Thank you very much.
Thank you for the opportunity to join you today. Messenger RNA is the most effective vaccine technology on the planet. In the worldwide race for a COVID vaccine, messenger RNA was the fastest by months. It is the most effective at 95% efficacy. It will be the fastest vaccine platform to respond to variants. It is the most scalable vaccine technology, having gone from novel technology to rolling out hundreds of millions of doses within a single year.
The committee will recall that prior to November 2020, no messenger RNA drug—vaccine or otherwise—had ever been approved for use in humans. In fact, prior to 2020, Moderna and BioNTech, the inventor of the Pfizer vaccine, had never even run a phase three trial. However, these previously untested and unproven companies are now providing Canada a lifeline to safety and economic stability.
Providence Therapeutics looks forward to joining these companies and adding to the worldwide supply of mRNA vaccines in early 2022. I would be remiss if I did not add that Providence has always been committed to prioritizing Canada's needs. Certainly, it is clear that Canada will need additional vaccines in 2022, as the current vaccines are not up to the task of suppressing the variants.
Let me recap the progress that Providence has made over the past year. Providence designed a vaccine in under four weeks. We negotiated and paid for the licence to the necessary intellectual property with Genevant of Vancouver. We established productive collaborations with the University of Toronto, Sunnybrook Research Institute and the Ontario Institute for Cancer Research. We completed over five preclinical animal trials to establish the safety and efficacy of our vaccine. After we qualified our good manufacturing practices, or GMP, we manufactured enough vaccine to complete all of our early clinical trials. Our phase one trial has been fully enrolled. Our last patient visit for follow-up is scheduled for April 20 of this month. The final results will be unblinded and available to the public in approximately six weeks.
In the meantime, we have provided limited access to the Government of Canada via the strategic innovation fund and the National Research Council, plus the provinces of Alberta and Manitoba, as these groups evaluate opportunities to support phase two and three trials and manufacturing scale-up for commercialization. I am pleased to advise the committee that Providence has a vaccine that is on track to being best in class when compared with Pfizer and Moderna, specifically in the areas of tolerability, stability and immune response.
Providence met with Health Canada on March 18 for a preclinical trial application, or pre-CTA meeting, to lay the groundwork for phase two and three trials in Canada. These trials will be non-inferiority or comparator trials wherein the Providence vaccine will be tested directly, head to head, against an approved vaccine. The primary readout will be a surrogate marker of immunity. This will allow Providence to run these trials in Canada. All participants will receive a vaccine, either Providence or competitor, and no participant will be given a placebo.
One critical item required for these trials that has not been resolved yet is that Providence must have access to the competitor vaccine to run the trial. We approached the Canadian government and were instructed to ask the company in question. We did. We have been informed that they are not willing to provide doses. We have circled back with the Canadian government and are currently waiting for a further reply. It has been suggested that we should speak to the provinces. We have. However, because this is a multi-provincial trial, it would be difficult to guarantee that all doses came from the same production lot.
It is Providence's opinion that if the Canadian government is committed to supporting R and D and trials in Canada, then providing access to doses should reasonably fall within its responsibilities. We respectfully ask specifically for that practical support, keeping in mind that all doses received will in fact be administered to Canadians in the end.
This committee and other witnesses are certainly aware that COVID variants are currently threatening the success of Canada's vaccine rollout.
I would like to state for the record that Providence has been warning of this outcome for months and in fact brought up the need for a broader-based vaccine to the Government of Canada back in March 2020.
Providence has a funding application currently under review with the NRC to advance a variant vaccine forward to approval by Q1 of 2022. This variant add-on trial is set to start in October 2021. This is relevant, as right now variants are successfully evading the currently approved vaccines and Canadians will need these variant vaccines as early as possible in 2022.
If Canada desires to avoid future loss of life and lockdowns with all the attendant economic and mental suffering, absent a broad-based universal COVID vaccine, updated variant vaccines will be required yearly for the foreseeable future.
As I am speaking to the finance committee, I will note that Canada's financial contribution received in 2020 from the NRC and NGen totalled $1.6 million. In 2021, Providence has received $1.8 million to date from Canada. The total authorized refund amounts awarded to Providence to date are $4.9 million from the NRC phase one grant, and $3.5 million from NGen.
I look forward to your questions. Thank you.