Mere hours after the FDA expanded emergency use authorizations (EUAs) to permit booster doses of both the Moderna and Pfizer-BioNTech Covid-19 vaccines to allow a single-dose booster for all individuals ages 18 and older, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted in favor of the expanded indication.
The ACIP recommendations reads as follows:
- “A single Covid-19 vaccine booster dose is recommended for persons aged ≥18 years who received an mRNA Covid-19 vaccine primary series based on individual benefit and risk, at least 6 months after the primary series, under the FDA’s Emergency Use Authorization.” ACIP unanimously voted “yes” to this recommendation.
- “A single Covid-19 vaccine booster dose is recommended for persons aged ≥50 years who received an mRNA Covid-19 vaccine, at least 6 months after the primary series, under the FDA’s Emergency Use Authorization.” ACIP unanimously voted “yes” to this recommendation.
Before today, the Johnson & Johnson single-dose, adenovirus-vectored vaccine was the only currently authorized Covid-19 vaccine authorized for booster dosing in all adults—previously, both mRNA-1273 and BNT162b2 boosters were only available for adults ages 65 and older and adults ages 18-64 at high risk of severe Covid-19 infection and with frequent institutional or occupational exposure to SARS-CoV-2. ACIP still recommends that everyone in these populations should receive a Covid booster.
But now, with this latest EUA—and the authorization for heterologous booster dosing back in October—any U.S. adult age 18 and older can receive a single booster dose of the vaccine of their choice. The only difference, ACIP noted, is that whereas the previously authorized populations and those ages 50-64 should receive a Covid booster, those ages 18-49 who were not included in the initial authorizations may get a booster depending on their individual benefits and risks.
“The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech Covid-19 vaccines to individuals 18 years of age and older,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a statement. “Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one.”
This last point is important: according to a presentation at the ACIP meeting, four in 10 fully vaccinated adults are unsure whether or not they are eligible to receive an additional dose. In fact, some U.S. states have already moved to start handing out Covid boosters to all adults, ignoring previous federal guidance.
The FDA’s decision was based on the following data:
- For mRNA-1273: FDA “analyzed the immune response data from 149 participants 18 years of age and older from the original clinical studies who received a booster dose at least six months after their second dose and compared it to the immune responses of 1,055 study participants after completing their two-dose series. The antibody response against the SARS-CoV-2 virus 29 days after a booster dose of the vaccine demonstrated a booster response.”
- For BNT162b2: FDA “analyzed the immune response data from approximately 200 participants 18 through 55 years of age who received a single booster dose about six months after their second dose. The antibody response against the SARS-CoV-2 virus one month after a booster dose of the vaccine when compared to the response one month after the two-dose primary series in the same individuals demonstrated a booster response.”
Overall, local and systemic reactions were less frequent following booster doses than primary series shots for both vaccines, though the Moderna booster seemed to produce more reactions than the Pfizer-BioNTech. Most adverse event reports were non-serious (over 93%).
The FDA acknowledged that, unlike with previous vaccine authorizations, the agency did not convene its Vaccines and Related Biological Products Advisory Committee for this decision, “as the agency previously convened the committee for extensive discussions regarding the use of booster doses of Covid-19 vaccines and, after review of both Pfizer’s and Moderna’s EUA requests, the FDA concluded that the requests do not raise questions that would benefit from additional discussion by committee members.”
With this new authorization, the Biden administration can finally achieve its goal of rolling out boosters to all U.S. adults who have received a primary Covid-19 vaccine series, which the administration initially hoped to achieve by the end of September. And it may come just in time—public health experts have begun expressing concern over what appears to be another surge in Covid-19 cases, which might be exacerbated by the upcoming holiday season.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 31
Topic ID: 79,31,730,933,31,926,192,561,927,151,928,925,934