Q. Is a COVID-19 vaccine safe?
A. The U.S. vaccine safety system is a deliberate and multi-phase process to ensure all vaccines are as safe as possible. Safety is a top priority. Vaccine candidates conduct clinical trials with many thousands of study participants to generate scientific data and other information for the FDA to determine their safety and effectiveness.
If the FDA determines a vaccine meets its safety and effectiveness standards, it can make these vaccines available for use in the U.S. by approval or Emergency Use Authorization (EUA). After the FDA makes its determination, ACIP will review the available data in order to make vaccine recommendations to the CDC.
ACIP will then recommend vaccine use. After a vaccine is authorized or approved for use, vaccine safety monitoring systems will watch for adverse events (possible side effects). CDC is working to expand safety surveillance through new systems and additional information sources, as well as enhancing existing safety monitoring systems.
Q: How was the COVID-19 vaccine studied?
A: Each authorized COVID-19 vaccine has been studied in large trials of over 30,000 volunteers and shown to be highly effective in preventing COVID-19 disease. The trials involved people of different ages, sex, race/ethnicity, weight, and medical conditions.
Pregnant women and people with weakened immune systems were excluded from the COVID-19 vaccine trials, and so the currently available studies do not provide direct information about vaccine safety and effectiveness in these groups of people. The CDC recommends that those who are pregnant consult with their doctor before taking the vaccine.
Q. Can the COVID-19 vaccine cause me to become infected or infect others?
A. No, you cannot become infected or infect others from receiving the COVID-19 vaccine, because the vaccine contains no live virus. Instead, the vaccine directs your body to produce a protein that teaches your body how to fight off the virus.
Q. How long will it take for COVID-19 vaccines to take effect?
A. The COVID-19 vaccine is expected to provide some protection a couple of weeks after your first shot and reaches its greatest effectiveness after your second shot. It is very important to take the second shot within the recommended time period for maximum vaccine effectiveness.
Q. What have the trials revealed?
A. Through their respective clinical trials, Pfizer and Moderna have indicated their vaccines are
approximately 95% effective.
Information gathered through clinical trials becomes public in the course of the EUA submission. Once the EUA is submitted, these documents become accessible by the public through the FDA.
Q. Can I get a COVID-19 vaccine if I am pregnant?
A. Pregnant women and people with weakened immune systems were excluded from the COVID-19 vaccine trials, and so the currently available studies do not provide direct information about vaccine safety and effectiveness in these groups of people. The CDC recommends that those who are pregnant consult with their doctor before taking the vaccine.
Q. Can children get a COVID-19 vaccine?
A. Currently, a pediatric vaccine is not available, and it may be some time before one is approved and becomes available. Clinical trials need to be conducted with children before determining if the existing COVID-19 vaccines are safe and effective for them.
Q. Will youth with high risk conditions be included in any of the phases?
A. The availability of a vaccine for youth, under the age of 16 years, will depend on the availability of a pediatric vaccine. Clinical trials need to be conducted with children before determining if the existing COVID-19 vaccines are safe and effective for them.
Q. When injected with the vaccine, are you injecting me with COVID-19?
A. No, you are not being injected with the virus that causes COVID-19. None of the early COVID-19 vaccines tested in the U.S. use a live virus that causes COVID-19. The goal for each vaccine is to teach our immune systems how to recognize and to fight the virus that causes COVID-19. At this time, the vaccines closest to receiving approval are mRNA – messenger ribonucleic acid – vaccines. Like other vaccines, mRNA vaccines work by training the immune system to recognize a virus threat and begin producing antibodies to protect itself.
Q. After getting a flu shot, I always get the flu. Will this cause me to get COVID-19?
A. No, you cannot become infected, or infect others, from receiving the COVID-19 vaccine, because the vaccine contains no live virus. Instead, the vaccine directs your body to produce a protein that teaches your body how to fight off the virus. Some people develop flu-like symptoms, such as mild fever and muscle aches, after getting a flu vaccination. These symptoms are not the same as having influenza.
Q. I have allergies. Is this vaccine safe for me?
A. While serious allergic reactions were not seen in vaccine clinical trials of thousands of patients, rare allergic reactions to vaccines are possible. If you have a history of serious allergic reactions, you should discuss your situation with your healthcare provider. The COVID-19 vaccine does not contain any animal products such as eggs.
Q. What are the side effects of this vaccine?
A. Some people may experience side effects, which are a part of the normal immune response to a vaccine.
The majority of the side effects, while not seen in every individual, are signs that your body is recognizing the vaccine and mounting an immune response. Based on prior studies, side effects may include pain, redness and swelling at the site of the injection., fatigue, headache, muscle pain, chills, joint pain, fever, nausea, malaise, and swollen lymph nodes. These symptoms may occur within 2 days after the shot and last 1 to 2 days. Side effects may be more frequent after the 2nd shot (booster) and less frequent among older adults.
Long-term side effects are unknown, although most vaccines do not have long-term side effects. Vaccine studies are ongoing and will continue to monitor and watch for adverse events.
Q. It took four years to develop the mumps vaccine, how can the COVID-19 vaccine be safe and thoroughly tested so quickly?
A. Many things helped this vaccine get developed so rapidly. Significant resources were invested to fund the basic research and clinical trials, accelerating timelines greatly. Joining existing trial sites instead of developing new sites was a time saver. The virus has a good vaccination target and relatively low mutation rate. Additionally, the amount of infection in the communities allowed scientists to quickly compare vaccinated to unvaccinated populations and conclusively shows the vaccine worked. Last, but not least, are the huge number of brave volunteers willing to try the “novel” vaccines during the clinical trials.
Q. How long will the vaccine protect me from COVID-19? Will this be an annual vaccination, like the flu?
A. We are still learning about length of immunity. To determine how long protection lasts, follow-up studies are required to detect levels of both types of immune responses – antibody and T cell – as well as any repeated exposure risks. As more information becomes available, more information will be shared on the length of immunity.
Q. Can I get COVID-19 after the first dose of the vaccine?
A. Although the first dose of vaccine offers some immunity, you will still be considered susceptible to COVID-19. The first dose of the vaccine will provide some protection, but the recommendation is to receive two doses to be protected as intended. Pfizer and Moderna have indicated their vaccines are approximately 95% effective.
Q. All the research indicates that I am at high risk for contracting COVID-19, yet I am not considered eligible for the vaccine. How is that fair?
A. The vaccine manufacturers, CDC, and the state are all committed to getting the vaccine to everyone as soon as possible. ACIP is a group of medical and public health experts that develop recommendations on how to use vaccines to control diseases in the U.S. ACIP decides on vaccine prioritization recommendations by reviewing the FDA information, clinical trial data, and other information. Initially, the limited supply of vaccine will only be available to those determined to be most at risk of exposure to COVID-19. As the vaccine supply increases, more people will be added to those prioritized until it is available to the adult population at large.
Q. Is this vaccine preservative free?
A. Yes. The vaccine candidates that are likely to be the first offered are preservative free.