NEW YORK and MAINZ, GERMANY, August 12, 2020 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) at present introduced that preliminary, peer-reviewed knowledge from their BNT162 mRNA-based vaccine growth program, Mission Lightspeed, towards SARS-CoV-2, had been revealed on-line within the journal Nature. These preliminary medical knowledge on BNT162b1, a nucleoside-modified messenger RNA (modRNA) candidate that encodes an optimized SARS-CoV-2 receptor binding area (RBD) antigen, confirmed that BNT162b1 was administered in a dose that was effectively tolerated and generated dose-dependent immunogenicity, as measured by RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titers. These knowledge had been made accessible to the general public on July 1, 2020 by way of a web based preprint server, medRxiv. For added particulars, please learn the beforehand issued press launch.
The posted preprint model of the manuscript reported that, by 7 days after the second dose, 30µg of BNT162b1 elicited a SARS-CoV-2 neutralizing geometric imply titer (GMT) 2.8-times the GMT of a SARS-CoV-2 convalescent human serum panel. Primarily based on new knowledge, the ultimate, peer-reviewed paper reviews that neutralizing titers continued to rise, and, by 14 days after the second dose of 30µg, the contributors’ GMT was 4.6-times the convalescent serum panel GMT.
“The publication of peer-reviewed knowledge from our mRNA-based vaccine growth program towards SARS-CoV-2 in a world-renowned publication like Nature gives additional validation of our speedy progress towards creating a protected and efficient potential vaccine to assist deal with this present pandemic,” mentioned Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Analysis & Improvement, Pfizer. “We’re inspired by the general development of this system and look ahead to producing further knowledge from our ongoing research.”
“Since our inception, we’ve been deeply grounded in science, which makes sharing our knowledge in a peer-reviewed publication like Nature an much more necessary milestone. The scientific rigor of our method is key through the present pandemic. Supporting the rising physique of data is instrumental for locating solutions to profit world well being,” mentioned Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We purpose to repeatedly observe that scientific rigor in reporting further knowledge from our world trials, that are ongoing at greater than 100 medical websites worldwide. Our purpose stays to convey a protected and efficacious vaccine to the worldwide group.”
The businesses are additionally persevering with the peer-review course of for preliminary knowledge posted to the medRxiv preprint server for BNT162b1 from the German Section 1/2, open-label, non-randomized, non-placebo-controlled, dose-escalation trial.
Pfizer and BioNTech just lately chosen BNT162b2 because the vaccine candidate to progress to a Section 2/three research, which is now enrolling. BNT162b2 was chosen primarily based on the totality of obtainable knowledge from preclinical and medical research, together with choose immune response and tolerability parameters in comparison with the BNT162b1 candidate. The businesses are persevering with to gather knowledge from the Section 1/2 trials and count on to submit knowledge on BNT162b2 for peer-review and potential publication within the close to future. Consistent with their dedication to transparency, the businesses intend to additionally put up the manuscript on a preprint server at the moment.
The Section 2/three research is an event-driven trial that’s deliberate to enroll as much as 30,000 contributors between 18 and 85 years of age. The businesses plan to enroll a various inhabitants, together with contributors in areas the place there’s important anticipated SARS-CoV-2 transmission. For additional details about this trial, go to utilizing the quantity NCT04368728.
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Pfizer Disclosure Discover
The knowledge contained on this launch is as of August 12, 2020. Pfizer assumes no obligation to replace data or forward-looking statements contained on this launch as the results of new data or future occasions or developments.
This launch accommodates forward-looking details about Pfizer’s efforts to fight COVID-19, the BNT162 mRNA vaccine program, and a collaboration between BioNTech and Pfizer to develop a possible COVID-19 vaccine, together with their potential advantages, anticipated publication of information, manufacturing and distribution and the anticipated timing of medical trials, that entails substantial dangers and uncertainties that would trigger precise outcomes to vary materially from these expressed or implied by such statements. Dangers and uncertainties embrace, amongst different issues, the uncertainties inherent in analysis and growth, together with the power to satisfy anticipated medical endpoints, graduation and/or completion dates for medical trials, regulatory submission dates, regulatory approval dates and/or launch dates, in addition to the opportunity of unfavorable new preclinical or medical trial knowledge and additional analyses of current preclinical or medical trial knowledge; dangers related to preliminary knowledge; the danger that medical trial knowledge are topic to differing interpretations and assessments, together with through the peer assessment/publication course of, within the scientific group typically, and by regulatory authorities; whether or not the scientific journal publications referenced above will happen and, if that’s the case, when and with what modifications; whether or not regulatory authorities can be happy with the design of and outcomes from these and future preclinical and medical research; whether or not and when any biologics license purposes could also be filed in any jurisdictions for any potential vaccine candidates below the collaboration; whether or not and when any such purposes could also be permitted by regulatory authorities, which is able to rely upon myriad elements, together with making a willpower as as to whether the product’s advantages outweigh its identified dangers and willpower of the product’s efficacy and, if permitted, whether or not any such vaccine candidates can be commercially profitable; choices by regulatory authorities impacting labeling, manufacturing processes, security and/or different issues that would have an effect on the provision or industrial potential of any such vaccine candidates, together with growth of merchandise or therapies by different firms; manufacturing capabilities or capability, together with whether or not the estimated numbers of doses might be manufactured inside the projected time intervals indicated; uncertainties relating to the power to acquire suggestions from vaccine technical committees and different public well being authorities relating to any such vaccine candidates and uncertainties relating to the industrial influence of any such suggestions; and aggressive developments.
An additional description of dangers and uncertainties might be present in Pfizer’s Annual Report on Kind 10-Okay for the fiscal 12 months ended December 31, 2019 and in its subsequent reviews on Kind 10-Q, together with within the sections thereof captioned “Danger Components” and “Ahead-Wanting Data and Components That Could Have an effect on Future Outcomes,” in addition to in its subsequent reviews on Kind 8-Okay, all of that are filed with the U.S. Securities and Trade Fee and accessible at and
Biopharmaceutical New Applied sciences is a subsequent era immunotherapy firm pioneering novel therapies for most cancers and different severe illnesses. The Firm exploits a big selection of computational discovery and therapeutic drug platforms for the speedy growth of novel biopharmaceuticals. Its broad portfolio of oncology product candidates consists of individualized and off-the-shelf mRNA-based therapies, revolutionary chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, focused most cancers antibodies and small molecules. Primarily based on its deep experience in mRNA vaccine growth and in-house manufacturing capabilities, BioNTech and its collaborators are creating a number of mRNA vaccine candidates for a spread of infectious illnesses alongside its various oncology pipeline. BioNTech has established a broad set of relationships with a number of world pharmaceutical collaborators, together with Genmab, Sanofi, Bayer Animal Well being, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.
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BioNTech Ahead-looking Statements
This press launch accommodates “forward-looking statements” of BioNTech inside the which means of the Personal Securities Litigation Reform Act of 1995. These forward-looking statements could embrace, however will not be restricted to, statements regarding: BioNTech’s efforts to fight COVID-19; the potential variety of websites and contributors in our Section 2/three trial; the collaboration between BioNTech and Pfizer to develop a possible COVID-19 vaccine; and our expectations relating to the potential traits of BNT162b2 in our Section 2/three trial and/or in industrial use primarily based on knowledge observations so far, together with anticipated benefits over BNT162b1. Any forward-looking statements on this press launch are primarily based on BioNTech present expectations and beliefs of future occasions, and are topic to a variety of dangers and uncertainties that would trigger precise outcomes to vary materially and adversely from these set forth in or implied by such forward-looking statements. These dangers and uncertainties embrace, however aren’t restricted to: competitors to create a vaccine for COVID-19; the power to supply comparable medical leads to bigger and extra various medical trials; the power to successfully scale our productions capabilities; and different potential difficulties. For a dialogue of those and different dangers and uncertainties, see BioNTech’s Annual Report on Kind 20-F filed with the SEC on March 31, 2020, which is out there on the SEC’s web site at All data on this press launch is as of the date of the discharge, and BioNTech undertakes no responsibility to replace this data except required by legislation.
Posted: August 2020
BNT162 (SARS-CoV-2 vaccine) FDA Approval Historical past