This is the dude spreading this fear porn…..
April 8th, 2022 / 2:05 p.m.
John R. Fulton President, Spokesperson and Representative for Biolyse Pharma Corporation, BioNiagara
I'd like to start by thanking the Standing Committee on Industry and Technology for inviting me today. I am the president of BioNiagara in St. Catharines.
I'd like to make a little clarification. In the last meeting, they referred to BioNiagara as the company that wishes to produce a COVID-19 vaccine. It's actually Biolyse Pharma, a GMP and GLP industrial-level sterile fill injectable drug manufacturer based in St. Catharines.
In October 2005, during the bird flu H5N1 pandemic, there was a worldwide shortage of the patented antiviral drug oseltamivir, known as Tamiflu, which at the time was considered the only therapeutic with any effect on this killer virus. Biolyse quickly reverse-engineered Tamiflu and secured access to millions of Christmas trees, which contain the main ingredient necessary to fabricate this drug.
At the time, Roche's Tamiflu was under patent, and for Biolyse to scale production to meet the needs of this global crisis, a compulsory licence would have had to be issued by Industry Canada, now ISED, to protect Biolyse from litigation. After I contacted the director of patent policy in Ottawa, I discovered that there was legislation on the books that allowed generic manufacturers to produce patented medicines for global emergencies. This is currently known as Canada's access to medicines regime, or CAMR.
As of 2005, Biolyse would have been the first company in the world to attempt to have a drug manufactured using this emergency legislation. In 2003, under Prime Minister Jean Chrétien, Canada was the first country in the world to proudly adopt this legislation from the World Trade Organization's TRIPS agreement. In October 2006, seven months after applying to have oseltamivir added to schedule 1 of the Patent Act, which is the necessary first step in applying for a compulsory licence, it was successfully listed, and we were the first to achieve that.
By then, Canada and other countries had sent billions to Roche for their Tamiflu. Fortunately, by then, seven months later, after applying to have us added, the bird flu had ceased to be an immediate threat to Canadians and to the world's population. Unfortunately, now without a country in need, there was no market for our generic version of Tamiflu, and we abandoned the project.
Let's fast forward to March 1, 2021. When the COVID-19 pandemic hit in early 2020, the supply of the essential medicines and personal protective equipment became critical. The lack of domestic production capacity was a reality check for the Canadian government and its provinces. In response to the insecurity of global supply, a federal government COVID-19 vaccine task force was formed to seek out high-potential Canadian candidates for the manufacturing of vaccines.
In May 2020, Deloitte, the contractor, contacted Biolyse Pharma on behalf of the COVID-19 vaccine task force. Deloitte was ecstatic to have discovered one of the few remaining domestic manufacturers of sterile injectables in Canada, which was several years into the construction of a biologics manufacturing centre designed to produce monoclonal antibodies. As a result of Deloitte's inquiry, Biolyse pivoted to repurposing the facility for vaccine production.
Biolyse already had the available expertise and equipment to produce millions of doses of adenovirus vector or mRNA vaccines. At that time, Biolyse was also busy supplying Canadian hospitals and international health ministries with its sterile injectable medicines, while undergoing the major expansion of its 125,000-square-foot, seven-acre, St. Catharines-based manufacturing plant.
At the bequest of Deloitte, Biolyse put forth all the requested information to support its fill and finish capacity for specific vaccine platforms—more specifically, volume capacity at each stage of the production process, formulation, API production, filtration, filling, sealing, labelling, packaging and all types of specialized equipment readily available and on site for vaccine production.
The main advantage of Biolyse's response to the task force was that all the equipment and expertise necessary to fabricate biologics as well as the Health Canada licences to produce vaccines were immediately available and on site. For example, Biolyse has bioreactors up to 2,500 litres, numerous large industrial chromatography systems, multiple high-speed fill lines—it takes three years to get a fill line now if you want to purchase or fabricate it—and all the necessary GLP laboratories, water purification and air filtration systems required.
It's worth noting that such specialized equipment would generally take years to acquire, especially since ordering such equipment was nearly impossible during the pandemic due to global demand and supply chain chaos.
Considering the readiness of Biolyse with the potential of producing a minimum of 20 million and up to 80 million vaccine doses per year, supported by the existing equipment and its level two biosecurity, GMP-GLP facility, Biolyse and Deloitte determined that, with an investment from the federal government of as little as $4 million, which at the time would have been equivalent to a small PPE order, Biolyse could hire the necessary contractors and staff to accelerate the repurposing for vaccine production and, within four to six months, be in a position to attract one of the vaccine candidates that Biolyse had open dialogues with and were seeking to expand their production capacity.
It won’t be a woman, homosexual or transgender because that’s giving in and pandering to democrats. It will be someone who doesn’t say much, someone who listens without mouthing an opinion right away and is very analytical. He will dissect every word and body language which will make the deep state dough balls very nervous! Ben Carson does come to mind.
I am a widow living on Social Security and my husband’s pension. I am also a free-thinking, independent woman who definitely does NOT need a man in my home to feel safe and cared for!! Please don’t presume all women are cut from the same cloth…..a hard working life builds immense strength.
THEY WILL TRY BUT THEY WILL NOT BREAK HIM!! BARRON WILL UNDERSTAND.