Vaccine development process is safe, claims of the contrary are baseless

All of our lives have been drastically impacted by the ongoing coronavirus pandemic — and we know all of us are eager to return to the way things were before the pandemic began. However, that simply won’t be possible without a safe, effective vaccine. Fortunately, due to the strength of American innovation and unprecedented public-private partnerships, a COVID-19 vaccine is on the horizon. We, as the top Republican on the House Energy and Commerce Committee’s Oversight and Investigations Subcommittee and a physician on the Energy and Commerce Health Subcommittee, have been closely following our nation’s progress — and we are confident that we will have a safe, effective vaccine soon.

On July 21, 2020, the House Energy and Commerce Committee’s Oversight and Investigations Subcommittee held a hearing on vaccine development. The subcommittee heard from AstraZeneca, Johnson & Johnson, Merck, Moderna, and Pfizer. All five companies are working on various vaccines and therapeutics for COVID-19 and have received federal funding. Moderna, Pfizer, AstraZeneca, and Johnson & Johnson are all now conducting “phase 3” clinical trials for their COVID-19 vaccine candidates, which is the last stage of testing prior to regulatory approval. AstraZeneca and Johnson & Johnson both recently paused their studies to examine an illness in one of the participants. This is standard protocol, and should give us even more confidence that vaccine companies are following standard safety procedures in their trials — not rushing through the process.

Currently, the Trump administration is working with many pharmaceutical companies to assist in two ways: To advance research and development and to ensure that when a COVID-19 vaccine is approved for safety and efficacy, it is ready to be shipped and distributed across the United States. 

Through “Operation Warp Speed” and the “Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)” partnership, the federal government is doing everything it can to ensure that the private companies developing a vaccine have the resources they need. This assistance is also helping companies to begin establishing manufacturing capability and to initiate the purchasing of necessary raw materials including glass vials for packaging and needles and syringes for the administration of the vaccines. These programs are also facilitating the condensing of the regulatory timeline. For example, the government is currently providing financial support to a number of companies to allow for simultaneous development and production of a vaccine before it receives final approval from the Food and Drug Administration (FDA). Usually, companies will not begin to invest in producing a vaccine or treatment until it has first completed testing and received regulatory approval. We need to ensure that any COVID-19 vaccine is available as soon as it receives the final approval from the FDA.

All five companies assured the subcommittee that any vaccine they produce will meet all safety standards set by the FDA. They also vowed to be transparent about the testing and development process so there are no questions about safety or efficacy.

Many who are working closely on vaccine development are cautiously optimistic that we will have a viable vaccine this fall. While there is no question this an ambitious timeline, we are witnessing an unprecedented effort to develop a vaccine as quickly as possible. COVID-19 has already claimed the lives of over 200,000 Americans and impacted the lives of millions more. The federal government’s effort to help develop and make available a safe and effective vaccine as soon as possible should be something to celebrate. While some have chosen to put politics ahead of people by making baseless allegations about the integrity of the vaccine development and approval process, there is zero evidence to support such claims. Americans can have every confidence that a vaccine will receive regulatory approval only if the scientific data shows it is safe and effective. While making claims that undermine the public’s confidence in an eventual vaccine candidate might make for good politics, undermining Americans’ confidence may unnecessarily prolong the pandemic. If we see a successful vaccine this fall, it will be due solely to the triumph of American innovation and the private and public sectors working together in an unprecedent fashion to achieve this monumental accomplishment.

Rep. Brett Guthrie serves as the Republican Leader on the House Energy and Commerce Committee’s Oversight and Investigations Subcommittee and on the Health Subcommittee. Rep. Larry Bucshon, M.D. serves on the House Energy and Commerce Committee’s Health Subcommittee and was a practicing heart surgeon for over 15 years prior to entering Congress.