Pregnancy & Lactation: Risk data not available
Warnings
The Janssen (Johnson and Johnson) coronavirus disease 2019 (COVID-19) vaccine is currently being studied to prevent coronavirus disease 2019 caused by the SARS-CoV-2 virus.
Information from clinical trials is available at this time to support the use of Janssen (Johnson and Johnson) COVID-19 vaccine to prevent COVID-19. In clinical trials, approximately 21,895 individuals 18 years of age and older have received the Janssen (Johnson and Johnson) COVID-19 vaccine. Millions of people have received the vaccine under EUA since February 27, 2021.
Janssen (Johnson and Johnson) COVID-19 vaccine has not undergone the standard review to be approved by the FDA for use. However, the FDA has also approved an EUA for the Janssen (Johnson and Johnson) COVID-19 vaccine to allow:
- a single primary dose to people 18 years and older who are unable to receive or unwilling to receive other FDA-authorized or -approved COVID-19 vaccines.
- a single booster dose at least 2 months after the first dose of the Janssen (Johnson and Johnson) COVID-19 vaccine for people 18 years and older who are unable to receive or unwilling to receive other FDA-authorized or -approved COVID-19 vaccines.
- a single booster dose to people 18 years of age and older who have completed primary vaccination with a different authorized or approved COVID-19 vaccine who are unable to receive or unwilling to receive other FDA-authorized or -approved COVID-19 vaccines.
Talk to your doctor about the risks and benefits of receiving this medication.
Janssen (Johnson and Johnson) COVID-19 vaccine may cause life-threatening blood clots. Symptoms of blood clots can include shortness of breath, chest pain. leg swelling. persistent abdominal pain, severe or persistent headaches, blurred vision, or petechiae (tiny red or purple spots on the skin) and may occur 1 to 2 weeks after vaccination. If any of these symptoms should occur, seek immediate medical attention. If you have a history of blood clots with low platelets following the Janssen (Johnson and Johnson) COVID-19 vaccine or AstraZeneca (not currently approved in the US) COVID-19 vaccines, you should not receive the Janssen (Johnson and Johnson) COVID-19 vaccine.