Pfizer on Friday announced it is submitting its request to the FDA for permission to distribute its coronavirus vaccine to the public, citing sufficient data showing the vaccine is safe and effective at blocking COVID-19.
If authorized by the FDA, 50 million pre-manufactured doses of the vaccine can begin to be distributed globally, starting with roughly 20 million healthcare workers across the country, once a CDC advisory panel agrees with prioritizing them to be the first in line to receive shots.
On November 18, the company released a preliminary analysis from its coronavirus vaccine trial suggesting that it was 95% effective at preventing COVID-19 infections. The results from the trial, which has recruited 43,000 participants, were based on 170 people who got infected with the coronavirus. Of them, 8 were in the half of study participants who received the vaccine and the other 162 had received placebo shots, pointing to a high statistical significance of the shots’ effectiveness.
The company submitted its application this week after collecting additional safety data for the FDA, which required that drug companies collect two months of safety data from half of the patients in the trial before submitting an application for public distribution.
The “Emergency Use Authorization” request to the FDA bolsters the company’s preliminary findings with that safety data, suggesting Pfizer’s shots produced only fatigue in 3.8% of participants and headaches in 2%, as noteworthy side effects.
“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally. Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” Pfizer Chairman and CEO, Dr. Albert Bourla, said in a statement.
In its statement, Pfizer announced that it will be ready to distribute the vaccine candidate within hours after authorization.
As of Friday, COVID-19 has caused some 11,720,000 cases and 252,000 deaths in the US, since the first cases in late January. Vaccines have been seen as a key intervention needed to help stop the pandemic. While most vaccines take years to develop, four vaccines are now in late-stage trials, spurred by a $10 billion investment from the federal Operation Warp Speed.
Pfizer has sought to distance itself from the Trump administration’s push to fast-track vaccines, telling the New York Times that it did not receive any research or development funding from OWS. The pharmaceutical company has a $1.95 billion advanced purchase agreement with OWS to distribute the vaccine in the US.
Pfizer’s request represents a first step in actually getting a vaccine to the public, following review by FDA scientists, as well as independent vaccine experts on federal advisory committees.
Pfizer estimates that it will produce 50 million doses of its vaccine this year in the US and Europe. The two doses of the vaccine are given 28 days apart and must be kept at -94 degrees for long term storage. Pfizer and delivery companies like UPS are gearing up to manufacture dry ice for this storage requirement. Pfizer hopes to manufacture 1.3 billion doses worldwide in 2021.
There were 10 severe cases of COVID-19 among the 170 diagnosed cases in the study. Only one of those was in the vaccination group, suggesting the shots help limit disease symptoms. About 42% of the study participants were of varied ethnic and racial backgrounds, and the efficacy held constant among them. “The observed efficacy in adults over 65 years of age was over 94%,” according to Pfizer.
In an unusual step to bolster public confidence, FDA commissioner Stephen Hahn said the agency would post its scientific review of vaccines before authorization, redacting only proprietary information belonging to manufacturers, but making all health and safety data public.
In surveys, public willingness to get a vaccine in the US has declined since the summer, dropping to about half of all people asked, according to the Pew Research Center. Public health officials have grown concerned about too few people getting the vaccine if this distrust grows. Estimates suggest that 60% or more of people need to have some form of immune protection — either from a vaccine or after recovering from COVID-19 — to stop the spread of the virus.