29 Apr FDA and CDC Recommend Resuming Distribution of Johnson & Johnson Vaccine
In a joint statement, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have recommended lifting a pause on the distribution of the Johnson & Johnson (J&J) COVID-19 vaccine.
On April 13, the agencies recommended a pause on the J&J one-dose vaccine after reports of six cases of a rare and severe type of blood clot in individuals following administration of the vaccine. Reports of adverse events following the use of the J&J vaccine suggested 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 under the age of 50.
During the pause, medical and scientific teams at the FDA and CDC examined available data to assess potential risks. The two agencies have determined the following:
- Use of the J&J COVID-19 vaccine should be resumed in the United States.
- The available data shows that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.
- The available data suggests that the chance of TTS occurring is very low, but the FDA and CDC will continue to monitor the safety of all vaccines.
While this adverse event is very rare, individuals who receive the J&J vaccine should be on the lookout for possible symptoms of blood clots for three weeks after receiving the vaccine. Women under the age of 50 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.
Health care providers administering the vaccine, vaccine recipients, and caregivers should review fact sheets for providers, and recipients and caregivers.
Distribution of the J&J vaccine will continue, and decisions regarding the distribution of the vaccine will be made by state and local officials. Employers should continue to monitor updates from local officials to learn more about vaccine availability and distribution. Individuals with questions about COVID-19 vaccines should have those discussions with their health care provider.
We will keep you updated on any noteworthy developments.
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