close to 9% during pregnancy and 37% during the first year postpartum.² The interventions studied by the Task Force included cognitive behavioral therapy and interpersonal therapy; most sessions were initiated in the second trimester of pregnancy and varied in number of sessions and intensity. The Task Force includes the following in the list of risks that should prompt a referral: a history of depression, current depressive symptoms that fall short of that needed for a depression diagnosis, low income, adolescent or single parenthood, recent intimate partner violence, elevated anxiety symptoms, physical or sexual abuse, or a history of significant negative life events. (See “Postpartum anxiety: More common than you think,” in the April issue.)

Atrial fibrillation

The Task Force found insufficient evidence to recommend for or against the use of electrocardiography (EKG) to screen for atrial fibrillation (AF).³ Atrial fibrillation is common, affecting 3% of men and 2% of women between the ages of 65 and 69 years, and it increases in prevalence with age.⁴ It is a major risk factor for stroke, although it is commonly first diagnosed after a stroke. Treatment with anticoagulant therapy reduces the incidence of stroke in patients with symptomatic AF, but this treatment is associated with the risk of major bleeding. The problem in screening for AF with EKG is that it is associated with misdiagnosis, over-treatment, and further testing. The Task Force could not find any direct evidence of the totality of benefits and harms of screening asymptomatic adults with EKG, and it raised the possibility that benefit with less harm might be achieved by screening with pulse palpation and heart auscultation, followed by EKG testing of those with an irregular pulse.

Revisions of previous recommendations

Cervical cancer screening

The Task Force continues to recommend screening for cervical cancer in women 21 to 65 years of age.⁵ The major change in the current recommendation is for women ages 30 to 65 years. For this group, the Task Force now recommends screening every 5 years with high-risk human papillomavirus (hrHPV) testing alone as a possible alternative to screening every 3 years with cytology alone. They also halfheartedly endorse co-testing as an option, even though it may result in more tests and procedures compared with either cytology or hrHPV testing alone, with equal effectiveness. For women ages 21 to 29 years, cervical cytology alone every 3 years is still the only recommended regimen.

Skin cancer prevention

The Task Force made 2 revisions to the 2012 recommendation on preventing skin cancer through behavioral counseling to avoid ultraviolet (UV) radiation.⁶ These recommendations continue to focus on those with fair skin. The first revision: The earliest age at which children (through their guardians) can benefit from counseling on UV avoidance has been lowered from age 10 years to 6 months. The second revision: Some adults older than age 24 can also benefit from such counseling if they have fair skin and other skin cancer risks such as using tanning beds, having a history of sunburns or previous skin cancer, having an increased number of nevi (moles) and atypical nevi, having human immunodeficiency virus (HIV) infection, having received an organ transplant, or having a family history of skin cancer.

Continue to: Those at risk...

Those at risk can reduce their chances of skin cancer by using broad-spectrum sunscreens and sun-protective clothing, and by avoiding sun exposure and indoor tanning beds.

Fall prevention

In a reversal of its 2012 recommendation, the Task Force now recommends against the use of vitamin D supplementation to prevent falls in community-dwelling adults 65 years or older.⁷ In a reanalysis of previous studies on this topic, along with new evidence, the Task Force concluded that vitamin D supplementation offers no benefit for preventing falls in adults who are not vitamin D deficient.

Screening for scoliosis in adolescents

In 2004 the USPSTF recommended against screening for idiopathic scoliosis in children and adolescents 10 to 18 years of age. In its most recent review, the Task Force continued to find no direct evidence of the benefit of screening and inadequate evidence on the long-term benefits of reduction in spinal curvature through exercise, surgery, and bracing. However, following a reanalysis of the potential harms of these treatments and the use of a new analytic framework, the Task Force concluded it is not possible at this time to assess the balance of benefits and harms of screening.⁸

Prostate cancer screening

In its most controversial action, the Task Force reversed its 2012 recommendation against routine prostate-specific antigen–based screening for prostate cancer in men ages 55 to 69 years and now lists this as a “C” recommendation.⁹ The potential benefits of screening include preventing 1.3 deaths from prostate cancer per 1000 men screened over 13 years and approximately 3 cases of metastatic prostate cancer. However, no trials have found a reduction in all-cause mortality from screening. Contrast that with the known harms of screening: 15% false positive results over 10 years; 1% hospitalization rate among those undergoing a prostate biopsy; over-diagnosis and resultant treatment of 20% to 50% of men diagnosed with prostate cancer through screening; and incontinence and erectile dysfunction in 20% and 67%, respectively, of men following prostatectomy.⁹

Evidence is insufficient to recommend for or against the use of electrocardiography in screening for atrial fibrillation.

Based on these outcomes, the Task Force “does not recommend screening for prostate cancer unless men express a preference for screening after being informed of and understanding the benefits and risks.”⁹ The Task Force continues to recommend against screening men ages 70 years and older.

Continue to: The change in this recommendation...

The change in this recommendation and its wording present dilemmas for family physicians: whether to discuss potential screening with all men ages 55 to 69; to selectively discuss it with those at high risk (principally African Americans and those with a strong family history of prostate cancer); or to address the issue only if a patient asks about it. In addition, if a man requests screening, how often should it be performed? Most clinical trials have found equal benefit from testing less frequently than every year, with fewer harms. The Task Force provided little or no guidance on these issues.

Final advice: D recommendations

The Task Force reaffirmed that 7 services have either no benefit or cause more harm than benefit (TABLE 1¹). Family physicians should be familiar with these services, as well as all Task Force D recommendations, and avoid recommending them or providing them. High quality preventive care involves both providing services of proven benefit and avoiding those that do not.

Over the past year through early 2019, the US Preventive Services Task Force made 34 recommendations on 19 different topics. Twenty-six were reaffirmations of recommendations made in previous years (TABLE 1¹); the Task Force attempts to reassess topics every 7 years. Two new topics were addressed with 2 new recommendations, and 6 previous recommendations were revised or reversed (TABLE 2^2-9).

This Practice Alert discusses the new and the changed recommendations. (In 2018, the Practice Alert podcast series covered screening for ovarian cancer [April], prostate cancer [June], and cervical cancer [October], and EKG screening for cardiovascular disease [November].) All current Task Force recommendations are available on the USPSTF Web site.¹

New topics

Perinatal depression prevention

The Task Force recommends that clinicians counsel pregnant women and women in the first year postpartum who are at increased risk for perinatal depression, or refer for such services. The recommendation applies to those who are not diagnosed with depression but are at increased risk.

Perinatal depression can negatively affect both mother and child in several ways and occurs at a rate close to 9% during pregnancy and 37% during the first year postpartum.² The interventions studied by the Task Force included cognitive behavioral therapy and interpersonal therapy; most sessions were initiated in the second trimester of pregnancy and varied in number of sessions and intensity. The Task Force includes the following in the list of risks that should prompt a referral: a history of depression, current depressive symptoms that fall short of that needed for a depression diagnosis, low income, adolescent or single parenthood, recent intimate partner violence, elevated anxiety symptoms, physical or sexual abuse, or a history of significant negative life events. (See “Postpartum anxiety: More common than you think,” in the April issue.)

Atrial fibrillation

The Task Force found insufficient evidence to recommend for or against the use of electrocardiography (EKG) to screen for atrial fibrillation (AF).³ Atrial fibrillation is common, affecting 3% of men and 2% of women between the ages of 65 and 69 years, and it increases in prevalence with age.⁴ It is a major risk factor for stroke, although it is commonly first diagnosed after a stroke. Treatment with anticoagulant therapy reduces the incidence of stroke in patients with symptomatic AF, but this treatment is associated with the risk of major bleeding. The problem in screening for AF with EKG is that it is associated with misdiagnosis, over-treatment, and further testing. The Task Force could not find any direct evidence of the totality of benefits and harms of screening asymptomatic adults with EKG, and it raised the possibility that benefit with less harm might be achieved by screening with pulse palpation and heart auscultation, followed by EKG testing of those with an irregular pulse.

Revisions of previous recommendations

Cervical cancer screening

The Task Force continues to recommend screening for cervical cancer in women 21 to 65 years of age.⁵ The major change in the current recommendation is for women ages 30 to 65 years. For this group, the Task Force now recommends screening every 5 years with high-risk human papillomavirus (hrHPV) testing alone as a possible alternative to screening every 3 years with cytology alone. They also halfheartedly endorse co-testing as an option, even though it may result in more tests and procedures compared with either cytology or hrHPV testing alone, with equal effectiveness. For women ages 21 to 29 years, cervical cytology alone every 3 years is still the only recommended regimen.

Skin cancer prevention

The Task Force made 2 revisions to the 2012 recommendation on preventing skin cancer through behavioral counseling to avoid ultraviolet (UV) radiation.⁶ These recommendations continue to focus on those with fair skin. The first revision: The earliest age at which children (through their guardians) can benefit from counseling on UV avoidance has been lowered from age 10 years to 6 months. The second revision: Some adults older than age 24 can also benefit from such counseling if they have fair skin and other skin cancer risks such as using tanning beds, having a history of sunburns or previous skin cancer, having an increased number of nevi (moles) and atypical nevi, having human immunodeficiency virus (HIV) infection, having received an organ transplant, or having a family history of skin cancer.

Continue to: Those at risk...

Those at risk can reduce their chances of skin cancer by using broad-spectrum sunscreens and sun-protective clothing, and by avoiding sun exposure and indoor tanning beds.

Fall prevention

In a reversal of its 2012 recommendation, the Task Force now recommends against the use of vitamin D supplementation to prevent falls in community-dwelling adults 65 years or older.⁷ In a reanalysis of previous studies on this topic, along with new evidence, the Task Force concluded that vitamin D supplementation offers no benefit for preventing falls in adults who are not vitamin D deficient.

Screening for scoliosis in adolescents

In 2004 the USPSTF recommended against screening for idiopathic scoliosis in children and adolescents 10 to 18 years of age. In its most recent review, the Task Force continued to find no direct evidence of the benefit of screening and inadequate evidence on the long-term benefits of reduction in spinal curvature through exercise, surgery, and bracing. However, following a reanalysis of the potential harms of these treatments and the use of a new analytic framework, the Task Force concluded it is not possible at this time to assess the balance of benefits and harms of screening.⁸

Prostate cancer screening

In its most controversial action, the Task Force reversed its 2012 recommendation against routine prostate-specific antigen–based screening for prostate cancer in men ages 55 to 69 years and now lists this as a “C” recommendation.⁹ The potential benefits of screening include preventing 1.3 deaths from prostate cancer per 1000 men screened over 13 years and approximately 3 cases of metastatic prostate cancer. However, no trials have found a reduction in all-cause mortality from screening. Contrast that with the known harms of screening: 15% false positive results over 10 years; 1% hospitalization rate among those undergoing a prostate biopsy; over-diagnosis and resultant treatment of 20% to 50% of men diagnosed with prostate cancer through screening; and incontinence and erectile dysfunction in 20% and 67%, respectively, of men following prostatectomy.⁹

Evidence is insufficient to recommend for or against the use of electrocardiography in screening for atrial fibrillation.

Based on these outcomes, the Task Force “does not recommend screening for prostate cancer unless men express a preference for screening after being informed of and understanding the benefits and risks.”⁹ The Task Force continues to recommend against screening men ages 70 years and older.

Continue to: The change in this recommendation...

The change in this recommendation and its wording present dilemmas for family physicians: whether to discuss potential screening with all men ages 55 to 69; to selectively discuss it with those at high risk (principally African Americans and those with a strong family history of prostate cancer); or to address the issue only if a patient asks about it. In addition, if a man requests screening, how often should it be performed? Most clinical trials have found equal benefit from testing less frequently than every year, with fewer harms. The Task Force provided little or no guidance on these issues.

Final advice: D recommendations

The Task Force reaffirmed that 7 services have either no benefit or cause more harm than benefit (TABLE 1¹). Family physicians should be familiar with these services, as well as all Task Force D recommendations, and avoid recommending them or providing them. High quality preventive care involves both providing services of proven benefit and avoiding those that do not.

One of the most important commitments family physicians can undertake in protecting the health of their patients and communities is to ensure that their patients are fully vaccinated. This task is increasingly complicated as new vaccines are approved every year and recommendations change regarding new and established vaccines. To assist primary care providers, the Centers for Disease Control and Prevention (CDC) annually updates 2 immunization schedules—one for children and adolescents, and one for adults. These schedules are available on the CDC Web site (https://www.cdc.gov/vaccines/schedules/index.html).

These updates originate from the Advisory Committee on Immunization Practices (ACIP), which meets 3 times a year to consider and adopt changes to the schedules. During 2018, relatively few new recommendations were adopted. The September 2018 Practice Alert¹ in this journal covered the updated recommendations for influenza immunization, which included reinstating live attenuated influenza vaccine (LAIV) to the active list of influenza vaccines.

This current Practice Alert reviews 3 additional updates: 1) a new hepatitis B (HepB) vaccine; 2) updated recommendations for the use of hepatitis A (HepA) vaccine for post-exposure prevention and before travel; and 3) inclusion of the homeless among those who should be routinely vaccinated with HepA vaccine.

Hepatitis B: New 2-dose product

As of 2015, the annual incidence of new hepatitis B cases had declined by 88.5% since the first HepB vaccine was licensed in 1981 and recommendations for its routine use were issued in 1982.² The HepB vaccine products available in the United States are 2 single-antigen products, Engerix-B (GlaxoSmithKline) and Recombivax HB (Merck & Co.). Both can be used in all age groups, starting at birth, in a 3-dose series. HepB vaccine is also available in 2 combination products: Pediarix, containing HepB, diphtheria and tetanus toxoids, acellular pertussis, and inactivated poliovirus (GlaxoSmithKline), approved for use in children 6 weeks to 6 years old; and Twinrix (GlaxoSmithKline), which contains both HepB and HepA and is approved for use in adults 18 years and older.

The HepB vaccine is recommended for all children and unvaccinated adolescents as part of the routine vaccination schedule. It is also recommended for unvaccinated adults with specific risks (TABLE 1²). However, the rate of HepB vaccination in adults for whom it is recommended is suboptimal (FIGURE),³ and just a little more than half of adults who start a 3-dose series of HepB complete it.⁴A new vaccine against hepatitis B, HEPLISAV-B (Dynavax Technologies), was licensed by the US Food and Drug Administration in late 2017. ACIP now recommends it as an option along with other available HepB products. HEPLISAV-B is given in 2 doses separated by 1 month. It is hoped that this shortened 2-dose series will increase the number of adults who achieve full vaccination. In addition, it appears that HEPLISAV-B provides higher levels of protection in some high-risk groups—those with type 2 diabetes or chronic kidney disease.³ However, initial safety studies have shown a small absolute increase in cardiac events after vaccination with HEPLISAV-B. Post-marketing surveillance will be needed to show whether this is causal or coincidental.³

If a HepB series must be completed with different products, just be sure 3 doses are given—even if HEPLISAV-B is one of the agents.

As with other HepB products, use of HEPLISAV-B should follow the latest CDC directives on who to test serologically for prior immunity, and on post-vaccination testing to ensure protective antibody levels were achieved.² It is best to complete a HepB series with the same product, but, if necessary, a combination of products at different doses can be used to complete the HepB series. Any such combination should include 3 doses, even if one of the doses is HEPLISAV-B.

Hepatitis A: Vaccination assumes greater importance for more people

A Practice Alert in early 2018 described a series of outbreaks of hepatitis A around the country and the high rates of associated hospitalizations.⁵ These outbreaks have occurred primarily among the homeless and their contacts and those who use illicit drugs. This nationwide outbreak has now spread, resulting in more than 7500 cases since July 1, 2016.⁶ The progress of this epidemic can be viewed on the CDC Web site (https://www.cdc.gov/hepatitis/outbreaks/2017March-HepatitisA.htm).⁷ At its October 2018 meeting, ACIP added homelessness to the list of those (previously unvaccinated) who should receive the HepA vaccine (TABLE 2).⁶

Continue to: Remember that the current recommendation...

Remember that the current recommendation is to vaccinate all children 12 to 23 months old with HepA, in 2 separate doses. Two single-antigen HepA products are available: Havrix (GSK) and Vaqta (Merck). For the 2-dose sequence, Havrix is given at 0 and 6 to 12 months; Vaqta at 0 and 6 to 18 months. Even a single dose will provide protection for up to 11 years. In addition to these vaccines, there is the combination HepA and HepB vaccine (Twinrix) mentioned earlier.

Previous recommendations for preventing hepatitis A after exposure, made in 2007, stated that HepA vaccine was preferred for healthy individuals ages 12 months through 40 years, while immune globulin (IG) was preferred for adults older than 40, infants before their first birthday, immunocompromised individuals, those with chronic liver disease, and those for whom HepA vaccine is contraindicated.⁸ The 2007 recommendations also advised vaccinating individuals traveling to countries with intermediate to high hepatitis A endemicity.

A single dose of HepA vaccine was recommended for all those 12 months or older, although older adults, immunocompromised individuals, and those with chronic liver disease or other chronic medical conditions planning to visit an endemic area in ≤ 2 weeks were supposed to receive the initial dose of vaccine and could also receive IG (0.02 mL/kg) if their provider advised it. Travelers who declined vaccination, those younger than 12 months, or those allergic to a vaccine component could receive a single dose of IG (0.02 mL/kg), which provides protection up to 3 months.

Consider prescribing daily pre-exposure prophylaxis for men and women at risk from sexual exposure to HIV or who inject illicit drugs.

Several factors influenced ACIP to reconsider both the pre- and post-exposure recommendations. Regarding IG, evidence of its decreased potency over time led the committee to increase the recommended dose (see below). IG also must be re-administered every 2 months, the supply of the product is questionable, and many health care facilities do not stock it. By comparison, HepA vaccine offers the advantages of easier administration, inducing active immunity, and providing longer protection. Another issue involved infants ages 6 to 11 months traveling to an area with endemic measles transmission and who must therefore receive the measles, mumps, and rubella (MMR) vaccine. MMR and IG should not be co-administered, and, for infants, the health risk from measles outweighs that from hepatitis A.

Updated recommendations. After considering all this information, ACIP made the following changes to its hepatitis A virus (HAV) prevention recommendations (in addition to adding homeless people to the list of HepA vaccine recipients)⁹:

• Administer HepA vaccine as post-exposure prophylaxis to all individuals 12 months and older.
• IG may be administered, in addition to HepA vaccine, to those older than 40 years, depending on the provider’s risk assessment (degree of exposure and medical conditions that might lead to severe complications from HAV infection). The recommended IG dose is now 0.1 mL/kg for post-exposure prevention; it is 0.1 to 0.2 mL/kg for pre-exposure prophylaxis for travelers, depending on the length of planned travel.
• Administer HepA vaccine alone to infants ages 6 to 11 months traveling outside the United States when protection against hepatitis A is recommended.

These recommendations have been published in the Morbidity and Mortality Weekly Report.⁹

One of the most important commitments family physicians can undertake in protecting the health of their patients and communities is to ensure that their patients are fully vaccinated. This task is increasingly complicated as new vaccines are approved every year and recommendations change regarding new and established vaccines. To assist primary care providers, the Centers for Disease Control and Prevention (CDC) annually updates 2 immunization schedules—one for children and adolescents, and one for adults. These schedules are available on the CDC Web site (https://www.cdc.gov/vaccines/schedules/index.html).

These updates originate from the Advisory Committee on Immunization Practices (ACIP), which meets 3 times a year to consider and adopt changes to the schedules. During 2018, relatively few new recommendations were adopted. The September 2018 Practice Alert¹ in this journal covered the updated recommendations for influenza immunization, which included reinstating live attenuated influenza vaccine (LAIV) to the active list of influenza vaccines.

This current Practice Alert reviews 3 additional updates: 1) a new hepatitis B (HepB) vaccine; 2) updated recommendations for the use of hepatitis A (HepA) vaccine for post-exposure prevention and before travel; and 3) inclusion of the homeless among those who should be routinely vaccinated with HepA vaccine.

Hepatitis B: New 2-dose product

As of 2015, the annual incidence of new hepatitis B cases had declined by 88.5% since the first HepB vaccine was licensed in 1981 and recommendations for its routine use were issued in 1982.² The HepB vaccine products available in the United States are 2 single-antigen products, Engerix-B (GlaxoSmithKline) and Recombivax HB (Merck & Co.). Both can be used in all age groups, starting at birth, in a 3-dose series. HepB vaccine is also available in 2 combination products: Pediarix, containing HepB, diphtheria and tetanus toxoids, acellular pertussis, and inactivated poliovirus (GlaxoSmithKline), approved for use in children 6 weeks to 6 years old; and Twinrix (GlaxoSmithKline), which contains both HepB and HepA and is approved for use in adults 18 years and older.

The HepB vaccine is recommended for all children and unvaccinated adolescents as part of the routine vaccination schedule. It is also recommended for unvaccinated adults with specific risks (TABLE 1²). However, the rate of HepB vaccination in adults for whom it is recommended is suboptimal (FIGURE),³ and just a little more than half of adults who start a 3-dose series of HepB complete it.⁴A new vaccine against hepatitis B, HEPLISAV-B (Dynavax Technologies), was licensed by the US Food and Drug Administration in late 2017. ACIP now recommends it as an option along with other available HepB products. HEPLISAV-B is given in 2 doses separated by 1 month. It is hoped that this shortened 2-dose series will increase the number of adults who achieve full vaccination. In addition, it appears that HEPLISAV-B provides higher levels of protection in some high-risk groups—those with type 2 diabetes or chronic kidney disease.³ However, initial safety studies have shown a small absolute increase in cardiac events after vaccination with HEPLISAV-B. Post-marketing surveillance will be needed to show whether this is causal or coincidental.³

If a HepB series must be completed with different products, just be sure 3 doses are given—even if HEPLISAV-B is one of the agents.

As with other HepB products, use of HEPLISAV-B should follow the latest CDC directives on who to test serologically for prior immunity, and on post-vaccination testing to ensure protective antibody levels were achieved.² It is best to complete a HepB series with the same product, but, if necessary, a combination of products at different doses can be used to complete the HepB series. Any such combination should include 3 doses, even if one of the doses is HEPLISAV-B.

Hepatitis A: Vaccination assumes greater importance for more people

A Practice Alert in early 2018 described a series of outbreaks of hepatitis A around the country and the high rates of associated hospitalizations.⁵ These outbreaks have occurred primarily among the homeless and their contacts and those who use illicit drugs. This nationwide outbreak has now spread, resulting in more than 7500 cases since July 1, 2016.⁶ The progress of this epidemic can be viewed on the CDC Web site (https://www.cdc.gov/hepatitis/outbreaks/2017March-HepatitisA.htm).⁷ At its October 2018 meeting, ACIP added homelessness to the list of those (previously unvaccinated) who should receive the HepA vaccine (TABLE 2).⁶

Continue to: Remember that the current recommendation...

Remember that the current recommendation is to vaccinate all children 12 to 23 months old with HepA, in 2 separate doses. Two single-antigen HepA products are available: Havrix (GSK) and Vaqta (Merck). For the 2-dose sequence, Havrix is given at 0 and 6 to 12 months; Vaqta at 0 and 6 to 18 months. Even a single dose will provide protection for up to 11 years. In addition to these vaccines, there is the combination HepA and HepB vaccine (Twinrix) mentioned earlier.

Previous recommendations for preventing hepatitis A after exposure, made in 2007, stated that HepA vaccine was preferred for healthy individuals ages 12 months through 40 years, while immune globulin (IG) was preferred for adults older than 40, infants before their first birthday, immunocompromised individuals, those with chronic liver disease, and those for whom HepA vaccine is contraindicated.⁸ The 2007 recommendations also advised vaccinating individuals traveling to countries with intermediate to high hepatitis A endemicity.

A single dose of HepA vaccine was recommended for all those 12 months or older, although older adults, immunocompromised individuals, and those with chronic liver disease or other chronic medical conditions planning to visit an endemic area in ≤ 2 weeks were supposed to receive the initial dose of vaccine and could also receive IG (0.02 mL/kg) if their provider advised it. Travelers who declined vaccination, those younger than 12 months, or those allergic to a vaccine component could receive a single dose of IG (0.02 mL/kg), which provides protection up to 3 months.

Consider prescribing daily pre-exposure prophylaxis for men and women at risk from sexual exposure to HIV or who inject illicit drugs.

Several factors influenced ACIP to reconsider both the pre- and post-exposure recommendations. Regarding IG, evidence of its decreased potency over time led the committee to increase the recommended dose (see below). IG also must be re-administered every 2 months, the supply of the product is questionable, and many health care facilities do not stock it. By comparison, HepA vaccine offers the advantages of easier administration, inducing active immunity, and providing longer protection. Another issue involved infants ages 6 to 11 months traveling to an area with endemic measles transmission and who must therefore receive the measles, mumps, and rubella (MMR) vaccine. MMR and IG should not be co-administered, and, for infants, the health risk from measles outweighs that from hepatitis A.

Updated recommendations. After considering all this information, ACIP made the following changes to its hepatitis A virus (HAV) prevention recommendations (in addition to adding homeless people to the list of HepA vaccine recipients)⁹:

• Administer HepA vaccine as post-exposure prophylaxis to all individuals 12 months and older.
• IG may be administered, in addition to HepA vaccine, to those older than 40 years, depending on the provider’s risk assessment (degree of exposure and medical conditions that might lead to severe complications from HAV infection). The recommended IG dose is now 0.1 mL/kg for post-exposure prevention; it is 0.1 to 0.2 mL/kg for pre-exposure prophylaxis for travelers, depending on the length of planned travel.
• Administer HepA vaccine alone to infants ages 6 to 11 months traveling outside the United States when protection against hepatitis A is recommended.

These recommendations have been published in the Morbidity and Mortality Weekly Report.⁹

One of the most important commitments family physicians can undertake in protecting the health of their patients and communities is to ensure that their patients are fully vaccinated. This task is increasingly complicated as new vaccines are approved every year and recommendations change regarding new and established vaccines. To assist primary care providers, the Centers for Disease Control and Prevention (CDC) annually updates 2 immunization schedules—one for children and adolescents, and one for adults. These schedules are available on the CDC Web site (https://www.cdc.gov/vaccines/schedules/index.html).

These updates originate from the Advisory Committee on Immunization Practices (ACIP), which meets 3 times a year to consider and adopt changes to the schedules. During 2018, relatively few new recommendations were adopted. The September 2018 Practice Alert¹ in this journal covered the updated recommendations for influenza immunization, which included reinstating live attenuated influenza vaccine (LAIV) to the active list of influenza vaccines.

This current Practice Alert reviews 3 additional updates: 1) a new hepatitis B (HepB) vaccine; 2) updated recommendations for the use of hepatitis A (HepA) vaccine for post-exposure prevention and before travel; and 3) inclusion of the homeless among those who should be routinely vaccinated with HepA vaccine.

Hepatitis B: New 2-dose product

As of 2015, the annual incidence of new hepatitis B cases had declined by 88.5% since the first HepB vaccine was licensed in 1981 and recommendations for its routine use were issued in 1982.² The HepB vaccine products available in the United States are 2 single-antigen products, Engerix-B (GlaxoSmithKline) and Recombivax HB (Merck & Co.). Both can be used in all age groups, starting at birth, in a 3-dose series. HepB vaccine is also available in 2 combination products: Pediarix, containing HepB, diphtheria and tetanus toxoids, acellular pertussis, and inactivated poliovirus (GlaxoSmithKline), approved for use in children 6 weeks to 6 years old; and Twinrix (GlaxoSmithKline), which contains both HepB and HepA and is approved for use in adults 18 years and older.

The HepB vaccine is recommended for all children and unvaccinated adolescents as part of the routine vaccination schedule. It is also recommended for unvaccinated adults with specific risks (TABLE 1²). However, the rate of HepB vaccination in adults for whom it is recommended is suboptimal (FIGURE),³ and just a little more than half of adults who start a 3-dose series of HepB complete it.⁴A new vaccine against hepatitis B, HEPLISAV-B (Dynavax Technologies), was licensed by the US Food and Drug Administration in late 2017. ACIP now recommends it as an option along with other available HepB products. HEPLISAV-B is given in 2 doses separated by 1 month. It is hoped that this shortened 2-dose series will increase the number of adults who achieve full vaccination. In addition, it appears that HEPLISAV-B provides higher levels of protection in some high-risk groups—those with type 2 diabetes or chronic kidney disease.³ However, initial safety studies have shown a small absolute increase in cardiac events after vaccination with HEPLISAV-B. Post-marketing surveillance will be needed to show whether this is causal or coincidental.³

If a HepB series must be completed with different products, just be sure 3 doses are given—even if HEPLISAV-B is one of the agents.

As with other HepB products, use of HEPLISAV-B should follow the latest CDC directives on who to test serologically for prior immunity, and on post-vaccination testing to ensure protective antibody levels were achieved.² It is best to complete a HepB series with the same product, but, if necessary, a combination of products at different doses can be used to complete the HepB series. Any such combination should include 3 doses, even if one of the doses is HEPLISAV-B.

Hepatitis A: Vaccination assumes greater importance for more people

A Practice Alert in early 2018 described a series of outbreaks of hepatitis A around the country and the high rates of associated hospitalizations.⁵ These outbreaks have occurred primarily among the homeless and their contacts and those who use illicit drugs. This nationwide outbreak has now spread, resulting in more than 7500 cases since July 1, 2016.⁶ The progress of this epidemic can be viewed on the CDC Web site (https://www.cdc.gov/hepatitis/outbreaks/2017March-HepatitisA.htm).⁷ At its October 2018 meeting, ACIP added homelessness to the list of those (previously unvaccinated) who should receive the HepA vaccine (TABLE 2).⁶

Continue to: Remember that the current recommendation...

Remember that the current recommendation is to vaccinate all children 12 to 23 months old with HepA, in 2 separate doses. Two single-antigen HepA products are available: Havrix (GSK) and Vaqta (Merck). For the 2-dose sequence, Havrix is given at 0 and 6 to 12 months; Vaqta at 0 and 6 to 18 months. Even a single dose will provide protection for up to 11 years. In addition to these vaccines, there is the combination HepA and HepB vaccine (Twinrix) mentioned earlier.

Previous recommendations for preventing hepatitis A after exposure, made in 2007, stated that HepA vaccine was preferred for healthy individuals ages 12 months through 40 years, while immune globulin (IG) was preferred for adults older than 40, infants before their first birthday, immunocompromised individuals, those with chronic liver disease, and those for whom HepA vaccine is contraindicated.⁸ The 2007 recommendations also advised vaccinating individuals traveling to countries with intermediate to high hepatitis A endemicity.

A single dose of HepA vaccine was recommended for all those 12 months or older, although older adults, immunocompromised individuals, and those with chronic liver disease or other chronic medical conditions planning to visit an endemic area in ≤ 2 weeks were supposed to receive the initial dose of vaccine and could also receive IG (0.02 mL/kg) if their provider advised it. Travelers who declined vaccination, those younger than 12 months, or those allergic to a vaccine component could receive a single dose of IG (0.02 mL/kg), which provides protection up to 3 months.

Consider prescribing daily pre-exposure prophylaxis for men and women at risk from sexual exposure to HIV or who inject illicit drugs.

Several factors influenced ACIP to reconsider both the pre- and post-exposure recommendations. Regarding IG, evidence of its decreased potency over time led the committee to increase the recommended dose (see below). IG also must be re-administered every 2 months, the supply of the product is questionable, and many health care facilities do not stock it. By comparison, HepA vaccine offers the advantages of easier administration, inducing active immunity, and providing longer protection. Another issue involved infants ages 6 to 11 months traveling to an area with endemic measles transmission and who must therefore receive the measles, mumps, and rubella (MMR) vaccine. MMR and IG should not be co-administered, and, for infants, the health risk from measles outweighs that from hepatitis A.

Updated recommendations. After considering all this information, ACIP made the following changes to its hepatitis A virus (HAV) prevention recommendations (in addition to adding homeless people to the list of HepA vaccine recipients)⁹:

• Administer HepA vaccine as post-exposure prophylaxis to all individuals 12 months and older.
• IG may be administered, in addition to HepA vaccine, to those older than 40 years, depending on the provider’s risk assessment (degree of exposure and medical conditions that might lead to severe complications from HAV infection). The recommended IG dose is now 0.1 mL/kg for post-exposure prevention; it is 0.1 to 0.2 mL/kg for pre-exposure prophylaxis for travelers, depending on the length of planned travel.
• Administer HepA vaccine alone to infants ages 6 to 11 months traveling outside the United States when protection against hepatitis A is recommended.

These recommendations have been published in the Morbidity and Mortality Weekly Report.⁹