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Wednesday, November 18, 2020

Main efficacy evaluation demonstrates BNT162b2 to be 95% efficient in opposition to COVID-19 starting 28 days after the primary dose;170 confirmed circumstances of COVID-19 have been evaluated, with 162 noticed within the placebo group versus Eight within the vaccine group Efficacy was constant throughout age, gender, race and ethnicity demographics; noticed efficacy in adults over 65 years of age was over 94% Security knowledge milestone required by U.S. Meals and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved Information exhibit vaccine was nicely tolerated throughout all populations with over 43,000 members enrolled; no critical security considerations noticed; the one Grade Three antagonistic occasion larger than 2% in frequency was fatigue at 3.8% and headache at 2.0% Corporations plan to submit inside days to the FDA for EUA and share knowledge with different regulatory businesses across the globe The businesses anticipate to supply globally as much as 50 million vaccine doses in 2020 and as much as 1.Three billion doses by the tip of 2021 Pfizer is assured in its huge expertise, experience and current cold-chain infrastructure to distribute the vaccine world wide

NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) in the present day introduced that, after conducting the ultimate efficacy evaluation of their ongoing Part Three examine, their mRNA-based COVID-19 vaccine candidate, BNT162b2, met the entire examine’s main efficacy endpoints. Evaluation of the information signifies a vaccine efficacy fee of 95% (p<0.0001) in members with out prior SARS-CoV-2 an infection (first main goal) and likewise in members with and with out prior SARS-CoV-2 an infection (second main goal), in every case measured from 7 days after the second dose. The primary main goal evaluation is predicated on 170 circumstances of COVID-19, as specified within the examine protocol, of which 162 circumstances of COVID-19 have been noticed within the placebo group versus Eight circumstances within the BNT162b2 group. Efficacy was constant throughout age, gender, race and ethnicity demographics. The noticed efficacy in adults over 65 years of age was over 94%.

There have been 10 extreme circumstances of COVID-19 noticed within the trial, with 9 of the circumstances occurring within the placebo group and one within the BNT162b2 vaccinated group.

Thus far, the Information Monitoring Committee for the examine has not reported any critical security considerations associated to the vaccine. A evaluate of unblinded reactogenicity knowledge from the ultimate evaluation which consisted of a randomized subset of no less than 8,000 members 18 years and older within the section 2/Three examine demonstrates that the vaccine was nicely tolerated, with most solicited antagonistic occasions resolving shortly after vaccination. The one Grade 3 (extreme) solicited antagonistic occasions larger than or equal to 2% in frequency after the primary or second dose was fatigue at 3.8% and headache at 2.0% following dose 2. According to earlier shared outcomes, older adults tended to report fewer and milder solicited antagonistic occasions following vaccination.

As well as, the businesses introduced that the protection milestone required by the U.S. Meals and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved. Pfizer and BioNTech plan to submit a request inside days to the FDA for an EUA primarily based on the totality of security and efficacy knowledge collected up to now, in addition to manufacturing knowledge regarding the standard and consistency of the vaccine. These knowledge additionally might be submitted to different regulatory businesses world wide.

“The examine outcomes mark an essential step on this historic eight-month journey to deliver ahead a vaccine able to serving to to finish this devastating pandemic. We proceed to maneuver on the pace of science to compile all the information collected up to now and share with regulators world wide,” stated Dr. Albert Bourla, Pfizer Chairman and CEO. “With lots of of hundreds of individuals across the globe contaminated day by day, we urgently must get a secure and efficient vaccine to the world.”

“We’re grateful that the primary world trial to achieve the ultimate efficacy evaluation mark signifies {that a} excessive fee of safety in opposition to COVID-19 might be achieved very quick after the primary 30 µg dose, underscoring the facility of BNT162 in offering early safety,” stated Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “These achievements spotlight the potential of mRNA as a brand new drug class. Our goal from the very starting was to design and develop a vaccine that will generate speedy and potent safety in opposition to COVID-19 with a benign tolerability profile throughout all ages. We imagine we now have achieved this with our vaccine candidate BNT162b2 in all age teams studied thus far and stay up for sharing additional particulars with the regulatory authorities. I wish to thank all of the devoted ladies and men who contributed to this traditionally unprecedented achievement. We are going to proceed to work with our companions and governments world wide to arrange for world distribution in 2020 and past.”

The Part Three scientific trial of BNT162b2 started on July 27 and has enrolled 43,661 members up to now, 41,135 of whom have acquired a second dose of the vaccine candidate as of November 13, 2020. Roughly 42% of world members and 30% of U.S. members have racially and ethnically numerous backgrounds, and 41% of world and 45% of U.S. members are 56-85 years of age. A breakdown of the variety of scientific trial members might be discovered right here from roughly 150 scientific trials websites in United States, Germany, Turkey, South Africa, Brazil and Argentina. The trial will proceed to gather efficacy and security knowledge in members for an extra two years.

Primarily based on present projections, the businesses anticipate to supply globally as much as 50 million vaccine doses in 2020 and as much as 1.Three billion doses by the tip of 2021. 4 of Pfizer’s services are a part of the manufacturing and provide chain; St. Louis, MO; Andover, MA; and Kalamazoo, MI within the U.S.; and Puurs in Belgium. BioNTech’s German websites can even be leveraged for world provide.

Pfizer is assured in its huge expertise, experience and current cold-chain infrastructure to distribute the vaccine world wide. The businesses have developed specifically designed, temperature-controlled thermal shippers using dry ice to keep up temperature situations of -70°C±10°C. They can be utilized be as non permanent storage models for 15 days by refilling with dry ice. Every shipper accommodates a GPS-enabled thermal sensor to trace the placement and temperature of every vaccine cargo throughout their pre-set routes leveraging Pfizer’s broad distribution community.

Pfizer and BioNTech plan to submit the efficacy and security knowledge from the examine for peer-review in a scientific journal as soon as evaluation of the information is accomplished.

About Pfizer: Breakthroughs That Change Sufferers’ Lives

At Pfizer, we apply science and our world sources to deliver therapies to folks that reach 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 modern medicines and vaccines. Day by day, Pfizer colleagues work throughout developed and rising markets to advance wellness, prevention, therapies and cures that problem probably the most feared ailments of our time. According to our accountability as one of many world’s premier modern biopharmaceutical corporations, we collaborate with well being care suppliers, governments and native communities to help and increase entry to dependable, inexpensive 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 put up info which may be essential to traders on our web site at  As well as, to be taught extra, please go to us on  and observe 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 November 18, 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 accommodates 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 candidate BNT162b2 (together with qualitative assessments of accessible knowledge, potential advantages, expectations for scientific trials, anticipated timing of regulatory submissions and anticipated manufacturing, distribution and provide), 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 flexibility 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 scientific knowledge (together with the Part Three knowledge that’s the topic of this launch), together with the potential of unfavorable new preclinical or scientific trial knowledge and additional analyses of current preclinical or scientific trial knowledge; the flexibility to supply comparable scientific or different outcomes, together with the speed of vaccine effectiveness and security and tolerability profile noticed up to now, in further analyses of the Part Three trial or in bigger, extra numerous populations upon commercialization; the chance that scientific trial knowledge are topic to differing interpretations and assessments, together with throughout the peer evaluate/publication course of, within the scientific group typically, and by regulatory authorities; whether or not and when knowledge from the BNT162 mRNA vaccine program might be printed in scientific journal publications and, if that’s the case, when and with what modifications; whether or not regulatory authorities might be glad with the design of and outcomes from these and any 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 some 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 willpower as as to whether the vaccine candidate’s advantages outweigh its identified dangers and willpower of the vaccine candidate’s efficacy and, if accepted, whether or not it will likely 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 industrial potential of a vaccine, together with growth of merchandise or therapies by different corporations; disruptions within the relationships between us and our collaboration companions or third-party suppliers; dangers associated to the supply of uncooked supplies to fabricate a vaccine; challenges associated to our vaccine candidate’s ultra-low temperature formulation and attendant storage, distribution and administration necessities, together with dangers associated to dealing with after supply by Pfizer; the chance that we might not have the ability to efficiently develop non-frozen formulations; the chance that we might not have the ability to create or scale up manufacturing capability on a well timed foundation or have entry to logistics or provide channels commensurate with world demand for any potential accepted vaccine, which might negatively affect our means to produce the estimated numbers of doses of our vaccine candidate inside the projected time durations indicated; whether or not and when further provide agreements might be reached; uncertainties concerning the flexibility to acquire suggestions from vaccine technical committees and different public well being authorities and uncertainties concerning the industrial affect of any such suggestions; uncertainties concerning the affect of COVID-19 on Pfizer’s enterprise, operations and monetary outcomes; and aggressive developments.

An additional description of dangers and uncertainties might 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 “Threat Elements” and “Ahead-Trying Data and Elements 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 

About BioNTech

Biopharmaceutical New Applied sciences is a subsequent era 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 growth 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. 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 variety 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, Regeneron, Genevant, Fosun Pharma, and Pfizer. For extra info, please go to 

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 might embody, however will not be restricted to, statements regarding: BioNTech’s efforts to fight COVID-19; the collaboration between BioNTech and Pfizer to develop a possible COVID-19 vaccine; our expectations concerning the potential traits of BNT162b2 in our Part 2/Three trial and/or in industrial use primarily based on knowledge observations up to now; the anticipated timepoint for extra readouts on efficacy knowledge of BNT162b2 in our Part 2/Three trial; the character of the scientific knowledge, which is topic to ongoing peer evaluate, regulatory evaluate and market interpretation; the timing for submission of knowledge for, or receipt of, any potential Emergency Use Authorization; the timing for submission of producing knowledge to the FDA; and the flexibility of BioNTech to produce the portions of BNT162 to help scientific growth and, if accepted, market demand, together with our manufacturing estimates for 2020 and 2021. Any forward-looking statements on this press launch are primarily based on BioNTech present expectations and beliefs of future occasions, and are topic to quite a lot of 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 are usually not restricted to: the flexibility to fulfill the pre-defined endpoints in scientific trials; competitors to create a vaccine for COVID-19; the flexibility to supply comparable scientific or different outcomes, together with our said fee of vaccine effectiveness and security and tolerability profile noticed up to now, within the the rest of the trial or in bigger, extra numerous populations upon commercialization; the flexibility 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 info on this press launch is as of the date of the discharge, and BioNTech undertakes no responsibility to replace this info until required by legislation.

Supply: Pfizer Inc.
 
 

Posted: November 2020

BNT162b2 (SARS-CoV-2 vaccine) FDA Approval Historical past