AstraZeneca dose shelf life set to expire Monday extended by one month: Health Canada
Health Canada has extended by one month the expiration date of about 45,000 doses of AstraZeneca that were due to expire on Monday, according to the Ontario government.
On Saturday, the Department of Health released a statement saying Health Canada had extended the shelf life of specific lots of AstraZeneca vaccine from six months to seven months, following the review of stability data.
“Doses of vaccine with an initial expiration date of May 31, 2021 can now be used until July 1, 2021,” a spokesperson for the Department of Health said in a statement.
“On May 27, 2021, Health Canada received a submission from AstraZeneca that included product stability and mathematical modeling data demonstrating that the quality, safety and efficacy of both lots would be maintained for an additional month, to a total of seven months, “the statement said.
“This change will ensure that provinces and territories can use their existing inventory and provide Canadians with access to much-needed doses of vaccine.”
The news comes as pharmacists and doctors rushed to administer around 45,000 doses that were due to expire on Monday.
About 90,000 people who received their first injection of AstraZeneca between March 10 and March 19 became eligible to make their follow-up appointment on Tuesday.
These individuals were involved in the initial rollout of AstraZeneca vaccines to participating pharmacies in Toronto, Windsor and Kingston.
A list of eligible pharmacies that have received a second dose can be found on the provincial government website. Primary care offices and pharmacies can also reach out to eligible Ontarians.
Speaking to CP24 on Saturday afternoon, Dr Dirk Huyer, a member of the vaccine distribution working group and the province’s epidemic response coordinator, said he was satisfied with the decision.
“I think Health Canada is motivated by safety. And they are motivated by upholding the principles of an appropriate and safe vaccine. I can’t speak to their specific process, but they carefully review all vaccine submissions and vaccine products to make sure it’s as safe as possible, ”Huyer said.
Asked about concerns about the timing of the extension, Huyer said he was confident the agency had reviewed all the data and other information provided by the manufacturer to assess the expiration of the vaccine.
“I think Health Canada fully understands AstraZeneca and all vaccines. They monitor regularly, pay regular attention and assess safety, ”he said. “We have a strong safety oversight process in Ontario and Canada,” Huyer said.
The province suspended use of the AstraZeneca vaccine earlier this month due to an increased risk of rare blood clots, but 10 days later decided to resume administration of the vaccine for the second doses so that the vials placed in the refrigerator do not expire.
This week, pharmacists and doctors scrambled to get their hands on the remaining doses to administer before Monday.
Many residents felt frustrated by the lack of clarity regarding which pharmacies were offering the second injection.
“We started getting the vaccine in pharmacies in Toronto not until Thursday afternoon, late evening, and then throughout Friday we had refills because it is slowly released from the dispenser as it goes. as they go through this QA (quality assurance) process and checking temperature logs, ”Ontario Pharmacists Association CEO Justin Bates told CP24 on Saturday morning. Bates said pharmacies expect to receive more vials later Saturday and Monday.
Before Health Canada announced the extended expiration date, Bates said he was concerned about some doses deteriorating due to the temporary pause in vaccine delivery earlier this month.
“Science has evolved and that’s part of why we wanted to take a break a few weeks ago with the first dose vaccinations. So this has led to some of these problems. There is no question that the time it takes to get this product out in pharmacies increases the possibility of having some waste, ”Bates said.
“But we are prepared to do whatever we need to do to extend the hours. Many pharmacies close on Sundays and will remain open to welcome patients [..],” he added.
Toronto pharmacist Mina Maseh says Health Canada needs to properly explain its decision to extend the expiration date of the AstraZeneca vaccine. He said he gets a lot of questions from customers who want to take the vaccine but are hesitant because of questions about the expiration date.
“We’re a little frustrated. Everything just keeps coming out of left field. Nobody really tells us anything until it gets on the news,” Maseh said in an interview with CP24.
“Health Canada, I’m sure they’ve done due diligence and regulatory inspections, but unless they’re speaking to the public and explaining it, I don’t know how they expect it to be. that health professionals answer all these questions, “he continued.
Maseh urged the federal agency to step in and provide pharmacists with an explanation so they can confidently pass it on to their patients, he said.
“Let’s not put more doubt in people’s eyes and minds because they were already skeptical,” he said, “Why are we causing more hesitation in more patients right now with a last second announcement? “
“If they do not provide [the data], we can not do anything. We’re not going to put a single patient at risk for something that may not have been properly inspected, ”continued Maseh.
This weekend, 162 pharmacies in Toronto, Kingston and Windsor are expected to administer second doses of AstraZeneca.
The government released its second dose strategy on Friday and said AstraZeneca vaccines could be given at 10-week intervals for those who received their first dose between March 10 and March 19. During this time, the second doses for all those who received a first injection of AstraZeneca will continue with an interval of 12 weeks.
The province does not offer AstraZeneca injections to anyone as a first dose, except in very limited circumstances where a person is allergic to approved mRNA vaccines administered in Ontario.
Ontario received 254,500 doses of AstraZeneca the week of May 17, which will support the second doses 12 weeks apart.
– with the report by Béatrice Vaisman