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When will COVID-19 vaccines get full FDA approval? And what will that mean?

vaccines fully approved FDA
Photo via Marco Verch Professional Photographer/Flickr (CC BY 2.0)
  • This story is regularly updated for relevance. Last updated: Aug. 4, 2021

The three vaccines currently utilized in the United States for COVID-19 are under what the Food and Drug Administration calls “emergency use authorization.” But both vaccines under that designation using mRNA technology—the Pfizer/BioNTech vaccine and the Moderna vaccine—are now seeking to be fully approved by the FDA, with Pfizer’s request in May 7 and Moderna’s made on June 1.

As of late July, President Joe Biden said the vaccines could get full approval by the fall of 2021, and the New York Times is reporting that it appears that Pfizer could be fully approved by the start of September.

BioNTech CEO Dr. Ugur Sahin, as reported by NPR, called the submission of the application for FDA approval “an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future.”

For the FDA to grant approval, Pfizer-BioNTech will have to provide follow-up data six months after vaccinations—potentially shedding more light on its efficacy over time.

Full approval could also provide some entities that are encouraging vaccination to make a better case to those who are still resistant to inoculation or even allow those entities to move from recommended it to requiring it.

As CNET noted, “Companies and schools across the country have been hesitant to mandate the COVID-19 vaccine, but that could soon change” should one or more of the vaccines get full FDA approval. Full approval allows a company to market directly to consumers, for starters, and gives some entities the authority to vaccinate that they wouldn’t have otherwise.

Currently, the COVID-19 vaccine isn’t mandated across the board, as it’s under emergency authorization use. However, whether a state, local government, or employer requires the COVID-19 vaccination is a matter of state or other applicable law, according to the CDC.

CNET noted that the Supreme Court case of Jacobson v. Massachusetts determined states may impose “reasonable regulations” such as a vaccine requirement during a pandemic, to protect the “safety of the general public.”

“The vaccine, unlike many other inoculations, is not required by the military at this time” because of its emergency use status, the New York Times noted. “Once it becomes a standard, approved vaccine, the military can order troops to take the shot.”

Meanwhile, other vaccines, like Novavax, could move straight to a full approval request instead of asking the FDA for emergency approval.

CNET noted that the U.S. Equal Employment Opportunity Commission said employers in the U.S. could require employee vaccinations, though some feel it’s a bit trickier to do so when the COVID vaccines aren’t fully approved by the FDA.

“Since the vaccine has only been given emergency approval, employers may require employees to show proof of vaccination but can’t mandate the employee show their medical information,” CNET wrote. “Once given full approval, however, employers will more easily be able to mandate the vaccine—as they can with the seasonal flu shot.”

By mid-July, though, it was still unclear when the FDA would grant full approval to any of the vaccines. Biden, though, said he wants the FDA to give full approval to the vaccines “quickly.” Said Biden: “My expectation talking to the group of scientists we put together, over 20 of them plus others in the field, is that sometime maybe in the beginning of the school year, at the end of August, beginning of September, October, they’ll get a final approval.”

Sources: NPR, CNET, New York Times


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