Election Day vaccine unlikely: FDA to issue tougher standards for authorization

Addressing concerns that a COVID-19 vaccine might be rushed to the public before Election Day, the Food and Drug Administration (FDA) will issue stricter guidelines for a vaccine to earn “emergency use authorization,” according to The Washington Post. 

Emergency use authorization (EUA) is not the same as full FDA approval, but grants permission to use unapproved products “when there are no adequate, approved and available alternatives,” Live Science previously reported. In recent weeks, President Donald Trump has repeatedly hinted that a COVID-19 vaccine could earn authorization before Nov. 3, raising concerns from the public and health professionals that such a vaccine might be deployed without clearing all the necessary tests.

To bolster confidence in a future authorized vaccine, the FDA is expected to release the new EUA standards as soon as this week, according to The Washington Post. The heightened standards should make it very unlikely that a vaccine would be authorized by or before November. 

The new standards are expected to require vaccine manufacturers to monitor participants in late-stage trials for a minimum of two months after they receive the full course of the vaccine, according to two individuals familiar with the situation who spoke with the Post on the condition of anonymity.

During clinical trials, some participants receive the vaccine and some instead get a placebo, so the rate of COVID-19 infection can be compared between the two groups. The FDA will now require that late-stage trials continue for long enough that five cases of severe COVID-19 occur in the placebo group and that some cases occur in older adults who receive the placebo, as well. These requirements should allow the manufacturers to better assess whether the vaccine truly protects both younger and older adults against the virus. 

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Given these standards and the time it takes to prepare, file and review an application for authorization, “it’s hard to imagine how an EUA could possibly occur before December,” Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA advisory board on vaccines, told The Washington Post.

That said, some experts question whether the public will readily accept any authorized vaccine, even with the new standards in place; some argue that no vaccine should be given emergency use authorization, but that we should hold out for full approval.

Read the full story at The Washington Post. 

Originally published on Live Science. 

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