CDC panel recommends resuming Johnson & Johnson vaccinations
The nationwide pause on the use of Johnson & Johnson’s coronavirus vaccine should be lifted, a CDC vaccine advisory committee recommended Friday.
The CDC Advisory Committee on Immunization Practices voted, 10-4 with one abstention, that the vaccine’s benefits outweigh the risks, and that it will save lives.
The panel did not specifically ask for a warning label, but recommended the Food and Drug Administration (FDA) add a label intended to make providers aware of the risk of a rare complication involving blood clots in women under the age of 50.
Women in that age group should get the vaccine if they feel comfortable and are aware of the risks, but should also know there are other options available if they are not comfortable, the panel decided.
Background: The CDC and FDA recommended a temporary halt in Johnson & Johnson vaccinations last week after rare cases of blood clots.
So far, 15 cases of clotting syndrome have been confirmed, each of them occurring in women. There were three known deaths, and 13 cases in women between age 18 and 49.
What the label will say: Johnson & Johnson has already negotiated the label language with FDA, a company official said.
The warning label states, in part, that the relationship between the vaccine and the blood clotting syndrome, called thrombosis with thrombocytopenia, is “plausible.” The label notes an increased clotting risk in women aged 18-49, with some fatal cases.
What’s next: The recommendation will need to be approved by CDC Director Rochelle Walensky, who would then suggest resumption of the shots within a matter of hours or days.
There are about 9.5 million doses of the vaccine sitting on shelves across the country that could be deployed immediately.