Pfizer and BioNTech SE announced on Tuesday that the European Medicines Agency (EMA) has put BNT162b2, their mRNA-based vaccine candidate against SARS-CoV2, under a rolling review.
Pfizer shares are advancing 1.3% and BioNTech is jumping 10% in Tuesday’s pre-market trading. In a joint statement, Pfizer (PFE) and BioNTech said that the review follows “encouraging” preliminary results from pre-clinical and early clinical studies in adults, which suggest that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant T cells that target SARS-CoV-2. A combination of an antibody and T cell response is believed to be important in eliciting protection against viral infection and disease.
Pfizer and BioNTech (BNTX) said that they plan to cooperate with the EMA’s Committee for Medicinal Products for Human Use (CHMP) to complete the rolling review process, which is expected to facilitate the submission of the marketing authorization application (MAA) for BNT162b2.
As part of the rolling review, the CHMP has begun evaluating data generated in pre-clinical trials. Going forward, the CHMP reviews data as they become available from ongoing studies, before a complete application is submitted. By reviewing the data as they become available, the CHMP can reach its opinion sooner on whether, or not the investigational medicine or vaccine should be authorized. The EMA said that it will complete its assessment according to its usual standards for quality, safety and effectiveness.
After a positive opinion is adopted by the CHMP, the European Commission is the authority to grant a marketing authorization.
The BNT162b2 vaccine candidate is based on BioNTech’s 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 including the US, Brazil, South Africa and Argentina. To date, the trial has enrolled about 37,000 participants with more than 28,000 having received their second vaccination.
Preliminary data from the Phase 1/2 portions of the study have demonstrated that BNT162b2 was well tolerated with mild to moderate adverse events in all age groups. Assuming clinical success, Pfizer and BioNTech, plan to seek regulatory review for BNT162b2 as early as October 2020. Previously, the companies had said that, if regulatory approval is obtained, they would be seeking to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.
Shares in Pfizer are down 6.3% year-to-date, but the analyst consensus currently rates the stock a cautiously optimistic Moderate Buy. The rating is based on 4 Buy and 7 Holds over the last three months, with an average price target of $42.66.
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)
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