Following a federal panel's decision to recommend use resumption of the Johnson & Johnson vaccine, the Federal Drug Administration and the Centers for Disease Control and Prevention on Friday gave clearance for health authorities across the U.S. and its territories to restart administration.
The pause was recommended last week Tuesday following at least six instances of rare blood clotting in women between the ages of 18 to 48, which has resulted in the death of at least two people. To that end, while the FDA and the CDC recommended use, a warning label will be included as part of the J&J vaccine of the rare but severe side effect.
V.I. Dept. of Health Commissioner Justa Encarnacion on Friday told the Consortium that the department trusts the CDC's recommendation and would resume use of the J&J shot. "The Dept. of Health trusts the federal authorities making those decisions," she said, adding that the department was awaiting a federal decision on the shot. "We were waiting on their approval."
The commissioner pointed to the 481 Virgin Islanders who have taken the J&J shot with no negative reaction. Ms. Encarnacion stated that D.O.H. was one of the first in the nation to pause use of the vaccine following the recommendation of federal authorities, adding that some states continued administration.
On Friday, the CDC said the vaccine's positive impact vastly outweighs the rare blood clot reaction.
“This vaccine was shown to be safe and effective for the vast majority of people,” CDC Director Rochelle Walensky told reporters, even as she warned that some women might be at risk of the blood-clotting reaction.
Dr. Walensky revealed the rate of the rare blood clot in persons who receive the J&J vaccine to be 1.9 cases per million people, but seven cases per million women ages 18 to 49. The rate was 0.9 per million in women over 50. Some 7.2 million Americans had taken the vaccine before the recommended pause.
J&J Chief Medical Officer Joanne Waldstreicher told members of the vaccine committee the company agreed that a label should be added to the vaccine warning of the blood-clot risk.
“We believe the J&J Covid vaccine is central to the effort to end the pandemic,” Dr. Waldstreicher said, stating that the J&J vaccine would likely prevent more deaths and hospitalizations compared to the rare blood clot reaction.
According to the Wall Street Journal, a CDC official said that if vaccinations with J&J’s shot resumed, it could prevent up to 1,400 deaths from Covid-19 and up to 3,500 admissions to hospital intensive-care units over a six-month period, though there could be up to 45 cases of the rare blood-clot condition.
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