Pfizer, BioNTech ‘within days’ of submitting COVID-19 vaccine to FDA
Pfizer and BioNTech said they are “within days” of submitting their COVID-19 vaccine candidate to the FDA for an emergency use authorization after meeting a required safety milestone.
In addition, a final analysis of phase 3 data demonstrated that the messenger RNA (mRNA)-based vaccine candidate BNT162b2 is 95% effective against COVID-19 beginning 28 days after the first of two doses, the companies said in a news release.
The efficacy estimate was based on 170 confirmed cases of COVID-19 among trial participants — 162 in the placebo arm and eight in the treatment arm. There are more than 43,000 people enrolled in the trial, including more than 38,000 who have received both doses of the vaccine.
According to the release, 10 of the cases of COVID-19 among trial participants were severe — nine of them in the placebo group.
“Efficacy was consistent across age, gender, race and ethnicity demographics, [and] observed efficacy in adults over 65 years of age was over 94%,” the companies said.
The companies announced last week that an interim analysis showed the vaccine was more than 90% effective. This week, Moderna Inc. said a COVID-19 vaccine candidate that it codeveloped with the NIH was 94.5% effective based on an interim review of data.
Both programs expect to produce tens of millions of vaccine doses by the end of the year and a billion or more in 2021. All indications suggest that health care workers and nonmedical essential workers will be among the first to receive a vaccine once one is approved.
Speaking at several virtual medical conferences recently, National Institute of Allergy and Infectious Diseases Director Anthony S. Fauci, MD, has said he is encouraged by the announced results from these trials.
“We look at this with cautious optimism that by the end of this calendar year and well into 2021, we will be administering doses, first to the highest priority, and then ultimately to virtually everyone in the United States as we get into 2021,” Fauci said during the American Heart Association Scientific Sessions.
According to the release, the data monitoring committee for the Pfizer and BioNTech vaccine uncovered no serious safety concerns. Only two grade 3 adverse event occurred in 2% or more of participants: fatigue (3.8%) and headache (2%).
The companies noted previously that a median of 2 months of safety data following the second vaccine is specified by the FDA in its guidance for considering emergency use authorization.