4 important facts about COVID-19 vaccine safety

Here’s a look at the safety and science behind COVID-19 vaccines

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It’s helpful to understand the safety and science of COVID-19 vaccines.

Fact 1: Safety steps were followed in developing the vaccines

The U.S. Food and Drug Administration (FDA) gave the Pfizer-BioNTech, Moderna and Johnson & Johnson’s Janssen COVID-19 vaccines emergency use authorization (EUA). The phrase “emergency use authorization” simply means that there is a public health emergency (like a pandemic) and there are no other approved options ready to use. 

The FDA used a checklist to authorize COVID-19 vaccines during this emergency. Its experts reviewed data on tens of thousands of people to decide the vaccines’ safety and strength. Key factors helped to speed the process along:

  • Earlier scientific gains: Scientists used 20 years of research on other coronavirus diseases, reports the CDC. They also applied findings from cancer research and other fields to develop the new mRNA vaccines. 
  • Teamwork: Researchers and leaders from universities, private industry, nonprofit groups and the U.S. government worked together on this common goal.

The brief pause of Johnson & Johnson’s Janssen COVID-19 vaccine reflected the vaccine safety system is working. The safety issue was caught early and the pause is a sign of the federal government’s commitment to transparency as the CDC and FDA reviewed the data. Medical and scientific teams with the FDA and CDC did a thorough review that found Johnson & Johnson’s Janssen COVID-19 vaccine is safe and effective in preventing COVID-19. COVID-19 vaccines have undergone, and will continue to undergo, intensive safety monitoring. 

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Fact 2: Serious reactions to the COVID-19 vaccines are rare

Most people who have received a COVID-19 vaccine experience only mild side effects. Common ones include a sore arm, headache or fatigue that last less than a day, according to the CDC. In rare cases, people had a severe allergic reaction within 15 minutes of getting the vaccine. That’s why you’ll be watched for 15 to 30 minutes after you get your COVID-19 vaccine to make sure you’re OK. 

With Johnson & Johnson’s Janssen vaccine there is a rare and severe blood clot reaction. As of April 23, 2021, and out of more than 6.8 million doses administered, the FDA and CDC found a total of 15 cases of a severe blood clot in people after receiving  Johnson & Johnson’s Janssen COVID-19 vaccine. The FDA and CDC state that women younger than 50 years old should be aware of the rare risk of blood clots with low platelets after vaccination. Other COVID-19 vaccines, such as Pfizer and Moderna, are available where this risk has not been seen.

Questions about COVID-19 testing or vaccines? 

We’ve gathered important information about testing services and vaccine access in one place — including answers to your most frequently asked questions. Find it all at our COVID-19 Resource Center.

Fact 3: Almost everyone should get the vaccine

The CDC recommends that almost everyone get the vaccine when they are eligible. It’s very important for people with diabetes, high blood pressure or other high-risk health issues to get the vaccine. This is because the risk of becoming very sick from COVID-19 is much greater for those with a chronic health problem.

There are also a few groups of people who should wait to get the vaccine, including children and those with a known allergy to an ingredient in the vaccines. Trials on children as young as 6 months are currently underway because younger children were not included in the first round of studies. 

Fact 4: Trial participants were racially diverse

The breakdown of races and ethnicities in the clinical trials for the 3 vaccines was designed to reflect the U.S. population. These trials showed that COVID-19 vaccines are as safe and effective for all races and ethnicities. This is important to know because CDC data shows that the disease caused by COVID-19 has resulted in serious illness and death among Black Americans and other people of color at higher rates than white Americans.

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The information in this story is accurate as of press time and posting. To limit the spread of the coronavirus, it’s important to continue practicing social distancing (keeping at least 6 feet away from people outside your household) and washing your hands frequently. You should also be appropriately masked any time you’ll be in public. According to the CDC’s latest guidance, this means layering a disposable surgical mask underneath a snug-fitting cloth mask or placing a mask fitter over your cloth mask to ensure a tight fit. Because the situation surrounding COVID-19 continues to evolve, we encourage readers to follow the news and recommendations for their own communities by using the resources from the CDC, WHO and their local public health department.

The information is a summary and is subject to change. The current FDA-authorized COVID-19 vaccines may not be appropriate for everyone. There are special considerations for people with certain conditions, of different ages, and who have had treatments such as monoclonal antibody therapy or convalescent plasma. If you have questions about the COVID-19 vaccine, talk to your health care provider or visit the CDC’s Frequently Asked Questions

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