Doctor are you getting the new COVID-19 vaccine?

Like many of you, my family has hosted Zoom calls during the pandemic as we have tried to stay connected and fill the void of not being able to gather in person for family celebrations and holidays. Topics of discussion have ranged from the typical family chatter, catching up on the latest happenings, local and national politics and yes, COVID-19. Since the late summer, I’ve been asked periodically by my family, “Doc are you going to take the vaccine?” My family members have not been shy about sharing their opinions about the upcoming COVID-19 vaccine. Do any of these sounds familiar to you?

· “You will find me at the back of the line to get that vaccine.”

· “They are not going to experiment on me, I am not a guinea pig.”

· “I am not sure how long it will take for me to work up the nerve to get the vaccine. It seems like I should get one when it’s available but I’m just not sure.”

While I do not have all of the answers, I will discuss these and other concerns that are top of mind with the information available today. As you have probably heard, the U.S. Food and Drug Administration (FDA) recently issued its first emergency use authorization for the Pfizer COVID-19 vaccine. There are several vaccines on the horizon for review; as you might expect, there will be some differences between them worth pointing out in future weeks and months.

I would like to share some perspective on my deliberations regarding the vaccine. In addition to being an emergency medicine physician, I am a father of school aged children, I have parents over the age of 65, and a spouse who is also a physician. I too needed to be better informed about this new vaccine so I decided to read the 53 page FDA briefing document prepared for the recent meeting of an expert panel advising the FDA on the Pfizer vaccine.

How did Pfizer set up this clinical trial?

They initially enrolled approximately 30,000 participants in the trial; they later added another 14,000 participants, which included more young people and more people with chronic medical conditions. They evenly divided participants between two groups, those receiving the actual vaccine and those receiving a placebo (injection of saline). Neither the participant receiving the injection or the person administering the injection knew what was in the injection vial (vaccine or placebo). The vaccine trial included two doses given 21 days apart with follow up visits over the 2 months following the second dose, to monitor the health and safety of the participant. At the time of the analysis for FDA review, more than 36,000 participants had received a two-month follow-up evaluation after the second dose.

Who was in the trial?

The trial was conducted in multiple countries including Argentina, Brazil, Germany, South Africa, and Turkey but the majority (76%) of participants were in the United States. The racial and ethnic diversity across participants in the trial exceeded my expectations; 26% were Hispanic or Latino, 9.8% African American, 4.4% Asian, and 0.7% American Indian or Alaskan Native. Participants not only included those who were generally healthy but also individuals with chronic medical conditions like high blood pressure, HIV, and diabetes. Obesity was present in 35% of participants, lung disease in 7.8% and more than 1 in 5 were over the age of 65.

Are they experimenting on us with this vaccine by injecting us with COVID-19?

While there are different types of vaccines for COVID-19 under development, this vaccine does not inject you with the COVID-19 virus. Many of our traditional vaccines use a live but weakened (safe) version of an actual virus to create immunity to that virus. This is a new, innovative type of vaccine known as a nucleoside modified messenger RNA vaccine; yes, the is a mouth full of scientific jargon more easily referred to as a modRNA or mRNA vaccine. The vaccine contains a copy of the “fingerprint” of the COVID-19 virus and it teaches your immune system to recognize and fight the virus. While I am using the term “fingerprint,” you will more commonly see references to the vaccine’s ability to teach your immune system to recognize the spike glycoprotein on the outside of the COVID-19 virus. This modern approach to creating a vaccine likely contributed to the rapid speed of its production.

Does this vaccine work?

While we can always use more information to aid our decisions, the data presented looks very promising and the FDA has determined that it is safe and effective for emergency use. Here is what the data showed on effectiveness:

· 17,411 participants received two doses of the actual vaccine, 8 developed COVID-19 and 0 of those individuals required hospitalization;

· 17,511 participants received two doses of placebo (saline), 162 developed COVID-19 infection, 2 requiring hospitalization;

· Quick math — there were 20x more COVID-19 infections in those who did not get the actual vaccine (received placebo);

· Among participants with diabetes, 1 in 1,372 participants receiving the vaccine developed COVID-19 and 19 of the 1,374 participants receiving placebo developed COVID-19 infection;

· Among the 6,000 participants with obesity who received the vaccine, 3 developed COVID but in the 6,103 participants with obesity who received the placebo, 67 became infected with COVID-19;

· The vaccine is 95% effective in preventing COVID-19 infection more than 7 days after the 2nd dose.

They say African Americans are affected more by COVID-19 and many are encouraging African Americans to get vaccinated. We have some history with health care providers experimenting on us and I am not sure.

I understand. COVID-19 does not discriminate in who it infects; it does not care about your race, ethnicity, language, income, or title. Individuals and communities with high levels of chronic medical conditions, multigenerational households, and jobs as essential workers have higher rates of exposure to the virus and/or more complications when infected, including higher hospitalization and death rates. We have seen this play out in the African American, Hispanic or Latino, and Native American communities. We have also seen poorer outcomes in those over the age of 65.

And yes, we have a shameful history in our nation of medical experimentation on minority communities, including the African American community. Let’s look at the data in this vaccine analysis:

· There were 1,758 African Americans who received two doses of the vaccine and 1,758 African Americans who received two doses of the placebo. There were zero (0) cases of COVID-19 infection in those African Americans who received the vaccine and seven (7) cases in those who received the placebo.

· There were also 5,074 Hispanic or Latino participants who received two doses of the vaccine and 5,090 who received two doses of the placebo. Only six (6) Hispanic or Latino participants who received the vaccine developed COVID-19 whereas 114 who received the placebo developed COVID-19.

What about the side effects?

The most common side effect seen thus far is a local reaction (like pain, redness, etc) at the site of the injection, which occurred in 84% of participants. Others can include fatigue, headache, muscle pain, and chills. These typically occurred in the first 48 hours after vaccination and lasted for one to two days. While there were no significant side effects or severe adverse events that give me great concern, I believe that continued data collection is needed as mass vaccinations move forward across the U.S. and around the world. For now, this side effect trend reminds me of my recent tetanus and diphtheria (Td) booster, except my booster pain lasted for several days longer.

It is also worth noting that there were 6 participants in the trial who died; 2 deaths were in the vaccine group and 4 deaths were in the placebo group. The causes of death were primarily due to cardiovascular disease or were unknown. The deaths were not linked to participation in the trial and were noted to be similar to both the causes and the rate of deaths that would be expected in the non-trial populations of similar age groups.

So, doctor are you going to get the vaccine?

Yes, I like my odds with the vaccine. I think about the patients I have cared for and lost due to COVID-19. My heart aches for my family members and friends who have lost their lives due to this virus. So many of my friends and colleagues in health care are putting their lives on the line each day to care for patients in this fight. The socially distanced lifestyle is not easy but certainly necessary during this time; wearing a mask is both protective and now fashionable. Washing your hands has always been the right thing to do.

The politics of 2020 have been especially difficult. During a time when the public has needed reliable information with their best interest at heart, misinformation and disinformation has been widespread, divisive and harmful. As we fight through this latest COVID-19 wave, with better clarity of information and a new vaccine, there is hope on the horizon; we can get to the other side of this pandemic together.

(Views expressed in this article are my own and not of my employer or other organizations with which I am affiliated. They also do not represent medical advice.)