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 American experts stressed the rarity of such events — especially with more than 6.8 million doses of the Johnson & Johnson (J&J) vaccine having been administered in the U.S. so far.
Later on Tuesday, J&J said in a statement that it is pausing clinical trials for the vaccine and delaying the shot’s rollout in Europe in response to the reports.
Canada approved the one-shot Johnson and Johnson vaccine in early March.
Canada has pre-ordered 10 million doses, 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 green-lit 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.
Johnson & Johnson said Tuesday it was aware of the rare reports of blood clots and was working with regulators to assess the data and provide relevant information.
It said the decision to both pause clinical trials run by the company’s pharmaceutical arm, Janssen, and “proactively delay” the rollout in Europe was made “while we update guidance for investigators and participants.”
“We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public,” the company said.
Procurement Minister Anita Anand has said she didn’t expect any J&J doses to be in provinces ready for injection until the first week of May.
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.
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.
There had been no such reports in the country until Tuesday when the public health agency announced its first patient, a woman living in Quebec.
The agency along with the Quebec Ministry of Health and Social Services said the female patient, whose age has not been revealed, is at home recovering.
The shot the woman had received is known as the CoviShield vaccine, and was produced at the Serum Institute of India. The institute is manufacturing its own version of the AstraZeneca vaccine under license, in collaboration with Canadian partner Verity Pharmaceuticals.
“The person was taken care of by the health and social services network and received the care appropriate to their condition,” Quebec health officials said in a statement. “She is now recovering at her home and there is no fear for her life.”
As of April 7, Health Canada said 500,000 CoviShield vaccines had been distributed throughout the country, along with 1.5 million doses of AstraZeneca’s.
The U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet Wednesday to discuss the cases. The U.S. Food and Drug Administration has also launched an investigation into the cause of the clots and low platelet counts.
A timeline for the pause in the U.S. is unclear. While the temporary suspension is only a recommendation, it’s expected many U.S. federal distribution channels will hit pause while the review takes place. States and other providers are likely to follow.
— with files from Global News’ Emerald Bensadoun and Sean Boynton, the Associated Press and ReutersView link »