July 1, 2021, 5:09 p.m. News Staff — COVID-19 vaccines remained the primary focus of the latest meeting of the CDC’s Advisory Committee on Immunization Practices, held online June 23-25. The group reviewed the state of the COVID-19 pandemic in the United States, with a focus on the safety of mRNA vaccines and the incidence of heart inflammation in young adults, along with a discussion on possible COVID-19 booster vaccines.
Pamela Rockwell, D.O., of Ann Arbor, Mich., the Academy’s liaison to the ACIP, told AAFP News that other topics considered during the meeting included draft recommendations for a dengue vaccine and proposed recommendations on the use of certain influenza vaccines for the 2021-22 influenza season, as well as guidance on the use of zoster and pneumococcal vaccines.
The COVID-19 Vaccine Safety Technical Work Group gave a presentation on an association between heart inflammation and COVID-19 vaccines. According to the work group, as of June 11, 1,226 cases of myocarditis or pericarditis had been reported to the CDC’s Vaccine Adverse Event Reporting System. Overall, there have been 12.6 cases of heart inflammation per million doses, with the case rate higher in individuals receiving the Moderna vaccine.
Most cases of heart inflammation have occurred in people ages 30 and younger, typically within one week of receiving the second dose of mRNA vaccine. International reports of myocarditis after mRNA COVID-19 vaccination show that most cases have occurred in men aged 16-30 and have been mild, with chest pain the most common symptom.
Rockwell told AAFP News that this adverse effect is rare and the treatment is largely supportive, and that while no long-term data is currently available, early data on acute outcomes are good.
The work group stated that current data suggests a likely association between heart inflammation and mRNA vaccination. As a result, the group will continue to review the data on myocarditis and pericarditis from VAERS and the V-safe After Vaccination Health Checker, and will update the ACIP on an ongoing basis.
In addition, the following recommendations were given:
In response to the data presented, the Academy joined several other medical and health care organizations in releasing a statement on the benefits of vaccination against COVID-19. The statement noted that heart inflammation is an extremely rare side effect resulting from vaccination, and repeated that the vaccines are safe, effective and prevent COVID-19 illness.
Doran Fink, M.D., Ph.D., deputy director of the FDA’s Division of Vaccines and Related Products Applications, also presented at the meeting. Fink told the committee that the FDA is finalizing language on a warning statement for health care professionals, vaccine recipients and parents or caregivers of adolescents, and that the warning statement will be added to the fact sheets for both the Pfizer/BioNTech and Moderna vaccines in the near future.
While no formal vote on COVID-19 vaccines was held, ACIP members in attendance suggested that individuals continue to receive the Pfizer and Moderna vaccines as the benefits of vaccination still clearly outweigh the risks in adolescents and young adults.
Finally, the committee discussed the possibility of individuals requiring additional or booster doses of COVID-19 vaccine. Because a number of variables remain unknown, the ACIP concluded that it would only recommend that individuals receive booster doses if there were evidence showing a drop in the effectiveness of the vaccines currently in use and if an “escape” variant of the virus negatively affected the protection the vaccines provide. In the meantime, the ACIP will continue to closely monitor certain populations that may be at increased risk of infection. It will also review more data from vaccine manufacturers in the coming months to determine the safety and effectiveness of booster doses.
ACIP members voted unanimously to recommend use of Dengvaxia, which prevents dengue disease caused by dengue virus serotypes 1, 2, 3 and 4. As licensed by the FDA, Dengvaxia may only be administered to children ages 9 to 16 years who live in areas where dengue is endemic and who have had laboratory confirmation of at least one previous dengue infection. According to the CDC, dengue is common in the U.S. territories of Puerto Rico, the U.S. Virgin Islands and American Samoa, while localized outbreaks have occurred in Florida, Hawaii and Texas.
The committee voted unanimously to approve language on the co-administration of influenza and COVID-19 vaccines. The language aligns with recommendations from the CDC issued earlier this year, which state that COVID-19 vaccines and other vaccines may now be administered without regard to timing, including the simultaneous administration of COVID-19 vaccines and other vaccines on the same day.
The 2021-22 influenza season is the first season in which all vaccines available to protect against influenza will be quadrivalent vaccines. In related news, the age indication for Flucelvax, a quadrivalent vaccine that offers protection against four different influenza strains, has been expanded. The vaccine can now be administered to individuals 2 years of age and older. This age change was approved by the FDA in March 2021.
The committee also approved changes in language with regard to the timing of influenza vaccination. Specifically,
New language for vaccination of pregnant patients in the third trimester was also added to consider influenza vaccination soon after the vaccine becomes available to reduce the risk of influenza illness of their infants during the first months of life.
Finally, the committee approved updated language on the incidence of severe allergic reactions to influenza vaccination. The ACIP General Best Practice Guidelines for Immunization recommends referral to an allergist for evaluation to possibly determine the component responsible for a severe allergic reaction (e.g., anaphylaxis) before making decisions regarding administration of additional doses of the same vaccine or other vaccines that have the same components.
The committee unanimously approved a recommendation to allow children younger than 18 who require pre-exposure prophylaxis for rabies to receive a two-dose vaccine series, with the doses administered seven days apart. Previously, the vaccine was administered in a three-dose series.
The committee also recommended that children younger than 18 with sustained and elevated risk of rabies exposure be able to receive a booster dose of rabies vaccine as an alternative to a titer check. The booster dose should be administered at least 21 days, but no later than three years, after receiving the last dose of the vaccine series.
Data were presented on the use of the recombinant zoster vaccine in immunocompromised populations. Persons with immunocompromising conditions have a higher risk of herpes zoster and RZV immunogenicity and safety data presented support a favorable benefit-risk profile in immunocompromised adults who are at an increased risk of herpes zoster. The committee debated whether RZV should be recommended for use in immunocompromised adults ages 19 years and older, but no vote was taken.
The committee provided updates on two new pneumococcal conjugate vaccines.
The first, a 20-valent pneumococcal conjugate vaccine (Prevnar 20) manufactured by Pfizer Inc., received approval from the FDA on June 8. The vaccine has been licensed for use in adults 18 and older.
The second, a 15-valent pneumococcal conjugate vaccine manufactured by Merck, is currently under investigation. The FDA has accepted a biologics license application for priority review, and licensure is anticipated to occur in July. Like Prevnar 20, the Merck vaccine will be licensed for use in adults 18 and older.
The committee debated several policy questions pertaining to recommendations for use of the new vaccines in younger adults with underlying medical conditions and in adults aged 50 or older or 65 or older.
The committee also debated a simplified recommendation for currently available adult pneumococcal vaccines. Next steps include presentation of additional cost-effective analyses; grading of recommendations, assessment, development and evaluation; and evidence to recommendation framework for risk-based recommendations for younger adults not targeted by the current age-based recommendations to be presented at a meeting in September, and a refinement on policy options on age- and risk-based recommendations on PCV15 and PCV20 use in adults for a vote in October.
The committee will vote on recommendations for all newly licensed vaccines at its October meeting.