Flu Shot Weak This Season, Recs for Catch-up HPV Vaccines: CDC

This past season's flu vaccine was only about 30% effective overall, and ineffective against a late-surging strain, the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) stated in its 2-day meeting on June 27 and 28.

The committee also updated its recommendations on vaccines, including those for hepatitis A virus (HAV), meningococcus, and pneumococcus, and recommended a shared decision-making process between physicians and patients for those aged 27 to 45 years to get catch-up vaccines for the human papillomavirus.

Influenza

The committee voted unanimously (14 yes, 0 no) to continue its recommendation for all those aged 6 months or older without contraindications to receive an annual influenza vaccine.

There will be a new table with dose volumes for quadrivalent inactivated influenza vaccines (IIV4), which differ among vaccines.

ACIP unanimously approved the Vaccines for Children (VFC) Program resolution for influenza vaccines, which updates the table of inactivated influenza vaccines in the VFC Program.

The committee voted unanimously to affirm the updated statement, "Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices-United States, 2019-20 Influenza Season."

The 2018 to 2019 influenza season was moderately severe. There were two waves of influenza viruses of similar magnitude; the first wave was caused by an influenza A(H1N1)pdm09 virus and the second wave was caused by an H3N2 virus.

Three US networks — the US Flu Vaccine Effectiveness (VE) Network, the Hospitalized Adult Influenza Vaccine Effectiveness Network [HAIVEN], and the New Vaccine Surveillance Network [NVSN] — evaluated vaccine effectiveness. Preliminary results found that, overall, vaccine was approximately 30% effective against influenza illness and hospitalizations and prevented approximately 40,000 to 90,000 hospitalizations.

For influenza A(H1N1)pdm09, vaccine reduced associated outpatient illness by 44% and hospitalizations by 48% - 60%. Vaccine provided no protection against predominant H3N2 virus because the predominant H3N2 strain was of a different clade than that contained in the vaccine. The HAIVEN based its findings on a small number of cases and the negative VE could be a result of chance or bias. These VE estimates will be updated when final data become available.

There were no new safety signals seen for trivalent inactivated influenza vaccine (IIV3), IIV4, quadrivalent live attenuated influenza vaccine (LAIV4), IIV3 high-dose (IIV-HD), cell culture-based IIV4 (ccIIV4), adjuvanted IIV3 (aIIV3), or recombinant IV4 (RIV4) during the 2018 - 2019 season. During the 2019 - 2020 season, safety monitoring will look more closely at aIIV3 (Fluad, Seqirus), RIV4 (Flublok Quadrivalent, Sanofi Pasteur), pregnancy reports, and anaphylaxis reports in those with history of egg allergy.

Human Papillomavirus

On June 26, the committee voted to provisionally recommend vaccination against human papilloma virus (HPV) with human papillomavirus 9-valent vaccine, recombinant (Gardasil, Merck) on the basis of shared clinical decision-making for those aged 27 through 45 years who have not been adequately vaccinated, according to a company news release.

The committee also voted to broaden recommendations for routine and catch-up vaccination for males through age 26 years who have not been adequately vaccinated. According to the CDC, females and males should be routinely vaccinated at 11 to 12 years of age and can be vaccinated as young as age 9 years.

"Although administration of the HPV vaccine is safe and effective in patients ages 27 to 45, the target age for vaccination — the age at which vaccination confers the greatest benefits to the patient — continues to be 11 to 12 years," Christopher M. Zahn, MD, vice president of Practice Activities at the American College of Obstetricians and Gynecologists, said in a statement.

"The HPV vaccine can halt transmission of the virus and can prevent life-threatening cancers later in life. Today's decision from ACIP should encourage physicians to discuss the vaccine routinely with their 27- to 45-year-old patients and should help more patients feel confident in their decisions to protect themselves by getting vaccinated."

Hepatitis A Virus

The current recommendation for HAV vaccination of all children aged 12 to 23 months remains unchanged; the committee voted unanimously to recommend that children and adolescents aged 2 through 18 years who have not previously received hepatitis A vaccine receive a catch-up vaccination at any age.

Persons with clotting factor disorders was removed from the list of groups with increased risk for HAV or severe HAV disease, as their risk has fallen over time with improved processing of factor VIII and factor IX concentrates; the risk for viral transmission is now the same as that for the general population. Persons with HIV was added to the list.

The committee voted unanimously to recommend that all those with HIV aged 1 year or older receive the hepatitis A vaccine.

The committee voted unanimously to affirm the updated statement, "Prevention of Hepatitis A Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices."

ACIP also voted unanimously to approve the VFC resolution for hepatitis A vaccines.

Meningococcal Vaccine

The committee voted unanimously to recommend a serogroup B meningococcal (MenB) booster vaccination for persons aged 10 years or older with increased risk for serogroup B meningococcal disease who previously received a complete MenB primary series. "This recommendation does not apply to persons who previously completed a MenB primary series as an adolescent based on individual clinical decision-making and who are not at increased risk for serogroup B meningococcal disease," according to ACIP.

The booster should be administered 1 year after completion of the primary series and should be repeated every 2 to 3 years for as long as the increased risk remains. In certain cases, a booster interval of 6 months or longer is recommended.

Persons with increased risk include those with complement deficiency, complement inhibitor use, or asplenia; microbiologists; and those exposed during an outbreak.

The group cautions that MenB vaccines are not interchangeable and the same MenB vaccine should be used for all doses.

The committee affirmed the updated statement, "Meningococcal Vaccination: Recommendations of the Advisory Committee on Immunization Practices."

ACIP unanimously approved the VFC resolution for meningococcal vaccine. The resolution was updated to reflect meningococcal conjugate vaccines that are currently available and new recommendations for serogroup B meningococcal vaccine booster doses. In addition, the language regarding the intervals for one serogroup B vaccine has been updated to bring it more in line with that in the current ACIP recommendation.

"I'm a little bit bothered by a booster recommendation with limited information that we have, but based on the rationale for the initial approval and the risk group being definitely at risk, I was persuaded by the discussion earlier today to vote for the approval," Robert L. Atmar, MD, Baylor College of Medicine, Houston, Texas, said at the meeting.

"I'm reassured that we have some assurance that there'll be follow-up by the CDC," said Paul Hunter, MD, City of Milwaukee Health Department, Wisconsin.

Pneumococcal Vaccines

The committee voted by a narrow margin (8 no, 6 yes) against recommending the 13-valent pneumococcal conjugate vaccine (Prevnar13, Pfizer; PCV13) for all adults aged 65 years or older who have not received it previously, recommending that patients and physicians make the decision together. The recommendation was a reversal of a 2014 recommendation.

"This revised recommendation reinforces that Prevnar 13 is considered safe and effective by the [US Food and Drug Administration] and ACIP and helps address remaining persistent vaccine type pneumococcal disease in the population of adults age 65 years or older, which causes thousands of pneumococcal pneumonia cases every year in the United States," Luis Jodar, Chief Medical and Scientific Affairs Officer, Pfizer Vaccines, said in a news release.

"Direct vaccination remains the best available tool to help prevent against pneumococcal disease and the revised recommendation emphasizes the importance of the health care professional and patient relationship in shared decision making regarding vaccination."

The director of the CDC and the US Department of Health and Human Services will review the provisional recommendations and final recommendations will be made official when they are published in the CDC's Morbidity and Mortality Weekly Report.

Merck news release June 26, 2019.

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