Do Emergency Use Authorizations Ensure Vaccine Safety?

Do Emergency Use Authorizations Ensure Vaccine Safety?

Pharmaceutical giants Moderna and Pfizer have applied to the Food and Drug Administration for emergency use authorization, or EUA, for their COVID-19 vaccines.

These fast-tracked approvals may not guarantee that the drugs have been proven safe and effective. They are based, instead, on the idea that the benefits of the vaccines during the pandemic outweigh the risks.

Dr. Jeremy A. Greene M.D., a physician at Johns Hopkins School of Medicine, and attorney Christopher Robertson, a professor of Law at Boston University School of Law, wrote an article for The Conversation, in which both experts explain how the process of EUA works.

They said that EUA is a relative new pathway for the FDA to grant approval for new drugs and was first used in 2005 for an anthrax vaccine designated for military use. Since 2009, the FDA has “issued dozens of EUA’s for drugs, devices and diagnostics based on the best available evidence for prevailing health crisis,” wrote the authors.

Once an emergency has been established that leads to a life-threating crisis, the administration follows three guideposts to issue an EUA.

The first is that it is “reasonable to believe that the product may be effective.” Then the agency weighs the risks versus the benefits of the product in alleviating the crisis, but not necessarily its complete safety, according to The Conversation. Finally, an EUA is granted if “there is no adequate, approved, and available alternative to the product.”

Traditional FDA approval relies on proof of safety and “evidence of efficacy” based on two controlled trials, said Greene and Robertson, who added that while an EUA is less reassuring than the traditional FDA stamp of approval, the urgency of the pandemic factors into the importance of providing a potentially lifesaving vaccine to the public.

According to a recent Gallup poll, 58% of Americans say they would get a COVID-19 vaccine, up from a low of 50% in September. The authors wrote that granting an EUA “plays an important role in mobilizing COVID-19 vaccines as promising new tools in a rapidly unfolding public crisis. Hopefully, by early summer there will be sufficient knowledge and sufficient supply to support a traditional FDA approval of the vaccines, based on the best available evidence.”

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