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While the effectiveness of the mRNA vaccine declines over time, a booster injection has been shown to trigger an immune response similar to the protection generated after a second dose, Pfizer said in a 52-page presentation published by the agency Wednesday.
Pfizer said data from Israel’s Covid vaccination program giving boosters to the general population shows that a third stroke “has a similar reactogenicity profile to that seen after receiving the second dose in the series. primary and restores high levels of protection against Covid-19 results (return to approximately 95% protection). The data was collected from July 1 to August 30, when the delta variant was in full swing across the country.
The FDA released the data as the agency faces pressure from the Biden administration to allow booster shots for the general population as early as next week.
Based on the data, Pfizer said it is “seeking authorization for a booster dose of [the Pfizer vaccine] given intramuscularly approximately 6 months after dose 2 in persons over 16 years of age.
The company also included data from a Phase 3 trial involving around 300 people aged 19 to 55. A third of the participants were overweight and a third were obese, according to the documents.
The staff report is intended to inform the FDA’s Vaccines and Related Biologics Advisory Committee, which is meeting on Friday to consider Pfizer and BioNTech’s request to approve Covid booster doses for the general public. The published documents offer an overview of the FDA’s perspective on third shots.
Pfizer and Covid Vaccine Partner BioNTech Seek Agency Authorization to Distribute Booster Doses to People 16 Years and Older Across the United States