An Important Historic Moment: Approval of COVID-19 Vaccine

Tomorrow will be an historic moment in our country’s history. It is the day the Food and Drug Administration (FDA) is expected to approve the emergency use of a COVID-19 vaccine that holds the promise to end the most severe public health crisis of our lifetime. We expect the approval of the Pfizer vaccine tomorrow, and this should be followed very shortly by recommendations from the Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP) for additional guidance on both the risks and benefits of the vaccine as well as its administration.

As I have been talking about the vaccine with caregivers, community members and media outlets, the questions I get the most are about the safety and efficacy of the vaccine. As a researcher myself, I have been closely following the Pfizer and Moderna clinical trials. In fact, I enrolled in the Pfizer clinical trial here with the UMass Medical School, which has been led by Robert Finberg, MD, Chair of the Department of Medicine. I personally wanted to participate in the study because I believe in the importance of these trials to test safety and efficacy, and I would never ask our caregivers to do something that I was not willing to do myself. Here are a few thoughts I want to share from my experience with the clinical trial and what I’ve learned from other experts:  

  • I enrolled in the trial at a time when we didn’t know about its safety and efficacy, but based on the results of that trial and the approval tomorrow by the FDA for emergency use, I believe it has now been proven to be safe and effective.
  • The clinical trials showed that the Pfizer and Moderna vaccines were 90 to 95% effective, and those who developed COVID-19 (those in the 5 to 10% category) had mild cases.
  • Some people question the safety of the vaccine because the clinical trials were conducted much faster than other vaccine trials. Clinical studies are highly regulated with strict protocols in place to prevent taking shortcuts and skipping important safety steps. The speed of this process was largely because we are in a world-wide pandemic, so all involved were hyper-focused on making these trials a top priority.

Bottom line is that I believe this vaccine to be safe and effective – based on the best information from the FDA and the CDC and other leading experts from around the world – and is the best solution to get us out of our current situation and help us save more lives. So, I hope our communities will consider getting the vaccine.

I’ll end with a line from the classic novel A Tale of Two Cities: “It was the spring of hope” – this vaccine is a result of some of the brightest minds in medicine working toward the common goal of ending this pandemic – and “it was the winter of despair” – the current spike of COVID-19 hospitalizations and deaths is disheartening. I know it’s frustrating that we’re here again in another surge and our UMass Memorial family of caregivers now must rise to the occasion once again to care for those who are sick with this terrible disease.

The end of this crisis is near, starting with tomorrow’s landmark announcement about the vaccine. Stay tuned for more details and stay strong we can do this!

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