Is the COVID-19 Vaccine Safe?
Yes. All of the coronavirus vaccines approved or authorized by the U.S. Food and Drug Administration (FDA) and recommended by the Centers for Disease Control and Prevention (CDC) are very safe and also very good at preventing serious or fatal cases of COVID-19. The risk of serious side effects associated with these vaccines is very small.
Lisa Maragakis, M.D., M.P.H., senior director of infection prevention, and Gabor Kelen, M.D., director of the Johns Hopkins Office of Critical Event Preparedness and Response, answer questions about the safety of the COVID-19 vaccines.
COVID-19 Vaccine Safety — What We Know
Since the authorization of the first COVID-19 vaccines in December 2020, millions of people in the U.S. have been safely vaccinated. As of October 2021, nearly 405 million doses of the vaccines have been given. More than 10 months of data show the vaccines are safe and effective at preventing serious disease or death due to COVID-19. Additional shots and boosters are also being authorized for certain groups to make the protection even stronger.
In addition, the FDA has fully approved the Pfizer-BioNTech COVID-19 vaccine, which means more data show how well that particular vaccine works. The FDA may fully approve the Moderna coronavirus vaccine and others in the future.
Are there risks or safety concerns regarding the COVID vaccines?
As part of their normal activities, the CDC and FDA monitor possible safety issues with the COVID-19 vaccines. These agencies are thorough and transparent about COVID-19 vaccine side effects. While millions in the U.S. have been vaccinated with only mild side effects, some rare issues have been reported and reviewed.
- In April 2021, the CDC and FDA temporarily paused administration of the Johnson & Johnson (J&J) vaccine so they could review data on a small number of cases of serious blood clots following shots with that vaccine. Most of these incidents occurred in women under age 50. After this review, the FDA and CDC determined that the benefits of the J&J vaccine outweigh the risk of this very rare side effect, and resumed authorization of vaccination with the J&J shot. Read more about side effects related to a rare blood clot.
- After observing rare occurrences of myocarditis following the second injection of the Pfizer and Moderna COVID-19 vaccines, the CDC released information for the public. Most of these myocarditis events happened in teens and young adults, and the majority of the cases were mild and cleared up on their own. Read more about side effects related to myocarditis.
This review process continues to monitor vaccine safety. Potential risks of COVID-19 vaccines are reviewed and weighed against the benefits of protection that the vaccines offer as well as the known, serious risk of harm due to COVID-19.
The COVID-19 Vaccines: What you need to know | Las vacunas anticovid-19: información imprescindible
How was the COVID vaccine developed so quickly?
The relatively quick development of these vaccines does not mean safety measures were skipped. There are several reasons why the COVID-19 vaccines were developed faster than other vaccines:
- The technologies used to develop the COVID-19 vaccines have been in development for years to prepare for outbreaks of infectious viruses. The manufacturing processes were ready very early in the COVID-19 pandemic.
- Countries shared genetic information when it was available about SARS-CoV-2, the coronavirus that causes COVID-19, which gave vaccine developers an early start at finding a vaccine.
- The testing processes for the vaccines didn’t skip any steps, but the vaccine developers conducted some stages of the process simultaneously to gather as much data as quickly as possible.
- Governments gave money to vaccine developers in advance, so the companies had resources they needed.
- Some types of COVID-19 vaccines were created using messenger RNA (mRNA), a new technology that allows a faster approach than the traditional way vaccines are made.
- Social media enabled companies to reach out to and enroll study volunteers, and plenty of people wanted to help, so there were enough research participants to test the COVID-19 vaccines.
- Because SARS-CoV-2 is so contagious and widespread, many volunteers who got the vaccines were exposed to the virus, and with so many exposures, it took a shorter time to see if the vaccines worked.
- Companies began manufacturing vaccines ahead of their authorization or approval so some supplies would be ready if authorization occurred.
What steps are taken to help make sure the COVID-19 vaccines are safe?
Safety is always a top priority as federal agencies work with vaccine manufacturers and independent scientific organizations to develop, study, authorize and approve new vaccines. Here are some of the steps taken for COVID-19 vaccines, as well as other vaccines:
- Careful testing. All vaccines go through clinical trials to test safety and effectiveness. For the COVID-19 vaccine, the FDA set high safety standards for vaccine developers to meet. This graphic from the National Institutes of Health shows the four phases a vaccine goes through before it is released to the public.
- Authorization for emergency use. If a vaccine or medicine is needed to address an emergency situation such as the COVID-19 pandemic, once it is shown to be safe and effective, the FDA can grant it an emergency use authorization (EUA). An EUA allows a vaccine, treatment or medication to be used before the formal FDA approval.
- Continuous monitoring for problems and side effects. Once a vaccine gets an EUA and is being given to people, the FDA and the CDC continue to watch carefully in case problems arise. Data on the vaccine’s safety record accumulates over time, as more and more people who receive it report on their experience and any side effects. One important way to report adverse events after vaccination is through the Vaccine Adverse Event Reporting System.
Learn more from the CDC about the safety steps for the COVID-19 vaccine.
Demographics of the COVID-19 Vaccine Trials
Do I still have to wear a mask if I get a vaccine?
The CDC continues to monitor the spread of COVID-19 and makes recommendations for wearing face masks, both for those who are fully vaccinated as well as people who are not fully vaccinated.
The CDC also recommends that masks and physical distancing be required when going to a doctor’s office, hospital or long-term care facility, including all Johns Hopkins hospitals, care centers and offices.
Johns Hopkins Medicine’s mask safety guidelines have not changed, and we still require everyone to wear masks inside all of our facilities.
Can I get COVID-19 from the vaccine?
You cannot and will not get COVID-19 from any of the vaccines. The COVID-19 vaccines do not have any virus or other infectious material in them.
What about the safety of COVID-19 vaccination for diverse groups of people?
The FDA and other reviewers closely consider diverse populations and include them in the trials. The clinical trials for the first two COVID-19 vaccines included members of underrepresented minorities and older age groups, and people with conditions such as obesity, diabetes, and heart and respiratory conditions.
Does Johns Hopkins Medicine recommend that I get a COVID-19 vaccine?
Yes, we recommend that everyone who is eligible get vaccinated with one of the three currently authorized COVID-19 vaccines. Johns Hopkins Medicine is administering all three vaccines: Pfizer-BioNTech, Moderna and Johnson & Johnson. We view all three as highly effective in preventing serious disease, hospitalization and death from COVID-19 (including disease caused by the very contagious delta variant of the coronavirus), and we believe that their benefits outweigh their risks.
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