Pfizer is submitting approval knowledge to the FDA

Walgreens health professional Luis S. Solano prepares a dose of Pfizer BioNTec’s vaccine against coronavirus disease (COVID-19) on February 22, 2021 at the Victor Walchirk Apartments in Evanston, Illinois.

Kamil Krzaczynski | Reuters

Pfizer and BioNTech announced Monday that they had provided the Food and Drug Administration with early-stage clinical trial data as part of their U.S. application for approval of a Covid vaccine booster for all 16 and older – not just people with weak immune systems have submitted.

In a phase 1 study, a booster dose of the vaccine produced “significantly higher neutralizing antibodies” against the original coronavirus strain and the beta and delta variants, the companies said in a press release. Study participants received a third dose of the two-dose vaccine around eight to nine months after the second vaccination, they said.

“The data we’ve seen so far suggest that a third dose of our vaccine elicits antibody levels well in excess of those on the primary two-dose schedule,” said Albert Bourla, Pfizer CEO. “We are excited to provide this data to the FDA as we continue to work together to address the evolving challenges of this pandemic.”

The companies said the results of the late-stage trial evaluating the third dose are expected shortly and will also be presented to the FDA and other regulatory agencies worldwide.

The drug makers’ announcement comes after federal health officials on Friday approved the administration of Covid booster shots of Pfizer and Moderna vaccines to Americans with weakened immune systems, which include cancer and HIV patients, as well as people with organ transplants.

New data from the US suggests that immunocompromised individuals do not generate adequate immune responses after receiving two doses of a Covid vaccine.

The latest data from Pfizer investigates the booster’s safety and immune response in people with otherwise healthy immune systems.

Federal health officials are not currently recommending booster doses for the general public, but Dr. White House chief media officer Anthony Fauci has said everyone is “likely” to need a booster at some point.

Covid vaccine makers, including Pfizer and Moderna, have repeatedly argued that everyone will need a booster dose at some point and possibly additional doses each year, just like they did with seasonal flu.

Pfizer cited data from Israel, where state officials last month said the two-dose vaccine was only 39% effective against the disease, attributing the drop in performance to the highly contagious Delta variant. When Pfizer submitted its original application to the FDA in December, it said its vaccinations were about 95% effective at preventing Covid infections.

The vaccine is still considered highly effective against serious illness, hospital admissions and deaths, according to Israeli health officials.