The FDA and CDC Promised Transparency in the Vaccine Approval Process. Here’s How Congress Can Hold Them to It

The COVID-19 pandemic continues to have a devastating impact on the health and economic well-being of families and communities across the country, and this virus will remain a significant threat until a safe and effective vaccine can be made available to all.

While we all hope to get potential vaccines reviewed, produced and distributed as quickly as possible, we can’t sacrifice safety and efficacy for speed. It is also critically important that the public has confidence in the federal government’s vaccine review process, which includes assurances that the Food and Drug Administration (FDA) has followed the necessary protocols to ensure vaccine safety and effectiveness. Together, we’ve introduced the Safe Authorization for Vaccines during Emergencies (SAVE) Act to ensure that the FDA and the Centers for Disease Control and Prevention (CDC) follow well-established measures so that COVID-19 vaccines meet rigorous standards that the public can rely on.

The FDA and CDC have existing vaccine review processes that are considered the gold standard by public-health experts around the world. During the normal vaccine approval process, the CDC and FDA each have advisory committees that meet and issue findings and recommendations on the safety and effectiveness of vaccines before they enter the market, including whether specific vaccines are safe for certain populations such as children or seniors.

For the COVID-19 vaccine, however, an expedited review process called an emergency use authorization is being used. There’s never been an emergency use authorization for a new vaccine before, and it is important to ensure that any expedited review process does not come at the expense of safety and efficacy.

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By taking key oversight measures, we can ensure the safety and effectiveness of a potential vaccine and promote transparency, even during an expedited process. By extension, we can also help bolster public confidence in the vaccine review process, as well as any vaccine product that enters the market. However, we have a lot of work ahead of us. Public trust in the vaccine approval process is critical to achieving widespread use, and right now, the public is skeptical.

A CBS poll released in September found that two-thirds of Americans would think the process had been rushed if a vaccine enters the market this year, and only one in five plan to get vaccinated as soon as possible. Another poll from the Kaiser Family Foundation showed that 62% of Americans worry that political pressure will lead to premature approval of a vaccine. If a majority of Americans are unwilling to take a vaccine, that vaccine will not be able to provide our communities with the protection that we need to return to normal life.

We must make sure that doctors and public-health experts are evaluating each vaccine as it is being reviewed and are providing feedback in a public, transparent manner that is free from political influence. Doing so will help strengthen the safety of a vaccine and bolster the American people’s confidence in it.

At a recent Health, Education, Labor, and Pensions Committee hearing, FDA commissioner Dr. Stephen Hahn and CDC director Dr. Robert Redfield committed that their respective agencies would conduct oversight measures, including allowing their independent advisory committees to meet, review data and issue public findings as part of the expedited COVID-19 vaccine review process.

In addition, in September leading COVID-19 vaccine manufacturers took an unprecedented step of jointly releasing a public pledge committing to an evidence-based vaccine review process focused solely on safety and efficacy.

We need to enshrine these commitments into law. That’s what the SAVE Act does.

Our bipartisan bill codifies into law that these FDA and CDC advisory committee meetings must meet and report findings, even if a COVID-19 vaccine goes through the expedited emergency use authorization process. And if these meetings do not occur, the Secretary of Health and Human Services must publicly explain why.

Our bill will help ensure that a vaccine review process can take place in a transparent way, free from political influence, without slowing down its development.

A safe and effective COVID-19 vaccine is the only way we will be able to fully reopen our economy and get back to our normal lives. Through this bipartisan legislation, we can help reassure Americans when a vaccine is available, that it is safe.

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Contributor: Maggie Hassan and Lisa Murkowski