Pfizer is about to ask the FDA to authorize its coronavirus vaccine, a critical step before it can be given to more people

coronavirus vaccine trial injection shot patient covid 19
The first patient enrolled in Pfizer's COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore, receives an injection.
  • Pfizer and BioNTech are about to request that the US Food and Drug Administration review their coronavirus vaccine for emergency authorization.
  • The vaccine was 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.
  • Visit Business Insider's homepage for more stories.

Pfizer and BioNTech will on Friday ask regulators to sign off on the emergency use of their coronavirus vaccine, a step that could allow the shot to be given more widely.

The two companies said Friday that they were preparing to file for an emergency use authorization with the US Food and Drug Administration, days after announcing that the vaccine was 95% effective at preventing COVID-19 in a late-stage trial.

Pfizer and BioNTech added that they planned 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 may 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 vaccinated people could still spread the disease. 

Moderna, a biotech company, is also planning to seek emergency authorization from the FDA for its vaccine. Moderna said its vaccine was 94.5% effective at preventing people from contracting COVID-19 in a preliminary analysis. The results have not been published in a scientific journal, and the company is still collecting more information. 

The FDA will 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 hopes the public will 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 after careful review, the US government has said the first doses would likely go to healthcare workers and other high-risk groups. Most Americans will have to wait until mid-2021 for access to a vaccine.

Pfizer said it hopes 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 means Americans may not safely be able to return to pre-pandemic "normal" for months to years. 

Both Pfizer and Moderna's vaccine require two shots, 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 and stored in at ultra-cold 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 expect months-long back orders and delays due to high demand, further delaying when Americans vaccinated.

Because of the difficulty transporting, storing, and administering vaccines, experts say Americans should continue to wear masks, social distance, 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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