FDA Expands Authorization for Pfizer’s COVID-19 Vaccine Booster

FDA recently expanded the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine booster to include individuals 12 years of age and older.

The authorization follows two months after the agency expanded the authorization for the booster to include individuals 18 years and older. The booster dose is the same dosage strength as the dose approved in the primary series (30 micrograms).

“The recent rise in COVID-19 cases is concerning to all and today’s decision by the FDA to further expand the Emergency Use Authorization of a booster dose of our vaccine is critical to help us ultimately defeat this pandemic,” Albert Bourla, chairman and chief executive officer of Pfizer, said in the announcement.

“We continue to believe that broad use of boosters is essential to preserving a high level of protection against this disease and reducing the rate of hospitalizations,” Bourla continued.

Separately, FDA is amending the existing emergency use authorization to reduce the administration time of a booster dose from at least six months to at least five months following completion of the primary dose series in individuals 12 and older.

The agency based its decision on a real-world evidence study from the Ministry of Health of Israel.

Researchers administered over 4.1 million third doses of the Pfizer-BioNTech COVID-19 vaccine at least 5 months after the primary series. There were no new safety concerns in adolescents 12 through 17 years of age.

Finally, FDA expanded the current authorization to include a third primary series dose at least 28 days following the second dose for individuals five through 11 years of age with certain kinds of immunocompromise.

The agency based the expanded authorization on information from an independent report evaluating the safety and effectiveness of a third dose in adults who received solid organ transplants.

As of December, Pfizer and BioNTech delivered 1 billion doses of their vaccine to low-and middle-income countries and expect to deliver an extra 1 billion doses to these nations in 2022.

The companies stated that they will continue to supply the vaccine, including booster doses, until their existing supply agreement with the government ends in April 2022.

Ugur Sahin, MD, CEO and co-founder of BioNTech, stated that the vaccine booster increases immunity and improves protection across all age groups, which is crucial given the increasing spread of the Omicron variant.