Pfizer submitted data to FDA for authorization of Covid vaccine booster dose for the general population

August 18, 2021: -On Monday, Pfizer and BioNTech said they had submitted early-stage clinical trial data to the Food and Drug Administration as their U.S. application that seeks authorization of a Covid vaccine booster for not just people with weak immune systems but everyone aged 16 and older.

In a phase one trial, the companies said that a booster dose of the vaccine generated “significantly higher neutralizing antibodies” against the original coronavirus strain and the beta and delta variants. Participants in the trial got a third dose of the two-dose vaccine about eight to nine months after they receive their second dose, they said.

“The data we’ve seen to date suggests the third dose of our vaccine elicits antibody levels that hugely exceed those seen after the two-dose primary schedule,” Pfizer CEO Albert Bourla said. “We are pleased to submit these data to the FDA as we keep working together to address the evolving challenges of the pandemic,” Bourla added.

The companies said late-stage trial results evaluating the third dose are expected shortly and submitted to the FDA and other regulatory authorities worldwide.

On Friday, the drugmaker’s announcement comes after federal health officials approved administering Covid booster doses of Pfizer’s and Moderna’s vaccines to Americans with weakened immune systems, including cancer and HIV patients and people who had organ transplants.

U.S. new data suggested immune-compromised individuals don’t produce an adequate immune response after they received two doses of a Covid vaccine.

Pfizer’s latest data looks at the booster’s safety and immune response in people with otherwise healthy immune systems.

Federal health officials do not recommend booster doses for the general public at this time. Still, White House chief medical advisor Dr. Anthony Fauci has said everyone will “likely” need a booster shot at some point.

Covid vaccine makers, which include Pfizer and Moderna, have repeatedly contended that everyone will eventually need a booster dose and potentially extra doses each year, just like the seasonal flu.

Pfizer has cited data from Israel, where country officials said the two-dose vaccine was just 39% effective against getting the disease last month, blaming the drop in performance on the highly contagious delta variant. When Pfizer submitted its original application to the FDA in December, its shots were about 95% effective in preventing Covid infections.

According to Israeli health officials, the vaccine is still considered highly effective against severe disease, hospitalizations, and deaths.