Delay in FDA vaccine approval is fatal – Reason.com

In August, as cases of Covid-1 cases began to rise again across the country, Rochelle Wallensky, director of the Centers for Disease Control and Prevention, had a simple message for Americans: Get vaccinated. “Our vaccines are working tremendously,” he told CNN. “They are doing a good job [the delta variant] About serious illness and death. They interrupt. “

President Joe Biden’s top medical adviser, Anthony Fawcett, echoed the message, expressing support for vaccinating public school teachers. And this was echoed by the Food and Drug Administration (FDA), which regulates vaccines and must stop their use before they can be widely deployed.

“Vaccinating more people in our population is important to move this epidemic forward and to get past it,” said Janet Woodcock, the FDA’s acting commissioner. Woodcock also stressed that the FDA has thoroughly reviewed the vaccines and found them to be safe and effective.

Yet for most of the year, that message was shattered by regulatory reality. As of mid-August, the FDA has not yet officially approved any of the Covid-1 vaccines. Instead, they were operated under “emergency use approval,” a temporary condition that indicates that the FDA was not yet sure about them.

Officially, the FDA was still collecting security information. But that’s why Woodcock made it clear that vaccines are safe and effective. The agency’s main priority seems to be to look at its slow, laborious approval process, even if it means sending mixed signals to the public during epidemics, confusing people and possibly discouraging vaccinations. Can spend.

In late August, the FDA fully approved a vaccine made by Pfizer. But the other two are still approved for emergency use only, and emergency approval for vaccinating young children is still a few months away.

In 2020, the first vaccines temporarily waited a few weeks for approval after the FDA submitted the results of clinical trials for review. Quick action could have stopped the severe winter wave, perhaps saving many lives in the process. In other words, the vaccines seem to be working well. But not the FDA.

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