The First Coronavirus Vaccine Is Headed For FDA Review
If authorized, healthcare workers and vulnerable groups might start getting the two-shot vaccine before the end of the year.
Pfizer on Friday announced it is submitting its request to the FDA for permission to distribute its coronavirus vaccine, citing data showing the vaccine is safe and 95% effective at blocking COVID-19.
Submission of the request kicks off an orchestrated series of reviews at the FDA, which oversees the safety of new vaccines, and the CDC, which oversees their distribution. If authorized by the agencies and their counterparts in Europe, 50 million premanufactured doses of the Pfizer vaccine can begin to be distributed globally. Preliminary US plans are to start with the roughly 20 million healthcare workers across the country, given approval of a CDC advisory panel.
On Nov. 18, Pfizer 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 the application for public distribution.
“It’s likely terrific news, although I think the key is that the public becomes informed beyond press releases,” vaccine expert Peter Hotez of the Baylor College of Medicine told BuzzFeed News. “It’s important to remember a company press release is not meant for you, for me, or the American people. It’s meant for their shareholders.” For that reason, he said, full release of the effectiveness and safety data collected by Pfizer, as well as the federal agency reviews, is vital.
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 Chair and CEO 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, using its own distribution network.
Michael Einhorn, president of the vaccine distributor Dealmed, based in New York, expressed concern about Pfizer’s plans bypassing channels established for the flu vaccine to rely on its own distribution network to get its coronavirus vaccine into people’s arms. “I’m sure they are trying to do the right thing, but that seems unnecessarily complicated,” he told BuzzFeed News.
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.
The EUA 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. Late on Friday, the FDA scheduled a vaccine advisory panel review on Dec. 10. Federal officials had confirmed this week they would schedule a simultaneous CDC distribution panel review with that meeting, moving possible approval of the request and first distribution of vaccines in mid-December.
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.
The safety data will include records of 100 children, ages 12 to 15, who received the Pfizer vaccine as well, according to the company.
“The data we have seen, in fairness only in news releases, is on the face of it extraordinarily good,” said Biotechnology Innovation Organization chair Jeremy Levin. “We need to see the safety data, but the bottom line is that Pfizer appears to have brought something of great value to the public, in only a nine month period of time.”
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. Any politicization of the scientific reviews, seen in the Trump administration’s calls for FDA to authorize hydroxychloroquine use in March, will only hinder public acceptance of a vaccine and cost more lives, said Levin.
Einhorn, the vaccine distributor, expressed concern about confusion already voiced by doctors and people he speaks to about who would get a vaccine, and when. State health officials have not contacted his company, which yearly distributes flu vaccines to doctor’s offices, clinics, and other medical offices, about any of the coronavirus vaccines, he said. “We usually start planning in February to distribute flu vaccines in September.”
While the temperature requirements and double shots are complications for distributing the vaccine, Einhorn saw them as lesser worries. “Vaccine distributors already understand the need to control temperatures and medical offices already know how to track every dose,” he said.
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.
This story has been updated with comment from Michael Einhorn of Dealmed and Peter Hotez of the Baylor College of Medicine.
This story has been updated with comment from Biotechnology Innovation Organization chair Jeremy Levin.
The story was updated with the FDA’s scheduled of a VRBPAC meeting for December 10.