WASHINGTON — Pfizer is recommending U.S. regulators approve a booster dose of its COVID-19 vaccine at approximately six months after the second dose, according to a document provided to the Food and Drug Administration ahead of a key meeting.
The FDA posted the documents online on Wednesday, two days before scientific advisers are scheduled to publicly debate Pfizer's evidence for COVID-19 booster shots.
In making the case for booster shots, Pfizer pointed to a real-world study from Israel that showed a third dose of the vaccine restored COVID-19 protection to 95%. Additionally, Pfizer said data from its own trials showed vaccine efficacy declined by about 6% every two months after trial participants received their second dose of the shot.
According to an agenda posted online, Friday's meeting will include presentations from Pfizer, the Centers for Disease Control and Prevention, FDA staff and researchers from Israel and the U.K.
In its report, the FDA staff held off on making a recommendation on whether or not a booster dose of Pfizer's vaccine should be approved. While the staff said it found a booster shot was safe and raised antibody levels, the report said staff has not independently reviewed or verified the underlying data or conclusions from some of the studies, including the one from Israel.
Earlier this week, an international group of scientists — including two top U.S. regulators — wrote an opinion piece in a scientific journal that the average person doesn't need a COVID-19 booster yet.
The experts reviewed studies of the vaccines' performance and concluded the shots are working well despite the extra-contagious delta variant, especially against severe disease.
“Even in populations with fairly high vaccination rates, the unvaccinated are still the major drivers of transmission" at this stage of the pandemic, they concluded.
The White House's initial plan was to offer Pfizer or Moderna boosters starting Sept. 20, if approved by U.S. regulators. However, the FDA has said it doesn't have enough evidence yet to judge Moderna boosters. The White House plan called for boosters eight months after a person received the second dose.
If the FDA approves a third dose of the Pfizer vaccine, then advisers to the CDC will recommend who should get one.
The Associated Press contributed to this report.