A COVID-19 vaccine must be safe and effective
Boston Globe – October 5, 2020
In this op-ed, Kenneth Wener, MD (Infectious Diseases, LHMC) and Mary LaSalvia, MD (Infectious Diseases, BIDMC) join infectious disease leaders across Boston in highlighting the importance of rigorous standards of safety and efficacy for a COVID-19 vaccine.
To build trust and confidence in a COVID-19 vaccination strategy, there needs to be a framework. Creating one is critical because widespread acceptance and distribution of safe and effective vaccines is the best approach to ending the coronavirus pandemic.
Preliminary results of several candidate vaccines have been promising, with each inducing the type of immunity that might protect against becoming infectedwith SARS-CoV-2, the virus that causes COVID-19. Proof that one or more of these vaccines does, in fact, protect against COVID-19 and is safe to administer to the general population can only come from large-scale placebo-controlled clinical trials. Such trials, involving tens of thousands of volunteers, are underway. While we can’t predict the results of these trials, we’re confident that when concluded, they will provide definitive evidence about whether a particular vaccine candidate is safe and can prevent or lessen the severity of COVID-19.
Each of these vaccine trials is overseen by monitoring committees made up of trusted and experienced physicians, scientists, statisticians, and ethicists who are independent of the Food and Drug Administration and of the companies and investigators sponsoring and conducting these trials. These committees (often known as data and safety monitoring boards) have an obligation to ensure the safety of trialparticipants, and have the power to recommend a study be paused or halted entirely if a vaccine appears to be unsafe.
The monitoring boards are given snapshots of the data at regular intervals to determine whether sufficient evidence has accumulated to show that a vaccine is effective based on predetermined benchmarks. This process ensures that a trial does not continue longer than needed if an important health benefit is demonstrated, and also guards against ending a trial prematurely in the absence of such a benefit.
As infectious diseases specialists at Greater Boston hospitals, we are committed to recommending distribution of a COVID-19 vaccine only when a vaccine meets the rigorous standards of safety and efficacy detailed in the various vaccine trial protocols. Any emergency use authorization or approval of a vaccine must be contingent upon it meeting those criteria. We endorse the position of the Infectious Diseases Society of America that before an approval is granted for any COVID-19 vaccine, trial results should receive rapid review by the independent committees that advise the FDA and the Centers for Disease Control and Prevention on vaccine approvals, both composed of independent scientists with expertise in vaccine safety, efficacy, eligibility, and distribution. Finally, in order to ensure public confidence, it will be essential that the data on which a decision to grant an approval is based be made publicly available in real time for all to see.
While we support rapid distribution of a COVID-19 vaccine that meets these standards of safety and efficacy, we cannot endorse distribution of a vaccine that is released in the absence of ample transparent evidence. Premature release of a vaccine could have profound negative consequences, including a loss of public trust and the potential for wasting of resources and expenditure of substantial time, effort and money toward the wrong goal.
Dr. Robert Redfield, director of the CDC, recently noted that once a safe and effective vaccine is available, distribution and administration to the population at large will be a massive undertaking with significant logistical challenges (for which we are now preparing), and it will take time. We are committed to ensuring equity and transparency in any vaccine distribution effort, following principles and guidelines laid out by the National Academies of Science, Engineering and Medicine. Moreover, we are steadfast in our commitment to ensure vaccine access by members of vulnerable communities, which are being prioritized in each of our distribution plans.
Any COVID-19 vaccine that receives authorization for use within the next year will set a record for being the fastest vaccine ever developed and should be considered a remarkable success for humankind. But even with an authorized vaccine, we will not be out of the woods. The level of protection may vary in different populations, and we will not know how long this protection will last. People should continue protecting themselves against COVID-19 as the citizens of the Commonwealth have been doing so well by wearing masks and continuing to physically distance. We expect this advice will stand for months to years, not weeks to months. We need to redouble our adherence to these protective measures as we enter the cold and flu season this fall and winter. With patience and determination, we remain here for you. We will get through this together and see the end of the pandemic.