![]() That number has now risen to 15, Tom Shimabukuro, a CDC vaccine safety expert, told the committee. “And they’re going to have to shop for vaccine.”īefore Friday’s meeting, there had been six reported cases of the clotting problems, all of them among women between the ages of 18 and 48 who had been given the vaccine. “Women are not going to be offered … across the country an option to a second vaccine and that’s going to place certain women at a disadvantage,” said ACIP chairman José Romero, who nonetheless voted for the recommendation to lift the pause. Many clinics do not stock multiple brands of vaccine at once, they said, and a choice not to take the J&J will in some cases be a choice not to get vaccinated on that particular day. “I am concerned that the consumers - and women in this age group in particular - will not be adequately informed just by the FDA factsheets,” Bell said after the vote.įDA issues scathing report of Emergent plant responsible for contaminated Covid-19 vaccinesĭuring the discussion, a number of members of the committee expressed worries that women who want to forgo the J&J vaccine might have a difficult time finding another option. That option was not put to a vote and Bell voted to support the stripped-down recommendation. ![]() “I’ve very sorry that we haven’t chosen to put up front the knowledge that we have: That this is unique, it’s clustered, it’s almost certainly related to the vaccine and there are options.”īeth Bell, a professor of global health at the University of Washington and chair of the ACIP’s Covid-19 vaccine work group, had favored another option, which would have involved recommending resumption of use of the vaccine while also noting women under the age of 50 should be aware of the risk and may want to choose another vaccine. “This is an age group that is most at risk that is getting this vaccine predominantly to save other people’s lives … not their own,” said Sarah Long, a professor of pediatrics at Drexel University College of Medicine. The votes against the motion were not objections to resumption of use of the vaccine, but reflective of the feeling of some members of the committee that the recommendation should have included some information about the risk the vaccine may pose to some people - a risk group currently defined as predominantly women under the age of 50. ![]() The committee voted 10 to 4 to recommend use of the vaccine one member who is involved in some Covid vaccine clinical trials abstained. “But in the absence of that reality it is still the right decision for any given woman who is considering her own risk benefit-risk balance.” “Had we had an endless supply of any vaccine, then of course it would be ideal for younger women to receive vaccines that have not been found to be associated with clotting,” Bar-Zeev said. “It’s a real risk and it’s a serious event if it occurs. “I think the decision was a very pragmatic one, and a very transparent one, a very clear one, and a correct one,” said Naor Bar-Zeev, a statistical epidemiologist at Johns Hopkins Bloomberg School of Public Health. Those symptoms include headache, shortness of breath, bruising, and persistent abdominal pain. Going forward, though, the vaccine’s label - and the factsheet given to people who receive it - will warn of the rare risk, urging people who develop worrying symptoms a number of days after vaccination to seek medical care. Even for the age group that appears at highest risk - women aged 30 to 39 - the risk from Covid is greater than the risk of developing TTS after getting the J&J vaccine, CDC scientists told the committee. (That vaccine is not authorized for use in the U.S.) A number have recommended its use be limited to older adults in the case of the U.K., the recommendations is people 18 to 29 years old be offered other vaccines when possible.ĪCIP, as the panel is known, found that Johnson & Johnson’s vaccine is safe for the vast majority of people and is saving lives. The path recommended by the Advisory Committee on Immunization Practices and taken by the FDA and CDC - to return the vaccine to use without limitations on who can get it - diverges from the one chosen by a number of other countries regarding the AstraZeneca vaccine, which has also been tied to blood clots in rare instances. Exclusive analysis of biotech, pharma, and the life sciences Learn More
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