Pfizer-BioNTech included data in its FDA submission showing the 3rd mRNA shot restores protection against symptomatic COVDI-19 to about 95%.
Pfizer-BioNTech submitted a request on Tuesday for an expanded Emergency Use Authorization (EUA) to allow all adults aged ≥18 years to receive a booster dose of the partners' COVID-19 vaccine.
The Food and Drug Administration (FDA) is expected to grant the request, and potentially before Thanksgiving and in anticipation of Christmas holiday travel and gatherings.
COVID-19 cases continue to decline but research in the US and abroad has shown that immunity against severe disease granted by 2 doses of the Pfizer and the Moderna mRNA vaccines and the single-dose Johnson & Johnson (J&J) vaccine wanes significantly after 6 months, findings that have refueled calls for booster doses for all adults.
Accompanying its request, according to the Associated Press, Pfizer is submitting early results of a phase 3 study of the booster shot given to 10 000 participants which concluded that a booster inoculation could restore protection against symptomatic infection to approximately 95% and was conducted at a time when circulation of the highly contagious Delta variant was surging. The booster efficacy data has not yet been peer-reviewed or published in a scientific journal.
Approval by the Food and Drug Administration (FDA) of the expanded EUA would bring the country closer to realizing the Biden Administration’s goal stated in August to provide booster doses (a third shot for mRNA Pfizer-BioNTech and Moderna recipients or a second shot for Janssen/Johnson & Johnson recipients) for all US adults by mid-September.
The plan was dealt a blow when scientific advisers to the FDA rejected the plans based on limited evidence available to demonstrate that healthy adults require a booster dose and a strong preference to prioritize sending warehoused doses to parts of the world that remain largely unvaccinated.
The boosters were instead recommended for a more limited group of adults at least 6 months after receiving the Pfizer 2-dose series including those aged ≥65 years, people aged 18-64 years who are deemed at high risk for severe COVID-19 disease (including the immunocompromised) and people aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting.
FDA issued a subsequent announcement on October 20, 2021, authorizing:
If the FDA authorizes Pfizer’s request for expanded boosters, the Centers for Disease Control and Prevention then will make recommendations for how to use them.