Made-in-Ontario treatments for up to hundreds of thousands of COVID-19 patients are sitting in storage, while Merck and Health Canada blame each other for the length of time it's taking to review the drug.

Molnupiravir is an antiviral treatment for COVID developed by Merck, an American pharmaceutical company.

On Dec. 3, Merck and Public Services and Procurement Canada announced that the company was providing the federal government up to one million treatment courses of molnupiravir, 500,000 of them this year.

The deal's price tag hasn't been made public, but one million courses would cost about $900 million if Ottawa paid the same price the U.S. did.

Three days later, Merck executives, along with federal and provincial representatives, revealed that molnupiravir was being made by Thermo Fisher Scientific at its facility in Whitby, east of Toronto.

Company executives and elected officials at the Dec. 6 announcement said Whitby was one of three global sites producing molnupiravir for sale by Merck to upper- and middle-income countries. Product made in Ontario would be used in the U.K., the European Union, the Asia-Pacific, Latin America and Canada, once Health Canada approved it, said Ryan Turnbull, the Liberal MP for Whitby.

Thermo Fisher was making courses of molnupiravir before Dec. 6, Merck Canada's CEO Marwan Akar said. Companies can manufacture drugs in Canada before the regulator approves their use by patients.

"This is truly an exciting day, and history is in the making here in Ontario," said Vic Fedeli, Ontario's minister of Economic Development, Job Creation and Trade.

Added Francois-Philippe Champagne, the federal minister of Innovation, Science and Industry: "This is a great achievement, for which we should all be very, very proud, (for) not only providing a made-in-Canada solution for Canadians, but helping Canada ... help around the world."

Almost two months later — and as another wave of COVID crests — Canadians have yet to benefit from the agreement.

Meanwhile, Thermo Fisher's Whitby facility has been churning our treatment cycles for use in Canada, which sit in storage, Merck Canada's media team told iPolitics in an email.

"Treatment courses from that site are already available in Canada and ready to be allocated to provinces, as soon as Merck Canada receives market authorization by Health Canada," the company said.

But Health Canada and Merck are blaming each other for stalling the approval.

Health Canada has reviewed molnupiravir through a rolling review process (as it has for all COVID therapeutics and vaccines) by allowing Merck to submit clinical trial data and other information as it becomes available, rather than waiting for all of it to be ready.

"Additional information continues to be provided (by Merck) to Health Canada for review, the most recent having been received this past week," a Health Canada spokesperson said this week in an email.

"The timeline for completion of the review (of molnupiravir) is dependent on the ongoing assessment of the data."

Merck's spokesperson said the opposite.

"Merck Canada submitted the final wave of the rolling submission for its investigational oral antiviral to Health Canada at the end of 2021," the company said before being shown Health Canada's comments. "Health Canada has all the available evidence to (decide whether to approve it)."

After the regulator's comments were shared with Merck, its spokesperson doubled down.

"We filed information about molnupiravir as it became available throughout the review process, and we provided relevant information, as requested, to help Health Canada determine the most appropriate use of molnupiravir," Merck said.

"Health Canada currently has in its possession the same data that was submitted to regulatory agencies in other countries, which have already authorized molnupiravir."

Merck's antiviral has been approved for use in the U.K., the U.S., Colombia, Mexico, Panama, Taiwan, Thailand, United Arab Emirates, Japan, and Australia.

Merck filed its initial application for approval to the Canadian regulator in early August.

Months after Merck's initial filing, Pfizer filed paperwork to Health Canada applying for approval of its antiviral COVID treatment, Paxlovid. It was approved on Jan. 17. The federal government bought up to one million courses of Paxlovid, as well, and expects to receive more than 150,000 cycles by the end of March.

Both Paxlovid and molnupiravir are considered especially useful in continuing to manage the pandemic, because they come in pill form and can be taken at home.

Clinical trial data has shown that Paxlovid is more effective than molnupiravir. In one trial, Merck's drug was found to lower the likelihood of vulnerable people being hospitalized or dying from COVID by 30 per cent, while Pfizer's reduced the likelihood of these outcomes by 89 per cent.

Between Merck and Thermo Fisher, the companies planned to invest $19 million in the Whitby site. Their agreement would also maintain 50 jobs, possibly more, if global demand for molnupiravir grows, Champagne said.

Ontario-made COVID remedy in storage, as Merck, regulator at odds

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