The Hill: Ignore the misinformation: The FDA will ensure the safety of any COVID-19 vaccine
By Reps. Greg Walden (R-OR), Michael Burgess (R-TX), and Brett Guthrie (R-KY).
The U.S. Food and Drug Administration (FDA) is the world’s premiere organization for making sure new drugs and vaccines are safe and effective. That’s why when the most talented doctors and scientists in the world submit their COVID-19 vaccines for approval by the FDA, and the FDA deems them safe and effective, we will confidently get vaccinated, and we will encourage other Americans to do likewise. That’s how we can protect those most vulnerable from this vicious virus and get our way of life back once again.
As the House Energy and Commerce Committee Republican leader, the Oversight and Investigations Subcommittee Republican leader, and the Health Subcommittee Republican leader, we oversee U.S. public health, including efforts of private sector companies and federal health agencies working around the clock on a COVID-19 vaccine.
Throughout this pandemic, we have worked closely with our country’s top doctors and public health officials. We’re conducting ongoing and thorough oversight of efforts to develop a vaccine, including public hearings with officials from the Department of Health and Human Services (HHS), the National Institutes for Health (NIH) and FDA – as well as representatives of vaccine manufacturers. It’s clear from our work that America’s public health officials and the vaccine manufacturers they oversee are adhering to the world’s top safety standards. Unfortunately, we have seen a disturbing amount of misinformation designed to scare people about the safety and effectiveness of potential vaccines. This rhetoric must stop.
The human suffering from the COVID-19 pandemic is unlike anything we’ve seen in our lifetimes. The virus has claimed over 176,000 Americans and many people have lost their jobs. The stress and uncertainty have negatively impacted people’s mental health, on top of appearing to worsen the addiction and substance use disorder crisis in the U.S. To fight off this invisible enemy, unprecedented efforts and resources are being deployed. One of those efforts is Operation Warp Speed (OWS), a public-private vaccine and therapeutic partnership with the goal of delivering 300 million vaccine doses by January 2021. Operation Warp Speed has narrowed more than 100 vaccine candidates to only the strongest candidates, and the federal government has provided over $12 billion to support the development of a COVID-19 vaccine.
Operation Warp Speed is moving at an unprecedented pace – without cutting safety corners. Indeed, OWS is requiring the leading vaccine candidates to each enroll at least 30,000 people in large-scale studies as doctors and health experts had urged in order to ensure safety.
Public health officials have repeatedly said the only risk is in the financial investment being made by the federal government, not in the safety of any vaccine that is approved. For example, OWS is already doing manufacturing demonstrations. Typically, vaccine approval is obtained before investments are made in the manufacturing process, so money isn’t lost if a vaccine does not end up receiving approval. However, Operation Warp Speed is simultaneously producing the vaccine while we await final approval by the FDA. If FDA says “no,” then the whole production line is dumped. But if a vaccine works, then we’ll be months ahead and ready to save lives in record time. This kind of financial risk is well worth the potential lives that could be saved by having doses ready to go immediately. Still, when it comes to approvals, including for the COVID-19 vaccine, FDA Commissioner Dr. Stephen Hahn reiterated in a recent op-ed that “…all FDA decisions have been, and will continue to be, based solely on good science and data.”
At a July hearing with vaccine manufacturers, members of our committee asked how can we have a safe and effective vaccine in under 18 months when the fastest time period a vaccine was ever developed, which was for Mumps, took four years. Vaccine manufacturer representatives are confident this can be achieved without compromising safety, citing factors such as staff working around the clock, unprecedented interaction with regulators, and previous scientific work in contributing to the extraordinary speed in developing a vaccine. It’s also worth noting that, even though we are in a public health emergency, the FDA has set – and is demanding – high safety standards. FDA guidance requires the COVID-19 vaccine to be at least 50 percent effective.
At the Energy and Commerce Committee, Republicans are leading an effort called the Second Wave Preparedness Project to complement the work of public health officials and ensure the U.S. government’s response to COVID-19 continues to move in the right direction. Through hearings, conversations with public health officials, and our oversight work, we are confident a vaccine – when one becomes available – will be safe and effective. August is National Immunization Awareness Month, and it’s disappointing to see people, even some of our colleagues, fuel doubt on social media and in news articles about the safety of the vaccine for what could only be political reasons. Rest assured, in our roles at the Energy and Commerce Committee, we will continue our oversight to ensure only a safe and effective vaccine is delivered to the American people. And when it is, we’ll take our turn in line to get it.
Greg Walden is Energy and Commerce Committee Republican leader, Dr. Michael Burgess is Health Subcommittee Republican leader, and Brett Guthrie is Oversight and Investigations Subcommittee Republican leader.Originally published here.
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