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Brigitte Kiecken, president of Biolyse Pharma, is hoping the Canadian government will allow her St. Catharines company to produce, or at a minimum, package COVID-19 vaccines at its factory helping to reduce the global vaccine shortage.Glenn Lowson/The Globe and Mail

Whenever he needs motivation for his fight to expand vaccine production, John Fulton thinks of a family member: a 67-year-old woman in Kenya who died of COVID-19 this month.

“They tried to get her to hospital, but all the hospitals in her area were full,” said Mr. Fulton, a consultant at Biolyse Pharma in St. Catharines, Ont.

“It’s a war zone there,” he said, describing the surge of pandemic deaths in Kenya. “This is what drives us.”

Canada vaccine tracker: How many COVID-19 doses have been administered so far?

Tracking Canada’s COVID-19 vaccine rollout plans: A continuing guide

Moderna, Pfizer, AstraZeneca or Johnson & Johnson: Which COVID-19 vaccine will I get in Canada?

Canada pre-purchased millions of doses of seven different vaccine types, and Health Canada has approved four so far for the various provincial and territorial rollouts. All the drugs are fully effective in preventing serious illness and death, though some may do more than others to stop any symptomatic illness at all (which is where the efficacy rates cited below come in).

PFIZER-BIONTECH

  • Also known as: Comirnaty
  • Approved on: Dec. 9, 2020
  • Efficacy rate: 95 per cent with both doses in patients 16 and older, and 100 per cent in 12- to 15-year-olds
  • Traits: Must be stored at -70 C, requiring specialized ultracold freezers. It is a new type of mRNA-based vaccine that gives the body a sample of the virus’s DNA to teach immune systems how to fight it. Health Canada has authorized it for use in people as young as 12.

MODERNA

  • Also known as: SpikeVax
  • Approved on: Dec. 23, 2020
  • Efficacy rate: 94 per cent with both doses in patients 18 and older, and 100 per cent in 12- to 17-year-olds
  • Traits: Like Pfizer’s vaccine, this one is mRNA-based, but it can be stored at -20 C. It’s approved for use in Canada for ages 12 and up.

OXFORD-ASTRAZENECA

  • Also known as: Vaxzevria
  • Approved on: Feb. 26, 2021
  • Efficacy rate: 62 per cent two weeks after the second dose
  • Traits: This comes in two versions approved for Canadian use, the kind made in Europe and the same drug made by a different process in India (where it is called Covishield). The National Advisory Committee on Immunization’s latest guidance is that its okay for people 30 and older to get it if they can’t or don’t want to wait for an mRNA vaccine, but to guard against the risk of a rare blood-clotting disorder, all provinces have stopped giving first doses of AstraZeneca.

JOHNSON & JOHNSON

  • Also known as: Janssen
  • Approved on: March 5, 2021
  • Efficacy rate: 66 per cent two weeks after the single dose
  • Traits: Unlike the other vaccines, this one comes in a single injection. NACI says it should be offered to Canadians 30 and older, but Health Canada paused distribution of the drug for now as it investigates inspection concerns at a Maryland facility where the active ingredient was made.

How many vaccine doses do I get?

All vaccines except Johnson & Johnson’s require two doses, though even for double-dose drugs, research suggests the first shots may give fairly strong protection. This has led health agencies to focus on getting first shots to as many people as possible, then delaying boosters by up to four months. To see how many doses your province or territory has administered so far, check our vaccine tracker for the latest numbers.

Coronavirus tracker: How many COVID-19 cases are there in Canada and worldwide? The latest maps and charts

As global shortages become more severe and vaccine inequities grow sharper, Biolyse believes it could help bridge the gap by producing up to 20 million doses of COVID-19 vaccines annually.

But to do so, it needs to win approvals from the federal government – a difficult challenge so far, and an example of the bureaucratic and corporate obstacles that hinder the task of expanding vaccine supplies globally.

“We have the equipment and facilities and the engineering and the staff,” Biolyse president Brigitte Kiecken said. “We could have done this quite rapidly. But it’s been brick wall after brick wall, and lots of confusion and not knowing what’s going on.”

Federal officials say the problem is that Canadian companies such as Biolyse are too small to be of interest to the major manufacturers of COVID-19 vaccines.

With the exception of factories that are already making critical products such as polio vaccines, “Canadian biomanufacturing assets were of a scale which was not of interest to these firms,” said John Power, a spokesperson for François-Philippe Champagne, the federal Minister of Innovation, Science and Industry.

“Manufacturing capacity for vaccines is often purpose-built, and pivoting production capacity takes time,” he said in an e-mailed response to questions from The Globe and Mail.

The global needs are stark and extreme. While many wealthy countries are rapidly vaccinating their populations, most poorer countries are far behind. Of the 690 million vaccine doses administered worldwide so far, for example, less than 2 per cent have been in Africa.

“Limited stocks and supply bottlenecks are putting COVID-19 vaccines out of reach of many people in this region,” said Matshidiso Moeti, the Africa director for the World Health Organization, in a statement on Thursday.

Kenya has been engulfed in a tidal wave of COVID-19 cases and deaths in recent weeks, but it has struggled to obtain vaccines in the midst of the global shortage. It expects to vaccinate only 22 per cent of its population by the middle of next year.

“How many more mothers-in-law are going to die in that period of time?” Mr. Fulton asked, thinking of his brother’s relative.

Biolyse, which normally produces cancer drugs, believes it is one of the few companies in Canada with the capacity to produce COVID-19 vaccines this year. If it wins approval, it could be manufacturing the vaccines within six months. A number of lower-income countries have already expressed interest in buying vaccines from Biolyse, the company says.

But the company has been trying to catch the attention of Ottawa and the major vaccine manufacturers for nearly a year – with almost no success. When it approached Johnson & Johnson, the U.S.-based company said it was not interested.

It may have finally made a breakthrough this week when it won a meeting with about 20 officials from four federal departments. “Someone is finally listening,” Mr. Fulton told The Globe in an interview on Thursday. “I found it encouraging.”

Biolyse is hoping to use the provisions of Canada’s Access to Medicines Regime, or CAMR, a rarely used law that was introduced in 2004 to help Canadian companies produce life-saving medicine such as HIV drugs for humanitarian use in lower-income countries, even when these drugs are under patent by other companies.

If Biolyse can persuade the federal government to add COVID-19 vaccines to a required list under the Patent Act, it could proceed with making vaccines for export under a compulsory licence from the CAMR system, possibly using the vaccine technology that was patented by Johnson & Johnson or AstraZeneca.

This would create jobs in Canada, while helping the government fulfill its promise of helping poorer countries that have limited access to vaccines, Ms. Kiecken said in a letter to federal officials in late March.

The CAMR law has “basically been forgotten,” Mr. Fulton said. “The phone number was disconnected, and it took us a month to find someone. But if you can’t do this in the middle of a pandemic, when can you do it? People are dying. We don’t have time for niceties.”

Knowledge Ecology International, a U.S.-based non-profit group that focuses on social justice in intellectual property issues, said the CAMR process is “rife with unanswered questions and dead ends.”

It noted that the federal CAMR website contains only two contact numbers, of which one is an invalid number and the other did not respond. Application forms for compulsory licences under CAMR are not readily available, it said, and the entire application process is “convoluted and difficult.”

Riyadh Nazerally, a spokesperson for the Innovation, Science and Economic Development department, confirmed that federal officials met with Biolyse this week to discuss the compulsory licensing process.

The government has provided details to the company on the “regulatory and technical requirements” for applications under the CAMR process, he said.

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