The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and the University of Delaware have entered into a research agreement with the Food and Drug Administration (FDA). The arrangement, which […]
By Dr. Bill Chasanov
[caption id="attachment_207347" align="alignright" width="362"] Bill Chasanov[/caption]
On Dec. 10, the U.S. Food and Drug Administration’s vaccine advisory panelgave the thumbs up to the Pfizer-BioNTech COVID-19 vaccine. Less than a week later, Beebe administered the first doses in Sussex County to our front-line health care workers.The relief from this deadly virus may finally begin almost nine months after it spread in Delaware, claiming hundreds of lives.No matter your profession or stage in life, the big question surrounding the vaccine has been safety and effectiveness. The reports of higher than 90% efficacy is certainly a good sign.In a previous column, we discussed the amazing technology around these vaccines. But what about side effects? The data is promising here, too, and it should be noted that two other world leaders – Canada and the United Kingdom – have begun distribution as well.According to Pfizer’s data submitted to the FDA, the most common side effects were swelling and redness at the vaccine injection site. Other noted common side effects in the trial included fatigue, headache, and muscle pain, which had a greater chance of occurring after the second dose than the first dose.The data comes from Pfizer’s most recent clinical trial that included 44,000 participants from various age groups as well as races and ethnicities. For the participants, every symptom or side effect is closely monitored and investigated. More than 70,000 volunteers were enrolled in the Pfizer-BioNTech and Moderna COVID-19 vaccine clinical trials. Current results from both trials indicated that the vaccines were well-tolerated and greater than 90% effective. These minimal side effects, combined with its efficacy, show the benefits that a vaccine could provide to this deadly pandemic that continues to set records in recent weeks.While it is understandable to have vaccine hesitancy, the initial data suggests overwhelming positives compared to the potential COVID-19 risk factors. My Beebe colleagues have also jumped at the opportunity to receive the vaccine.The Pfizer-BioNTech vaccines have gone through clinical trials which have been presented to the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices and the FDA’s Vaccine Biologic Related Products Advisory Committee. Through this, the Pfizer-BioNTech has received Emergency Use Authorization.It is good to start a conversation with your primary care provider if you have concerns.Lastly, it is important to remember that masks will remain important throughout the winter and spring – and possibly even longer. Please remember to follow the three Ws: Wear your mask, Wash your hands, and tatch your distance.To stay updated on COVID-19 vaccines, follow Beebe Healthcare’s Facebook page and visit beebehealthcare.org, as well as the Division of Public Health’s website: coronavirus.delaware.gov/vaccine.Dr. William Chasanov is board certified in internal medicine and infectious disease. He serves as the clinical transformation officer at Beebe Healthcare.