Health Canada is “closely” monitoring the U.S. review of the Johnson & Johnson COVID-19 vaccine after reports of extremely rare blood clotting in some recipients.
On Tuesday, U.S. health regulators recommended pausing the use of the vaccine after six female recipients between the ages of 18 and 48 experienced the adverse event. One woman died and a second woman has been hospitalized in critical condition.
The experts stressed the rarity of such events — especially with more than 6.8 million doses of the J&J vaccine having been administered in the U.S. so far.
Johnson & Johnson vaccine under review in Europe after blood clot reports
Canada approved the one-shot Johnson and Johnson vaccine in early March.
Canada has pre-ordered 10 million doses of the Johnson & Johnson vaccine, with options to order up to 28 million more. However, deliveries to the country are not expected to begin until the end of April.
Prime Minister Justin Trudeau said Canada is “still on track” to receive its first shipment of the J&J vaccine by the end of this month.
“But obviously, we’re following closely the developments in the United States and we can assure everyone that Health Canada will, every step of the way, put the health of Canadians first and foremost in any decisions we make around distributing vaccines,” he said.
Health Canada said it is “following the issue closely” and working with the drugmaker, the U.S. FDA and other regulators as the data is reviewed.
While the vaccine was greenlit on March 5, “there have been no shipments to Canada” at this time,” Health Canada said.
“Health Canada has asked Janssen [the pharmaceutical arm of Johnson & Johnson] to provide information on any cases of these rare blood clotting events.”
Dr. Howard Njoo, Canada’s deputy chief public health officer, said Health Canada will analyze the data itself once it’s received.
“They will be analyzing the data and making the decision as it matters in the Canadian context,” he said.
(1 of 2) HC is aware of the U.S.’ pause on the use of the Janssen #COVID19 vaccine due to reports of unusual blood clots. Health Canada authorized this vaccine on March 5; however, there have been no shipments to Canada. https://t.co/9xNRIDrz4I
— Health Canada and PHAC (@GovCanHealth) April 13, 2021
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 move comes after Europe’s drug regulator earlier this month said it had found a possible link between AstraZeneca’s COVID-19 vaccine and very rare blood clots in some adults who received the shot.
Johnson & Johnson says batch of COVID-19 vaccines failed quality check
The potential issue with the J&J vaccine is very similar to the clots being reported after using the AstraZeneca shot, which uses the same technology but not the same formula.
The European Medicines Agency’s review prompted many European countries to change their recommendations for AstraZeneca.
The AstraZeneca shot has not yet been cleared in the U.S. but has been approved for use in Canada since February.
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.
— with files from the Associated Press and Reuters
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