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Officials with the Centers for Disease Control and Prevention will meet Thursday with health experts to consider whether to place restrictions on Johnson & Johnson’s COVID-19 vaccine amid continuing concerns over blood clot formations, especially in pregnant women.
In April, federal authorities temporarily suspended use of J&J’s single-dose vaccine in order to study a half-dozen women who developed blood clots after taking the vaccine. But officials decided that the rewards of continuing to distribute the vaccines outweighed any risks; use resumed within a few days but officials required J&J to include a new warning label.
Though complications from the J&J vaccine continue to be rare, at least nine women died after developing blood clots following the vaccine. Also, the Washington Post reported Wednesday, the occurrence of clotting in people who have taken the J&J vaccine has increased since federal officials examined the issue in April.
Roughly one woman per 100,000 between the ages of 30-49 experienced blood clots after getting the Johnson & Johnson shot, according to a fact sheet released by the Food and Drug Administration on Tuesday.
“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,” the Post reported. “During that period, 14 million doses of the vaccine were given, according to the study published last month, which has not yet been peer-reviewed.”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 Advisory Committee on Immunization Practices is scheduled to vote on whether to restrict the J&J initial vaccine and booster or choose instead to issue a preferential recommendation for other vaccines, the Post reported. Whatever the committee recommends will have to be reviewed by the CDC, which has reached out to state health agencies to determine how reliant they are on the J&J vax. CDC Director Dr. Rochelle Walensky would have to sign off on them, the Post noted.
The committee 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 spoke to the Post on condition of anonymity.
Any changes in recommendations will likely apply to both the initial J&J vaccine and subsequent boosters, a second clinician who is familiar with the process told the Post.
“We are committed to understanding and communicating all known risks, including rare events of [the blood clot condition], and strongly support raising awareness of the signs and symptoms of this rare event,” said Jake Sargent, a spokesman for Johnson & Johnson, according to the Post.
Of the three approved COVID-19 vaccines, J&J’s are the least distributed in the U.S. — 17 million compared to around 470 million for the Pfizer and Moderna vaccines, the CDC says.
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