As physicians and members of Congress, we know the surest and safest way to defeat coronavirus and return life to a state of normal is by developing a safe, effective vaccine.
When the coronavirus pandemic began, the Trump administration had the foresight to launch Operation Warp Speed (OWS), a multi-agency wide effort to develop and deliver a vaccine, therapeutics, and diagnostic tests that could identify and treat the virus in record time.
This public-private partnership, which uses federal research dollars to supplement and accelerate private companies’ vaccine development efforts, could now be mere months away from having a COVID-19 vaccine approved and ready to save lives.
Thanks to this effort, it is entirely possible vaccinations could begin by the end of this year – truly extraordinary when considering the normal timeline for vaccine development.
We want the public to be confident that when a vaccine is approved, it will be safe and effective.
To that end, we’re confident enough in the science to commit to receiving an FDA-approved vaccine ourselves after it has been made available for high-risk individuals, frontline workers, and other critical populations.
Typically, vaccine development takes 10-15 years. Under Operation Warp Speed, the goal is to shorten that to 12-18 months and, remarkably, researchers are actually ahead of this already accelerated schedule.
While this is the fastest timeline for vaccine development – ever – it is important to remember that OWS does not allow vaccine manufacturers or the FDA to cut corners in the approval process.
We’re confident enough in the science to commit to receiving an FDA-approved vaccine ourselves after it has been made available for high-risk individuals, frontline workers, and other critical populations.
Instead, it saves time by allowing vaccine development steps to occur simultaneously. For example, manufacturing of vaccine doses is occurring at the same time that safety and efficacy tests are ongoing.
Normally, such production would not occur until the FDA approval process is complete. These simultaneous timelines save months and years of production time, and thus help to ensure that once a vaccine is approved, millions of doses will be immediately ready for distribution, especially for the most vulnerable.
Under normal circumstances, it would not make sense to produce such a large volume of doses that may have to be discarded if the vaccine isn’t approved.
However, these are not normal times, and taxpayers are shouldering much of the financial risk due to the overwhelming importance that a successful vaccine will play in America’s recovery.
As of this writing, the federal government has already invested $12 billion in six vaccine candidates.
Operation Warp Speed’s accelerated timeline has led some to worry that corners may be cut in the development and approval process, and an unsafe or ineffective vaccine will be approved.
We are here to help allay these concerns and reiterate what Operation Warp Speed does and does not do. Any vaccine approved for public use must have still gone through rigorous scientific testing by the Food and Drug Administration (FDA) to ensure it is safe and effective.
Already, three vaccine candidates have begun Phase 3 clinical trials – the final phase of testing. In this phase, vaccine candidates are tested on roughly 30,000 volunteers. These volunteers are evaluated to determine if the vaccine is effective, as well as whether it causes any side effects.
Only if the FDA determines that a vaccine candidate meets its stringent criteria will that safe, effective vaccine then be approved for public distribution.
Operation Warp Speed has worked with private industry to ensure millions of doses of the eventual successful vaccines will be available for Americans in a timely fashion. However, not all the necessary doses will be available on Day 1 post-approval.
Once vaccinations begin, it may still take months to produce and administer enough doses for every American who wants one.
In light of this, we must be strategic and use science to guide our decision-making around who receives the first rounds of vaccines.
First and foremost, we should prioritize the most at-risk patients, as well as any critical personnel such as health care workers, long-term care providers, staff of senior living facilities, and others who interact with at-risk populations.
Securing vaccines for these frontline patients and workers will greatly reduce the threat COVID-19 poses to our society.
Once we have vaccinated these individuals, doses should be made available for lower-risk groups. A risk-based, voluntary, and science-backed strategy for administering any successful vaccine is critically important to this effort.
Our country still has a long road ahead, but we have many reasons for cautious optimism. If a safe and effective vaccine candidate is approved by the end of the year, we will have the resources available to begin distributing and administering the vaccine quickly and effectively.
If instead none of the vaccine candidates currently in trials end up meeting the FDA’s rigorous criteria, then we have the infrastructure readily in place to continue testing and developing other promising vaccine candidates.
Thanks to Operation Warp Speed, we are harnessing the full power of American ingenuity to defeat the coronavirus.
Dr. Phil Roe practiced as an OBGYN and ran a successful medical practice in Johnson City, Tennessee, for 31 years.
Dr. Brad Wenstrup specializes in podiatric medicine and surgery. He served in private practice for 27 years. He currently serves as a colonel in the U.S. Army Reserve, seeing patients at Walter Reed Medical Center and acting as medical policy adviser to the Office of the Chief of the Army Reserve.
Dr. Andy Harris specializes in anesthesiology and is the former head of obstetric anesthesiology at Johns Hopkins University. He still practices part-time on Maryland’s Eastern Shore.
Dr. Larry Bucshon was a practicing physician and surgeon specializing in cardiothoracic surgery. During his time in private practice, Larry performed hundreds of heart surgeries and served as President of Ohio Valley HeartCare.