A third dose of Pfizer’s Covid vaccine six months after a second injection restores protection against infection to 95% in a real setting in Israel, according to data submitted by the company to the Food and Drug Administration.
While the effectiveness of the mRNA vaccine declines over time, a booster injection has been shown to elicit 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 (back to about 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 as early as next week. But agency staff declined to take a position on the need for a third move, citing the lack of verified data in a 23-page report released later Wednesday.
Staff said they were reviewing other “potentially relevant” studies of decreased immunity to Pfizer’s vaccine, but the studies have produced mixed results and some of these data may be more reliable than others. . The Israeli data comes from an observational study, which does not meet the same standards as a formal clinical trial.
“It must be recognized that while observational studies can provide insight into real-world efficacy, there are known and unknown biases that may affect their reliability. Due to these biases, some studies may be more reliable than d ‘others,’ wrote FDA staff in their review.
Pfizer’s report is intended to inform the FDA’s Vaccines and Related Biologics Advisory Committee, which meets on Friday to consider the request by Pfizer and its coronavirus vaccine partner, BioNTech, to approve doses of Covid reminder for the general public. The published documents offer an overview of the FDA’s perspective on third shots.
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 people 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.
Pfizer and BioNTech Seek Agency Authorization to Distribute Booster Doses to People 16 Years and Older in United States