U.S. federal health agencies are recommending an immediate “pause” in the use of Johnson & Johnson’s single-dose COVID-19 vaccine after six U.S. recipients developed a rare disorder involving blood clots.
The U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention said in a joint statement on Tuesday that the pause has been recommended “out of an abundance of caution”
The New York Times was first to report the suspension, citing officials briefed on the decision.
“Right now, these adverse events appear to be extremely rare,” the FDA wrote on Twitter. “Treatment of this specific type of blood clot is different from the treatment that might typically be administered.”
All the six recipients were women between the ages of 18 and 48. One woman died and a second woman in Nebraska has been hospitalized in critical condition, the NYT reported.
More than 6.8 million doses of the J&J vaccine have been administered in the U.S.
The CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. The FDA will then review that analysis as it also investigates these cases, it said in a statement.
Though this is a recommendation, experts say the U.S. administration is likely to follow it.
U.S. federal distribution channels, including mass vaccination sites, will pause the use of the J&J shot, and states and other providers are expected to follow.
A press conference will be held at 10 a.m. EDT where officials will provide further detail on the pause.
The move from the U.S. regulators comes less than a week after Europe’s drug regulator said it was reviewing rare blood clots in four people in the U.S. who received the shot.
Johnson & Johnson has said it was aware of the rare reports of blood clots and was working with regulators to assess the data and provide relevant information.
“At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine,” the company said in a statement emailed to the Associated Press last week.
The European Medicines Agency’s review follows an investigation of blood clots reported by some people given the AstraZeneca vaccine, which has prompted many European countries to change their vaccine recommendations.
Canada also moved to change recommendations for use of the AstraZeneca vaccine after the reports of very rare blood clots in some recipients, although there have been no such reports in the country.
Canada approved the one-shot Johnson and Johnson vaccine in early March, however, deliveries to the country are not expected to begin until the end of April.
Canada has pre-ordered 10 million doses of the Johnson & Johnson vaccine, with options to order up to 28 million more.
A spokesperson for Janssen Canada previously told Global News on March 31 that it anticipates fulfilling the 10 million doses by the end of the third quarter “with first delivery targeted in the next several weeks.”
— with files from Reuters and the Associated Press
© 2021 Global News, a division of Corus Entertainment Inc.
