United States Eagerly Awaiting FDA Approval for Pfizer/BioNTech Coronavirus Vaccine

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After a year of almost unrelentingly negative news, with widespread social unrest and economic  ramifications which affected the entire world, the US Food and Drug Administration was on the cusp of approving a coronavirus vaccine on Thursday.

Demonstrating 95% efficacy according to its developer, the pharmaceutical giant Pfizer, with the results of its clinical studies already published in the New England Journal of Medicine, the vaccine is under close scrutiny today by the FDA.

The approval hearings for the vaccine were being streamed online and broadcast on television across the United States. At the end of the hearing, the advisory panel in charge of recommending the vaccine for approval gave its thumbs-up, handing the issue on to the FDA itself, which is expected to follow its lead and give the green light to the vaccine as early as Friday.

The U.S. Food and Drug Administration (FDA) is now working toward quickly finalizing and issuing emergency approval for the vaccine candidate, according to top FDA officials who issued a statement to the media on Friday.

“Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the US Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization,” said FDA Commissioner Dr. Stephen Hahn and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research in a joint statement.

“The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution,” they added.

United States Health and Human Services Secretary Alex Azar told ABC’s “Good Morning America” on Friday the FDA “informed Pfizer that “We could be seeing people getting vaccinated Monday, Tuesday of next week.”

Already approved in the United Kingdom, with the shot being given on a non-trial basis there for the first time on Monday of this week, the final go-ahead is being awaited with a desperation that has not been seen since the development of the polio vaccine many decades earlier.

Thessaloniki native Albert Bourla spearheads vaccine effort at Pfizer

Created by Pfizer, whose Greek-born CEO is Dr. Albert Bourla, and the German firm of BioNTech, headed by Ugur Sahin, the vaccine was the first to be placed before the FDA for its approval. Developed at unprecedented speed, it was created and went through three phases of clinical trials over just the span of several months, as opposed to the usual years it takes to produce such vaccines.

In a Tweet posted late on Thursday, Dr. Bourla said that his firm “stands ready to begin delivering the first batch of doses immediately, if we receive authorization.”

Tested around the world on more than 40,000 volunteer subjects, the RNA- based vaccine was proven to be more than 95% effective, according to Pfizer.

The long-awaited hearings come on a day when the US experienced more than 3,100 deaths in the past 24 hours, according to a report from the Washington Post, the first time that number had been reached since the beginning of the pandemic.

Pfizer/BioNTech’s new coronavirus vaccine is now awaiting FDA approval. Credit: Pfizer/Twitter

The number of Americans who are hospitalized with the virus reached a record 106,000 on Wednesday.

However, the tide may be turning ever so slowly now as another coronavirus vaccine, from Cambridge, Massachusetts-based Moderna, appears to be close to approval as well.

Canada and Saudi Arabia have also approved the Pfizer vaccine for general use.

During the Thursday afternoon part of the hearings, Juan Gea-Banacloche, a Mayo Clinic epidemiologist, asked the Pfizer officials how confident their firm is that the second dose of the vaccine will even be needed. Their answer was in essence that at this point, there isn’t enough evidence to determine whether or not just one dose of the vaccine would give the same long-term protection as two shots.

Additionally, it was disclosed during the hearings that the data regarding how well the vaccine protects against asymptomatic infections is expected to be released by early 2021.

Dr. Paul Offit, who voted in favor of the vaccine during Thursday’s panel meeting, told interviewers from MSNBC that he expects the FDA is “probably going to approve it by Saturday.”

That could mean that the first vaccines could be distributed to high-priority populations in the United States as early as Monday.

“So my sense is what’s going to happen today is the (Centers for Disease Control and Prevention) is going to discuss what they think about whether or not they would recommend this vaccine, but they can’t really recommend it until the FDA has approved it,” Offit explained to MSNBC.

“I think they’re going to discuss it today,” he stated, adding “the FDA is probably going to approve it by Saturday and then the CDC is going to vote on Sunday so that by Monday the vaccine could be rolling out and being given to American citizens.”

Operation Warp Speed, the Trump administration’s $195 billion dollar program to fast-track the development of a vaccine, allowed for the pre-ordering 100 million doses of it in July. The same program also gave its backing to Moderna’s efforts to produce a vaccine.

More than 100 employees at the FDA have worked nearly 24 hours a day to review the application which Pfizer submitted back on Nov. 20, distilling months of analysis into mere weeks as they read thousands of pages of data necessary to make the approval a reality.