The CDC and FDA recommended a temporary pause on the use of Johnson & Johnson’s COVID-19 vaccine in the US out of “an abundance of caution” over 6 cases of a rare but severe type of blood clot among recipients, CNN reported this morning.
Key Facts from a joint CDC-FDA statement:
- The 6 reported cases were among more than 6.8 million Johnson & Johnson vaccine doses administered in the US
- All 6 cases occurred among women between ages 18-48
- Symptoms occurred 6-13 days after vaccination
- A CDC-convened meeting of the Advisory Committee on Immunization Practices tomorrow will review the cases and assess their significance
- The FDA will review that analysis, while continuing its investigation
The agencies advise keeping the pause in place until all reviews are complete, to give health providers a chance to plan for the proper recognition and management of these adverse events.
A Reassuring take: “Amid concerns over J&J vaccine, it’s vital to stress that when any vaccine is given to countless millions worldwide, very rare adverse effects will emerge. The benefit/risk ratio is still hugely favorable & far better than virtually any medicine…” tweeted the O’Neill Institute’s Lawrence Gostin.