PTX-COVID19-B

Human trials began on January 26, 2021 with 60 volunteers between the ages of 18 to 65 in Toronto.[12][13][3] Of these, 15 would receive a placebo and 3 groups of 15 would receive different doses of the vaccine.[10] The volunteers will be monitored for 13 months. The company said that enough data would be available in May which could result in a Phase 2 clinical testing beginning soon after that, pending regulatory approval. If the results of a subsequent larger human trial are positive, the vaccine could enter a commercialization phase in 2022.[14] The Phase 1 clinical trial lead was Piyush Patel. At the 29 April meeting with the House of Commons, Sorenson estimated that PTX-COVID19-B could be approved by Health Canada by "January or February 2022".[15]^: 8

Shortly after the first human trials on PTX-COVID19-B began in late January, on 11 February 2021, Manitoba Premier Brian Pallister announced a "term sheet" between the province and Providence Therapeutics through which Manitoba would receive 2 million doses of PTX-COVID19-B pending its approval by Health Canada.[11] The term sheet includes "best-price guarantee" PTX-COVID19-B.[13] According to a provincial statement released by the Manitoba government, pending approval of the vaccine, the actual manufacturing would take place in Winnipeg by Emergent BioSolutions.[11] Pallister said that, "Building a secure, made-in-Canada vaccine supply will put Canadians at the head of the line to get a COVID vaccine, where we belong."[11] The down payment would be 20% with a subsequent 40% to be paid when the vaccine was approved by Health Canada; the balance would be paid on delivery of the doses.[13] Specifics about the contract were released in April 2021: the total cost was estimated as CAD $36 million and the agreement included a clause for a non-refundable advance payment of CAD $7.2 million.[2] Sorenson made this comment to Global News: "Under no circumstances is Manitoba going to be on the hook for $7.2 million unless they get real value out of it".

Canada's National Research Council (NRC) provided Providence Therapeutics with CAD $5 million for the launch of January 2021 first phase of PTX-COVID19-B clinical trials.[2]

As part of the federal government's "next generation manufacturing supercluster" program, Providence and Northern mRNA had also been "cleared to access up to $5 million" towards the manufacturing start up process, according to a federal government spokesperson.[2]The CBC report in late April 2021 also stated that "it could be eligible for a slice of $113 million in additional funding from the National Research Council of Canada Industrial Research Assistance Program". The federal government had provided funding to some other companies in Canada that were also working to develop a COVID-19 vaccine.[2]

Sorenson as Providence Therapeutics CEO posted an open letter to Prime Minister Justin Trudeau, in which he requested $CDN 150 million upfront to be used to pay for clinical trial and material costs.[16][9]

On 29 April 2021, Sorenson appeared before the House of Commons standing committee on international trade, to ask the Minister of Procurement, Anita Anand, to consider PTX-COVID19-B as an alternative to Moderna and Pfizer for the "2022 booster vaccines".[15] Sorenson said that the NRC had approached Providence Therapeutics in 2020 after the company had announced their Phase I trial PTX-COVID19-B. Sorenson told the Standing Committee that, "We've had really good dialogue ever since phase I started. That process has gone on. That started probably [in February], as we geared up to conclude our phase I trial and release data. Although the NRC is capped at $10 million, which is certainly not sufficient to carry out phase II and phase III trials, the NRC has, through the bureaucracy, elevated us back up to the strategic innovation fund. That occurred about three weeks ago. We're now working with the strategic innovation fund."[15]^: 7

He later said that no reply had been received from the government.[17]

In a meeting with the federal COVID-19 vaccine task force and Sorenson, task force members expressed concerns that "Providence might not be able to scale up production fast enough".[2]