Source: IZ Express
The Advisory Committee on Immunization Practices (ACIP) met on April 19, to review the Food and Drug Administration’s (FDA) April 18 amendments to the emergency use authorizations (EUA) for use of bivalent mRNA COVID-19 vaccines. The amendments further simplify U.S. COVID-19 vaccine recommendations and provide additional flexibility for people at higher risk of COVID-19 complications. No votes were taken, but members were generally supportive of the changes. After the meeting, the Centers for Disease Control and Prevention (CDC) released a media statement recommending use of these vaccines as authorized by FDA.
- Bivalent mRNA COVID-19 vaccines are authorized for all recommended doses for people age 6 months and older.
- Monovalent mRNA vaccines are no longer authorized for use in the United States.
- Previously unvaccinated people age 6 years and older, and those in that age group who have not received a bivalent mRNA COVID-19 vaccine, are considered fully vaccinated following a single bivalent dose.
- Children age 6 months through 5 years should receive a primary series of at least two doses (with at least one bivalent dose), but the total number of doses needed is determined by the formulation used and the number of previous doses. The CDC is developing support materials to assist physicians and other healthcare professionals with these determinations.
- Adults age 65 years and older who have received a bivalent mRNA vaccine dose have the option to receive a second bivalent mRNA dose at least 4 months after their most recent dose.
- Individuals with immunocompromise who received a bivalent mRNA vaccine dose have the option to receive a second bivalent mRNA vaccine dose at least 2 months after their most recent dose, and subsequent doses at the discretion of their physician or other healthcare professional.
- Due to lack of data, the FDA did not extend this authorization to children younger than age 5 who received Pfizer-BioNTech COVID-19 vaccination.
- No changes were made to the recommendations for use of monovalent Novavax and Janssen (Johnson & Johnson) COVID-19 vaccines.
During the meeting, ACIP also received COVID-19 vaccine program updates, discussed vaccine safety and efficacy, and reviewed implementation issues related to the updated bivalent vaccine authorizations. Presentation slides are available online. The sections below outline additional key points.
Next steps for implementation of revised CDC guidance:
- The elimination of monovalent mRNA vaccine options reduces the number of mRNA COVID-19 vaccine products from 11 to 5
- Clinicians should download and use the four new FDA EUA Fact Sheets that reflect these changes
- CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States should be reviewed for specific guidance
- The CDC will issue additional clinic tools to assist providers in coming weeks, especially for children age 6 months through 5 years, whose new interim recommendations are particularly complex
- The CDC will host a Clinician Outreach and Communication Activity (COCA) webinar on these changes on Thursday, May 11.
- The bivalent vaccines demonstrate very good effectiveness against severe disease outcomes
- Only 16.7% of eligible people in the United States have received a bivalent vaccine
- The CDC continues to monitor the statistical signal suggesting a possible increased risk for ischemic stroke following receipt of Pfizer-BioNTech COVID-19 bivalent vaccine. The signal has diminished over time, which is reassuring. Recommendations for use of the vaccine are unchanged.
- The COVID-19 PHE ends on Thursday, May 11
- All government-purchased COVID-19 vaccine doses will continue to be distributed and administered free of charge at least through summer 2023
- After COVID-19 vaccines become commercially available in the fall, most recipients will have access to vaccination with no out-of-pocket costs. The Vaccines for Children program, commercial insurance, Medicaid, and Medicare will cover the cost of these vaccines.
- A new federal “Bridge Access Program” is intended to maintain COVID-19 vaccine access for uninsured adults
- The Public Readiness and Emergency Preparedness (PREP) Act providing immunity from liability for medical countermeasures against COVID-19 will be extended through December 2024. This revised declaration will provide liability protection for pharmacy professionals to administer COVID-19 and seasonal influenza vaccines to people age 3 years or older.
- In June 2023, the virus strain or strains to be included in COVID-19 vaccine anticipated to be distributed in fall 2023 will be selected
- ACIP members and CDC staff highlighted the need for further changes to recommendations for younger children, including immunocompromised children, and the need to consider recommending vaccination during each pregnancy.
The next scheduled ACIP meeting will be held Wednesday-Thursday, June 21–22, although additional emergency meetings may be announced before that time. Information about past and future ACIP meetings may be found on the ACIP website.
- ACIP main page for content from previous meetings, as well as information about future settings
- CDC: ACIP Presentation Slides: April 19 meeting web page
- FDA: Fact Sheets for Bivalent COVID-19 mRNA Vaccine
- Pfizer-BioNTech
- Healthcare professionals (4/18/2023)
- Recipients and caregivers (4/18/2023)
- Moderna
- Healthcare professionals (4/18/2023)
- Recipients and caregivers (4/18/2023)
- Pfizer-BioNTech
- CDC: Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States
- CDC: (media statement) CDC Simplifies COVID-19 Vaccine Recommendations, Allows Older Adults and Immunocompromised Adults to Get Second Dose of the Updated Vaccine
- HHS: Fact Sheet: HHS Announces Intent to Amend the Declaration under the PREP Act for Medical Countermeasures against COVID-19.