FDA Authorizes Pfizer's COVID-19 Booster for People Over 65 or at High Risk

• Emergency Use Authorization (EUA) granted for individuals 65 years of age and older, and individuals ages 18 through 64 within certain high-risk groups
• EUA is supported by clinical data showing a booster dose of the Pfizer-BioNTech vaccine elicits high neutralization titers against SARS-CoV-2 and all currently tested variants
• Reactogenicity profile within seven days of the booster dose was typically mild to moderate, with frequency of reactions similar to or lower than after the primary vaccination series
• A booster dose given at least six months after completion of the primary vaccination series may help preserve a high level of protection against COVID-19

The Food and Drug Administration granted emergency use authorization Wednesday for a third dose of Pfizer and BioNTech's COVID-19 vaccine to be given to three groups — those 65 and older, those at high risk of developing severe COVID-19 and those at risk of developing "serious complications" due to "frequent institutional or occupational exposure," likely including frontline healthcare workers and prisoners. The authorization makes the Biden administration's plan to roll out booster shots this week at least partially possible.

The booster dose is to be administered at least six months after completion of the primary series, and is the same formulation and dosage strength as the doses in the primary series.

“This first FDA authorization of a COVID-19 vaccine booster is a critical milestone in the ongoing fight against this disease,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Over the last year and a half, we have aimed to stay vigilant as the pandemic has evolved – including evaluating the impact of a booster dose. We believe boosters have an important role to play in addressing the continued threat of this disease, alongside efforts to increase global access and uptake among the unvaccinated. Today’s FDA action is an important step in helping the most vulnerable among us remain protected from COVID-19.”

“Today’s emergency use authorization is supported by clinical data underlining that a booster induces a strong immune response against tested variants of concern and can address a current public health need. We will continue to monitor new SARS-CoV-2 strains, to be prepared for potential emerging escape variants,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We and our collaboration partner have submitted booster data to other regulatory agencies around the world. We are simultaneously working to expand access to our vaccines globally.”

The FDA based this EUA on the totality of scientific evidence shared by the companies and reviewed by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), including data from the Pfizer-BioNTech clinical program evaluating the safety, tolerability and immunogenicity of a booster dose of the COVID-19 vaccine. A booster dose of the vaccine elicited significantly higher neutralizing antibody titers against the initial SARS-CoV-2 virus (wild type), as well as the Beta and Delta variants, when compared with the levels observed after the two-dose primary series. The reactogenicity profile within seven days after the booster dose was typically mild to moderate, and the frequency of reactions was similar to or lower than after dose two. The adverse event profile was generally consistent with other clinical safety data for the vaccine.

As a next step, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss a potential recommendation for the use and rollout of boosters to Americans.

Pfizer and BioNTech continue to supply the vaccine, including sufficient volume for boosters, under their existing supply agreement with the U.S. government, which continues through April 2022. The companies do not expect the introduction of booster doses in the U.S. to impact the existing supply agreements in place with governments and international health organizations around the world. Pfizer and BioNTech have pledged to provide two billion doses to low- and middle-income countries in 2021 and 2022 – at least one billion doses each year.

Under the EUA in the U.S., a third dose of the vaccine was previously authorized for individuals at least 12 years of age who have undergone solid organ transplant, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. This authorization of a third dose for immunocompromised individuals – administered at least 28 days following the second dose – is separate and distinct from the booster dose authorized today. 

The third dose for immunocompromised individuals is meant to address the fact that these individuals sometimes do not build enough protection after two doses of the vaccine. In contrast, the booster dose authorized today refers to an additional dose of the vaccine that is given to those who have built enough protection after the primary vaccination series, but may have decreased protection over time due to waning of immunity.

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Moderna only recently submitted to the FDA data supporting a booster dose of its COVID-19 vaccine. It halved its third dose from 100 micrograms to 50 micrograms. Pfizer's booster shot is the same as the first two doses.

Johnson & Johnson recently announced data from its vaccine trials suggesting the single-shot Janssen vaccine remained mostly effective at preventing severe disease but also that a second dose could boost protection.

Scientists at the National Institutes of Health are also working to release data from trials in which they mix-and-match booster shots. The results are expected to be announced as early as this month.

"We are right in the middle of those trials to see, can you mix and match any one of the three that have emergency use authorization, can you start with one and boost with the others? We're going to know more about that just in the course of the next two or three weeks," NIH Director Francis Collins told "Face the Nation" on Sunday.

September 23, 2021