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While the effectiveness of the mRNA vaccine wanes over time, a booster shot was shown to elicite an immune response similar to the protection generated after a second dose, Pfizer said in a 52-page presentation released by the agency Wednesday.
Pfizer said data from Israel’s Covid vaccination program administering boosters to the entire population show that a third shot “has a reactogenicity profile similar to that seen after receipt of the second primary series dose and restores high levels of protection against Covid-19 outcomes (back to approximately 95% protection).” The data was collected from July 1 through Aug. 30 when the delta variant was surging throughout the country.
The FDA released the data as the agency faces pressure from the Biden administration to authorize booster shots for the general population as early as next week.
Based on the data, Pfizer said it “is requesting licensure of a booster dose of [the Pfizer vaccine] administered intramuscularly approximately 6 months after dose 2 in individuals greater than 16 years of age.”
The company also included data from a Phase 3 trial of about 300 people aged 19 to 55. One-third of participants were overweight, and one-third were obese, according to the documents.
The staff report is meant to brief the FDA’s Vaccines and Related Biological Products Advisory Committee, which meets Friday to review Pfizer and BioNTech’s request to approve Covid booster doses for the general public. The documents published offer a glimpse of the FDA’s view on third shots.
Pfizer and its partner on the Covid vaccine BioNTech are seeking the agency’s OK to distribute booster doses to people 16 and older across the U.S.
Original news source Credit: www.cnbc.com