A person receives the third dose of the COVID19 vaccine at Sheba Medical Center in Ramat Gan, Israel on July 14, 2021.
Amir Lévy | Getty Images
According to data submitted by the company to the Food and Drug Administration, the third dose of Pfizer’s COVID vaccine six months after the second injection restored protection against infection to 95% in a real setting in Israel.
While the effectiveness of the mRNA vaccine declines over time, a booster has been shown to elicit 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 giving reminders to the general population shows that a third stroke “has a similar responsiveness profile to that seen after receiving a second primary set of doses and increased risk of COVID-19 results “. Restores a high level of protection against (revert to approximately 95% protection). Data was collected from July 1 to August 30, when the delta variant was increasing 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 early next week.
Based on the data, Pfizer said it was “applying for a license for the booster supplements.” [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 nearly 300 people aged 19 to 55. According to the documents, a third of the participants were overweight and a third were obese.
The report is to inform the FDA’s Vaccines and Related Biologics Advisory Committee, which meets on Friday to consider a request from Pfizer and its coronavirus vaccine partner, BioNTech, to approve a COVID booster dose for the general public. The published documents offer an overview of the FDA’s approach to third shots.
Pfizer and BioNTech Seek Agency Authorization to Distribute Booster Doses to People 16 Years and Older Across the United States