Johnson & Johnson has agreed with the U.S. Food and Drug Administration to add a warning label to the vaccine
FRIDAY, April 23, 2021 (HealthDay News) — The U.S. Food and Drug Administration on Friday lifted the temporary pause it had placed on the Johnson & Johnson COVID-19 vaccine and said it will add a note to the shot’s labeling warning of the potential for rare blood clots.
The move came just hours after recommendations from a panel of experts at the Centers for Disease Control and Prevention, which supported resuming use of the vaccine. The CDC Advisory Committee on Immunization Practices (ACIP) determined that the benefits of the vaccine in preventing deaths and hospitalizations far outweigh the risks of rare blood clots, risks that are mainly borne by young women.
The panel vote was 10 in favor, four opposed, and one abstention. The opposing votes favored a stronger warning for women younger than 50 that would give them the option of choosing another vaccine. The panel’s recommendation comes more than a week after the CDC pressed “pause” on the rollout of the J&J vaccine. It now goes to CDC Director Rochelle Walensky for final approval.
In coming to its decision, ACIP considered a risk/benefit analysis that estimates that, for every one million doses of the Johnson & Johnson vaccine administered: 13 cases of blood clots will occur in women 18 to 49, but at the same time, 12 COVID-19-related deaths, 127 intensive care unit (ICU) admissions for COVID-19, and 657 related hospitalizations will be prevented; two cases of blood clots will occur in women 50 and older, but 593 deaths, 1,292 ICU admissions, and 4,794 hospitalizations will be prevented; two cases of blood clots will occur in men 18 to 49, but 11 COVID deaths, 114 ICU admissions, and 601 hospitalizations will be prevented; and no cases of blood clots will occur in men 50 and older, but 708 deaths, 1,485 ICU admissions, and 5,513 hospitalizations will be prevented.
The pause in use of the one-dose vaccine came after six U.S. reports, one fatal, of a rare but severe form of blood clot tied to use of the J&J shot, all occurring in women. At Friday’s meeting, a CDC scientist presented nine new confirmed cases of the disorder, bringing the total to 15, The New York Times reported. All the cases have been in women, and 13 have been in women between 18 and 49 years old. Three women have died from the rare clots and seven remain hospitalized, four of whom are in the ICU, the CDC scientist said.
Joanne Waldstreicher, M.D., the chief medical officer of Johnson & Johnson, said the company has agreed with the U.S. Food and Drug Administration to add a warning label to the vaccine, which notes that “most cases” of the clotting disorder have occurred in women between 18 and 49 years old.
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