On September 17, a preliminary step toward authorization of COVID-19 boosters was taken. A U.S. Food and Drug Administration (FDA) advisory panel recommended the FDA authorize a booster dose of the Pfizer-BioNTech COVID-19 vaccine for those at highest risk for exposure and severe outcomes from COVID-19. This includes people age 65 and older, people at high risk for severe COVID-19 illness, as well as healthcare workers and other workers at high risk for occupational exposure. Booster doses could be administered at least six months following completion of the original vaccine series, according to the recommendation.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) approved the recommendation unanimously after rejecting a proposal to recommend the FDA authorize booster doses of the vaccine for any recipient age 16 and older at least six months after completion of the original COVID-19 vaccine series. The panel said more safety and effectiveness data is needed for review before it will recommend booster doses for the general population.
There are multiple steps involved in the authorization of booster doses for COVID-19 vaccines. All steps in the process must be complete before plans for booster dose administration can be finalized and a booster dose can be given to any eligible Ohioans.
- Next, the FDA will consider VRBPAC’s recommendation and, if in support, will update the Pfizer-BioNTech COVID-19 vaccine emergency use authorization (EUA) to include booster doses for the eligible populations.
- The Pfizer-BioNTech COVID-19 vaccine (now known as Comirnaty) has received full FDA approval for its two-dose series for people age 16 and older.
- The emergency use authorization (EUA) remains in effect for the following uses:
- Two-dose vaccine series for people ages 12-15.
- Additional doses to strengthen immune response in recipients who are immunocompromised and may have had insufficient response to the initial two-dose regimen.
- Once authorized, a booster dose to help eligible, fully vaccinated people maintain protection.
- In addition, the Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP) will make recommendations for the booster dose and may further define eligibility for a booster dose.
- The VRBPAC recommendation could be modified by the FDA, the ACIP, or the CDC.
- The FDA will consider updates to the Moderna and/or Johnson & Johnson (Janssen) COVID-19 vaccine EUAs separately after applications are submitted by the vaccine manufacturers and those applications are reviewed. After the FDA and the CDC have taken action, the Ohio Department of Health (ODH) will finalize and share plans to administer the booster dose to eligible Ohioans. ODH has been working on distribution plans with partners to ensure that vaccine will be available as needed. However, until the federal government makes final recommendations on who is eligible and when, these plans cannot be finalized. Federal partners have assured us the vaccine supply will be sufficient to support any approved booster program. In addition, ODH does plan to track additional doses and report information on its dashboard to be consistent with CDC reporting.
ODH will continue to share developments in the approval process for the booster dose. As ODH prepares for approval of boosters, it encourage providers to order vaccine, if needed, to ensure sufficient supply is readily available for boosters. As always, please use existing supply prior to utilizing vaccine with longer expiration dates.
For more information, visit coronavirus.ohio.gov. If you have any questions or issues, please contact the vaccine provider relations team between 8 a.m. and 7 p.m. Monday through Friday by calling 1.844.9ODHVAX (1.844.963.4829) or by emailing COVIDVACCINE@odh.ohio.gov.