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NEW YORK & MAINZ, Germany–(BUSINESS WIRE) July 27, 2020 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) immediately introduced the beginning of a world (aside from China) Section 2/three security and efficacy medical research to judge a single nucleoside-modified messenger RNA (modRNA) candidate from their BNT162 mRNA-based vaccine program towards SARS-CoV-2.

After in depth evaluation of preclinical and medical information from Section 1/2 medical trials, and in session with the U.S. Meals and Drug Administration’s Middle for Biologics Analysis and Analysis (CBER) and different world regulators, Pfizer and BioNTech have chosen to advance their BNT162b2 vaccine candidate into the Section 2/three research, at a 30 µg dose stage in a 2 dose routine. BNT162b2, which just lately acquired U.S. Meals and Drug Administration (FDA) Quick Observe designation, encodes an optimized SARS-CoV-2 full size spike glycoprotein (S), which is the goal of virus neutralizing antibodies.

“Our collection of the BNT162b2 vaccine candidate and its development right into a Section 2/three research are the end result of an intensive, collaborative and unprecedented R&D program involving Pfizer, BioNTech, medical investigators, and research members with a singular focus of growing a protected and efficient COVID-19 RNA vaccine. The Section 2/three research protocol follows all of the U.S. Meals and Drug Administration (FDA) steerage on medical trial design for COVID-19 vaccine research,” stated Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Analysis & Growth, Pfizer. “The initiation of the Section 2/three trial is a significant step ahead in our progress towards offering a possible vaccine to assist combat the continued COVID-19 pandemic, and we look ahead to producing extra information as this system progresses.”

“At the moment, we’re beginning our late-stage world research, which can embody as much as 30,000 members. We chosen BNT162b2 as our lead candidate for this Section 2/three trial upon diligent analysis of the totality of the info generated to date. This resolution displays our major purpose to convey a well-tolerated, extremely efficient vaccine to the market as rapidly as potential, whereas we are going to proceed to judge our different vaccine candidates as a part of a differentiated COVID-19 vaccine portfolio,” stated Ugur Sahin, M.D., CEO and Co-Founding father of BioNTech. “Many steps have been taken in the direction of this necessary milestone and we wish to thank all these concerned for his or her extraordinary dedication.”

In regards to the BNT162b2 Candidate

Throughout preclinical and medical research of 4 BNT162 RNA vaccine candidates, BNT162b1 and BNT162b2 emerged as robust candidates based mostly on assessments of security and immune response. Pfizer and BioNTech chosen BNT162b2 because the candidate to progress to a Section 2/three research based mostly on the totality of obtainable information from our preclinical and medical research, together with choose immune response and tolerability parameters.

Within the preclinical research, BNT162b1 and BNT162b2 candidates induced favorable viral antigen particular CD4+ and CD8+T cell responses, excessive ranges of neutralizing antibody in numerous animal species, and useful protecting results in a primate SARS-CoV-2 problem mannequin.

Preliminary medical Section 1/2 information from almost 120 sufferers demonstrated a good total tolerability profile for BNT162b2, as in comparison with BNT162b1, with usually delicate to average and transient (1-2 days) systemic occasions, comparable to fever, fatigue and chills and no critical opposed occasions. Two 30 µg doses of BNT162b2 elicited neutralizing geometric imply titers (GMTs) usually just like the GMTs that had been elicited by the BNT162b1 vaccine candidate, as mirrored in information the businesses have beforehand posted on a preprint server. In older adults (65-85 years of age), two 30 µg doses, spaced three weeks aside, elicited a neutralizing antibody GMT greater than the GMT in a panel of 38 sera from topics who had contracted SARS-CoV-2. BNT162b2 vaccinated human members displayed a good breadth of epitopes acknowledged in T cell responses particular to the SARS-CoV-2 antigen, as in comparison with the BNT162b1 candidate. BNT162b2 demonstrated concurrent induction of excessive magnitude CD4+ and CD8+ T cell responses. BNT162b2 elicited 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 businesses consider that immune recognition of extra spike T cell epitopes could have the potential to generate extra constant responses throughout numerous populations and in older adults.

The businesses are persevering with to gather information from the Section 1/2 trials for all 4 vaccine candidates and count on to submit information on BNT162b2 for peer evaluation and potential publication within the close to future. Consistent with their dedication to transparency, the businesses intend to additionally publish the manuscript on a preprint server at the moment.

In regards to the Section 2/three Examine

Pfizer and BioNTech finalized the Section 2/three research protocol in response to suggestions from world regulators, together with the FDA and the German Paul-Ehrlich-Institut. The Section 2/three research is an occasion pushed trial that’s deliberate to enroll as much as 30,000 members between 18 and 85 years of age. The businesses plan to enroll a various inhabitants, together with members in areas the place there may be important anticipated SARS-CoV-2 transmission.

The Section 2/three trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded research to acquire security, immune response, and efficacy information wanted for regulatory evaluation. The trial’s major endpoints will probably be prevention of COVID-19 in those that haven’t been contaminated by SARS-CoV-2 previous to immunization, and prevention of COVID-19 no matter whether or not members have beforehand been contaminated by SARS-CoV-2. Secondary endpoints embody prevention of extreme COVID-19 in these teams. The research additionally will discover prevention of an infection by SARS-CoV-2, the virus that causes COVID-19. The first efficacy evaluation will probably be an event-driven evaluation based mostly on the variety of members with symptomatic COVID-19 illness. The trial design permits for interim analyses and unblinded evaluations by an impartial exterior Information Monitoring Committee.

By the top of the trial, the Section 2/three research is anticipated to be lively at roughly 120 medical investigational websites world wide, together with 39 states throughout america and international locations together with Argentina, Brazil, and Germany. Investigator websites are chosen based mostly on components together with scientific experience and capabilities, the epidemiology of the illness, and prior expertise conducting medical trials. For additional details about this trial, go to  utilizing the quantity NCT04368728.

Pfizer and BioNTech are dedicated to reducing well being disparities in underrepresented populations by the medical 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 medical research and isn’t at the moment accepted for distribution anyplace on the planet. If the Section 2/three trial is profitable, Pfizer and BioNTech count on to be prepared to hunt Emergency Use Authorization or some type of regulatory approval as early as October 2020. If authorization or approval is obtained, the businesses at the moment goal to produce globally as much as 100 million doses by the top of 2020 and roughly 1.three billion doses by the top of 2021.

About Pfizer: Breakthroughs That Change Sufferers’ Lives

At Pfizer, we apply science and our world assets to convey 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, improvement and manufacture of well being care merchandise, together with modern medicines and vaccines. On daily basis, Pfizer colleagues work throughout developed and rising markets to advance wellness, prevention, therapies and cures that problem essentially the most feared ailments of our time. According to our duty as one of many world’s premier modern 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 world wide. For greater than 150 years, we now have labored to make a distinction for all who depend on us. We routinely publish data 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 July 27, 2020. Pfizer assumes no obligation to replace forward-looking statements contained on this launch as the results of new data 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 obtainable information, potential advantages, expectations for medical trials and timing of regulatory submissions, and anticipated manufacturing, provide and distribution), 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 embody, amongst different issues, the uncertainties inherent in analysis and improvement, together with the power to fulfill anticipated medical endpoints, graduation and/or completion dates for medical trials, regulatory submission dates, regulatory approval dates and/or launch dates, in addition to dangers related to preliminary information, together with the potential of unfavorable new preclinical or medical trial information and additional analyses of current preclinical or medical trial information that could be inconsistent with the info used for collection of the BNT162b2 vaccine candidate and dose stage for the Section 2/three research; the chance that medical trial information are topic to differing interpretations and assessments, together with through the peer evaluation/publication course of, within the scientific neighborhood usually, and by regulatory authorities; whether or not and when information from the BNT162 mRNA vaccine program will probably be printed in scientific journal publications and, if that’s the 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 medical research; whether or not and when any biologics license and/or emergency use authorizationapplications could also be filed in any jurisdictions for BNT162b2 or every other potential vaccine candidates; whether or not and when any such purposes could also be accepted by regulatory authorities, which can rely upon myriad components, together with making a dedication as as to if the vaccine candidate’s advantages outweigh its identified dangers and dedication of the vaccine candidate’s efficacy and, if accepted, whether or not it is going to 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 a vaccine, together with improvement of merchandise or therapies by different firms; manufacturing capabilities or capability, together with whether or not the estimated numbers of doses may be manufactured throughout the projected time intervals indicated; whether or not and when extra provide agreements will probably be reached; uncertainties relating to the power to acquire suggestions from vaccine technical committees and different public well being authorities and uncertainties relating to the industrial influence of any such suggestions; and aggressive developments.

An additional description of dangers and uncertainties may be present in Pfizer’s Annual Report on Type 10-Okay for the fiscal 12 months ended December 31, 2019 and in its subsequent stories on Type 10-Q, together with within the sections thereof captioned “Danger Elements” and “Ahead-Wanting Data and Elements That Might Have an effect on Future Outcomes”, in addition to in its subsequent stories on Type 8-Okay, all of that are filed with the U.S. Securities and Alternate Fee and accessible at  and 

About BioNTech

Biopharmaceutical New Applied sciences is a subsequent technology immunotherapy firm pioneering novel therapies for most cancers and different critical ailments. The Firm exploits a wide selection of computational discovery and therapeutic drug platforms for the speedy improvement of novel biopharmaceuticals. Its broad portfolio of oncology product candidates consists of individualized and off-the-shelf mRNA-based therapies, modern 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 improvement and in-house manufacturing capabilities, BioNTech and its collaborators are growing 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 world pharmaceutical collaborators, together with Genmab, Sanofi, Bayer Animal Well being, Genentech, a member of the Roche Group, Genevant, Fosun Pharma, and Pfizer. For extra data, please go to 

BioNTech Ahead-looking statements

This press launch incorporates “forward-looking statements” of BioNTech throughout the which means of the Non-public 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 timing to provoke medical trials of BNT162 and anticipated publication of information from these medical trials; the potential variety of websites and members in our Section 2/three trial; the timing for any potential emergency use authorizations or approvals; the collaboration between BioNTech and Pfizer to develop a possible COVID-19 vaccine; our expectations relating to the potential traits of BNT162b2 in our Section 2/three trial and/or in industrial use based mostly on information observations to this point, together with anticipated benefits over BNT162b1; and the power of BioNTech to produce the portions of BNT162 to help medical improvement and, if accepted, 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 quite a lot 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 embody, however aren’t restricted to: competitors to create a vaccine for COVID-19; the power to provide comparable medical leads to bigger and extra numerous 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 Type 20-F filed with the SEC on March 31, 2020, which is on the market 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 until required by regulation.

Supply: Pfizer Inc.
 
 

Posted: July 2020