The FDA is ramping up its timeline to fully approve Pfizer-BioNTech’s two-shot COVID-19 vaccine, amid the surge of infections gripping much of the US.
Health officials have an unofficial deadline of Labor Day or sooner to fully approve the manufacturers’ vaccine, which is now one of three approved on an emergency basis in the US, according to The New York Times.
That accelerated timetable would require an “all-hands-on-deck approach” to green light the vaccine several weeks before President Biden’s stated goal of early fall, the report said.
The government’s official rubber stamp is considered a tool to drive up stagnant vaccinate rates as cases soar, because a number of private and public agencies are expected to require vaccinations once doses are fully approved, according to the outlet.
Officials also hope final approval would help assuage the fears of those who are worried about the safety of vaccines, and help clear up legal issues about mandates, the report said.
Pfizer filed its application for full approval in early May, which would allow the company to sell directly to customers, and allow it to be sold after the US is no longer in a state of emergency.
“I just have not sensed a sense of urgency from the FDA. on full approval,” Dr. Ashish K. Jha, the dean of the Brown University School of Public Health, told the newspaper.
“And I find it baffling, given where we are as a country in terms of infections, hospitalizations and deaths.”
About 70 percent of US adults have received at least one vaccine shot, but the country is still averaging about 84,000 new COVID-19 cases a day, an eight-fold increase from June, CDC data showed.
Moderna filed for final vaccination approval in June. Johnson & Johnson reportedly said it plans to do so later this year.
Pfizer and BioNTech also reportedly plan to apply for booster shots, the need for which is still being debated by federal health officials.
Full approval requires the FDA to review hundreds of thousands of pages of documents — about 10 times the data needed for an emergency approval, according to the report.
Pfizer and BioNTech vaccine’s effectiveness fell from 96 percent to 84 percent four to six months after the second shot, but the doses continued to prevent against severe disease, company scientists announced last week.