FDA Vaccine Approval Delays Are Deadly

The vaccines seem to be working well, but the FDA isn't.


In August, as COVID-19 cases began rising again throughout the country, Rochelle Walensky, the director of the Centers for Disease Control and Prevention, had a simple message for Americans: Get vaccinated. "Our vaccines are working exceptionally well," she said on CNN. "They continue to work well for [the delta variant] with regard to severe illness and death. They prevent it."

That message was reiterated by Anthony Fauci, President Joe Biden's top medical adviser, who has even expressed support for requiring public school teachers to be vaccinated. And it was echoed by the Food and Drug Administration (FDA), which regulates vaccines and must sign off on their use before widespread deployment.

"Getting more of our population vaccinated is critical to moving forward and past this pandemic," said Janet Woodcock, the FDA's acting commissioner. Woodcock also has emphasized that the FDA conducted thorough reviews of the vaccines, finding them safe and effective.

Yet for most of the year, that message was undermined by the regulatory reality. As of mid-August, the FDA still had not granted formal approval to any of the COVID-19 vaccines. Instead, they were administered under "emergency use authorizations," a provisional status suggesting that the FDA still wasn't sure about them.

Officially, the FDA was still collecting safety data. But given that Woodcock had clearly stated the vaccines were safe and effective, it seemed the agency's real priority was hewing to its slow, laborious drug approval process, even if that meant sending mixed signals to the public in the midst of a pandemic, confusing people and perhaps costing lives by discouraging vaccination.

In late August, the FDA fully approved a vaccine made by Pfizer. But two others are still only authorized for emergency use, and emergency authorization to vaccinate young children is still likely months away.

In 2020, the FDA waited weeks to provisionally approve the first vaccines after the results of clinical trials were submitted for review. Faster action could have stemmed the deadly winter wave, likely saving many lives in the process. The vaccines, in other words, seem to be working well. But the FDA isn't.