Is the Johnson & Johnson COVID-19 Vaccine Safe? Plus Availability, Alternatives, and More
Key takeaways:
In February 2021, the Johnson & Johnson (J&J) vaccine was authorized for emergency use in adults to prevent COVID-19. The FDA limited its use in May 2022 due to a risk of blood clots within a few weeks of receiving a dose.
On June 1, 2023, the FDA revoked the J&J vaccine’s emergency use authorization. This was done at the request of the manufacturer.
If you previously received the J&J vaccine and qualify for a booster shot, there are a few options available. The Pfizer and Moderna vaccines are preferred. But if you don’t want to receive an mRNA vaccine, the Novavax vaccine is another option for adults.
Table of contents
When it was first authorized for emergency use in February 2021, the Johnson & Johnson (J&J) COVID-19 vaccine served as an alternative to the Pfizer and Moderna vaccines. Both of these vaccines use messenger RNA (mRNA) technology, and some people were hesitant to receive them.
A little over a month later, the FDA and CDC recommended pausing the use of the J&J vaccine. This was done out of caution in response to reports of rare, but serious, blood clotting issues some people experienced within a few weeks of receiving a dose. Shortly after their review, the agencies lifted the pause. Then, in May 2022, the J&J vaccine’s use was limited to certain people.
Fast forward to today, and the COVID public health emergency is no longer in effect. And due to no demand for the vaccine in the U.S. anymore, the J & J vaccine is no longer available. But if you’ve previously received a dose, you may have questions about the vaccine’s safety and what this change means for you.
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Is the Johnson & Johnson vaccine safe?
It’s important to understand that when we say a vaccine is safe, it doesn’t mean it’s risk-free. Almost everything has risks, but the question is whether or not the benefits outweigh the risks. This is what the FDA evaluates when approving or authorizing a new vaccine.
While the J&J vaccine is no longer available, it went through a variety of safety checks during clinical trials. It was also monitored for safety after authorization.
Safety in clinical trials
Before it was authorized for use, the J&J vaccine was tested for safety and efficacy in over 40,000 people in advanced clinical trials. Most side effects were mild to moderate and only lasted a few days. There were several blood clot events in both the vaccine and placebo groups. But researchers couldn’t determine if the vaccine directly caused them since they may have been the result of underlying health conditions.
Safety monitoring after authorization
As with any vaccine, it’s important to monitor adverse events to protect the public from potential harm. Some adverse events may be uncovered in clinical trials. But others, especially if they’re very rare, might surface down the road as more people get vaccinated. Clinical trials are comprehensive, but they can’t capture everything.
Prior to its removal, nearly 19 million J&J vaccine doses were administered in the U.S. alone. And given the large number of vaccine doses administered, rare adverse events surfaced. But just because something happens after getting a vaccine doesn’t mean that it was caused by it.
If and when serious adverse events occur, they’re investigated by experts to see if they are linked to the vaccine or if they’re due to something else. Product use may be paused as a precaution until the risk is evaluated. This was the case with the J&J vaccine, which is covered next.
J&J vaccine and blood clots
In April 2021, the CDC and the FDA announced that they were investigating rare reports of a serious blood clot called cerebral venous sinus thrombosis (CVST) in people who had received the J&J vaccine.
CVST is a type of blood clot in the brain’s veins that stops blood from draining out, resulting in a stroke. It typically happens in 5 out of every 1 million people in the world every year, J&J vaccine aside. And a retrospective study found an increased risk of CVST shortly after a COVID diagnosis.
People who experienced this type of blood clot after their vaccination also had low blood platelets — small blood cells that help you form clots. Together, this condition is referred to as thrombosis (blood clot) with thrombocytopenia syndrome (low blood platelets), or TTS. The term vaccine-induced immune thrombotic thrombocytopenia (VITT) is also used.
At the time, there were six reported TTS cases out of nearly 7 million doses of the vaccine administered. Even so, the agencies decided to pause the vaccine as a precaution until they could have time to assess the risks and evaluate the possible causes.
Why was the J&J vaccine recommended (again) after the pause?
A CDC expert panel met a little over a week later to review the data. During the meeting, the panel reviewed the potential benefits and harms of resuming vaccination. The harm (TTS cases) was compared to vaccine benefits, including the prevention of hospitalizations, intensive care unit (ICU) admissions, and deaths.
The panel concluded that the benefits of resuming vaccination outweighed the risks. However, a TTS warning was added to the vaccine’s labeling. About 1 year later, the J&J vaccine’s use was limited to certain people who couldn’t or didn’t want to receive the Pfizer or Moderna vaccine.
Note: Due to no demand for the vaccine, as well as no intention of updating it for new variants, the J&J vaccine is no longer available in the U.S. The manufacturer had requested that the FDA revoke the vaccine’s authorization, which happened on June 1, 2023.
J&J vaccine and current TTS risk
If you received the J&J vaccine while it was available, you may be wondering if you’re still at risk of TTS. The short answer: No, probably not.
The risk of TTS from the J&J vaccine appears to be very low overall. And symptoms typically occur within 1 to 2 weeks of receiving a dose. The last vaccine doses expired on May 7, 2023, which means it’s likely been at least a few months since you’ve received the vaccine.
Even so, you may want to know what typical TTS symptoms look like. They include:
Headaches that are severe or won’t go away
Blurred vision
Shortness of breath
Chest pain
Leg swelling
Abdominal pain that won’t go away
Easy bruising or small blood spots under the skin (away from where the vaccine was administered)
If you previously received the J&J vaccine and start experiencing any of these symptoms, get medical attention right away.
Good to know: Very low platelets without blood clots have been reported in some people, usually within 42 days of receiving the J&J vaccine. Contact your provider right away if you notice easy bruising or unusual or excessive bleeding after receiving a dose.
Do other COVID vaccines have a risk of TTS?
The two mRNA vaccines, Pfizer and Moderna, don’t appear to be linked to TTS. The Novavax vaccine hasn’t been linked to TTS, either.
However, the AstraZeneca vaccine, which isn’t available in the U.S., has been linked to TTS cases in Europe.
Does the Johnson & Johnson vaccine have any long-term side effects?
Similar to other COVID vaccines, most people only experience mild side effects that resolve within a few days of receiving the J&J vaccine. This may include fever, fatigue, and muscle soreness. While rare, more serious side effects have been reported.
For example, some people have developed Guillain-Barré syndrome (GBS) within 42 days of receiving the J&J vaccine. GBS is a rare condition where your immune system starts attacking your nerves. It’s not clear if GBS is from the vaccine or another cause.
Fortunately, most people are able to recover from GBS. But some people may experience long-term nerve damage.
Alternative COVID vaccine options
If you originally received the J&J vaccine for your primary series and are eligible for a booster shot, the mRNA vaccines are preferred. But if you’re looking for another option, you may be eligible for a Novavax booster.
Experts recommend staying up-to-date with COVID vaccination. So if you’re unsure which option may be best for you, or if you have other questions, talk to your healthcare provider for more information.
The bottom line
The J&J vaccine’s use was previously limited to certain people due to a rare but serious blood clotting condition. As of May 2023, it’s no longer available in the U.S. at the request of its manufacturer.
It’s important to stay up-to-date with COVID vaccination. But if you originally received the J&J vaccine and qualify for a booster, you may have a few options. The Pfizer and Moderna vaccines are preferred, but Novavax is an alternative in certain situations. None of these vaccines have been linked to TTS. Talk to your provider about which option is best for you.
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References
Advisory Committee on Immunization Practices, et al. (2021). Thrombosis with thrombocytopenia syndrome (TTS) following Janssen covid-19 vaccine. National Center for Immunization and Respiratory Diseases.
American Heart Association/American Stroke Association Journals. (2021). Cerebral venous thrombosis and COVID-19.
Bussell, J. B., et al. (2022). Vaccine-induced immune thrombotic thrombocytopenia. American Society of Hematology.
Centers for Disease Control and Prevention. (2021). Joint centers for disease control and prevention and food and drug administration statement on Johnson and Johnson covid-19 vaccine.
Centers for Disease Control and Prevention. (2021). Updated recommendations from the advisory committee on immunization practices for use of the Janssen (Johnson & Johnson) covid-19 vaccine after reports of thrombosis with thrombocytopenia syndrome among vaccine recipients - United States, April 2021.
Centers for Disease Control and Prevention. (2023). Stay up to date with covid-19 vaccines.
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Dubovsky, P., et al. (2022). NVX-CoV2373 (novavax covid-19 vaccine) in adults (≥ 18 Years of age). Centers for Disease Control and Prevention.
European Medicines Agency. (2021). AstraZeneca’s covid-19 vaccine: European medicines agency finds possible link to very rare cases of unusual blood clots with low blood platelets.
Johnson & Johnson. (2021). Johnson & Johnson covid-19 vaccine authorized by U.S. food and drug administration for emergency use - first single-shot vaccine in fight against global pandemic.
Nicholson, M., et al. (2022). No apparent association between mRNA covid-19 vaccination and venous thromboembolism. Blood Reviews.
Our World in Data. (n.d.). Covid-19 vaccine doses administered by manufacturer, United States.
Taquet, M., et al. (2021). Cerebral venous thrombosis and portal vein thrombosis: a retrospective cohort study of 573,913 COVID-19 cases. eClinicalMedicine.
U.S. Food and Drug Administration. (2021). Food and drug administration and centers for disease control and prevention lift recommended pause on Johnson and Johnson (Janssen) covid-19 vaccine use following thorough safety review.
U.S. Food and Drug Administration. (2021). Food and drug administration issues emergency use authorization for third covid-19 vaccine.
U.S. Food and Drug Administration. (2022). Coronavirus (covid-19) update: Food and drug administration limits use of Janssen covid-19 vaccine to certain individuals.
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U.S. Food and Drug Administration. (2023). Fact sheet for healthcare providers administering vaccine (vaccination providers): Emergency use authorization (EAU) of the Janssen covid-19 vaccine to prevent coronavirus disease 2019 (covid-19).
U.S. Food and Drug Administration. (2023). Fact sheet for recipients and caregivers: Emergency use authorization (EUA) of the Janssen covid-19 vaccine to prevent coronavirus disease (covid-19).
