The first patient enrolled in Pfizer’s COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore receiving an injection. University of Maryland School of Medicine/AP Photo
Pfizer and BioNTech requested that the US Food and Drug Administration review their coronavirus vaccine for emergency authorization, they announced Friday.
The vaccine was found to be 95% effective at preventing COVID-19 in a late-stage trial.
The FDA has said it might take weeks to review the shot and decide whether it will authorize it.
The complicated logistics of delivering vaccines and ensuring each person gets properly immunized could mean most Americans won’t get access to the immunization until mid-2021.
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Pfizer and BioNTech have asked regulators to sign off on the emergency use of their coronavirus vaccine, a step that could allow the shot to be given more widely.
Pfizer CEO Albert Bourla announced Friday that the companies filed for an emergency use authorization with the US Food and Drug Administration later that day, soon after announcing that the vaccine was found to be 95% effective at preventing COVID-19 in a late-stage trial.
“This is a historic day,” Bourla said in a video release. “A historic day for science and for all of us.”
Pfizer and BioNTech said they plan to submit applications to other agencies worldwide in the coming days.
Pfizer said that of the 170 cases of COVID-19 seen in the clinical trial, 162 of those illnesses occurred in people who got a placebo. The company also said the vaccine did not cause serious side effects and might prevent severe disease.
The results have not been published in a medical journal or peer-reviewed by other scientists. It’s not clear how long protection from the shots lasts or whether the vaccine would stop people from being asymptomatic carriers of the coronavirus.
Moderna, a biotech company, is also planning to seek emergency authorization from the FDA for its vaccine. Moderna said a preliminary analysis found its vaccine to be 94.5% effective at preventing people from contracting COVID-19. The results have not been published in a scientific journal, and the company is still collecting more information.
The FDA will most likely take weeks to evaluate Pfizer’s vaccine and decide whether it will authorize it. The agency will have an advisory committee of scientists and independent experts carefully review the trial and other data.
Read more: Pfizer’s top scientist tells us the pharma giant is already thinking about a new version of its coronavirus vaccine for 2021 that can overcome one of its biggest limitations
Peter Marks, an FDA director who will oversee the vaccine review process, told Business Insider’s Andrew Dunn he hoped the public would gain confidence in the vaccine after the advisory committee’s public review process.
“The caveat here with saying this word ‘weeks’ is there are situations whereby the quality of what comes in and the complexity of what comes in will determine how long it will take to do a review that we can feel very confident in,” Marks said.
What happens after Pfizer files for emergency use of its COVID-19 vaccine?
If the FDA authorizes the vaccine, the US government has said the first doses would most likely go to healthcare workers and other high-risk groups. Most Americans may not get access to a vaccine until mid-2021.
Pfizer said it hoped to produce 50 million doses by the end of the year and up to 1.3 billion doses in 2021.
The complicated logistics of delivering vaccines and ensuring each person gets properly immunized mean Americans may not safely be able to return to pre-pandemic “normal” for months to years.
Both Pfizer and Moderna’s vaccines require two doses, meaning they require twice as many already-limited vials, syringes, refrigerators, and clinic visits. Plus, some scientists say getting 100% of vaccine recipients to return for a follow-up shot could be tricky.
Pfizer’s vaccine must get shipped in and stored at ultracold temperatures. That could pose problems for rural communities that lack reliable electricity or money for special freezers, though it can be stored using dry ice. Pfizer launched a pilot to test the vaccine’s distribution in Rhode Island, Texas, New Mexico, and Tennessee. Cargo executives say transporting the vaccine globally could take years.
Read more: The FDA just approved the first drug to treat COVID-19. Here’s how biotech giant Gilead created remdesivir and positioned it to be a billion-dollar treatment.
Some states and hospitals are rushing to buy specialty freezers, even after the Centers for Disease Control and Prevention instructed them not to. Makers of specialty freezers told Reuters they expected months-long back orders and delays because of high demand.
Because of the difficulty transporting, storing, and administering vaccines, experts say Americans should continue to wear masks, practice social distancing, and follow other COVID-19 safety protocols during this process.
“The moment you get a vaccine doesn’t mean you’re going to put your mask in the trash,” Maria Elena Bottazzi, a vaccine developer at Baylor College of Medicine, recently told Business Insider. “That is not going to happen.”
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