Canada closely watching U.S. pause of J&J COVID-19 vaccine over rare blood clots
OTTAWA -- Health Canada says it’s closely watching the situation south of the border, where federal health and safety officials have paused the use of the Johnson & Johnson COVID-19 vaccine over concerns of a small number of rare blood clotting events.
While the Johnson & Johnson vaccine has been approved for use in Canada since March 5, the single-shot vaccine has yet to be added into the national vaccine rollout campaign as doses haven't arrived in this country.
In a series of tweets, Health Canada said Tuesday morning that it is “following this issue closely and is working with the manufacturer, the U.S. Food and Drug Administration and other international regulators.”
The agency has also asked Janssen—the pharmaceutical company that manufactures the Johnson & Johnson vaccine—to provide information on any cases of these “rare blood clotting events.”
So far, the Centers for Disease Control and Prevention and the Food and Drug Administration have reported six cases in women between the ages of 18 and 48, out of more than 6.8 million doses administered.
In a statement, Johnson & Johnson said they are aware of the “extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals” and that safety is their top priority.
As a result, the company has “proactively” delayed its rollout of tens of millions of doses of the vaccine in Europe but did not indicate whether Canada would see the same kind of hold up.
CANADA EXPECTING 10M J&J DOSES
Prime Minister Justin Trudeau told reporters Tuesday morning that Canada is still expecting the first shipment of Johnson & Johnson vaccines by the end of April, but any decisions around its administration will factor in all available evidence.
“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,” Trudeau said, adding that it’s instances like this that show why it was key Canada order COVID-19 vaccine doses from a range of pharmaceutical companies.
The Johnson & Johnson viral vector vaccine was the fourth unique shot authorized for use in this country. The federal government has secured access to up to 38 million doses of the Johnson & Johnson vaccine, with a deal in place for at least 10 million doses and the option to purchase 28 million more.
While the addition of the Johnson & Johnson vaccine to Canada’s roster of approved shots is anticipated to help accelerate the mass immunization campaign, should federal authorities decide to hold off on using the shot in Canada, the government is still slated to have enough doses of the other vaccines to meet the promised September timeline.
PROCESS TO MIRROR ASTRAZENECA REVIEW: TAM
The Johnson & Johnson vaccine is now the second COVID-19 vaccine approved for use in Canada that’s being investigated following reports of blood clots in people who have been vaccinated.
Several countries halted or limited the use of the AstraZeneca vaccine after reports of blood clots emerged to study the connection, with the European Medicines Agency (EMA) stating last week that there appears to be an “association” between the vaccine and blood clots, and that blood clotting and low levels of blood platelets should be listed as a “very rare” side effect of the AstraZeneca vaccine.
Overall the EMA’s position mirrors that of Canada’s when it comes to the AstraZeneca vaccine: the benefits outweigh the risks. Domestically, the National Advisory Committee on Immunization (NACI) is recommending the vaccine not be administered to Canadians under the age of 55, pending the results of an ongoing review.
Chief Public Health Officer Dr. Theresa Tam said the same process that Health Canada and NACI has taken with the reports of adverse effects in relation to the AstraZeneca vaccine, should be expected when it comes to this new information around the Johnson & Johnson vaccine.
“Health Canada will need all of this data and do in the Canadian context, benefit and risk analysis,” said Tam during a press conference on Tuesday. “I would also expect to convene and support a discussion amongst provinces and territories as to how best to use the Janssen vaccine in the Canadian context.”
Shortly after, the Public Health Agency of Canada reported its first known case of a person in Canada who experienced blood clots with low platelets after receiving an AstraZeneca shot, from a shipment sent to Canada from the Serum Institute of India.
The woman, who received the vaccine in Quebec, is recovering at home, according to the provincial government.
Health Canada will be factoring in this report as part of its ongoing safety review of the AstraZeneca vaccine, and the agency has noted that the labels on these vaccines have already been updated to include information about the rare reports of blood clots.
Both the AstraZeneca and Johnson & Johnson shots are adenovirus-based vaccines, which is a different technology than the mRNA vaccines created by Pfizer-BioNTech and Moderna.
“It is very plausible that the same reason the same mechanism by which these clots are forming related to the AstraZeneca vaccine, are very much in play when we talk about the Johnson and Johnson vaccine,” said CTV Infectious Disease Specialist Dr. Abdu Sharkawy.
RISK 'EXTRAORDINARILY RARE,' DOCTORS SAY
Canadian physicians have been quick to point to the rarity of these reported blood clotting cases and continue to say that Canadians should feel comfortable receiving any vaccine that medical professionals advise as being safe for them.
“It doesn't mean these vaccines are not safe. It means that they are potentially not the most appropriate ones for a particular part of our population… These vaccines by and large, are incredibly safe in terms of preventing COVID-19 over the entire spectrum of a population,” Sharkawy said.
Similarly, in an interview on CTV News Channel, emergency room physician Dr. Lisa Salamon said that while the Johnson & Johnson news is “frustrating,” the situation in the U.S. shows a “less than one in a million” chance of experiencing blood clotting post-immunization.
“To put it in perspective, I mean, all the women who go on a birth control pill: you have a risk of four to five out of 10,000 of getting a blood clot from being on the birth control pill,” she said.
When Health Canada authorized the Johnson & Johnson vaccine, it shared data indicating that in clinical trials involving approximately 43,000 participants, the single dose of the Johnson & Johnson vaccine was shown to be 66 per cent effective in preventing moderate to severe COVID-19, two weeks after vaccination.
The majority of adverse reactions reported during the clinical trials were mild to moderate in severity, and resolved within a few days.
Health Canada has approved a clinical trial for the vaccine in children ages 12 to 17, but as of earlier this month had yet to begin enrolling Canadian participants.
According to a report from Reuters, the World Health Organization said Tuesday that it is awaiting ongoing reviews of the Johnson & Johnson vaccine from American and European regulators and is monitoring the global database tracking international adverse events.