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The Safety of the Covid-19 Vaccines

Image of Heather Saxby, FNP-BC, Mansilla Medical
Heather Saxby, FNP-BC, Mansilla Medical

We are finally here!

A new vaccine released faster than any previous vaccine initially made me apprehensive. But I spent some time this holiday listening to webinars* and reading reports about the PfizerBioNTech and Moderna vaccines. Here is what I have learned so far - please note this information is subject to change as we continue to learn more during vaccine roll out.

The testing and trials are good, and of the same rigor of other vaccines that have been studied. Messenger RNA (mRNA) vaccines are a kind that have been studied, used, and found to be very effective for things like rabies. In order to be declared safe and effective, the vaccine had to pass several independent reviews including the National Academy of Sciences, the National Institutes for Health, and the Food and Drug Administration (FDA).

This vaccine does NOT contain any live or dead coronavirus. Rather, it carries a message that teaches our cells to recognize the “spike” protein that’s on the surface of COVID-19 (that solar tennis ball looking graphic you have probably seen used in the news). Once the vaccine delivers that message, it is gone; it does not enter the cell’s nucleus or change our DNA. The vaccine itself does not hang out in our bodies very long. The vaccine is actually fragile and that’s why it has to be stored at such cold temperatures.

Because this vaccine is being released faster than typical vaccines (which is due to the world’s laser-focus on this global pandemic and not because of safety shortcuts), it is true we do not have long term data. We do not have safety data for pregnant women, breastfeeding women, or young children under 16. This is also expected - you can imagine the ethical considerations involved with doing clinical trials on pregnant women and children. Since the initial roll out, many pregnant women have safely received the vaccine. What we know of COVID-19 so far shows that these women are at higher risk of severe illness if infected; therefore, for pregnant and breastfeeding women the vaccine will be offered. The vaccine is also absolutely recommended for immunocompromised individuals.

But what about side effects?

With any medication or vaccine, some people will have a reaction of some kind, whether this is a true allergic reaction or a side effect/symptom. This is expected. Both companies have been very transparent throughout the process and have been under the world’s microscope. You may have heard about a few people who had a severe allergic reaction known as anaphylaxis after vaccine roll out. As of late December, the Vaccine Adverse Event Reporting System detected approximately 21 cases out of almost 2 million vaccines that had been given; seven of these patients had a previous noted episode of anaphylaxis in their medical history. Anaphylaxis is a severe reaction that typically occurs 15-30 minutes after a medication or vaccine and requires use of an Epipen. This is still considered a very rare, unlikely occurrence. One possible explanation being considered is a reaction to the vaccine component known as polyethylene glycol. This is also a prominent ingredient in colonoscopy prep and in a laxative known as Miralax. Many, many people use this medication safely. If you needed an Epipen after receiving a previous mRNA vaccine, or a component of this vaccine, or to polyethylene glycol, then you probably know you are already someone who needs to consult with an allergist prior to receiving the vaccine. Allergies that do NOT prohibit receipt of this vaccine include seasonal allergies, food allergies, egg allergies, latex, gelatin, other oral medications, foods, or pet dander. Normal reactions to ANY vaccine include redness, discomfort at the injection site, headache, fever, and body aches.

You can also help continue the transparency of this process. After you get your vaccine, you may sign up to receive a daily check in and report any side effects - https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html

Other things we do not know—how many months the vaccine will protect you. And while we know both Pfizer and Moderna vaccines show approximately 95% efficacy at preventing mild and severe symptoms of COVID-19 (once BOTH doses of this two-part vaccine are received!), we do not know if the vaccine will prevent us from carrying and transmitting the virus to others if we are exposed. That means until more is understood about how well the vaccine works, continuing with precautions like masks and physical distancing will be important.

I originally wrote some of this around the Christmas holiday, at which time COVID-19 had infected more than 18 million people in the United States and killed more than 326,000 Americans and more than 1.7 million people globally. In just three weeks, the death rate in the US has increased to 394,495 deaths in the United States. To put these staggering numbers in perspective, there were an estimated 22,000 flu deaths from the year 2019-2020 in the US.

At this time, there are very few contraindications to receiving the vaccine; however, we get to assess our personal risk versus benefit. According to CDC as of January 15, over 12 million people have already received a dose of the COVID-19 vaccine in the US. I want my kids to enjoy sleepovers, hugs, and indoor activities again with their grandparents. We need students safely back in classrooms with their peers and teachers. So I will do my part in keeping others safe, and look forward to my second dose of the vaccine!

Want to be part of this effort? If you are someone who is able to vaccinate others, please consider volunteering here in Virginia - https://vvhs.vamrc.org/

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