Pfizer says Israel data shows third strike renders effectiveness at 95%

A third dose of Pfizer’s Covf vaccine six months after a second shot restores protection from infection to 95% in a real-world environment in Israel, according to data transmitted by the company to the Food and Drug Administration.

While the effectiveness of the mRNA vaccine decreases over time, a boost of boost 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 that administer boosters to the entire population shows that a third stroke “has a reactogenicity profile similar to that seen after receiving the second primary dose of series and restoring high levels of protection against Covid-19 results (back to about 95% protection). ”Data were collected from July 1 to August 30 when the delta variant was in full swing across the country.

The FDA has released data that the agency is putting pressure on the Biden administration to authorize reinforcements for the general population as early as next week. But agency staff declined to take a position on the need for a third strike, citing a lack of verified data in a 23-page report released later Wednesday.

Staff said they are reviewing other “potentially relevant” studies on decreasing immunity from the Pfizer vaccine, but the studies have produced mixed results and some of these data may be more reliable than others. Israeli data come from an observational study, which does not adhere to the same standards of a formal clinical trial.

“It should be recognized that while observational studies may allow understanding of real-world efficacy, there are known and unknown biases that may influence its reliability. Because of these biases some studies may be more reliable than the latter. ‘others,’ FDA staff wrote in their analysis.

The Pfizer report is intended to inform the FDA’s Advisory Council on Vaccines and Related Biological Products, which meets Friday to review the request by Pfizer and its coronavirus vaccination partner, BioNTech, to approve doses of Covid booster for the general public. Published documents offer an insight into the FDA’s vision on third-party loans.

Based on the data, Pfizer said it “applies for a license for a booster dose of [the Pfizer vaccine] administered intramuscularly approximately 6 months after dose 2 in individuals over 16 years of age. “

The company also included data from a Phase 3 trial of about 300 people aged 19 to 55 years. One-third of the participants were overweight and one-third were obese, according to the documents.

Pfizer and BioNTech are seeking the agency’s OK to distribute booster doses to people 16 years of age or older in the United States