CDC Recommends Use of Johnson & Johnson’s Janssen COVID-19 Vaccine Resume

Updates as of April 25, 2021

What you need to know:

• CDC and the U.S. Food and Drug Administration (FDA) recommend use of Johnson & Johnson’s Janssen (J&J/Janssen) COVID-19 Vaccine resume in the United States, after a temporary pause.
• Reports of adverse events following the use of J&J/Janssen vaccine suggest an increased risk of a rare adverse event called thrombosis with thrombocytopenia syndrome (TTS). Nearly all reports of this serious condition, which involves blood clots with low platelets, have been in adult women younger than 50 years old.
• A review of all available data at this time shows that the J&J/Janssen COVID-19 Vaccine’s known and potential benefits outweigh its known and potential risks.
• However, women younger than 50 years old should be aware of the rare but increased risk of this adverse event and that there are other COVID-19 vaccine options available for which this risk has not been seen.
• CDC and FDA will continue to monitor the safety of all COVID-19 vaccines.
• Seek medical care right away if you develop any of the symptoms below after receiving the J&J/Janssen COVID-19 Vaccine.
• If you have any questions or concerns, call your doctor, nurse, or clinic.

J&J/Janssen Vaccine Questions and Answers

• There is a plausible causal relationship between J&J/Janssen COVID-19 Vaccine and a rare and serious adverse event—blood clots with low platelets (thrombosis with thrombocytopenia syndrome, or TTS). However, after reviewing all available safety data, CDC and FDA recommend use of this vaccine resume in the United States given that the known and potential benefits outweigh the known and potential risks.
• 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 more rare.
• For three weeks after receiving the vaccine, you should be on the lookout for possible symptoms of a blood clot with low platelets. These include:
  • 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 beyond the injection site

Seek medical care right away if you develop one or more of these symptoms.