The Canadian government could pre-order doses of the COVID-19 vaccine that’s furthest along in Health Canada’s authorization process before the end of the year, if the vaccine continues to show promising results in its clinical trials.
The vaccine, produced by pharmaceutical company AstraZeneca in partnership with the University of Oxford, has rapidly moved through the testing process since first being given to monkeys this spring. Since the vaccine, called AZD1222, was proven safe and effective in monkeys, it’s made good progress in human trials around the world.
The lone significant hiccup was when trials were halted about a month ago after one patient of the thousands who had been given the candidate had an adverse reaction to it. Less than a week later, the United Kingdom’s regulatory body gave AstraZeneca the go-ahead to restart its trials. Testing of the AstraZeneca-Oxford vaccine — which includes hybrid Phase 2/3 and regular final-phase trials — has since resumed in every country where trials were stalled, except for the United States.
Last Friday, Health Canada announced that AZD1222 was the first COVID vaccine it was considering authorizing through an interim expedited process that Health Minister Patty Hajdu approved because of the pandemic.
Through that process, AstraZeneca has been approved by Health Canada to submit information about its candidate through a rolling review, which allows the company to submit safety and efficacy data as soon as it’s available.
A Health Canada spokesperson told iPolitics on Wednesday that the department is expecting updated information on the “quality of (AstraZeneca’s) vaccine” this month, followed by additional clinical-study data in November and December. AstraZeneca also confirmed to iPolitics that it’s expecting results from its hybrid Phase 2/3 studies before the end of 2020.
“Once these results are available, we will share them with the European Medical Agency, Health Canada, Anvisa (the Brazilian Health Regulatory Agency), the U.S.F.D.A. and other regulatory agencies,” the company said in a statement to iPolitics.
AstraZeneca’s early trial results from an ongoing Phase 1/2 trial were published in the medical journal The Lancet in July.
AZD1222 generated a “robust” immune response against SARS-CoV-2, the new coronavirus that causes COVID-19, the company said.
Of the 1,077 healthy participants aged 18 to 55 whose experience with the vaccine was documented in the published report, 91 per cent showed neutralizing activity against the virus after receiving a single dose.
A T-cell response was also induced in all participants, and was maintained for two months after they were injected with the vaccine. T-cells attack and kill cells that are taken over by a virus.
Another function of the expedited vaccine-approval process Hajdu signed off on allows her to pre-order doses of a vaccine if it’s shown promising trial results. Canada must also have already agreed to purchase it, and it must be in the midst of the authorization process. AstraZeneca meets all these criteria.
Pre-ordering (or “pre-positioning,” as the interim order calls it) would let Canada import doses of AZD1222 before it’s approved for use. The Canadian government has agreed to buy 20 million doses of AZD1222.
“Pre-positioning a promising COVID-19 vaccine would facilitate timely access to Canadians by allowing the importation and storage of a vaccine in Canadian facilities before their market authorization in Canada,” Health Canada spokesperson André Gagnon wrote to iPolitics in an email.
“This would allow for faster distribution of the vaccine to provinces and territories immediately upon approval.”
