Pfizer has enough safety data about its coronavirus vaccine and is preparing to submit for FDA authorization, CEO says

Pfizer has accumulated enough safety data on its Covid-19 vaccine and is preparing to file for emergency use authorization from the US Food and Drug Administration, company CEO Albert Bourla said Tuesday.

Last week, the company released early clinical trial data showing its vaccine is more than 90% effective, and said it was waiting to apply to the FDA until it had gathered sufficient data on the safety of the vaccine.

NEW YORK, NY - NOVEMBER 09: People walk by the Pfizer headquarters on November 9, 2020 in New York City. Pharmaceutical company Pfizer announced positive early results on its COVID-19 vaccine trial and has proven to be 90% effective in preventing infection of the virus. (Photo by David Dee Delgado/Getty Images)

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“I think the questions about the safety at large also have been answered,” Bourla said in an interview hosted by The New York Times on Tuesday. “Our safety milestone has been achieved already, and we are preparing now for submissions.”

Moderna, another pharmaceutical company, announced Monday that early results from their clinical trials show their vaccine is 94.5% effective. The company plans to apply to the FDA for authorization soon after it accumulates more safety data later this month.

Dr. Anthony Fauci, the nation’s top infectious disease doctor, told CNN this week that Americans will likely start getting vaccinated “towards the latter part of December.”

The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee, a group of outside experts, for December 8, 9 and 10, a source familiar with the process told CNN Tuesday.

Moderna COVID-19 Vaccine Trial Underway in DeLand, Florida Tony Potts, a 69-year-old retiree living in Ormond Beach, receives his first injection as a participant in a Phase 3 COVID-19 vaccine clinical trial sponsored by Moderna at Accel Research Sites on August 4, 2020 in DeLand, Florida, US. Potts is one of 30,000 participants nationwide to be recruited for the Moderna trial who will receive two injections about a month apart and be monitored for two years. (Photo by Paul Hennessy/NurPhoto via Getty Images)

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The agency could make a decision at the end of the meeting on December 10 about whether to issue emergency use authorizations for the vaccines, the source said.

“It will make sense that in all likelihood the FDA will consider both applications together,” the source said, considering that both vaccines use the same technology and appear to have very similar safety and efficacy results from their large-scale Phase 3 clinical trials.

What happens after an EUA

If the FDA authorizes the vaccines, they can then be immediately distributed to states, according to a presentation made last month at the US Centers for Disease Control and Prevention.

A health worker wearing a protective mask works in a lab during clinical trials for a Covid-19 vaccine at Research Centers of America in Hollywood, Florida, U.S., on Wednesday, Sept. 9, 2020.

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However, no one can be vaccinated until a CDC advisory committee reviews the data, recommends the vaccine, and says which groups will receive it first.

If the FDA authorizes the vaccines, the CDC’s Advisory Committee on Immunization Practices, an independent panel of experts, will meet within 24 to 48 hours, according to a CDC spokesperson.

At that meeting, the committee will determine if everyone should get the vaccine, or if some people should be excluded. It will also decide which groups should get the vaccine first.

“We have all been alerted on ACIP we should be very flexible with our calendars because it’s likely there won’t be a lot of advanced notice given for this meeting. It will be done very, very quickly,” said Dr. William Schaffner, a committee member.

Once ACIP issues its recommendations, vaccinations can be given.

States are currently working out the details of running vaccination clinics. The Pfizer vaccine is particularly complicated, since it must be stored at minus 75 degrees Celsius, and doctors’ offices and pharmacies typically do not have freezers that go that low.

The first groups expected to receive the vaccine are health care workers, the elderly, essential works such as police officers, and those with underlying medical conditions.