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(Washington Post and The LEK Reports) The Vaccine advisers to the Centers for Disease Control and Prevention are meeting Thursday to weigh possible limits on the use of the Johnson & Johnson vaccine because of continued blood clot issues, mostly in young and middle-aged women, according to clinicians familiar with the agenda. FAQ: What to know about the omicron variant of the coronavirus
The single-dose vaccine has been linked to a rare and severe type of blood clot, which halted its use for 10 days in April as federal health officials looked more closely at six women who experienced the problem — the only known cases among more than 7 million people who received the vaccine in the United States at that time. One of the women died. The pause was lifted after an extensive safety review that determined the vaccine’s benefits outweighed the risks.
On Thursday, the Advisory Committee on Immunization Practices will be presented with new data that appears to show the rate of the clots in people who received the Johnson & Johnson shot has increased since April, although the problem is still rare. There have been about nine deaths related to the issue, according to a federal official familiar with the situation.Advertisement
The FDA, in an update to its fact sheet on the vaccine this week, said the highest reporting rate of clot issues — about one case per 100,000 doses administered — has been in women 30 to 49 years old.
A comprehensive review of the blood clot condition following vaccinations between last December and Aug. 31 found six deaths among 50 confirmed cases of the blood clot condition among recipients of the one-shot regimen. During that period, 14 million doses of the vaccine were given, according to the study published last month, which has not yet been peer-reviewed.
The panel is “certainly going to get some updates between the [April] pause and now — how many more cases are there [now] compared to before, and are there certain populations that may be at increased risk, based on age, gender and comorbidities,” said one clinician familiar with the agenda, who, like others, spoke on the condition of anonymity because they were not authorized to discuss it publicly.Advertisement
After reviewing the data, it is expected to vote on whether to update its recommendation for the vaccine’s use, according to the meeting agenda. The options include leaving the current recommendation to administer it to anyone 18 or older, “get rid of it, or only use it in certain populations,” the clinician said.
Another option, according to a federal official familiar with the situation, would be to recommend the Pfizer-BioNTech and Moderna vaccines over the Johnson & Johnson product, making what is known as a preferential recommendation.
Any changes in the vaccine’s use would likely apply to both the initial single shots and boosters, said a second clinician knowledgeable about Thursday’s meeting.
Such a recommendation would have to be endorsed by CDC Director Rochelle Walensky to become an official recommendation of the agency.
The vaccine mandates have been taking place across the world not only the U.S a federal judge in Kenya ordered the federal government of Kenya to temporally stop the vaccine mandate which says people who are not fully vaccinated cannot enter national parks hospitals and other public government owned areas.
The Senate voted on Wednesday of last week to block Biden vaccine mandate barley making a majority 52-48 vote.