COVID-19 Vaccine Information

One of the reasons that these COVID-19 coronavirus vaccines could be produced and tested so quickly is that two previous coronavirus diseases, SARS that emerged in China in 2002 and MERS that emerged in the Middle East in 2012, taught us a lot about developing safe and effective coronavirus vaccines. In addition, we also learned a lot about developing new mRNA vaccines from the recent research into new rabies and influenza vaccines. mRNA vaccines are an idea that is decades in the making. Information about the use of mRNA in the development of vaccines can be found here.
In addition, although the COVID-19 vaccines have been developed faster than any other U.S. vaccines, that increased speed of development was also made possible by making new funding and other resources available, by creating new partnerships between government and private-sector organizations, and by reducing non-scientific bureaucratic obstacles. In fact, development of these new vaccines has followed the same effectiveness and safety review processes as other vaccines, including studying tens of thousands of participants of different ages, races, and ethnicities for each vaccine.
For every vaccine used in the United States (including the COVID-19 vaccine), trials start with Phases 1 and 2, when small groups of people are vaccinated and then monitored for immune response and for safety. Then, in Phase 3, tens of thousands of people are vaccinated to be sure the vaccine is both safe and effective for all types of people.
Development of vaccines for use in the United States is strictly controlled by the U.S. Food and Drug Administration (FDA). After the FDA authorizes or approves a vaccine, an independent immunization committee at the Centers for Disease Control and Prevention (CDC) decides whether to recommend it and for whom. In all stages of the process, the most important factor is safety. Vaccines must meet the highest standards of safety and have minimal side effects, because they are given to healthy people to prevent disease. And in fact, the United States currently has the safest, most effective vaccines in its history.
The CDC and FDA monitor the safety of vaccines even after authorization and approval to be sure they are safe and effective in the long-term. These long-term studies to monitor the safety and effectiveness of vaccines as they are being widely used for the public are considered to be Phase 4 of vaccine research. These long-term studies, which include people at high risk for COVID-19, will help identify any common side effects or other safety concerns and will help clarify how long protection lasts after vaccination.
VDH shares the goal of ensuring safe vaccines and has the safety of the Commonwealth and its citizens as its number one priority. VDH works closely with the CDC to review all vaccines to be sure its recommendations are based on sound science.
Pfizer-BioNTech and Moderna, the developers of the first two COVID-19 vaccines to be used in this country, have now collected enough safety and effectiveness data to allow them to apply to FDA for full approval for their vaccines. The FDA is considering these applications now.

Vaccine side effects fall into one of three categories:
1) Local reactions, at or near the injection site
(2) Systemic reactions (such as fever, chills, headache, or muscle aches)
(3) Allergic reactions

This response addresses the local and systemic side effects. Allergic side effects are addressed in a later question and response. Although COVID-19 vaccination will help protect you from getting COVID-19 disease, you may have some short term local or systemic side effects from the vaccination, which are normal (and expected) signs that your body is building protection against COVID-19.
While we do not yet know all of the possible vaccine side effects, some vaccinated people have had local reactions such as pain or redness or tenderness at the injection site.  In terms of systemic side effects, a small number of vaccine recipients have had transient symptoms such as fatigue, nausea, chills, fever, headache or other body aches for a few days. These local or systemic side effects do NOT mean that the vaccine has given you a COVID-19 infection. Rather, these expected side effects mean that the vaccine is causing your body’s immune system to react and create antibodies to fight off the virus that causes COVID-19 if you are exposed in the future.
A small number of vaccine recipients have experienced swollen lymph nodes. For the two mRNA vaccines, these expected side effects are more common in younger people than older people and with the two-dose vaccine series, they are more common after the 2nd dose than after the first dose.
Less commonly, some people have reported redness, swelling, and itching around the injection site beginning a few days or in the second week after their first vaccine dose. Some of these reactions have been quite large. However, these local reactions, which are now called “COVID arm” are not considered to be allergic reactions and are not felt to represent a risk for anaphylaxis upon receipt of the second dose. In fact, a few of those people who experienced this reaction have had a similar reaction after their second dose. Thus, individuals with such delayed injection site reactions after the first mRNA COVID-19 vaccine dose should receive the second dose using the same vaccine product as the first dose and at the recommended interval, and preferably in the opposite arm. More information about these uncommon “COVID arm” reactions can be found here.
As happens occasionally with other vaccines such as influenza vaccine, fainting soon after injection has also been noted among a small number of COVID-19 vaccine recipients, especially among adolescents and other young adults. This kind of short term reaction after the first injection of a two-dose COVID-19 vaccine series is also not a reason to avoid the second dose.
For those older children recently authorized to receive COVID-19 vaccines, the side effects seen after vaccination in the recent research studies were similar to those seen in older adolescents and young adults.
Finally, even if you or your child experience discomfort after the first dose of mRNA COVID-19 vaccine, it is very important that you still receive the second dose a few weeks later for the vaccine to be effective.