Canada's federal health agency announced Wednesday that it is updating the label on vials of the Oxford-AstraZeneca vaccine with information about "very rare reports of blood clots", but continued to stand by the vaccine's safety and effectiveness against COVID-19.
Vaccine efficacy was 85 percent in adults 65 years and older in the updated analysis, the company said.
However, authorization by the Food and Drug Administration - considered the gold standard regulator - would go a long way to calm global doubts over the AstraZeneca vaccine.
In an unusual move earlier this week, a group of experts working with the company on the safety of its USA clinical trial contacted government agencies late on Monday to express concern about data that AstraZeneca made public just hours earlier.
"We look forward to filing our regulatory submission for Emergency Use Authorization in the United States and preparing for the rollout of millions of doses across America", Mene Pangalos, an executive vice president at AstraZeneca, said on Thursday.
The trial of 32,449 volunteers in the U.S., Peru and Chile showed people who got the vaccine were 76% less likely to have any symptoms of coronavirus compared to the one-third of participants who got placebo. The overall total of exported vaccines is bigger still since many more were not covered by the recent export regime.
While other companies are set to make billions from their Covid vaccines, AstraZeneca is producing theirs at cost throughout the pandemic.
The company added there are 14 additional or probable Covid cases left to be adjudicated.
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"AstraZeneca will also submit the primary analysis for peer-reviewed publication in the coming weeks".
"A key secondary endpoint, preventing severe or critical disease and hospitalization, demonstrated 100% efficacy".
AstraZeneca has updated the efficacy result of its coronavirus vaccine trial in the USA, after health officials insisted they wanted to include the latest information.
Earlier Wednesday, Dr. Anthony Fauci, the top United States infectious disease expert, told reporters he hoped that when all the data was publicly vetted by federal regulators, it would dispel any hesitancy caused by the spat.
AstraZeneca's newest calculations were based on 190 Covid-19 cases that occurred during the study, 49 more than it had included earlier in the week.
Fauci said that this was not necessary and that the data are "really quite good, but when they put it into the press release, it wasn't completely accurate".
This is the latest in a string of controversies surrounding the Oxford-AstraZeneca vaccine, over dosing, efficacy in the elderly, clots and supplies to the EU.
The organization said it has not received any reports of blood clots happening in Canada as a result of the vaccine.