As a healthcare provider I am very fortunate to have already received the COVID-19 vaccine. My decision to vaccinate was make carefully after reading extensively about the vaccine’s development and preliminary published data. I’ve received many questions about the vaccine in the office and in my inbox. I hope the information below is a helpful summary.

What is an mRNA Vaccine?

From the CDC: mRNA vaccines are a new type of vaccine to protect against infectious diseases. Instead of injecting a weakened or inactivated germ into the body, the mRNA vaccine teaches our cells how to make a protein that triggers an immune response. That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies.

The COVID-19 mRNA vaccines give instructions for our cells to make a piece of what is called the “spike protein.” The spike protein is found on the surface of the virus that causes COVID-19.

The COVID-19 mRNA vaccines are given in the upper arm muscle. Once the instructions (mRNA) are inside the immune cells, the cells use them to make the protein piece. After the protein piece is made, the cell breaks down the instructions and gets rid of them.

Next, the cell displays the protein piece on its surface. Our immune systems recognize that the protein doesn’t belong there and begin building an immune response and making antibodies, like what happens in natural infection against COVID-19.

At the end of the process, our bodies have learned how to protect against future infection. The benefit of mRNA vaccines, like all vaccines, is those vaccinated gain this protection without ever having to risk the serious consequences of getting sick with COVID-19.

Facts about COVID-19 mRNA Vaccines

mRNA vaccines do not use the live virus that causes COVID-19. They cannot give someone COVID-19.

mRNA vaccines do not affect or interact with our DNA in any way. The mRNA never enters the nucleus of the cell, which is where our DNA (genetic material) is kept. The cell breaks down and gets rid of the mRNA soon after it is finished using the instructions.

COVID-19 mRNA Vaccines Will Be Rigorously Evaluated for Safety

mRNA vaccines have been held to the same rigorous safety and effectiveness standards as all other types of vaccines in the United States. The only COVID-19 vaccines the Food and Drug Administration (FDA) will make available for use in the United States (by approval or emergency use authorization) are those that meet these standards.

The emergency use authorization (EUA) for COVID-19 vaccines expedites access of the vaccine to the public, but the FDA still requires safety and efficacy data in line with what is needed for eventual approval. The bar for vaccine EUAs is higher than the one set for COVID-19 treatments.

mRNA Vaccines Are New, But Not Unknown

Researchers have been studying and working with mRNA vaccines for decades. Interest has grown in these vaccines because they can be developed in a laboratory using readily available materials. This means the process can be standardized and scaled up, making vaccine development faster than traditional methods of making vaccines.

mRNA vaccines have been studied before for influenza, Zika, rabies, and cytomegalovirus (CMV). As soon as the necessary information about the virus that causes COVID-19 was available, scientists began designing the mRNA instructions for cells to build the unique spike protein into an mRNA vaccine.

Vaccine Efficacy

Early data suggest the Pfizer-BioNTech or Moderna vaccine has roughly 95% efficacy against COVID-19 after 2 doses of the same product separated by 21 or 28 days. Pfizer-BioNTech data over about 2 months showed 162 symptomatic, confirmed COVID-19 cases in the placebo group versus 8 in the vaccinated group. More than 43,000 people age 16 and up participated in the trial. After broader use nationally, we will learn more about real-world effectiveness including how long immunity lasts.

Vaccine Side Effects

Common reactions to the vaccine include injection site pain and flu-like symptoms (fatigue, aches, etc.) Symptoms were seen more frequently after the second dose. They should go away in a couple days and can be signs the immune system is working.

A small number of people have experienced significant allergic reactions with the COVID-19 vaccines. So far, according to reports, about 11 severe allergic reactions — representing about one in 190,000 doses administered — have been noted.

It is important to keep side effects from the vaccine in perspective. In Indiana, the I.U.P.U.I. Fairbanks School of Public Health calculates that for people 60 years and older who were not living in jails or nursing homes, Covid-19 killed about one in 58 of those infected. For people between the ages of 40 and 59, it was about one in 833, and for people younger than 40 it was about one in 10,000. For those who were not white, the fatality rate was more than three times that for whites.

Is the vaccine safe for people with autoimmune disease?

The vaccine was authorized to prevent COVID-19 in people age 16 and older. People with autoimmune conditions or who are immunocompromised are not excluded from getting the vaccine, but they are part of certain groups that require extra consideration.

Talk to your healthcare provider about all of your medical conditions, including if you:

have any allergies
have a fever
have a bleeding disorder or are on a blood thinner
are immunocompromised or are on a medicine that affects your immune system
are pregnant or plan to become pregnant
are breastfeeding
have received another COVID-19 vaccine

If you are immunocompromised or have an autoimmune disease, you and your doctor can decide together whether getting the vaccine now is right for you.

In a press release, the American College of Allergy, Asthma, and Immunology said the “Pfizer-BioNTech COVID-19 vaccine is not a live vaccine and it can be administered to immunocompromised patients. Physicians and other providers should inform such immunocompromised patients of the possibility of a diminished immune response to the vaccine. We do not know at this time if people with a weakened immune system will respond to the vaccine and be protected from COVID-19.”

The Basics are still important

It’s important for everyone to continue using all the tools available to help stop this pandemic as we learn more about how COVID-19 vaccines work in real-world conditions. Cover your mouth and nose with a mask when around others, stay at least 6 feet away from others, avoid crowds, and wash your hands often… even after vaccination.

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Reference:

Understanding mRNA COVID-19 Vaccines, Centers for Disease Control and Prevention, Accessed 12/30/2020.
Pharmacist Letter Therapeutic Research, Share Answers About mRNA COVID-19 Vaccines. Posted 12/21/2020. Accessed 12/30/20.
Centers for Disease Control Recommendations for underlying conditions. Accessed 12/30/2020.
American College of Allergy, Asthma, and Immunology Releases Guidance on Risk of Allergic Reactions to the Pfizer-BioNTech COVID-19 Vaccine Posted 12/14/2020. Accessed 12/30/2020.
8 Things to Know about the U.S. COVID-19 Vaccination Program Centers for Disease Control and Prevention. Accessed 12/30/2020.
Carroll, Aaron. (2020). ‘The Risks of the Covid Vaccine in Context.’ The New York Times. Dec. 30, 2020.

COVID-19 Vaccine FACT CHECK