UHN chief asks for speedy approval of COVID pill

TORONTO – The president and CEO of the University Health Network is urging Health Canada to approve Pfizer’s COVID-19 antiviral pill – called Paxlovid – to help curb the rising rate of hospitalizations across the country. Dr. Kevin Smith (pictured) said the surge in COVID-19 cases is affecting capacity at the UHN’s hospitals.

“We also have to remember that we don’t only have Omicron or COVID patients to look after, but many other delayed patients, not to mention the urgent and emergent patients who present because of motor vehicle accidents, heart attacks, strokes, all sorts of other emergency events,” he told CTV News.

In addition, Smith said, between 50 and 100 healthcare workers at UHN’s hospitals have been calling in sick every day.

“Obviously, when those people aren’t caring for patients, that makes it all the more difficult for us to ensure continuity of care,” he said.

Data from Pfizer’s 2,250-person clinical trial shows that the company’s oral medication was around 89 percent effective at preventing hospitalizations or deaths due to COVID-19 when compared against a placebo. There were also no deaths among the participants that took the Pfizer treatment.

“When we think about that, out of every 10 people who might be admitted (to hospital), almost nine of them could be avoided,” said Smith.

“Our big challenge right now is capacity and staffing. So, if we can turn that back to 80 or 90 percent of avoided admissions, we really can manage the system.”

Paxlovid works by preventing the SARS-CoV-2 virus from replicating itself in the patient’s body. “It’s very different than a flu remedy that one would see over the counter, which basically tries to address your symptoms. This prevents the disease from replicating and making you sicker and sicker,” Dr. Smith explained.

Once a PCR test confirms that a patient has COVID-19, the pills can be taken to mitigate the severity of the illness and reduce the numbers of hospitalizations and deaths. However, in Canada, the shortage of PCR testing also presents a problem.

Pfizer submitted its treatment to Health Canada for approval on Dec. 1, 2021. But while Pfizer’s antiviral pill has already been authorized in the U.S. and the U.K., Health Canada has yet to make a decision.

Merck’s antiviral pill, which was submitted on Aug. 13, is also awaiting approval from Health Canada. The U.S. authorized Merck’s treatment in late December.

Ottawa has already signed deals to procure one million of Pfizer’s antiviral pills and 500,000 of Merck’s pills, which will be distributed as soon as Health Canada gives the green light. Merck even announced last month that it would be producing its pills in Ontario.

Health Canada told CTVNews.ca in an email statement that the agency is still waiting for additional data from the companies. The agency also said it could not give a timeline on when a decision will be made.

“Timing for the completion of Health Canada’s review depends on many factors, including but not limited to a need for additional data, discussions with the sponsor, and requirements for updates to safety information,” Health Canada spokesperson Mark Johnson said.

“Health Canada will only authorize the use of anti-viral treatments if the independent and thorough scientific review of all the data included in the submissions show that the benefits of the treatments outweigh the potential risks.”

Smith believes there already is enough data to warrant approval now, citing the authorization of Pfizer’s pill in the U.S. and U.K. as well as the “risk for us to not be able to continue comprehensive hospital care.”

“I totally respect my colleagues at Health Canada, but my personal view is we now have enough data from those two approvals,” he said. “It really is time for us to use this at an emergency basis.”

While the Pfizer and Merck COVID-19 pills have been authorized for emergency use in the United States, reports indicate that the supply is tight, and the rollout varies from state to state.

Pfizer’s pills are being recommended for patients at the highest risk of developing severe COVID-19 illness. For example, people with weakened immune systems, including transplant patients and older adults, who are especially vulnerable.

So, many of the hundreds of thousands of people testing positive for the coronavirus daily would not be candidates for the treatments.

The Food and Drug Administration (FDA) authorized the pills for emergency use just before Christmas.