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Vaccine Awareness

COVID-19 Vaccines: Understanding the Process

Paul A. Offit, M.D.

Director, Vaccine Education Center

Sadly, some Americans no longer trust the FDA to protect the public from ineffective COVID-19-related products. At some level, this distrust is understandable.

On April 7, the FDA approved the use of hydroxychloroquine, an anti-malarial drug, for patients with COVID-19. The drug had never been shown to work and, in about 10 percent of recipients, it caused irregular heartbeat. Nonetheless, the drug was quickly approved through Emergency Use Authorization (EUA). When studies subsequently showed that hydroxychloroquine neither treated nor prevented COVID-19, the FDA withdrew its approval.

Then, on August 23, the FDA, again using an EUA, approved the use of convalescent plasma for the treatment of COVID-19. Once again, no scientific studies had been performed showing that convalescent plasma worked or was safe. Nonetheless, in a nationally televised press conference, both the Secretary of Health and Human Services and the Commissioner of the FDA declared the supposedly major breakthrough in the fight against this disease.

 By the end of August 2020, many in the press and public believed the FDA to be serving at the behest of the administration rather than protecting the public from pharmaceutical products that might be unsafe or ineffective.

Now, using the same EUA mechanism the FDA is on the verge of approving one or more vaccines for the American public. Many are understandably worried that the same low standards as hydroxychloroquine and convalescent plasma are being applied to these vaccines, again putting Americans at unnecessary risk. For several reasons, however, the supervision and approval of vaccines will differ from what happened with COVID-19 treatments.

This time is different

First, unlike hydroxychloroquine and convalescent plasma, vaccines were tested in large, prospective, placebo-controlled trials (called phase 3 studies) to determine their safety and effectiveness prior to authorization through EUA.

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The group determining whether companies can submit their vaccines for FDA approval is called the Data Safety Monitoring Board (DSMB), composed of independent researchers. It serves as a firewall between the company and phase 3 studies.

Second, the FDA also relies on a committee of independent experts called the FDA Vaccine Advisory Committee, to recommend whether COVID-19 vaccines should be approved for use once submitted by companies.

Third, after the FDA Vaccine Advisory Committee has made its recommendations, the CDC also reviews the data from the vaccine trials. The CDC process also includes an independent committee of experts, called the Advisory Committee on Immunization Practices (ACIP), which independently reviews the evidence, reaches its own conclusions, and makes recommendations about who should or shouldn’t get a vaccine.

Both the FDA and CDC advisory committee meetings are open to the public. Viewers can experience a process that boils down to committee members answering one question: “Would I give this vaccine to myself or my family members?”

In summary, COVID-19 vaccines, which will be given to tens of millions of Americans are being subjected to the same rigorous clinical studies and oversight as vaccines that have been licensed for every vaccine given to Americans for the past seventy years.

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