A recommendation that Johnson & Johnson’s Covid-19 vaccine should not be used in the US is likely to remain in place for another week after members of a government advisory committee said they did not have enough information to change their advice.
Experts on the Advisory Committee for Immunization Practices met on Wednesday to discuss the safety of the company’s vaccine after six women who received it later fell ill with very rare but serious blood-clotting problems. One of those people died, health officials said.
Those cases prompted the US Centers for Disease Control and Prevention and the Food and Drug Administration to issue a statement on Tuesday recommending that states and healthcare workers stop using the vaccine for an indefinite period of time.
That announcement effectively brought J&J’s rollout to an abrupt halt just weeks after the vaccine had been approved, with around 7m doses having been administered so far.
The CDC on Wednesday showed evidence that the vaccine might be linked to a rare type of cerebral blood clot known as CVST. All six cases occurred in women aged between 18 and 65, it said, far more than would have otherwise been expected for that demographic in that timeframe.
What made the cases so serious, officials said, was that several patients also reported low blood platelet counts, meaning the traditional treatment of heparin for blood clots might have made their illness worse. The woman who died, the CDC said, suffered both CVST and a low platelet count, with her symptoms starting 11 days after receiving the vaccine.
Supporters of the J&J jab had hoped the ACIP members would recommend vaccinations should restart, even if only for a certain portion of the population. The J&J vaccine is easier to store than either the Moderna or BioNTech/Pfizer inoculations and requires only one dose, making it important for vaccinating people who are harder to reach.
Nirav Shah, president of the Association of State and Territorial Health Officials, told the meeting: “The extension of the pause will invariably result in the fact that the most vulnerable individuals in United States, who were prime candidates for the Johnson & Johnson vaccine, will remain vulnerable, the most at risk will remain at risk, and those who would benefit immediately from vaccination will remain unvaccinated for an unknown period of time.”
But members instead asked for more time to gather and evaluate the evidence, in effect extending the pause for at least a week until they meet again.
Grace Lee, a professor of paediatrics at Stanford University who sits on the committee, said: “The benefit/risk balance to me is unclear without having a risk estimate of this particular potential adverse event by age, by gender and understanding other risk factors that may contribute.”