In all likelihood, there will be multiple manufacturers distributing their own variations of a vaccine in different countries, but who will have access and at what price?
As COVID-19 numbers rise again, the Prime Minister has re-emerged as a regular fixture at daily government briefings.
On Friday, September 25, Justin Trudeau announced that the federal government has signed another agreement to buy a vaccine. This time with AstraZeneca for up to 20 million doses of its COVID–19 vaccine.
That brings the number of agreements signed by the government with vaccine manufacturers to seven. The others are with Sanofi, GlaxoSmithKline, Johnson & Johnson, Novavax, Pfizer and Moderna.
Three of the companies have vaccine candidates in phase three trials. In all, the government has committed to purchasing some 300 million doses from vaccine manufacturers.
The Trudeau government has also announced its participation in the COVID-19 Vaccine Global Access Facility, or COVAX. It’s part of the World Health Organization’s (WHO) effort to deliver “fair, equitable and timely access to COVID-19 vaccines.”
The Canadian government is contributing $220 million to the facility. Its mandate includes delivering vaccines to “low- and middle-income countries.” Canada’s participation in the effort gives it the option of purchasing another 15 million doses of a vaccine.
“We cannot beat this virus in Canada unless we end it everywhere,” says Trudeau.
But while Trudeau is pushing an international approach to find a vaccine, other countries are going it alone.
The COVAX facility is backed by some 172 countries, but the U.S. is not supporting the effort. Neither is China or Russia.
And while the race to find a COVID-19 vaccine has seen unprecedented cooperation between nations, some experts say it seems to be headed for the kind of scenario that plagued the search for a vaccine for AIDS in the 80s and 90s.
Back then, pharmaceutical companies and their research and development backers chased profits, making what treatments became available unaffordable for many, especially in the developing world.
In Canada, where large pharmaceuticals enjoy high-level access in Ottawa, who pays for a COVID-19 vaccine and whether it is subsidized are also emerging questions.
Canadians could be asked to pick up some of the cost.
“There’s a lot of money on the table,” says Thomas Tenkate, an associate professor at Ryerson University’s School of Occupational and Public Health.
He notes that pharmaceutical companies and their shareholders have historically placed a steep price on their research and development of new drugs.
While vaccines developed in the world have been distributed universally – polio comes to mind – the scenario with COVID-19 is shaping up to be much different. In all likelihood there will be multiple manufacturers distributing their own variations of the vaccine in different countries.
“With so many clinical trials on the boil you’ve got to think there will be a range available,” says Tenkate.
Tenkate says most researchers and countries will be looking to see what the U.S. does. “There’s a lot of political pressure in the U.S. to have something done [a vaccine] quickly.”
FDA approval usually opens the floodgates to approvals in other countries. But not necessarily in Canada, where Health Canada rules around the approval of new drugs are notoriously stringent.
At his press conference, Trudeau made a point of stressing that any vaccine approved for distribution in Canada will have to pass Health Canada standards. But that process can also be prone to politics.
Questions of transparency, for example, were recently raised about the government’s own Vaccine Task Force. The task force is made up of infectious disease experts and representatives of pharmaceutical companies. It’s advising the government on what research projects to explore.
Gary Kobinger, director of the Infectious Disease Research Centre at the Université Laval, quit the group last week citing potential conflicts among group members as a reason. “You need people to trust the vaccine,” Kobinger told the CBC.
The government responded by bringing in protocols that require potential conflicts of task force members to be made public.
It usually takes anywhere from five to 10 years to develop a vaccine. But the big money is on a vaccine for COVID-19 by next spring or a little later. That’s a year and a half roughly since the onset of the disease.
Russia is already claiming to have developed a vaccine. The U.S. says it’s close. China has said a vaccine may be ready by November. The predictions are overly optimistic. Most of the larger clinical trials have just started in recent months.
There are some 126 clinical trials on the WHO’s radar. Some 26 involve human trials. Nine of those have reached phase three, but none will be completed until late 2022 at the earliest.
The largest human trial of 60,000 participants by Belgium-based Johnson & Johnson company Janssen Pharmaceutica won’t be completed until 2023, according to documents submitted to WHO.
The company says that it “anticipates the first batches of a COVID-19 vaccine to be available for emergency use authorization in early 2021, if proven to be safe and effective.”
Further monitoring of subjects after the trials are completed will be needed to make sure any side effects are manageable.
Tenkate worries that “corners may have to be cut because of the reduced timelines” to find a vaccine.
Whatever vaccine we end up with in the short term will be more akin to treatment than a cure.
When politicians talk about a vaccine for COVID-19, it’s easy to jump to conclusions, but there is no magic pill. And there won’t be for some time, given that almost 20 years later there is no vaccine for SARS – COVID-19’s, genetic predecessor.
The danger with a COVID vaccine is that we will, in all likelihood, not know enough about the side effects.
Each country will have its own approval process. And while the rules around those “are pretty consistent around the world,” says Tenkate, there are differences. What is greenlighted for sale in Russia may not receive approval in other Western countries.
For Canada, it will come down to “understanding the risks,” Tenkate says, particularly with the possibility of multiple vaccines.
“Ultimately, for a lot of people, it’s going to come down to trust.”