CA Halts Use Of J&J Vaccine Amid Blood Clot Reports
CA said that it would temporarily pause use of the Johnson & Johnson vaccine after six cases of serious blood clotting were reported.
Kat Schuster, Patch StaffPosted Tue, Apr 13, 2021 at 10:24 am PTUpdated Tue, Apr 13, 2021 at 10:44 am PT
CALIFORNIA — California paused the use of the Johnson & Johnson vaccine Tuesday following concerns over a handful of serious blood clotting reports, state officials confirmed.
The news comes after the federal government recommended an immediate pause in the use of the Johnson & Johnson vaccine nationwide after six U.S. recipients — all women between 18 and 48 — developed serious blood clots 6 to 13 days after being inoculated.
One woman died, and a second woman in Nebraska was hospitalized in critical condition.Subscribe
California’s Johnson & Johnson supply makes up 4 percent of the state’s allocation from the federal government this week, Gov. Gavin Newsom said Tuesday.
He said that California will follow the recommendations of the Centers for Disease Control and Prevention and the Food and Drug Administration and “temporarily pause use of J&J” out of “an abundance of caution.”
County health jurisdictions were anticipating supplies of the single-dose vaccine to increase, but the grim news could change those plans.
“California is following the FDA and CDC’s recommendation and has directed health care providers to pause the use of the Johnson & Johnson vaccine until we receive further direction from health and safety experts,” Dr. Erica Pan, state epidemiologist, said in a joint statement with the California Department of Public Health.
Supplies of the single-dose vaccine were already extremely limited because of a 15 million-dose batch that was ruined amid an ongoing struggle with a contracted manufacturer in Baltimore.
The pause “is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, and Dr. Anne Schuchat, principal deputy director of the CDC, said in a joint statement.
More than 6.8 million doses of the J&J vaccine have been administered in the U.S., the statement said. Federal officials pointed out that adverse reactions to the vaccine “appear to be extremely rare,” and the CDC and FDA will work to review the six clotting cases in question.
“Treatment of this specific type of blood clot is different from the treatment that might typically be administered,” officials said. “Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.”
The CDC will convene a meeting of its Advisory Committee on Immunization Practices on Wednesday to further review the cases and assess their potential significance.
Johnson & Johnson issued a statement saying, “At present, no clear causal relationship has been established between these rare events” and the company’s vaccine, according to news reports. “We continue to work closely with experts and regulators to assess the data and support the open communication of this information to healthcare professionals and the public,” J&J said.
California will convene the Western States Scientific Safety Review Workgroup to review the reports from the federal government.
The news could complicate California’s embattled vaccine rollout and Newsom’s goal to reopen the state by June 15, a decision that hinged upon most residents being inoculated by then.
Dosage supply was predicted to crater by about 15 percent in the Golden State this week following a massive shortfall in the production of the Johnson & Johnson vaccine — and now that number could fall even more.
Still, Newsom said Tuesday that “vaccines are still overwhelmingly safe. We’re vaccinating 3+ million people a week and are still on track to fully reopen.”
“As the federal government has said, we do not expect a significant impact to our vaccination allocations,” Pan said.
Newsom himself received the Johnson & Johnson shot on April 1.
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