With U.S. officials reportedly poised to approve the Pfizer-BioNTech vaccine within weeks, many are hoping this final endorsement could nudge some hesitant people toward the shot.
The vaccine is already fully approved by Health Canada. But some experts say the final stamp of approval from the U.S. Food and Drug Administration may also help convince some Canadians who are on the fence, and even persuade some large institutions to mandate vaccines.
“I don’t know if people hear it from movies or commercials that say, ‘This is FDA-approved,’” said Janessa Griffith, a PhD candidate at the University of Toronto and Women’s College Hospital who has studied coronavirus vaccine hesitancy.
“But that acronym has kind of become ingrained in us.”
The that the FDA has sped up its timetable to fully approve the Pfizer shot, and expects the process to be completed by the start of September. The vaccine is currently authorized for emergency use along with those produced by Moderna and Johnson & Johnson.
Griffith recently published research that mined thousands of tweets on COVID vaccines for patterns in hesitancy. The U.S. emergency authorization is one of the first things she sees people mentioning on social media as a reason not to get the shot, even if they have received vaccines for other diseases in the past.
“Because we’re so influenced by what happens south of the border, I think it would be a good thing for it to be officially approved because it would just kind of make that not an argument anymore,” she said.
There will still be “diehards” who refuse, she said, “but I think overall, it’s definitely a great step because hopefully that argument is just quashed.”
There’s been so much misinformation circulating online that there’s also some confusion about the approval process in Canada versus the U.S., Griffith said.
Vaccines made by are already “fully approved,” Health Canada spokesperson Anne Genier said in an email.
The agency put in place a “fast-tracked review process to assess COVID-19 vaccines,” she added.
“We’ve dedicated more scientific resources to complete these reviews so that they’re done quickly but without cutting corners,” she said, adding that a similar process was used in 2009 to review and authorize the H1N1 flu vaccine.
Under the interim process, the review starts right away, Genier said. Staff are also able to review new evidence as soon as it becomes available, instead of waiting until all studies in a submission package are completed.
The Pfizer vaccine is currently approved in Canada for youth age 12 and up.
On Tuesday, Moderna’s CEO said he expects to submit clinical data in early fall on vaccine trials in children aged six to 11.
In the U.S., where around 30 per cent of eligible adults still don’t have their shots, a found that three in 10 unvaccinated adults said they would be more likely to get the shot if it had full FDA approval.
But, the poll noted, this could just be a “proxy for general safety concerns” about the newness of the vaccine.
Full approval will probably change some minds, said Dr. Omar Khan, an assistant professor at the University of Toronto Institute of Biomedical Engineering. But it does seem that the reasons people don’t want the shots have been “a moving goalpost” for many, and he sees this is a good opportunity for “better science communication” about how vaccines work.
The difference between approval and authorization, said Dr. Christopher Labos, a Montreal-based cardiologist and epidemiologist, is more bureaucratic than scientific. The emergency authorization can be revoked if data changes, but “in terms of what the FDA would use to establish efficacy of the vaccine, that’s largely unchanged.”
Still, several U.S. universities and hospitals are expected to make the vaccines mandatory once the final stamp of approval arrives, the Times has reported. Although large Canadian institutions are unlikely to be misunderstanding the approval process, Griffith said they are influenced by their American counterparts.
If more U.S. universities, for example, start to mandate vaccines after they are fully FDA-approved, more Canadian schools might follow suit, she added.
Maya Goldenberg, an expert in vaccine hesitancy and an associate professor of philosophy at the University of Guelph, said this change in status will likely have some positive impact on American “fence-sitters” who wanted an even more robust vetting process.
“Many of those concerns are similarly shared by Canadians. Approval by other regulatory bodies suggests more scrutiny of the vaccine as a whole,” she said in a written statement to the Star.
“More approval gives us all reason to feel more confident about the product.”
May Warren is a Toronto-based breaking news reporter for the Star. Follow her on Twitter: