I hope this message finds you safe and well. I wanted to give you a brief update on the Pfizer COVID-19 vaccine.
Vaccine Safety and Efficacy
The FDA and the CDC have approved the first of six COVID-19 vaccines for emergency use authorization. The first of these is the Pfizer-BioNTech modified RNA vaccine aka BNT162b2. The FDA recently reviewed the Pfizer randomized clinical trial findings and has determined that this vaccine is safe and effective, and the CDC agrees with these findings. As your medical provider I want you to know that I have also dedicated a significant amount of time reviewing and analyzing the Pfizer vaccine data. I’ve reviewed the following:
- Pfizer clinical trials protocol – LINK
- Vaccines and Related Biological Products Advisory Committee Meetings brief and emergency use authorization – LINK
- Letter of authorization from the FDA – LINK
- Safety and Efficacy report from the New England Journal of Medicine – LINK
Based on my evaluation of the most current available data, I find that the Pfizer COVID-19 vaccine safety and efficacy profile is very good, particularly when weighed against the current state of the COVID-19 pandemic. Pfizer’s randomized double blind clinical trial has followed the expected scientific rigor and processes that are required for the development of modern day vaccines. This vaccine carries a similar side effect profile seen with other vaccines that we typically administer, including the influenza vaccine and the zoster vaccine. The common side effects include injection site pain and redness, as well as flu like symptoms after the injection. The Pfizer COVID-19 vaccine showed efficacy of 95%, which is excellent. Efficacy is a percent reduction in disease (new infection) risk compared to the unvaccinated group.
There are still some unknowns about this vaccine including the safety profile beyond 2 months post injection. Additionally, we do not know if it is safe in pregnant women, immunocompromised patients, and in people who have had allergic reaction to vaccines in the past or have a history of anaphylaxis. If you fall in any of these categories, please speak with me before you receive the vaccine.
I will be receiving this vaccine as soon as it is available to me and I also am recommending the Pfizer COVID-19 vaccine to all my eligible patients. The Pfizer COVID-19 vaccine is a 2-dose vaccine given 21 days apart and is recommended for persons age 16 years of age and older. Once you are vaccinated please make sure to report any side effects to our office.
The Pfizer COVID-19 vaccine will initially be available to frontline healthcare workers and residents of long-term care facilities. As the vaccine availability increases, vaccination recommendations will expand to include more groups. Our office is working closely with the Georgia Department of Public Health to ensure that we receive vaccines as soon as they are readily available. At this point there is no solid time frame for when this will happen. We anticipate that vaccines will be available more readily at hospitals and pharmacies before they arrive at urgent care centers and doctors’ offices. Rest assured that as soon as vaccines arrive in our office, we will notify all of our eligible patients. Additionally, when we identify facilities that are actively vaccinating specific groups, we will also notify you.
I also would like to recommend that you download the Vsafe app from the CDC, once you are vaccinated, https://www.cdc.gov/…/2019-ncov/vaccines/safety/vsafe.html . This application will be used once you are initially vaccinated to assist in reporting any side effects to the CDC and to help remind you of your second vaccine due date.
While release of the Pfizer COVID-19 vaccine is clearly a momentous event in our history and is one step closer to ending this pandemic, I want you to know that we are still having significant loss of life due to COVID-19 infection. I still strongly recommend that you continue to practice measures that will avoid infection including wearing masks, social distancing, avoiding large crowds, and washing your hands frequently. I do expect once we reach a significant threshold in vaccinating the population, likely around the fall of 2021, hospitalization and death rates will decrease significantly.
Warm wishes during this holiday season,
Dr. Edward Espinosa
91 W. Wieuca Road, NE
Atlanta, GA 30342