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California Physicians' Service Inc. - Blue Shield of California

12/01/2020 | Press release | Distributed by Public on 12/01/2020 10:37

What Does FDA Approval of a COVID-19 Vaccine Really Mean?

The health industry and regulators ramped up and sped efforts to bring a vaccine to Americans

Major pharmaceutical companies and public health officials are preparing to administer vaccines to fight COVID-19, the deadly disease that has ravaged the globe for almost a year and has killed more than a quarter-million Americans.

With billions of public dollars already spent, the first doses may be available within just a couple of weeks.

That's the payoff of Operation Warp Speed, a Manhattan Project-like multi-billion-dollar joint effort by the Department of Health and Human Services, the Pentagon and other federal agencies to support pharmaceutical and biotech companies developing, testing, manufacturing and distributing the vaccines.

The speedy development of the COVID-19 vaccines 'will go down in history as one of science and medical research's greatest achievements… several years of work compressed into months,' said the noted research scientist, author and physician Eric Topol of the Scripps Research Institute in San Diego.

The rush to market

Moderna and Pfizer have already completed three-phase trials of their messenger RNA (mRNA) vaccines. Pfizer and its German partner BioNTech have submitted findings to the Food and Drug Administration. They did not take government development money but do have $2 billion agreement to sell 100 million doses to the government. Moderna, which has a $2.5 billion government deal, developed its vaccine with the National Institutes of Health and filed for FDA approval on Monday. A third, early player, AstraZeneca, is conducting trials in the U.K. and Brazil.

The (mRNA) vaccines developed by Pfizer and Moderna are quite different from the immunizations that we all grew up with. Traditional vaccines, which can take years to develop, trigger an immune response in people with a weakened or inactivated form of the bacteria or virus.

The mRNA vaccines instead use a synthetic version of the novel coronavirus genetic material to teach human cells how to make a protein, or even just a piece of a protein, that triggers an immune response. (The AstraZeneca vaccine is close behind the others. It's been developed with the U.K.'s Oxford University and is based on a more traditional model.)

Not only does this process greatly speed up the time it takes scientists to develop a vaccine, but it makes manufacturing of the vaccine faster as well. Indeed, there could be as many as 20 million doses available before the end of the year and hundreds of millions by spring. Both the Moderna and Pfizer vaccines require two doses delivered a few weeks apart.

'Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of Covid-19 globally,' said Dr. Albert Bourla, Pfizer chairman and CEO.

Here's where things stand:

  • On Nov. 20, Pfizer and BioNTech submitted an application to the FDA for 'emergency use authorization,' a special provision in the law that grants the FDA authority to approve a product when there are no alternatives. The application included data from the three-phase vaccine trials, which are now being reviewed by the FDA staff scientists.
  • On the day after Thanksgiving, chartered United Airlines jets began distributing the Pfizer vaccine throughout the country, The Wall Street Journal reported. The Pfizer vaccine must be stored at super-cold temperatures. United sought and received special permission from the Federal Aviation Administration to carry the extra loads of dry ice necessary.
  • On Dec. 10, the FDA staff will present its findings to an independent advisory panel made up of scientific and public health experts from throughout the country. The panel will consider questions such as whether the vaccine has been shown safe and effective in certain racial, ethnic and age groups. The panel will take a non-binding vote at the end of the day-long online meeting, which will be viewable on YouTube and Twitter.
  • Final FDA approval could come as soon as right after the advisory panel adjourns. Theoretically, then, the first doses could be administered as early as Dec. 11, according to Moncef Slaoui, the chief scientific adviser to Operation Warp Speed-which has a goal of 300 million doses next year. In all likelihood, however, we're probably looking at mid-to-late December before any significant numbers are being vaccinated.

Dr. Stephen Hahn, FDA Commissioner, said the agency 'will review the [Pfizer] request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible.'

It is generally thought that the initial doses will be given to frontline healthcare workers and to nursing home residents. After those, expect that vaccines will be made available to older and at-risk people, essential workers, first responders and then to the general public. The government has promised that the vaccine will be free.