Updated April 30, 2021
On April 23, 2021, the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) announced that administration of the Johnson & Johnson/Janssen (J&J) COVID-19 vaccine can resume. Read the full update from the CDC.
Previously, on April 13, 2021, the federal agencies recommended a pause in the use of this vaccine while they investigated reports of a small number of women in the U.S. who developed a rare and severe type of blood clot within the two weeks following receipt of the J&J COVID-19 vaccine. Johns Hopkins Medicine immediately paused use of the J&J vaccine. Now, based on the new CDC and FDA guidance, we will resume use of the J&J vaccine when we receive additional supplies of this vaccine.
Summary of CDC and FDA Recommendations
The CDC and FDA include the following findings in their recommendations to resume administration of the Johnson & Johnson/Janssen vaccine:
- As of April 23, 2021, more than 8 million doses of the J&J/Janssen COVID-19 vaccine have been given in the United States. Experts reviewing safety reports for this vaccine found a small number of women who got the J&J vaccine and later developed thrombosis with thrombocytopenia syndrome (TTS). TTS is a serious condition that involves blood clots with low platelets.
- Nearly all reports of this serious condition have been in adult women younger than age 50.
- The risk of this adverse event is rare, occurring at a rate of about 7 per 1 million vaccinated women between 18 and 49 years old. For women 50 years and older and men of all ages, this adverse event is even rarer.
- A review of all available data at this time shows that this vaccine’s known and potential benefits outweigh its known and potential risks.
- However, women younger than age 50 should be aware of this rare adverse event and should know that other COVID-19 vaccines are available.
Read the full CDC recommendations to resume use of the J&J vaccine.
Occurrence of Blood Clots in COVID-19 Vaccines
While the occurrence of TTS is rare after receiving a COVID-19 vaccine, it is important to note there have been a few cases worldwide.
- Learn more from the European Medicines Agency report on the J&J vaccine and the AstraZeneca vaccine.
- Learn more from the CDC’s summary report about TTS and the J&J vaccine.
Although rare, TTS is a serious, but treatable condition. For three weeks after receiving the J&J vaccine, you should watch for possible symptoms of a blood clot with low platelets.
If you experience any of the following symptoms, call your primary care provider immediately or visit your closest urgent care center. If your symptoms are severe, call 911.
- Severe or persistent headaches or blurred vision
- Shortness of breath
- Chest pain
- Leg swelling
- Persistent abdominal pain
- Easy bruising or tiny blood spots under the skin near the injection site
Will Johns Hopkins continue to offer COVID-19 vaccines?
Johns Hopkins Medicine continues to administer the Pfizer and Moderna COVID-19 vaccines, and will now resume administration of the J&J vaccine, to our employees who wish to be vaccinated, to eligible patients, and to eligible people at our community vaccination sites.
We will continue to advise patients on possible side effects of any of our vaccines, including the rare possibility of TTS. Women under the age of 50 should be aware of the rare but increased risk of thrombosis with thrombocytopenia syndrome (TTS) and know that there are other COVID-19 vaccines available.
We will also continue to watch for any side effects from all vaccines and report them to the Vaccine Adverse Event Reporting System if needed.
All three vaccines have been thoroughly tested and found to be safe and effective in preventing severe COVID-19 and they are undergoing continuous and intense safety monitoring.
I am a female currently using birth control. Is the J&J COVID-19 vaccine safe for me?
The CDC and FDA recently recommended that U.S. vaccine providers resume administration of the Johnson & Johnson vaccine. However, women younger than age 50 should be aware of the rare but increased risk of thrombosis with thrombocytopenia syndrome (TTS) and should know that other COVID-19 vaccines are available.
Johns Hopkins encourages everyone to consult with a primary care physician, who can help you decide if one type of COVID-19 vaccine may be more appropriate for you.