US FDA panel recommends Covid-19 vaccine authorization

US Food and Drug Administration Commissioner Dr. Stephen Hahn said in a statement on Thursday that the Vaccines and Related Biological Products Advisory Committee meeting happening now to discuss the first Covid-19 vaccine emergency use authorization request from Pfizer is "an important step" in the process. 

Hahn said that the FDA’s career staff have been working “around the clock” to thoroughly evaluate the data and information in the EUA request “in a comprehensive and science based manner.” 

“I can assure you that no vaccine will be authorized for use in the United States until FDA career officials feel confident in allowing their own families to receive it,” he said. 

Hahn highlighted that the FDA is considered the “gold standard” regulator of medical products and that its review process is respected worldwide. Normally, this process for vaccines takes months, he said. 

“Even though the process has been expedited in association with the review of this EUA, the FDA’s expert review staff has reviewed thousands of pages of technical information,” he said, adding that the materials include clinical trial data, non-clinical data on lab development of the vaccine and manufacturing data. Career officials have been reviewing this data ahead of the meeting, he said. 

“Today’s meeting is an important step in the process – allowing outside scientific experts an opportunity to provide valuable advice and input for the agency to consider as part of its final review,” Hahn continued. “Importantly, final decisions about whether to authorize a vaccine for emergency use will be made by FDA’s career officials in the Center for Biologics Evaluation and Research.” 

 After the meeting, the FDA career staff will take into account the committee input, Hahn said, as they continue to review the EUA request. 

Volunteers who received a placebo in Covid-19 vaccine trials eventually will get to take the vaccine once one is authorized in the United States — but it may not be immediately, Dr. Doran L. Fink, deputy director of the FDA's division of vaccines said during the Vaccines and Related Biological Products Advisory Committee meeting on Thursday. 

The committee is convening to discuss a possible emergency use authorization for Pfizer's Covid-19 vaccine candidate.

"However, FDA does not consider issuance of an EUA for a Covid-19 vaccine to necessitate immediate unblinding of ongoing clinical trials," Fink added. "Of course trial participants may choose to withdraw from follow up for any reason, including to receive vaccine made available under EUA."

“We have not received additional data sets beyond the data sets that were submitted to us, comprising a cut-off date of November 14th,” Dr. Doran Fink, deputy director of the FDA's division of vaccines, said of the Pfizer vaccine during the Vaccines and Related Biological Products Advisory Committee meeting on Thursday.

“That being said, if the sponsor becomes aware of, or if we become aware of, any data that would potentially impact our benefit-risk assessment, we do have discussions with the sponsor regarding those data,” he added.

More on Pfizer's data: Pfizer's vaccine does have what researchers have described as breathtaking efficacy. The company released its first data in media releases, but turned over tens of thousands of pages of it data to the FDA for closer study.

The FDA published its summary and Pfizer's summary on the Vaccines and Related Biological Products Advisory Committee website Tuesday, and the 95% efficacy claims hold up.

If the Pfizer Covid-19 vaccine does receive emergency use authorization from the US Food and Drug Administration, it will undergo further evaluation for several months, Dr. Doran L. Fink, deputy director of the FDA's division of vaccines, said during the Vaccines and Related Biological Products Advisory Committee meeting on Thursday.

Fink said this further vaccine evaluation would include longer term follow up data for safety, including in larger numbers of vaccine recipients, and in populations with lower representation than in clinical trials.

“Further evaluation would also allow for more precise estimation of vaccine effectiveness in specific populations, and more robust assessment of effectiveness against specific aspects of SARS-coronavirus-2 infection or disease, for example asymptomatic infection," he added.

Dr. Doran Fink, deputy director of the FDA's division of vaccines, described during the Vaccines and Related Biological Products Advisory Committee meeting today what criteria is needed to be met in order to issue emergency use authorization of a Covid-19 vaccine. 

The advisory committee is convening to discuss a possible emergency use authorization for Pfizer's Covid-19 vaccine candidate. 

The criteria include: 

Fink added that issuance of an emergency use authorization for a Covid-19 vaccine "would be contingent upon the ability to conduct further vaccine evaluation."

“Today we will be considering whether to make available to millions of Americans, an as yet investigational vaccine that has been developed tested and reviewed in record time, with additional testing still underway in ongoing studies,” Dr. Doran L. Fink, deputy director of the FDA's division of vaccines, said during Vaccines and Related Biological Products Advisory Committee meeting happening now.

Fink said the committee has been working day and night and over the Thanksgiving holiday to keep this process going. 

He also said members have “sent and received” correspondences with Pfizer during this time.  

The advisory committee is expected to vote on a recommendation to the FDA on an emergency use authorization this afternoon. The vote doesn't mean the vaccine is authorized immediately.

The decision comes from the FDA, which typically follows the advisory committee's recommendation.

Coronavirus cases are spiking in the US as the holiday season quickly approaches. The country's daily death toll from Covid-19 topped 3,100 Wednesday. That's more deaths than those suffered in the 9/11 attacks.

Michael Osterholm, member of Biden's Covid-19 advisory board, says Americans need to have a hard discussion around Christmas.

There is no middle ground here, he cautioned.

Osterholm's comments come as calls have grown for the State Department to cancel its holiday parties due to the Covid-19 spike and concerns of the virus spreading further.

"Many of my colleagues are saying limit it to 10 people or whatever. You know, that's happy talk," he said. "Please, save a life, particularly the ones that you love, and don't get together for these holiday parties, holiday events. That's the very best thing that you could do to love someone today."

The need for coronavirus safety measures won't be over after that but gathering outside of your pods for Christmas could lead to a "surge upon a surge upon a surge," he told CNN.

The vaccine won't protect Americans in the immediate following months, he said, urging Americans to "please hold on until the vaccines do arrive."

The general public possibly won't see a sizable amount of vaccine until March or April in 2021, he added.

Watch the interview:

Safety and efficacy data on Pfizer and BioNTech's Covid-19 vaccine candidate published in the New England Journal of Medicine on Thursday morning — at the same time an advisory committee to the US Food and Drug Administration convened to discuss a possible emergency use authorization of the vaccine.

The Phase 3 trial data in the published paper fall in line with what the committee released in a briefing document this week ahead of its meeting.

The data come from more than 43,000 trial participants: 21,720 who were randomly given the vaccine and 21,728 who were randomly given a placebo. 

The data show that there were only eight Covid-19 cases among people who received the vaccine, compared with 162 cases among those given the placebo.

The paper notes that a two-dose regimen of the vaccine, called BNT162b2, has an efficacy of 95% in people ages 16 and older. "BNT162b2 was 95% effective in preventing Covid-19," the paper's abstract notes. "Safety over a median of 2 months was similar to that of other viral vaccines."

The data are to be discussed in a meeting on Thursday of FDA's Vaccine and Related Biological Products Advisory Committee, which will provide recommendations to the FDA on whether the vaccine is effective in preventing Covid-19 in people 16 and older and whether the potential benefits of the vaccine outweigh the risks.

“It’s a really important day for all of America,” US Food and Drug Administration Commissioner Dr. Stephen Hahn told NBC’s Savannah Guthrie Thursday as the FDA’s Vaccines and Related Biological Products Advisory Committee meets to discuss emergency authorization of Pfizer’s Covid-19 vaccines.

Thinking about how to get beyond the pandemic, Hahn said that a vaccine will be “the primary way in terms of stopping the spread beyond the mitigation efforts we need right now.” 

“So if, in fact, there is an authorization and we begin vaccinating, a national vaccine campaign, there is great hope, great light for this country and I think we all look forward to getting beyond this and having a more normal and healthy life,” Hahn said. 

More on today's meeting: The advisory committee is expected to vote on a recommendation to the FDA on an emergency use authorization this afternoon. The vote doesn't mean the vaccine is authorized immediately. The decision comes from the FDA, which typically follows the advisory committee's recommendation.