New guidelines issued by NACI around AstraZeneca vaccine

A nurse draws a dose from a vaccine vial in Prince Albert. Photo courtesy SHA.

The National Advisory Committee on Immunization (NACI) issued updated guidelines on the use of AstraZeneca/COVISHIELD in Canada Monday, recommending that use for populations under 55 be paused, pending further review of vaccine safety.

“Due to the ongoing assessment of very rare adverse events reported in Europe of thrombosis or blood clots with thrombocytopenia or low blood platelets occurring after immunization with the AstraZeneca vaccine,” Health Canada said in a release.

As of Monday no cases of these events have been reported in Canada. According to a release by the province of Saskatchewan they will be following the recommendation.

“However, through our ongoing international collaboration, Health Canada has become aware that additional cases of these events have been reported in Europe.”

In light of this evolving information, Health Canada will be issuing additional terms and conditions on the authorizations of the AstraZeneca and Verity Pharmaceuticals/Serum Institute of India vaccines. “These will include a requirement that the manufacturers conduct a detailed assessment of the benefits and risks of the vaccine by age and sex in the Canadian context. 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. Health Canada has been in discussions with AstraZeneca on this evolving issue.”

A shipment of 46,600 doses of AstraZeneca vaccine from the United States is expected to arrive in Saskatchewan this week.

Health Canada said that they will assess this information when it is received and will determine if additional regulatory actions are necessary. Health Canada will continue to work collaboratively with its international counterparts to collect and assess information.

The primary use of AstraZeneca in Saskatchewan to date was at the drive thru clinic in Regina, with more than 15,000 doses available to residents 58 years and older. Some residents younger than 55 would have received AstraZeneca including eligible health care workers and vaccinators though no thrombosis-like adverse events have been reported in Saskatchewan to date.

“While there remains fewer than 100 doses of AstraZeneca in the province right now, additional shipments are expected. The Saskatchewan Health Authority is examining the potential impacts to vaccine roll-out plans now and will have an update in the coming days,” the release from the province said.

The opposition Conservative Party is seeking clarity on the government’s position.

“For months, countries around the world have raised concerns about both the safety and efficacy of the AstraZeneca vaccine. This is why Conservatives have been calling for clarity from the government regarding their recommendations surrounding the AstraZeneca vaccine,” Michelle Rempel Garner Shadow Minister for Health and Pierre Paul-Hus Shadow Minister for Public Services and Procurement said in a statement issued Monday.

The opposition called the messaging from the NACI and Health Canada contradictory on the vaccine.

“This conflicting advice is highly concerning, given the fact that thousands of Canadians in this age group have already received the vaccine.

They called on Prime Minister Justin Trudeau to clearly communicate whether or not Health Canada is advising a pause on the use of the vaccine and communicate the same to the provinces. Health Canada is the agency responsible for providing approvals on vaccine safety, and provinces shouldn’t be left without critical data.

They added that if Health Canada’s advice is different from NACI, the government should explain why there is a discrepancy.

Health Canada’s guidance issued to healthcare practitioners last week still stands and provides vaccine recipients with information on the signs and symptoms to monitor for following vaccination.

As well, a shipment of Moderna vaccine that was expected March 30 has been delayed due to ongoing quality assurance processes. PHAC expects this shipment will be available for pick up from the manufacturer on April 1 for distribution in Canada. A delivery date to Saskatchewan is not yet known.