The office of U.S. Representative Phil Roe, First District Tennessee, released the following column on Sept. 17:
“Earlier this year, the Trump administration launched an all-hands-on-deck initiative called Operation Warp Speed to defeat COVID-19. Operation Warp Speed is a public-private partnership that is harnessing the full power of American ingenuity to produce coronavirus treatments, tests, and hundreds of millions of doses of a safe and effective COVID-19 vaccine.
We have already made great strides in our ability to respond to the threat of COVID-19. We have learned the best practices to prevent the spread of the virus and have developed better treatments to ensure those who do get sick experience better outcomes. Even with the incredible progress we’ve made, we must remember that this is a deadly and highly-infectious virus. The best way to get back to life as normal is to develop an effective vaccine and produce enough doses to ensure everyone who wants to be vaccinated can be. Fourteen vaccine candidates are already undergoing rigorous testing, and three of those candidates are already in Phase 3 trials – the final phase of clinical trials. This is exciting news. Thanks to Operation Warp Speed, we may be only months away from producing a COVID-19 vaccine.
It is important to remember that the development and approval of any COVID-19 vaccine will be based on science. Any potential vaccine must meet the Food and Drug Administration’s (FDA) rigorous criteria. During Phase 3 trials, the vaccine candidates will be tested on tens of thousands of volunteers to ensure that they are safe and effective against the virus. If a vaccine candidate is not shown to be both safe and effective, the FDA will not approve it. Period. When it comes to developing this vaccine, the highest priority is the health and safety of the American people.
Operation Warp Speed aims to produce a vaccine by January 2021, and we are well on our way to achieving that goal. However, it is also possible that a vaccine could be approved for some groups even sooner. If clinical trials show strong evidence that the vaccine works without harmful side effects, the FDA could approve an Emergency Use Authorization (EUA) for that vaccine even as the trials are ongoing.
Under an EUA, the vaccine would be conditionally approved for a narrow segment of the population, such as those who need the vaccine the most: high-risk individuals and front-line workers. If vulnerable groups are allowed to get the vaccine early, this would be the scientific and ethically-correct decision. An EUA would not mean the FDA is cutting corners; instead, the FDA would make this decision only if there is strong scientific evidence that the vaccine is effective and safe. If that’s the case, we could have a vaccine available for some populations before the end of the year. But if that evidence does not exist, the FDA will not approve an EUA. It’s that simple.
If a COVID-19 vaccine is conditionally approved under an EUA, it would not be the first time that the FDA accelerated approval of a vaccine due to the strength of evidence of the vaccine’s efficacy and safety. During the Obama administration, the FDA began the approval process for a vaccine for Ebola virus based on demonstrated effectiveness in clinical trials in 2015. The FDA ultimately approved the vaccine for use in adults age 18 and older in 2019.
Vaccine development typically takes between 10 and 15 years, so it is astounding that the Ebola vaccine was produced in less than 5 years. The FDA prioritized approval of the Ebola vaccine based on its positive trial results and the public health importance of an Ebola vaccine. Likewise, under Operation Warp Speed, the approval of any vaccine, including under an EUA, will be based on rigorous scientific results.
Unfortunately, many people have expressed fear or uncertainty about taking a COVID-19 vaccine. I can assure you that any vaccine that the FDA approves will be safe. I am so certain of this that I myself plan to receive a vaccine once the FDA has approved it. We all want to get life back to a state a normal. We want to have confidence that our family and friends are protected against COVID-19. A vaccine is the way to achieve this, and Operation Warp Speed is taking us there in record time. I have confidence in American ingenuity to produce a safe, effective vaccine that will allow us to fully reopen America.”