You may have heard about the Medical University of South Carolina’s role in developing a safe and effective COVID-19 vaccine: AstraZeneca and IQVIA selected us to join a Phase 3 trial with the goal of enrolling and collecting data on 30,000 people across 20 U.S. cities in about eight weeks.
This double-blind, randomized and placebo-controlled study will involve two groups of people who will receive two shots about a month apart. Two-thirds will receive the vaccine, and the remaining third will receive a placebo, a shot with no vaccine in it.
Everyone in the study will be monitored for two years. Those who show any signs of illness that could be COVID-19-related will undergo additional testing and safety protocols. Hundreds of individuals have expressed interest and started the trial at MUSC already.
I’m grateful to the MUSC providers, scientists and researchers involved in this Herculean effort for their dedication and expertise. Although this is an incredibly ambitious undertaking across the health care industry, I’m confident that we have the talent and capability to rise to this task. It will require all of us to succeed.
As of this writing, MUSC and all U.S. sites have delayed enrolling more patients in the trial due to a routine safety review enacted when a patient in the U.K. arm of the trial became ill. Such pauses are actually frequent occurrences in human clinical trials.
Broad safety protocols with intentionally low thresholds help to catch more potential problems and ensure scientifically valid, sound and effective therapies.
As the saying goes, it is certainly better to be safe than sorry when entrusted with the care of human life. Our hope is that now that the U.K trial arm has been restarted, the U.S. trial arm will resume soon.
This is one of at least five vaccine development efforts in the final phases of testing. If a vaccine is validated as safe and able to protect patients against a significant COVID-19 infection, the next steps would be Food and Drug Administration approval and deploying the vaccine.
The million-dollar question is: How long will it take until appropriate FDA approval is granted?
The answer is complicated: Six to eight months from now is an optimistic ballpark. Producing and delivering hundreds of millions of vaccine doses will then be the next hurdle, and individuals choosing to get vaccinated will be the last step.
We do have valuable tools to fight infection, such as masking, social distancing and practicing excellent hand hygiene. These approaches have enabled us to coexist, albeit reluctantly, with COVID, but having an effective vaccine will be like fixing a leaky faucet as opposed to putting a bucket underneath it to catch the drip. A vaccine is the key to getting the virus under control.
I know there are people who believe vaccinations are bad, and I worry for them and their loved ones. We as a society did so well in eradicating the scourge of polio, mumps, measles and smallpox that some now assume the disease-free state we have enjoyed for decades came about as a result of a natural circumstance, rather than the success of vaccination strategies.
If you talk to people who lived through the deadly impact of these dangerous diseases in the 1940s and ’50s, they will confirm the huge positive impact of vaccines. Despite the overwhelming amount of validated research and millions of successful outcomes, a quick perusal of the internet reveals why the medical community struggles to combat mis- and disinformation, which is available in staggering quantities and not just about a COVID-19 vaccine.
It’s important for me to lead by example. I began my participation in the trial at MUSC two weeks ago. My wife of 32 years, Kathy, is also a participant. We are very excited to be part of such an important and promising study with the potential to make a real impact on billions of lives. Other MUSC providers, faculty, staff and students are participating in the trial, and I’m confident they would express a similar sentiment.
Sharing this personal choice is important to me not only as a health care leader but also as a member of this community and state. It will take more than words or hard evidence to combat the false and misleading information — as well as long-simmering distrust of the medical community, particularly among underrepresented minority populations.
I hope my actions speak loudly and encourage trust as we move forward and, one day, end this pandemic.
Ultimately, with a safe vaccine available, choosing to be vaccinated won’t be only about your health; it also will be about the health of our community and those we love.
David Cole, M.D., FACS, is president of the Medical University of South Carolina.