Canada’s National Advisory Committee on Immunization (NACI) is expected to recommend today a pause in the use of the AstraZeneca-Oxford COVID-19 vaccine on those under the age of 55 because of safety concerns, sources told CBC News.
The updated guidelines will be issued later today, according to sources who spoke on the condition of anonymity. The expected change comes following reports of rare blood clots in some immunized patients.
Canada is expected to receive 1.5 million doses of this product from the U.S. on Tuesday.
Officials from NACI will provide an update to reporters at 3:10 p.m. ET. CBCNews.ca will carry the remarks live.
Meanwhile, Health Canada — which approved the vaccine for use in Canada in February — said its regulators would be adding “additional terms and conditions on the authorizations” for AstraZeneca and a biologically identical version of the drug manufactured by the Serum Institute of India, which has been branded Covishield.
The manufacturers will be required to conduct a “detailed assessment of the benefits and risks of the vaccine by age and sex in the Canadian context,” information that could lead to “additional regulatory actions.”
“This information will support the ongoing evaluation of these rare blood clotting events, and allow Health Canada to determine if there are specific groups of people who may be at higher risk,” the department said in a press release.
The AstraZeneca shot has not been widely used in people under the age of 55 in this country. Some jurisdictions, such as P.E.I., have been using some of their supply to immunize young people who work in public-facing sectors like grocery and convenience stores. In New Brunswick, the shot was made available to first responders and some teachers last week.
A spokesperson for P.E.I.’s health department confirmed use of the vaccine had been suspended for those 18 to 29 years of age.
Speaking to reporters in Niagara Falls, Ont., Ontario Premier Doug Ford said today that the province would follow NACI’s guidance and reserve the current supply of AstraZeneca for those in the older cohort.
He said there have been reports of blood clots in younger women in other places.
“I won’t hesitate to cancel that in half a heartbeat. If it’s going to put anyone in harm, we just won’t use it, simple as that,” he said, adding he didn’t want to “roll the dice” by using AstraZeneca on a group that may have an outsized chance of developing complications.
“The guidance from the federal government is that it is safe for people over 55,” Ford said. “I’m talking about younger people taking it, 35 years of age and in that range, that’s where the problem is.”
After a review, the European Union’s drug watchdog, the European Medicines Agency, found the vaccine is not linked to an increase in the overall risk of blood clots.
The EMA said, however, that it could not definitively rule out a link between the vaccine and rare types of blood clots associated with thrombocytopenia, or low levels of blood platelets.
Specifically, it pointed to 18 cases of an extremely rare type of blood clot called cerebral venous sinus thrombosis (CVST), a condition that is much more common in women than men. Most of the cases occurred within 14 days of receiving the AstraZeneca shot, and the majority were in women under the age of 55.
Dr. Joss Reimer, the medical lead on Manitoba’s vaccine implementation task force, said that the province also would pause its deployment of the vaccine among people under 55 because of a “very rare subtype, one specific type of blood clot.”
She said that while there have been no complications reported in Canada, “out of an abundance of caution” Manitoba will restrict the shot to people 55 to 64, for now.
Reimer said it’s not known yet how common this rare blood clot side effect is but early data out of Europe suggest it could be an outcome for 1 out of 100,000 AstraZeneca shots deployed, or even more than that — the science isn’t settled, she said.
“This is a pause while we wait for more information to better understand what’s happened in Europe. This is an important and evidence-based change,” she said, adding this sort of shift is a testament to Canada’s robust vaccine monitoring system.
Reimer said it’s “probably” fine to use the vaccine on all groups — but she’s not comfortable with just “probably” and wants to wait to see more data from Europe.
Last week, the Public Health Agency of Canada said it’s “possible” the vaccine may be associated with “very rare but serious cases of blood clots associated with thrombocytopenia.” Health Canada has maintained that the benefits of the AstraZeneca COVID-19 vaccine continue to outweigh the risks.
Health Canada has said it is aware that researchers in Europe have indicated that they have identified a possible cause for these very rare events, but says little information is available about the findings.
“We have been discussing the rare reports of blood clots and low platelet counts with the European Medicines Agency and other regulators,” Dr. Supriya Sharma, Canada’s chief medical adviser, said on Thursday. “Health Canada will make decisions for Canada based on the science and evidence.
“This is just the latest issue the company has faced over the last three months.
Earlier this year, a number of European countries halted vaccinations in response to questions about the AstraZeneca product’s efficacy in people over the age of 65, only to restart them after new evidence emerged.
After Health Canada approved the shot for all adults, NACI recommended the product be used only on people under the age of 65, citing a dearth of clinical trial data on the vaccine’s effectiveness in older people.
NACI changed course earlier this month after reviewing three “real-world studies,” saying the two-dose viral vector vaccine can and should be used on seniors.
Last week, the U.S. Data and Safety Monitoring Board (DSMB), which keeps an eye on clinical trials, found “outdated information” may have been reported by the company when it released data on U.S. trials.
Dr. Anthony Fauci, U.S. President Joe Biden’s chief medical adviser and the head of the NIAID, said the monitoring board was surprised by the the better-than-expected efficacy results published by AstraZeneca.