Pfizer’s (PFE) Pfizer Canada and BioNTech SE have announced the initiation of a rolling submission to Health Canada for BNT162b2, the lead candidate from the companies’ vaccine development program against Covid-19.
According to the statement, the rolling submission has been accepted under the Minister of Health’s Interim Order allowing companies to submit safety and efficacy data and information as they become available. Often referred to as a rolling review, this allows Health Canada to start its review right away and accelerate the overall review process.
However, Health Canada is clear that it will not make a decision on whether to authorize any vaccine being considered under rolling review until it has received the necessary evidence to support its safety, efficacy and quality.
Following the authorization of any vaccine submission, Health Canada will publish the evidence it reviewed in making its decision.
The BNT162b2 vaccine candidate is based on BioNTech’s (BNTX) proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. It encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), which is a target of virus neutralizing antibodies.
The vaccine candidate is currently being evaluated in a global Phase 3 study ongoing at more than 120 clinical sites worldwide. To date, the trial has enrolled approximately 37,000 participants with more than 28,000 having received their second vaccination.
“Pfizer Canada and BioNTech will continue regular and open dialogue with Health Canada providing results from their ongoing Phase 3 study” the two companies state.
Shares in Pfizer have dropped 6% year-to-date, and the stock scores a cautiously optimistic Moderate Buy Street consensus. This is based on 3 Buy and 7 Hold ratings over the last three months, with an average price target of $41 (13% upside potential).
After attending the company’s recent investor presentation, Mizuho analyst Vamil Divan believes the event “successfully illustrated how the company is evolving into a ‘New Pfizer.’”
The analyst believes that Pfizer’s extensive pipeline of vaccines and treatments will generate over $15 billion of annual sales by 2025.
As for the Covid-19 vaccine collaboration with BioNTech, Divan said, “we are encouraged by the data to date and believe Pfizer remains on track to have a clear sense of the vaccine’s profile by the end of October, with potential FDA approval shortly thereafter.”
He believes the vaccine can generate risk-adjusted sales of roughly $1.7 billion next year and $1.2 billion in 2022. Overall, Divan rates PFE shares a Buy, along with a $43 price target (17% upside potential). (See Pfizer stock analysis on TipRanks)