Op-Ed - The science is there -- COVID-19 vaccines' development did not cut corners

Op-Ed

By Rep. Michael Burgess

Today's doctors and nurses have access to medical tools, therapies, and cures that I could only dream about when I was in medical school. Between my time as a physician and as a congressman, I have witnessed several public health crises, including bird flu, swine flu, Ebola, and Zika, but never a health crisis as globally devastating as the COVID-19 pandemic. Equally so, I have not witnessed anything as inspiring as the development of the COVID-19 vaccine.

Operation Warp Speed (OWS) allowed for the collaboration of multiple federal agencies, the private sector, military, and scientists. This is an "all hands-on deck" endeavor. For these vastly different sectors to have worked together to develop safe and effective COVID-19 vaccines in less than one year of learning the genetic sequencing of this virus is nothing short of extraordinary. It is also important to note that this operation did not cut corners.

It is time to put an end to the rumors and false information. I have received both shots for the vaccine and take the Hippocratic Oath very seriously. I would not support a vaccine where science and data were not the driving decision makers in determining the safety and effectiveness of this vaccine.

The Food and Drug Administration (FDA) issued not one, but three Emergency Use Authorizations (EUA) for COVID-19 vaccines. One EUA for Pfizer, another for Moderna, and most recently Johnson & Johnson. All three candidates exceeded the rigorous and globally recognized safety standards set by the FDA. The FDA requires COVID-19 vaccine candidates to enroll at least 30,000 people in their clinical trials; however, several COVID-19 vaccine trials have recruited up to 60,000 individuals. This means there are tens of thousands more subjects than usual generating the scientific data used to determine safety. Furthermore, the vaccine candidate is required to be at least 50 percent effective. Both Pfizer and Moderna reported over 94 percent efficacy, and Johnson & Johnson reported a 72 percent efficacy in U.S. trials -- all exceeding the required standard.

The FDA did not alter the safety or effectiveness requirements for this vaccine. OWS made it possible for scientists and public health experts to work around the clock, seven days a week, ensuring limited delays when possible. Normally companies complete Phases I, II, and III of scientific trials sequentially before beginning the highly regulated manufacturing process. Instead, these vaccine candidates began the manufacturing process while undergoing trials, completing these steps simultaneously. While this is untraditional, it did not cut any corners. If the FDA determines the vaccine to be unsafe or ineffective, the companies are required to cease manufacturing. This is a large financial risk, and companies are still required to undergo every step of the approval process.

The transparency throughout the vaccine development process by FDA, OWS, and vaccine manufacturers should enable Americans to trust the safety and effectiveness of COVID-19 vaccines. What is usually a highly confidential process was made as publicly accessible as possible through live-streamed meetings and hearings at the agency and in Congress. Phase 3 of the vaccine trials are to be overseen by the Data and Safety Monitoring Board. This is an independent, multidisciplinary group comprised of public health and immunology experts, serving as an extra guardrail to prevent any politicization of the approval process. Vaccine candidates must also pass the Vaccine and Related Biological Products Advisory Committee, a panel comprised of external scientific and public health experts. This committee approved each vaccine during publicly broadcasted meetings.

It is important that you consult with your doctor, and I encourage you to receive the vaccine. When I became a doctor, I took an oath to "do no harm." I would not recommend this vaccine if I had any reservations about taking it myself.

Our nation has learned a lot from this past year, but I stated at the beginning of this pandemic that American innovation would see us to the end. The swift development of the COVID-19 vaccine is one of the best examples yet -- that by collaboration, trust, and innovation, we can make history.

Michael C. Burgess, M.D., represents the 26th District of Texas and is a member of the Energy and Commerce Health Subcommittee.

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