FDA Expected to Authorize Pfizer / BioNTech Coronavirus Vaccine for Emergency Use After Thursday Meeting

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The EUA is widely anticipated and has been telegraphed with unusual frankness from the top of the FDA to the downside.

“Our team has done their initial analysis, and we believe the criteria for success have been met,” FDA Commissioner Dr. Stephen Hahn told CNN on Tuesday.

The only real questions will be whether advisers recommend restrictions on the EUA – perhaps leaving children out of reach for now, for example. They will also discuss how to conduct post-EUA safety surveillance and whether to offer the vaccine to clinical trial volunteers who have received doses of placebo.

Unprecedented speed for vaccines

The US federal government is supporting the development of seven coronavirus vaccines – four of them in large-scale Phase 3 clinical trials. Two, manufactured by Pfizer and Moderna, have now requested EUAs.

All of them have been developed with unprecedented speed. The virus known as SARS-CoV-2 was not identified until January, but just weeks after its isolation, the Chinese government shared its genetic sequence and that was enough to start work on the vaccines. .

Companies, university researchers, and the federal government had been working to develop so-called platforms that could be used to rapidly transform new vaccines. The first two to the finish line, Pfizer and Moderna, use plug-and-play technology involving genetic material known as messenger RNA.

The approach had previously been tested against infectious diseases such as Zika and against cancer as well, so the researchers were convinced it was safe. It is also much faster than old-fashioned vaccine development techniques such as, for example, influenza vaccines, which require samples of the real virus that must be grown in specially selected, purified and turned into a vaccine – an uncertain and slow vaccine. process.

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MRNA vaccines only need a small piece of genetic code and use the human body itself to make its own vaccine. Tests carried out on tens of thousands of volunteers starting in the summer showed that it elicited an immune response and appeared to do so safely.

“We have shortened vaccination times here without compromising the safety and efficacy of vaccines,” said Dr Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, which approves vaccines, at a American Medical Association webinar.

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“The fact that we have so many cases of Covid-19 right now is so unfortunate for us as a country. The only advantage is that you do a clinical trial with an endpoint which is a clinical infectious disease, it was easy to access those endpoints because there are so many cases, ”Marks added.

“From August to October of this year, it became clearer to us that the first vaccines that passed would indeed receive emergency use clearance due to the incredibly pressing nature of this crisis.

Getting ‘on the ground’ with vaccine data

Pfizer’s vaccine has what researchers have described as jaw-dropping effectiveness. The company released its first data in press releases, but has turned over tens of thousands of pages of its data to the FDA for further study.

Pharmaceutical companies typically write summaries of their findings for regulators, but the FDA also requests all primary source documents – charts, even the individual record of each volunteer. Marks said staff members have studied this.

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“We are the ones who don’t just look at company charts. We get dirty and we look at the reports of adverse events, the bad spelling mistakes sometimes made by doctors, et cetera ”. said.

“They were 95% effective on a wide range of individuals,” he told WADA.

The FDA published its summary and Pfizer’s summary on the Advisory Committee for Vaccines and Related Biologics website on Tuesday, and the 95% efficacy claims stand.

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“The efficacy of the vaccine against confirmed COVID-19 occurring at least 7 days after dose 2 was 94.6%, with 9 and 169 cases respectively in the BNT162b2 (experimental name of the vaccine) and placebo groups,” reads. on in the FDA review document.

In other words, nine people who received the vaccine developed coronavirus infections with symptoms after the second stroke, while 169 people who received placebo injections became infected.

The committee will go through all of this data, but members will have read it all before Thursday’s meeting, which will be streamed live on YouTube, Twitter and the FDA website.

How is the meeting going

Staff from the FDA’s Office of Vaccine Research and Review will write the FDA study of Pfizer’s data. Dr Nancy Messonnier, who heads the National Center for Immunization and Respiratory Disease at the U.S. Centers for Disease Control and Prevention, will review the CDC’s plans for safety oversight and other CDC officials will take stock of the pandemic itself and plans for vaccine distribution.

Dr. Steven Goodman from Stanford University will talk about what it means for future clinical trials if a vaccine is approved. He will address the issue of asking people to forgo being vaccinated as protective and to test an unproven one.

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Other possible questions are whether to include pregnant women and children in an EUA.

“At this point, I would say we may not have the data we need to be able to counsel pregnant women, and we may need a further study,” Hahn said.

And the National Vaccine Advisory Committee has asked the FDA to exclude children from EUA.

“NVAC cautions against issuing an Emergency Use Authorization (EUA) for COVID-19 vaccines in children, given that children usually suffer from a generally mild illness, except multisystem inflammatory syndrome in children (MIS-C), a rare but serious disease that causes inflammation and various symptoms such as abdominal pain, vomiting, diarrhea, neck pain, rash, fatigue and bloodshot eyes, ”the group said last week.

Pfizer will also present its data.

Then the committee votes whether or not to recommend authorization.

But that doesn’t mean the vaccine is cleared immediately. The decision comes from the FDA, which usually follows the recommendation of the advisory committee.

“One question that will arise is how quickly will we see a vaccine released after this,” FDA’s Marks told WADA.

“It will depend on the discussion in the advisory committee, but hopefully within a week or so we will see an authorization if all goes well for all of them,” Marks said.

It could come even sooner. In anticipation of an EUA, the CDC’s Advisory Committee on Immunization Practices has scheduled emergency meetings for Friday and Sunday. This committee – which is separate from the FDA advisory committee – will recommend whether the CDC should offer the vaccine to the American public.

Once the CDC accepts this recommendation, Pfizer injections can begin to be administered.

The VRPBAC is expected to start again next week, with a meeting on December 17 to discuss Moderna’s EUA application.



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