Will the COVID-19 vaccine be safe?
I know there have been a lot (and I mean, a lot) of conspiracy theories regarding the COVID-19 vaccine, so I’m here to answer the question that more than a few of you have posed to me: Is the COVID19 vaccine going to be safe? By all measures, yes. And here’s why:
The standard process of vaccination approval is rigorous, scientific, and designed to ensure the scientific community and public’s confidence in the vaccine. Every vaccine being developed for ANY disease (including the 5 that are currently in phase 3 for SARS-CoV-2) has its own Data and Safety Monitoring Board. These boards are independent of the biotech or pharmaceutical companies developing it, independent of the political administration, the FDA, and even independent of Dr. Fauci. They are comprised of scientists, biologists, ethicists and statisticians. At pre-determined time intervals, they review the data and, if at any point, there appears to be foul play, indiscretions with the data, safety concerns, or lack of efficacy, they will stop the development and potentially cancelling the trial altogether. At that point, no one else has access to the data except this board, not even the scientists developing the vaccine or the subjects getting the vaccine, or placebo (thus, the double-blind and randomized control requirement of the study). They could require early cancellation of the trial if it is dangerous and they can even accelerate the trial if they reached the predetermined end point of efficacy. No one else gets to know or see the data or make any determinations on the trial at that point.
When pre-determined end-points of efficacy and safety are finally met, the developing company will apply to the FDA to either get an EUA (emergency use authorization) or submit a biological use application (the data is strong enough to pass the FDA process). After they have met the requirements to submit the application, the FDA reviews the data. The career scientists of the FDA and the FDA commissioner have spent their entire lives (way before COVID-19 existed) reviewing experimental vaccines and drug therapies. They are the best in the world at what they do, and apply the scientific process rigorously and ethically time and time again. These are scientists I trust, that Fauci trusts. And you can trust them too.
After it passes the application process, the commissioner and FDA then subject the data to yet ANOTHER independent advisory group, the VRBPAC group for further evaluation and a meticulous review of the data and results. And finally, the data is released the public so the scientific community can pour over the data and determine its validity and safety. That’s a LOT of scientists reviewing this data. That’s a lot of people 100x smarter than I will ever be looking at the vaccine that I will put in my body to protect myself and others from COVID-19 infections. So when a decision is made to approve a vaccine, it has gone through so much scrupulous analysis that its safety is clear. I am not saying there will be no side effects to anyone (that is statistically impossible), but you will know the potential harms and benefits. And for me, the benefit almost always outweights the harms (which may be a little arm soreness and maybe a day or two of fatigue).
So, when COVID-19 a vaccine is announced, I will review the data with and for you and do my own independent review. I’ll trust the scientists, but I’ll also do my own research (not from twitter, but in the data!) and I’ll let you know if I trust the vaccine. But all signs point toward trusting the system and trusting this vaccine that, like many other vaccines that preceded it such as measles, polio, influenza, will save a lot of lives.
Please note that, like the other information provided on this site, this material is not intended or implied to be a substitute for professional medical advice, diagnosis, or treatment. You are encouraged to consult your personal physician with questions or concerns. If you are experiencing a medical emergency, please call 911 or the emergency services number in your area.