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Coronavirus vaccine could get emergency approval before critical testing is complete, FDA says

A vaccine.
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The head of the U.S. Food and Drug Administration says that coronavirus vaccines may be given emergency approval before rigorous clinical trials are complete, according to recent news reports.

Only a couple of coronavirus vaccine candidates in the U.S. have advanced to phase 3 clinical trials, which are the most critical tests needed to prove, in tens of thousands of people, that a vaccine is both safe and effective at preventing COVID-19. Typically, a vaccine must pass these advanced trials before given approval — but the pandemic has pushed vaccine development to unprecedented timescales.

"It is up to the sponsor [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application," Dr. Stephen Hahn, the FDA Commissioner told The Financial Times. "If they do that before the end of phase three, we may find that appropriate. We may find that inappropriate, we will make a determination."

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Hahn said a safe way to roll out the vaccine prior to results from phase 3 trials, is to issue an emergency use authorization for only a select group of people, according to the Financial Times. "Our emergency use authorization is not the same as a full approval," he told the Times.

Emergency use authorization is permission granted to unapproved products to be used in an emergency to diagnose, treat or prevent serious or life-threatening conditions, "when there are no adequate, approved and available alternatives," according to the FDA. China and Russia have both given emergency approvals to coronavirus vaccines for a limited group of people prior to phase 3 results, according to the Times. 

But approving vaccines too soon can be risky, public health officials have warned.

Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, previously told Reuters that a vaccine should not receive an emergency use authorization before it's shown to be effective. "One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial," he said.

"To me, it's absolutely paramount that you definitively show that a vaccine is safe and effective, both," Fauci told Reuters. "We would hope that nothing interferes with the full demonstration that a vaccine is safe and effective."

Last week, the FDA gave an emergency use authorization to plasma therapy, or antibody-rich plasma taken from recovered patients, to treat COVID-19, quickly reversing its announcement that the FDA wouldn't issue an EUA until there was more data that the therapy works, Live Science previously reported. The authorization followed on the tail of President Donald Trump's remarks that the FDA's decision to wait for more data before giving an EUA to plasma therapy could be political, according to the report. 

Hahn told the Times that the decision to give an EUA on vaccines wouldn't be politically driven.

"We have a convergence of the COVID-19 pandemic with the political season, and we're just going to have to get through that and stick to our core principles," he told the Financial Times. "This is going to be a science, medicine, data decision. This is not going to be a political decision."

In the U.S., just two candidate vaccines are in phase 3 trials: one made by Moderna and the other by Pfizer and BioNTech, according to a Live Science roundup of coronavirus vaccine candidates in clinical trials. But there are several others that are expected to start phase 3 trials in the coming weeks. 

Originally published on Live Science.

  • Chem721
    One is compelled to wonder how many Pharm companies are going to submit for vaccine approval before their Phase III trials are complete and fully evaluated.

    Is the government going to inoculate them from the massive lawsuits likely to arise if there are nasty results? And could that inoculation itself go through all the phases of court appeals for years afterwards? To be sure, most vaccines take years to develop and market based on safety and efficacy. Short-circuiting the process with less than Phase III results and their evaluation seems a bit too soon, with the potential dangers lurking.

    These vaccines might cause antibody dependent enhancement in some people, or other nasty surprises waiting to be determined after an EUA and prior to the extensive evaluation of Phase III results.

    Quoting from the article:

    "To me, it's absolutely paramount that you definitively show that a vaccine is safe and effective, both," Fauci told Reuters. "We would hope that nothing interferes with the full demonstration that a vaccine is safe and effective."

    end quote

    (Dr. Anthony Fauci, one of the world's top experts, is the director of the National Institute of Allergy and Infectious Diseases.)

    This whole notion of an accelerated vaccine EUA could be a "floater", to find out how people react. It is likely the reaction from the pros will be as extremely negative as Dr. Fauci's, or more.

    Time will tell.
    Reply