Pfizer Inc (NYSE: PFE) and its associate BioNTech SE (Nasdaq: BNTX) garnered the market’s attention on Friday following the release of supplement positive info related to their second COVID-19 vaccine candidate trial and reaffirmed their plan to call for a regulatory review in October.
Beginning June, Pfizer had repeatedly been saying that it is aiming to apply for a review in October, and the enterprises began massive final-phase research in July for its vaccine candidate, one of the handfuls across the world in final stages of development.
Notably, despite the lead, the stock is down 1% in 2020, lagging behind stellar rallies of stock representing several top pharmaceutical firms. The stock of Pfizer closed at $38.88, up $0.16 or 0.41% from the prior close. BioNTech ended Friday’s trading at $73.02, reflecting a gain of $6.75 or 10.19%.
The New York-based Pfizer and Mainz, Germany-based BioNTech, have released Phase I clinical trial data for their second COVID-19 vaccine candidate BNT162b2, reflecting adequate safety and immunogenicity. Specifically, the data indicated that the vaccine candidate demonstrated comparable immune responses and negligible side effects than the other vaccine candidate BNT162b1, whose data was released ten days ago.
The latest data indicated that 30μg of BNT162b2, a week after the second dose, stimulated SARS-CoV-2-nullifying geometric mean titers (GMTs) in adults in the age group of 18-55 years.
The value was 3.8x in the GMT of a group of “38 sera of convalescent patients.” In older people aged between 65 and 85 years, the vaccine candidate induced a nullifying GMT 1.6x in the aforesaid group, documenting robust immunogenicity in the validated segment of patients.
Furthermore, patients were able to tolerate the vaccine candidate, with slight to moderate fever in less than 20% of the volunteers. Based on this data, the companies have planned to begin Phase II/III testing involving a two-dose treatment of 30µg BNT162b. Currently, the companies are signing up volunteers in Brazil, Argentina, and the US.
Regarding the outcome of the clinical trial, Kathrin Jansen, Pfizer senior vice president and vaccine research and development head, said, “The totality of the clinical and preclinical data-informed Pfizer and BioNTech’s decision to select BNT162b2 as the lead candidate to advance into pivotal trials. We are proud to share our findings with the scientific community as we continue our work to deliver a safe and effective vaccine to combat this devastating virus. We are especially pleased to offer these early data showing our vaccine candidate’s promising safety and immunogenicity profile from the US trial and we look forward to sharing T cell immune response data from the German trial in the near future.”
In the case of younger and older participants, the drug candidates were seen to demonstrate comparable dose-dependent SARS-CoV-2-nullifying antibody GMTs, which got increased after the second dose, reflecting the advantages of a two-dose therapy.
Other pharmaceutical enterprises which have entered into late-stage trials are Moderna and Britain’s AstraZeneca. Regarding the clinical trial data, Chris Bailey, Raymond James European Strategist, stated that the Pfizer/BioNTech data had paved the way for the creation of bullish sentiment on stock markets.
Ten days ago, Pfizer and BioNTech had reported positive outcomes on the continuing Phase I/II clinical trial of BNT162b1, another mRNA-based COVID-19 vaccine candidate. The data pertains to clinical trials conducted in the US. BNT162b1 is a “nucleoside-modified messenger RNA (modRNA) candidate” developed to encipher an “optimized SARS-CoV-2 receptor-binding domain (RBD) antigen.” The vaccine candidate enciphers an “optimized SARS-Co-V-2 full-length spike glycoprotein (S).”
Regarding the better immune profile of William Gruber, the senior vice president of vaccine clinical research and development at Pfizer, said, “Obviously, the better tolerated the vaccine, the more I think it will encourage public acceptance of a broad immunization. Both would have been great candidates. We were fortunate that B2 actually satisfied having both a favorable immune profile and fewer reactions.”
Currently, Pfizer and BioNTech are validating the outcome of the Phase I trials of COVID-19 drug candidates in the US and Germany.
Furthermore, additional info from the continuing US Phase I study was utilized to validate the safety and immunogenicity of 10μg, 20μg or 30μg dose levels of BNT162b1 and BNT162b2 in 195 volunteers. Pfizer published the peer-reviewed data in the Nature journal.
The successful outcome of the Phase I clinical trial is expected to turn the stock range-bound with a slight bullish bias in the short-term.
Technically, the stock has bounced off the support at 33. The next resistance is anticipated only near 42. The stochastic oscillator is in the bullish zone, while the stock is trading above its 50-day moving average. Therefore, we are anticipating the stock to move up in the short-term.
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