Vaccine advisers to the US Centers for Disease Control and Prevention are considering four choices for changing the agency’s recommendation on Johnson & Johnson’s coronavirus vaccine, including label changes or a complete end to its use.
The CDC’s Advisory Committee on Immunization Practices is holding an emergency meeting and is expected to vote later Friday on recommendations.
At issue: The vaccine has been linked to 15 cases of a rare blood clotting condition called thrombosis with thrombocytopenia syndrome, or TTS, all among women. Three have died.
It’s a tricky question because all but two cases have been in women under the age of 50, and no cases have been reported among men since the vaccine has been in general use, although the CDC says it’s unlikely the risk is zero among men.
CDC staff laid out several possible scenarios, all of which show that while resuming vaccination would result in more cases of blood clots, adding the J&J shot to the mix of available vaccines would save lives and keep people out of the hospital.
The committee’s four possible choices are:
- Recommend against use for all persons
- Reaffirm recommendation for all age and sex – US Food and Drug Administration to include warning statement with emergency use authorization
- Recommend vaccination only for adults aged 50 or older
- Reaffirm recommendations for use; women aged under 50 should be aware of the increased risk of TTS, and may choose another Covid-19 vaccine (ie mRNA vaccines)
Earlier, Johnson & Johnson officials said they had agreed with the FDA on new wording to add to the label saying the risk of blood clots is plausible and warning of the risks.