Pfizer says Israeli data show third shot restores 95% effectiveness

A man receives his third dose of COVID19 vaccine at Sheba Medical Center on July 14, 2021 in Ramat Gan, Israel.

Amir Levy | Getty Images

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

Although the effectiveness of the mRNA vaccine decreases over time, a booster shot was shown to elicit a similar immune response to protection generated after a second dose, Pfizer said in a 52-page presentation. published by the agency on Wednesday.

Pfizer said data from the Israeli Covid vaccination program that administers boers to the entire population shows that a third trait “has a reactogenicity profile similar to that seen after receiving the second dose of the primary series and restores high levels of protection. against Covid-19 results (back to approximately 95% protection). ”Data were collected from July 1 to August 30, when the delta variant was growing nationwide.

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 “requests the granting of 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.

The staff report is intended to inform the FDA Advisory Committee on Vaccines and Related Organic Products, which meets Friday to review Pfizer and BioNTech’s request to approve Covid booster doses for the general public. Published papers offer an insight into the FDA’s view on third parties.

Pfizer and its vaccine partner Covid BioNTech are looking for the agency to be good at distributing booster doses to people 16 and older in the United States

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