FDA Expands Use of Pfizer-BioNTech COVID-19 Vaccine

FDA announced on Jan. 3, 2022, that it was amending the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to expand single booster doses to children 12 through 15 years of age. The agency reviewed data from Israel from individuals aged 12–15 who received a booster dose five months after the primary two-dose vaccination series, allowing FDA to reassess the risk/benefit of the use of boosters in younger adolescents.

“The data shows there are no new safety concerns following a booster in this population. There were no new cases of myocarditis or pericarditis reported to date in these individuals,” FDA stated in a press release.

The EUA was also amended to shorten the time from primary vaccination to a booster dose to at least five months based on additional real-world data that has become available. The agency stated in a press release that no new safety concerns have been seen in the 4.1 million individuals over 16 years old in Israel who have received a booster dose at least five months after they received their first two doses.

“Additionally, peer-reviewed data from multiple laboratories indicate that a booster dose of the Pfizer-BioNTech COVID-19 Vaccine greatly improves an individual’s antibody response to be able to counter the omicron variant. Authorizing booster vaccination to take place at five months rather than six months may therefore provide better protection sooner for individuals against the highly transmissible omicron variant. Given the demonstrated safety and effectiveness of a booster dose when administered five months after the primary vaccination series, and the fact that a booster dose may help provide better protection against the rapidly spreading omicron variant, the FDA has determined that the known and potential benefits of administering a booster to individuals ages 12 and older at least five months following completion of the primary vaccination series, outweighs the known and potential risks,” the agency stated in the press release.

FDA will also allow children ages 5–11 who have undergone solid organ transplants or have immunocompromised conditions to receive a third primary series does to maximize the benefit of the Pfizer-BioNTech vaccine.

“The agency used prior analyses conducted as part of the authorization process for healthy children to inform safety in this population and determined that the potential benefits of the administration of a third primary series dose at least 28 days following the second dose of the two-dose regimen, outweighed the potential and known risks of the vaccine. To date, the FDA and CDC have seen no new safety signals in this age group,” the agency stated.

“Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind,” said Acting FDA Commissioner Janet Woodcock, M.D., in the press release. “With the current wave of the omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing and social distancing in order to effectively fight COVID-19.”

“Based on the FDA’s assessment of currently available data, a booster dose of the currently authorized vaccines may help provide better protection against both the delta and omicron variants. In particular, the omicron variant appears to be more resistant to the antibody levels produced in response to the primary series doses from the current vaccines,” said Peter Marks, M.D., PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the release. “With this in mind, the FDA has extended the range of individuals eligible to receive a booster, shortened the length of time between the completion of the Pfizer primary series for individuals to receive a booster and is authorizing a third protective vaccine dose for some of our youngest and most vulnerable individuals.”

Source: FDA