(OTTAWA) Health Canada’s senior medical adviser said Thursday a decision is expected within a week or 10 days on Pfizer’s antiviral treatment to treat COVID-19 symptoms at home.
Posted at 9:53 p.m.
It’s still unclear, however, when deliveries will begin or how many Canada will get initially, as supply issues for the US-made drug have made it incredibly difficult to get even in the US, where it has was authorized before Christmas.
Canadian health officials and some prime ministers have publicly pressured Health Canada to greenlight the drug that stops the SARS-CoV-2 virus that causes COVID-19 from reproducing in people’s bodies. a patient. The Pfizer clinical trial showed that for high-risk patients, the oral drug prevented hospitalizations by about 90%.
The results were so compelling that Pfizer ended the trial early to begin getting the drug approved and distributed more widely. The pharmaceutical company applied for clearances from the U.S. Food and Drug Administration on November 22 and from Health Canada on November 1.er December.
The United States authorized its use in patients aged 12 and over three weeks ago. The UK gave the green light on December 31.
But Health Canada’s senior medical adviser, DD Supriya Sharma, told The Canadian Press in an interview Thursday that the Canadian submission was incomplete and that more data came in the last week of December as well as earlier this week.
PHOTO SEAN KILPATRICK, THE CANADIAN PRESS ARCHIVES
DD Supriya Sharma, Senior Medical Advisor, Health Canada
“So maybe in the next week or 10 days or so we should have a decision,” she said.
Mme Sharma, however, pushes back against people’s criticism of Health Canada for taking too long.
It might be a bit blunt, but the people making these comments usually have no regulatory experience and don’t have access to or knowledge of the back and forth we go with the company
DD Supriya Sharma
She added that Canada has also tried to get Pfizer to ship some pills ahead of approval using a regulation that allows drugs approved elsewhere to be used in Canada for urgent health needs.
“They basically said they weren’t able to do this, they didn’t have a supply,” she said.
Mme Sharma argued that even if Health Canada had gotten all the data it needed three weeks ago, “we probably wouldn’t have been able to get a supply for Canada either.”
The United States has ordered more than 20 million tablets and was due to get four million in January, but US media reports that access to Paxlovid is currently virtually impossible in most of the country.
Canada said last fall that it had purchased one million tablets.
Pfizer Canada spokeswoman Christina Antoniou said information on shipments to Canada will not be available until Health Canada clears the drug. She did not specifically confirm that supply issues were preventing Pfizer from making earlier deliveries under urgent public health needs regulations.
“In our discussions, we have jointly determined that the most effective route to achieving this is through the bidding process that is ongoing,” she said.
Kevin Smith, CEO of the University Health Network in Toronto, publicly called for Paxlovid’s approval in early January, calling it an “essential addition” to hospital needs.
While he says he has respect for Health Canada’s regulatory process, he struggles to understand why the US and UK approved drugs much faster than Canada.
A second antiviral drug from Merck faces potentially bumpier approval in Canada. The company filed an application in August for Molnupiravir after early results suggested it reduced hospitalizations for high-risk patients by around 50%.
The final results have reduced that effectiveness to just 30% and there are also more concerns about side effects, Ms.me Sharma.
“It’s a little more complicated,” she said. So we’re moving forward with that, we’ve requested some additional data from the company, and we’re basically going to work on that review. We don’t have a specific timeline. ”