MORGANTOWN, W.Va. – As access to the coronavirus vaccine begins to make its way through the state and country, many people have questions about its safety, possible side effects, and effectiveness. To help assuage any fears about the vaccine, the WVU Medicine Pharmacy Team put together the following frequently asked questions.
What is an Emergency Use Authorization (EUA)?
Emergency Use Authorization occurs when the U.S. Food and Drug Administration (FDA) allows a drug or vaccine to be used during a public health emergency. The FDA may choose to grant EUA once studies have demonstrated the safety and effectiveness of a vaccine but before the manufacturer has submitted or the FDA has completed its formal review of the license application. EUAs provide timely access to critical medical products during a medical emergency when there are no sufficient treatments or vaccines available.
Which vaccines have been granted EUA?
To-date, two vaccines have been granted EUA. They are:
- Pfizer – for ages 16 and older – two doses given intramuscularly 21 days apart – EUA granted on Dec. 11
- Moderna – for ages 18 and older – two doses given intramuscularly 28 days apart – EUA granted on Dec. 18
Will the COVID-19 vaccines be safe?
In phase 3 clinical trials, COVID-19 vaccines are tested in tens of thousands of participants for safety and efficacy. To date, no serious safety concerns have been reported by an independent Data and Safety Monitoring Board overseeing the phase 3 clinical trials of the Pfizer and Moderna mRNA COVID-19 vaccines. Both vaccines met the safety and efficacy requirements outlined by the FDA to obtain EUA. In the safety analysis of the Pfizer and Moderna vaccines, patients were followed for at least two months after they received their second dose of the vaccine.
What side effects will the vaccine have?
In the Pfizer and Moderna vaccine clinical trials, the majority of side effects reported were mild to moderate, short lived, and happened within the first few days of receiving the vaccine. Examples of common mild to moderate side effects include pain at the injection site, headache, fatigue, fever, or chills. Side effect occurrence is typically higher after the second dose of vaccine.
In Phase 3 clinical trials, the most common severe side effects reported were as follows:
- Pfizer vaccine
- Fatigue: 3.8 percent
- Headache: 2 percent
- Moderna vaccine
- Fatigue: 9.7 percent
- Muscle pain: 8.9 percent
- Joint pain: 5.2 percent
- Headache: 4.5 percent
- Pain: 4.1 percent
Are there going to be long-term side effects from the vaccines?
Historically, long-term side effects from vaccines has been rare. A Vaccine Advisory Committee member to the FDA stated that historically, most side effects have been seen within the first 60 days of receiving vaccines.
How will side effects from the vaccines be treated?
Side effects from vaccines are typically short lived. You may take medications for pain or fever after you have been vaccinated. If you are concerned about your health after getting vaccinated, talk with your doctor. He or she will determine the appropriate treatment. You or your doctor can choose to report the side effect to the Vaccine Adverse Event Reporting System (VAERS). Information on how to submit a report to VAERS is available at https://vaers.hhs.gov/index.html or 1-800-822-7967.
Should pre-medications be given prior to vaccination?
Taking medications such as acetaminophen or ibuprofen before receiving the vaccine to try to prevent side effects like fever or pain is not recommended at this time. This is because there is not enough information on how this will impact antibody responses, though, you can take these medications after receiving the vaccine if you develop side effects.
Are there any contraindications (conditions or factors that would be a reason to withhold vaccination due to harm) to receiving the vaccine?
The only current contraindication to receiving the COVID-19 vaccines is anaphylaxis to any components of the COVID-19 vaccines. The vaccines are still being studied in pediatric populations. Individuals under 16 years of age are not eligible for the Pfizer vaccine, and those under 18 are not eligible for the Moderna vaccine.
Should I take the COVID-19 vaccine if I have a significant history of allergic reactions?
The CDC states severe allergic reaction (i.e. anaphylaxis) to any vaccine or injectable therapy (intramuscular, intravenous, or subcutaneous) is a precaution, but not a contraindication to receiving vaccination. Vaccine providers should observe these patients for 30 minutes after vaccination to monitor for the development of immediate adverse reactions.
This recommendation is due to two healthcare workers in the United Kingdom developing severe allergic reactions after receiving the vaccine. They both had a history of severe allergic reactions and both carried epinephrine auto injectors. Those with allergies to food, pets, insects, latex, or oral medications do not fall under this precaution and are monitored similarly to all other vaccine recipients (15 minutes).
Since the Pfizer vaccine was granted for EUA in the U.S., two healthcare workers in Alaska have had severe allergic reactions after vaccination. Both were treated with epinephrine and recovered. Data on the two U.S. allergic reactions are being shared with the CDC, and the FDA is working to investigate findings. If you have a history of severe allergic reactions you should discuss this with your healthcare provider.
Can I take the vaccine if I am pregnant?
Currently, there is no data on the safety and efficacy of COVID-19 vaccines in pregnant women as they were excluded from clinical trials. However, it is known that pregnant women can have an increased risk of severe illness or negative pregnancy outcomes, such as preterm birth, if they become infected with COVID-19.
The CDC and Advisory Committee on Immunization Practices (ACIP) have commented that the vaccine is unlikely to cause placental and fetal exposure and that there is minimal safety risk as the mRNA vaccine is not a live vaccine. Statements have also been made that the benefit of vaccination may outweigh the risk of severe COVID-19 disease.
For this reason, if a pregnant woman is part of a group who is recommended to receive a COVID-19 vaccine, she may choose to be vaccinated. A discussion with her healthcare provider can help her make an informed decision. Pregnant women who develop a fever after vaccination should take acetaminophen, as fever is associated with negative pregnancy outcomes.
Considerations for vaccination of a pregnant woman:
- Level of COVID-19 community transmission (risk of acquisition)
- Her personal risk of contracting COVID-19 (by occupation or other activities)
- The risks of COVID-19 to her and potential risks to the fetus
- The efficacy of the vaccine
- The known side effects of the vaccine
- The lack of data about the vaccine during pregnancy
Can I take the vaccine if I am breastfeeding?
Currently, there is no data on the safety and efficacy of COVID-19 vaccines in breastfeeding women, as they were excluded from clinical trials. The CDC has stated that since the mRNA vaccine does not contain live virus, it is not thought to be a risk to breastfeeding infants. For this reason, if a breastfeeding woman is part of a group who is recommended to receive a COVID-19 vaccine, she may choose to be vaccinated. A discussion with her healthcare provider can help her make an informed decision.
Will the vaccines cause infertility?
Currently, there is no evidence that any of the COVID-19 vaccines cause infertility. Claims circulating on social media is that antibodies formed after vaccination which target the COVID-19 spike protein may also target a protein found in placenta called syncytin-1. This has not been proven at this time. A Pfizer representative and virologists have stated the two proteins are not similar enough for this to happen.
Additionally, if this were found to be true, then this would also suggest that people who become infected with COVID-19 and recover would carry a similar risk of infertility due to the formation of antibodies after natural infection. However, there is currently no definitive evidence that COVID-19 infection causes infertility.
Can I take the vaccine if I am immunocompromised?
Currently, there is no data on the safety and efficacy of COVID-19 vaccines in immunocompromised people, as they were excluded from clinical trials. However, people with immunocompromised conditions or those on immunosuppressant medications might be at increased risk for severe disease if they get COVID-19. Therefore, the CDC recommends these individuals may still receive the COVID-19 vaccine. Immunocompromised individuals should discuss this with their healthcare provider.
It is important to note that the mRNA vaccines do not contain live virus. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the COVID-19 vaccine.
Can I take the vaccine if I have an autoimmune condition?
The CDC states people with autoimmune conditions may still receive an mRNA COVID-19 vaccine.
Can I take the vaccine if I currently am infected with COVID-19?
No. You should wait until you have recovered and no longer in isolation. See the question below for more information.
Can I take the vaccine if I have already had COVID-19 and recovered? How long after can I take it?
People who have already had COVID-19 and recovered should still receive the vaccine. This is because it is unknown exactly how long immunity lasts after recovering from COVID-19. Early studies show that it is not long lasting, and cases of reinfection have been reported. The Pfizer trial did include a small percentage of individuals who previously had COVID-19 and recovered. The CDC states current evidence suggests reinfection is uncommon within 90 days after initial infection, so vaccination may be deferred until the end of this period; however, it is not known when another vaccination will be available.
Can I take the vaccine if I am in quarantine?
Those in quarantine should wait until their quarantine period has ended to avoid exposing healthcare personnel during their vaccination visit.
Can I take the vaccine if I have had convalescent plasma or a monoclonal antibody?
Currently, there is no data on the safety and efficacy of COVID-19 vaccines in people who received convalescent plasma or a monoclonal antibody. Vaccination should be deferred until 90 days after receiving convalescent plasma or monoclonal antibodies. This is to avoid interference of these treatments with vaccine induced immune responses.
How long after the flu shot or other vaccines do I have to wait to take the COVID-19 vaccine?
Recent CDC guidance is to wait a minimum of 14 days after receiving the flu shot or any other vaccine to receive a COVID-19 vaccine. This is because we don’t know the safety or efficacy of taking the COVID-19 vaccine at the same time as other vaccines.
How effective will the vaccines be?
In Phase 3 trials, the Pfizer vaccine showed a 95 percent efficacy rate seven days after the second dose. The vaccine was 94 percent effective in adults older than 65. The Moderna vaccine showed a 94 percent efficacy rate 14 days after the second dose. These results were consistent across gender, age, race, and ethnicity.
How long will immunity last after I get vaccinated? Will I need to be vaccinated every year?
The length of immunity following vaccination is not yet known for COVID-19. Given the novel nature of this virus and vaccine development, long-term data is not yet available to guide future vaccine protocols.
How many people need to get the vaccine for “herd immunity?”
The number or percentage of population that need to be vaccinated in order to reach “herd immunity” is not yet known. This number is impacted by the pathogen itself (in this case a novel virus with still unknown aspects), how efficacious these new vaccines will be (preliminary data shows both Moderna and Pfizer to be greater than 90 percent), and how long immunity would last with these vaccines. This is an unknown at the moment, as we do not know how long immunity lasts either from vaccination or from natural infection.
For two-dose vaccines, what happens if I only receive one dose of the vaccine and not both?The Pfizer product is a two-dose vaccination series given 21 days apart. If more than 21 days have passed since the first dose, the second dose should be given at the earliest opportunity. You do not have to repeat any doses.
The Moderna product is a two-dose vaccination series given 28 days apart. If more than 28 days have passed since the first dose, the second dose should be given at the earliest opportunity.
Do not factor in the four-day “grace period” when scheduling your second dose (i.e., receiving the second dose on days 17-20 for Pfizer vaccine and days 24-27 for the Moderna vaccine). The CDC has stated that although giving the vaccine within the grace period is possible, it should be an exception and not standard practice. Data does not exist for second doses given at short intervals.
What happens if I am late for the second dose of a two-dose series vaccine?
The Pfizer product is a two-dose vaccination series given 21 days apart. The second dose is allowed within a four-day grace period (days 17-21). If more than 21 days have passed since the first dose, the second dose should be given at the earliest opportunity. You do not have to repeat any doses.
The Moderna product is a two-dose vaccination series given 28 days apart. The second dose is allowed within a four-day grace period (days 24-28). If more than 28 days have passed since the first dose, the second dose should be given at the earliest opportunity. You do not have to repeat any doses.
How will the second dose of the vaccine be ensured if I do get the first dose?
The CDC, federal agencies, and state public health departments are using a tool called the Vaccine Administration Management System (VAMS). This is an online tool that will allow clinicians to set up customized vaccine schedules and allow recipients to make vaccination appointment and receive a reminder about returning for a second dose, if required.
How do the Pfizer and Moderna mRNA vaccines work?
The vaccines contain synthetic mRNA, which is genetic information used to make the SARS-CoV-2 spike protein. The spike protein is the part of the virus that attaches to human cells. The spike protein alone cannot cause COVID-19. Once the spike protein is created it causes the immune system to make antibodies against the virus. These antibodies can the provide protection if a person comes into contact with the virus. The mRNA vaccines are non-infectious and do not enter the human cell nucleus so it cannot be inserted into human DNA. Additionally, mRNA is rapidly broken down, and this theoretically reduces chances for long term side effects. The mRNA vaccines do not have the ability to cause cancer.
Can I get COVID-19 from a vaccine?
No. None of the COVID-19 vaccines currently authorized for use or in development in the United States use the live virus that causes COVID-19. The vaccines will either contain mRNA (non-infectious genetic material), viral vectors, (modified versions of live viruses), or protein subunits (parts of viral proteins), which cannot cause infection. The CDC states that protection from the vaccine is not immediate, and it will take 1-2 weeks following the second dose of a two-dose series vaccine to be considered fully vaccinated. That means it is possible you could catch the virus from the community just before or after vaccination and get sick. The vaccine itself does not cause infection.
Will taking the vaccine cause a false positive COVID test?
No. The COVID-19 vaccines will not cause a false positive result on COVID-19 viral tests that test for a current infection. There is a possibility that you will test positive on some antibody tests that detect antibodies to the spike protein. A positive antibody test means you may have previously been infected with COVID-19, or it may result from vaccination.
Do I still need to wear a mask after I take the vaccine?
Yes. Wearing a mask and practicing social distancing is still important after receiving the vaccine. There will be limited doses available initially, and because people will be vaccinated in waves, it will take time to vaccinate enough of the population to stop the spread of COVID-19.
Additionally, we don’t know how long immunity will last. Furthermore, infection after a receiving a vaccine may still be possible, although it may be less severe, such as a mild or asymptomatic infection. Others can still be infected in this scenario, necessitating the continued use of masks.
When will I get the vaccine?
Supply will be limited at first and will likely be given to high risk exposure groups initially. Your timeline for vaccination depends on recommendations that will be provided by the state and the ACIP as well as how much supply of vaccine is available.
Why is vaccine development happening so fast?
The vaccine process is happening faster because vaccine research and development, clinical trials, manufacturing, and plans for distribution are occurring at the same time. This method removes delays that occur when these processes are carried out separately. Steps for development are not being eliminated.
For additional information, WVU Medicine officials, including Stephen Hoffmann, M.D., WVU Medicine pulmonologist and WVU Health System vice president of clinical integration; Todd Karpinski, Pharm.D., WVU Health System chief pharmacy officer; Meera Mehta, Pharm.D., WVU Medicine infectious diseases clinical specialist; and Colleen Sybert from WVU Medicine Human Resources, participated in a webinar for the WVU Health System on Dec. 22. It can be viewed in its entirety here.
For more information on COVID-19, visit WVUMedicine.org/COVID.