NEW YORK and MAINZ, Germany, Aug. 20, 2020 (GLOBE NEWSWIRE) — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) right this moment shared extra Section 1 security and immunogenicity knowledge from their ongoing U.S. examine of the BNT162 mRNA-based vaccine program towards SARS-CoV-2, which has superior into Section 2/Three analysis. The newly launched manuscript describes key security and immunogenicity knowledge from the U.S. Section 1 trial for the BNT162b2 vaccine candidate, which at 30ug recorded 7 days after the second dose elicited SARS-CoV-2-neutralizing geometric imply titers (GMTs) in youthful adults (18-55 years of age) that have been 3.Eight instances the GMT of a panel of 38 sera of SARS-CoV2 convalescent sufferers, and in older adults (65-85 years of age) the vaccine candidate elicited a neutralizing GMT 1.6 instances the GMT of the identical panel, demonstrating sturdy immunogenicity in youthful and older adults. Additional, throughout all populations, BNT162b2 administration was effectively tolerated with delicate to average fever in fewer than 20% of the individuals. As beforehand introduced, these knowledge knowledgeable the businesses’ choice to advance a 2-dose routine of the 30µg dose stage of BNT162b2, which encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), right into a Section 2/Three analysis. The manuscript is now obtainable on a web-based preprint server at and is concurrently present process scientific peer evaluate for potential publication.
The businesses are persevering with to investigate knowledge from the Section 1 trials within the U.S. and Germany. T cell immune responses elicited by BNT162b2 are being evaluated within the German examine and the businesses count on to submit the info for peer evaluate and potential publication. The businesses beforehand introduced that BNT162b2-vaccinated human individuals displayed a positive breadth of epitopes acknowledged in T cell responses particular to the SARS-CoV-2 spike antigen, as in comparison with the BNT162b1 candidate, and that BNT162b2 demonstrated concurrent induction of excessive magnitude CD4+ and CD8+ T cell responses towards the receptor binding area (RBD) and towards the rest of the spike glycoprotein that isn’t contained within the BNT162b1 vaccine candidate.
“The totality of the scientific and preclinical knowledge knowledgeable Pfizer and BioNTech’s choice to pick out BNT162b2 because the lead candidate to advance into pivotal trials. We’re proud to share our findings with the scientific neighborhood as we proceed our work to ship a secure and efficient vaccine to fight this devastating virus,” mentioned Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Analysis & Growth, Pfizer. “We’re particularly happy to supply these early knowledge displaying our vaccine candidate’s promising security and immunogenicity profile from the U.S. trial and we look ahead to sharing T cell immune response knowledge from the German trial within the close to future.”
“It is very important us to proceed sharing knowledge and associated info on our COVID-19 vaccine lead candidate,” mentioned Ugur Sahin, M.D., CEO and Co-Founding father of BioNTech. “The favorable security profile of BNT162b2 and the breadth of T cell responses we beforehand introduced have supported our choice to pick out this candidate for the pivotal Section 2/Three examine. As of right this moment, we’ve got already dosed greater than 11,000 individuals with BNT162b2 in that examine.”
The extra knowledge from the continuing U.S. Section 1 randomized, placebo-controlled, observer-blinded examine was utilized to guage the protection and immunogenicity of various dose ranges of BNT162b1 and BNT162b2 in 195 individuals randomized into 13 teams of 15 individuals (per group, 12 acquired the vaccine and three the placebo). Teams of individuals 18 to 55 years of age and 65 to 85 years of age acquired 10μg, 20μg, or 30μg dose ranges of BNT162b1 or BNT162b2 on a 2-dose schedule, 21 days aside.
In each youthful and older adults, BNT162b1 and BNT162b2 elicited comparable dose-dependent SARS-CoV-2–neutralizing antibody GMTs, which have been considerably elevated after the second dose, displaying clear good thing about a 2-dose routine. Though each vaccine candidates elicited decrease antigen-binding IgG (Immunoglobulin G) and neutralizing responses in older adults (65 to 85 years of age), in comparison with youthful adults (18 to 55 years of age), the neutralizing antibody GMTs measured 7 days after Dose 2 of 30μg of BNT162b1 or BNT162b2 in individuals 65 to 85 years previous have been similar to or greater than the GMT of a panel of SARS-CoV-2 convalescent sera from 38 sufferers (18 to 83 years of age) who had contracted SARS-CoV-2.
Individuals 18 to 55 years previous who acquired 10μg, 20μg, or 30μg of BNT162b1 reported delicate to average native reactions, primarily ache on the injection website, inside 7 days after an injection which have been extra frequent after Dose 2. In individuals 65 to 85 years previous, BNT162b1 elicited comparable, however milder, native reactions, with delicate to average injection website ache reported by 92% after Dose 1 and 75% after Dose 2. The same sample was noticed after vaccination with BNT162b2. No older grownup who acquired BNT162b2 reported redness or swelling. No participant who acquired both vaccine candidate reported a Grade four native response.
Systemic occasions after administration of BNT162b2 have been milder than these with BNT162b1. Total, after Dose 1, systemic occasions reported by individuals 65 to 85 years previous who acquired BNT162b2 have been just like these reported by those that acquired placebo. After Dose 2 of 30μg BNT162b2, solely 17% of individuals 18 to 55 years previous and eight% of individuals 65 to 85 years previous reported fever (≥38.zero to 38.9 °C), in comparison with 75% of 18 to 55 12 months previous individuals and 33% of 65 to 85 12 months previous individuals administered a second dose of 30μg of BNT162b1. Extreme systemic occasions (fatigue, headache, chills, muscle ache, and joint ache) have been reported in small numbers of youthful BNT162b2 recipients and have been transient and manageable. No extreme systemic occasions have been reported by older BNT162b2 recipients. There have been no experiences of Grade four systemic occasions by any BNT162 recipient.
The totality of information contributed to the choice by Pfizer and BioNTech to start the worldwide (aside from China) Section 2/Three security and efficacy portion of the scientific examine to guage BNT162b2 towards COVID-19. The examine is now actively enrolling within the U.S., Argentina and Brazil. Further enrollment is deliberate in Germany, Turkey and South Africa. The examine is an event-driven trial that’s deliberate to enroll as much as 30,000 individuals between 18 and 85 years of age. The Section 2/Three trial enrollment up to now has exceeded 11,000 individuals with a second dose underway.
Pfizer and BioNTech are dedicated to lowering well being disparities in underrepresented populations by way of the scientific trial course of. To that finish, many investigator websites are in numerous communities which were disproportionately affected by COVID-19 in order that people who’ve been most impacted have the chance to take part. The businesses are additionally working along with investigator websites and advocacy companions to lift consciousness concerning the significance of participation on this trial.
BNT162b2 stays underneath scientific examine and isn’t presently accredited for distribution anyplace on the earth. Assuming scientific success, Pfizer and BioNTech are on observe to hunt regulatory evaluate for BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, presently plan to provide as much as 100 million doses worldwide by the tip of 2020 and roughly 1.Three billion doses by the tip of 2021. These eager about studying extra concerning the examine can go to utilizing the quantity NCT04368728.
About Pfizer: Breakthroughs That Change Sufferers’ Lives
At Pfizer, we apply science and our international assets to carry therapies to folks that stretch and considerably enhance their lives. We try to set the usual for high quality, security and worth within the discovery, growth and manufacture of well being care merchandise, together with revolutionary medicines and vaccines. On daily basis, Pfizer colleagues work throughout developed and rising markets to advance wellness, prevention, remedies and cures that problem essentially the most feared ailments of our time. According to our accountability as one of many world’s premier revolutionary biopharmaceutical firms, we collaborate with well being care suppliers, governments and native communities to help and develop entry to dependable, reasonably priced well being care around the globe. For greater than 150 years, we’ve got labored to make a distinction for all who depend on us. We routinely publish info that could be necessary to traders on our web site at As well as, to study extra, please go to us on and comply with us on Twitter at @Pfizer and @Pfizer Information, LinkedIn, YouTube and like us on Fb at
Pfizer Disclosure Discover
The data contained on this launch is as of August 20, 2020. Pfizer assumes no obligation to replace forward-looking statements contained on this launch as the results of new info or future occasions or developments.
This launch incorporates forward-looking details about Pfizer’s efforts to fight COVID-19, the collaboration between BioNTech and Pfizer to develop a possible COVID-19 vaccine, the BNT162 mRNA vaccine program, and modRNA candidates BNT162b2 and BNT162b1 (together with qualitative assessments of accessible knowledge, potential advantages, expectations for scientific trials and timing of regulatory submissions, and anticipated manufacturing, provide and distribution), that entails substantial dangers and uncertainties that might trigger precise outcomes to vary materially from these expressed or implied by such statements. Dangers and uncertainties embody, amongst different issues, the uncertainties inherent in analysis and growth, together with the power to fulfill anticipated scientific endpoints, graduation and/or completion dates for scientific trials, regulatory submission dates, regulatory approval dates and/or launch dates, in addition to dangers related to preliminary knowledge, together with the potential of unfavorable new preclinical or scientific trial knowledge and additional analyses of present preclinical or scientific trial knowledge that could be inconsistent with the info used for choice of the BNT162b2 vaccine candidate and dose stage for the Section 2/Three examine; the danger that scientific trial knowledge are topic to differing interpretations and assessments, together with through the peer evaluate/publication course of, within the scientific neighborhood typically, and by regulatory authorities; whether or not and when knowledge from the BNT162 mRNA vaccine program will probably be revealed in scientific journal publications and, in that case, when and with what modifications; whether or not regulatory authorities will probably be glad with the design of and outcomes from these and future preclinical and scientific research; whether or not and when any biologics license and/or emergency use authorization purposes could also be filed in any jurisdictions for BNT162b2 or another potential vaccine candidates; whether or not and when any such purposes could also be accredited by regulatory authorities, which is able to rely on myriad elements, together with making a willpower as as to whether the vaccine candidate’s advantages outweigh its recognized dangers and willpower of the vaccine candidate’s efficacy and, if accredited, whether or not it is going to be commercially profitable; choices by regulatory authorities impacting labeling, manufacturing processes, security and/or different issues that might have an effect on the supply or business potential of a vaccine, together with growth of merchandise or therapies by different firms; manufacturing capabilities or capability, together with whether or not the estimated numbers of doses may be manufactured inside the projected time intervals indicated; whether or not and when extra provide agreements will probably be reached; uncertainties concerning the power to acquire suggestions from vaccine technical committees and different public well being authorities and uncertainties concerning the business affect of any such suggestions; and aggressive developments.
An additional description of dangers and uncertainties may be present in Pfizer’s Annual Report on Kind 10-Ok for the fiscal 12 months ended December 31, 2019 and in its subsequent experiences on Kind 10-Q, together with within the sections thereof captioned “Danger Components” and “Ahead-Wanting Info and Components That Might Have an effect on Future Outcomes”, in addition to in its subsequent experiences on Kind 8-Ok, all of that are filed with the U.S. Securities and Alternate Fee and obtainable at and
Biopharmaceutical New Applied sciences is a subsequent era immunotherapy firm pioneering novel therapies for most cancers and different critical ailments. The Firm exploits a big selection of computational discovery and therapeutic drug platforms for the fast growth of novel biopharmaceuticals. Its broad portfolio of oncology product candidates contains 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. Based mostly 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 ailments alongside its numerous oncology pipeline. BioNTech has established a broad set of relationships with a number of international pharmaceutical collaborators, together with Genmab, Sanofi, Bayer Animal Well being, Genentech, a member of the Roche Group, Genevant, Fosun Pharma, and Pfizer. For extra info, please go to
BioNTech Ahead-looking statements
This press launch incorporates “forward-looking statements” of BioNTech inside the which means of the Personal Securities Litigation Reform Act of 1995. These forward-looking statements could embody, however might not be restricted to, statements regarding: BioNTech’s efforts to fight COVID-19; the potential variety of websites and individuals in our Section 2b/Three trial; the collaboration between BioNTech and Pfizer to develop a possible COVID-19 vaccine; our expectations concerning the potential traits of BNT162b2 in our Section 2b/Three trial and/or in business use based mostly on knowledge observations up to now, together with anticipated benefits over BNT162b1; the timing for any potential emergency use authorizations or approvals; and the power of BioNTech to provide the portions of BNT162 to help scientific growth and, if accredited, market demand, together with our manufacturing estimates for 2020 and 2021. Any forward-looking statements on this press launch are based mostly on BioNTech present expectations and beliefs of future occasions, and are topic to numerous dangers and uncertainties that might trigger precise outcomes to vary materially and adversely from these set forth in or implied by such forward-looking statements. These dangers and uncertainties embody, however will not be restricted to: competitors to create a vaccine for COVID-19; the power to supply comparable scientific leads to bigger and extra numerous scientific 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 on the market on the SEC’s web site at All info on this press launch is as of the date of the discharge, and BioNTech undertakes no obligation to replace this info except required by legislation.
Posted: August 2020
BNT162 (SARS-CoV-2 vaccine) FDA Approval Historical past