In a Phase 1 in the U.S., 7 days after a momentary dose of 30 mg, BNT162b2 caused mean geometric titers (MGTs) that neutralized SARS-CoV-2 in young adults (18-55 years) who had 3.8 GMT that of a panel of 38 serums of CONvalescent PATIENTS of SARS-CoV-2, and in older adults (65-85 years), the candidate vaccine caused a GMT that neutralized 1.6 times the GMT of the same panelArray demonstrating superior immunogenicity in young and old adults.
Corporations reported in the past that human participants vaccinated with BNT162b2 had a favorable diversity of epitopes identified in the T mobile responses expressed to the SARS-CoV-2 complex antigen, and that BNT162b2 had a concomitant induction of high-magnitude CD4 and CD8 mobile responses. opposite to the receiver. (RBD) and opposed to the rest of the complex glycoprotein
In all populations, management of BNT162b2 was well tolerated with mild to moderate fever in less than 20% of participants.
These effects reported the variety of candidates BNT162b2 for the fundamental global phase 2/3 examined up to 30,000 participants that began in July 2020, which has so far recruited more than 11,000 participants, adding spaces where the transmission of SARS-CoV-2 is important. .
Assuming clinical success, Pfizer and BioNTech are on track to request a regulatory review of BNT162b2 as of October 2020 and, if regulatory approval or approval is obtained, they are lately planning to supply up to one hundred million international doses by the end of 2020 and approximately 1.3 billion. doses until the end of 2021
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today shared more knowledge on phase 1 protection and immunogenicity of their ongoing U.S. exam. From the BNT162 mRA-CoV-2 mRA vaccine program, which are completed in the phase 2/3 evaluation. The recently published manuscript describes the key knowledge of protection and immunogenicity of the U.S. Phase 1 trial. For candidate vaccine BNT162b2, which at 30 mg was recorded 7 days after the time the dose caused mean geometric titers (GMT) that neutralized SARS-CoV-2 in young adults (18-55 years) who had 3.8 times the GMT of a panel of 38 serums of convalescent SARS-CoV2 patients, and in older adults (65-85 years), the candidate vaccine received a GMT that neutralizes 1.6 times the GMT of the same. upper immunogenicity in younger and older adults. In addition, in all populations, the management of BNT162b2 was well tolerated with mild to moderate fever in less than 20% of participants. As announced in the past, this knowledge reported the resolution of companies to advance a 2-dose 30 g dose regimen of BNT162b2, which encodes a state-of-the-art Glycoprotein optimized for full-length SARS-CoV-2. (S), in phase 2/3 of evaluation. The manuscript is now available on an online prepress server in https://www.medrxiv.org/content/10.1101/2020.08.17.20176651v1 and is peer-reviewed for possible publication.
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The companies continue to analyze knowledge of Phase 1 trials in the United States and Germany. Immune responses from T-phones caused through BNT162b2 are being evaluated in the German study and companies plan to submit knowledge for peer review and prospective publication. Corporations in the past reported that human participants vaccinated with BNT162b2 had a favorable diversity of epitopes identified in the T mobile responses expressed to the SARS-CoV-2 complex antigen, compared to candidate BNT162b1, and that BNT162b2 had a simultaneous induction of large scaling the cd4 and CD8 T mobile responses opposite the receptor binding domain (RBD) and opposite to the rest of the complex glucoprotein that is not contained in the candidate vaccine BNT162b1.
“All clinical and preclinical knowledge served as the basis for Pfizer and BioNTech’s resolution of choosing BNT162b2 as the primary candidate for fundamental trials. We are proud to share our findings with clinical network paintings as we continue our work to deliver an effective vaccine to combat this devastating virus,” said Kathrin U. Jansen, Ph.D., senior vice president and director of vaccine research and development at Pfizer. “We are delighted to offer the first knowledge that the promising immunogenicity and type profile of our candidate vaccine from the U.S. trial appears. And look to the future to share knowledge about the immune reaction of the T cells of the German trial in the near future.”
“It is vital for us to continue with the percentage knowledge and similar data about our leading candidate vaccine COVID-19,” said Ugur Sahin, M.D., CEO and co-founder of BioNTech. “The favorable protection profile of BNT162b2 and the magnitude of the T-cell responses we have announced in the past supported our resolve to choose this candidate for the phase 2/3 fundamental study. To date, we have managed BNT162b2 to more than 11,000 participants. study.”
Additional U.S. Phase 1 blind, randomized, and placebo-controlled knowledge was used to assess the protection and immunogenicity of other dose grades of BNT162b1 and BNT162b2 in 195 randomized participants in thirteen teams of 15 participants (per group, 12 vaccine won and 3 placebo won). ). Groups of participants over 18 to 55 and 65 to 85 years gained doses of 10 mg, 20 go 30 mg of BNT162b1 or BNT162b2 on a 2-dose regimen, 21 days apart.
In younger and older adults, BNT162b1 and BNT162b2 caused a similar antibody against sarS-CoV-2 dose-dependent, TMG, which increased substantially after the moment dose, obviously appearing as the advantages of a 2-dose regimen. Although vaccine applicants obtained a decrease in IgG (immunoglobulin G) and neutralizing antigen binding responses in older adults (65 to 85 years), compared to younger adults (18-5 5 years), MGT neutralizing antibodies measured 7 days after dose 2 of 30 mg of BNT162b1 or BNT162b2 in elderly participants aged 65 to 85 , comparable to or higher than the GMT of a SARS-CoV-2 recovery panel of 38 patients (elderly aged 18 to 83) who had contracted SARS-CoV-2.
Participants over the age of 18 to 55 who gained 10 mg, 20 or 30 mg of BNT162b1 reported mild to moderate local reactions, basically pain at the injection site, within 7 days of injection, which were more common after dose 2. In elderly participants aged 65 to 85 years, BNT162b1 caused similar but milder local reactions, with mild to moderate injection site pain reported at 92% after dose 1 and 75% after dose 2. A similar trend was observed after vaccination with BNT162b2. No elderly man who won BNT162b2 reported redness or swelling. No participant who won any of the candidate vaccines reported a grade four local reaction.
Systemic occasions after the management of BNT162b2 were lighter than those of BNT162b1. Overall, after dose 1, the systemic occasions reported by participants aged 65 to 85 who won BNT162b2 were reported by those who won placebo. After the 2 dose of 30 g of BNT162b2, only 17% of elderly participants aged 18 to 55 years and 8% of elderly participants aged 65 to 85 reported fever (up to 38.0 38.9 C), compared to 75% of elderly participants 18 to 33% of elderly participants aged 65 to 85 years were given a momentary dose of 30 mg of BNT162b1. Severe systemic occasions (fatigue, headache, chills, muscle pain and joint pain) were reported in a small number of young BNT162b2 receptors and were brief and manageable. No serious systemic occasions were reported through larger receptors of BNT162b2. No BNT162 receptors were reported from grade four systemic occasions.
The knowledge suite contributed to Pfizer and BioNTech’s resolution to initiate phase 2/3 of overall protection and efficacy (excluding China) of the clinical phase to compare BNT162b2 against COVID-19. He is now actively concerned in the United States, Argentina and Brazil. Additional registrations are provided for in Germany, Turkey and South Africa. He is an event-based essay that is expected to recruit up to 30,000 participants between the ages of 18 and 85. The recruitment of the phase 2/3 trial to date has exceeded 11,000 participants with a current dose.
Pfizer and BioNTech are committed to reducing fitness disparities in underrepresented populations through the clinical trial process. To this end, many research sites are located in communities that have been disproportionately affected through COVID-19, so those most affected have the opportunity to participate. Corporations are also collaborating with the sites of researchers and advocacy partners to raise awareness of the importance of participation in this trial.
BNT162b2 remains the subject of a clinical examination and has not been approved for international distribution lately. Assuming clinical success, Pfizer and BioNTech are on track to seek a regulatory review of BNT162b2 from October 2020 and, if approved or approved, recently plan to supply up to one hundred million international doses by the end of 2020 and approximately 1.3 billion doses through the end of 2021. People who wish to receive more information about the test can visit ClinicalTrials.gov with NCT04368728.
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The data contained in this press release date back to August 20, 2020. Pfizer assumes no legal responsibility to update any forward-looking statements contained in this press release as a result of new data or long-term events or events.
A more detailed description of the hazards and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the year ended December 31, 2019 and in its upcoming reports on Form 10-Q, adding the “Risk Factors” and “Prospective Information and Factors That May Affect Future Results” sections. , as well as in its upcoming reports on Form 8-KArray, all of which are filed with the U.S. Securities and Exchange Commission. And they can be obtained at www.sec.gov and www. pfizer.com.
About BioNTech
Biopharmaceutical New Technologies is a next-generation immunotherapy company, a pioneer in new treatments for cancer and other serious diseases. The Company operates a wide variety of computer discoveries and curative drug platforms for the immediate progression of new biopharmaceuticals. Its extensive portfolio of oncology candidate products includes commercially individualized mNA-based treatments, state-of-the-art chimeric antigen receptor T cells, two-point specific control point immunomodulators, targeted anticancer antibodies, and small molecules. Building on their deep experience in the progression of mNR vaccines and their internal production capabilities, BioNTech and its partners are presenting several mNR vaccine applicants for a variety of infectious diseases, throughout their diverse oncology portfolio. BioNTech has established a wide diversity of relationships with several global pharmaceutical companies, adding Genmab, Sanofi, Bayer Animal Health, Genentech, member of the Roche Group, Genevant, Fosun Pharma and Pfizer. For more information, visit www.BioNTech.de.
BioNTech’s forward-looking statements
This press release includes BioNTech’s “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but are not limited to, statements relating to: BioNTech’s efforts to combat COVID -19; The prospective number of sites and participants in our phase 2b/3 trial; collaboration between BioNTech and Pfizer to expand the possible COVID-19 vaccine; our expectations related to the forward-looking features of BNT162b2 in our Phase 2b/3 trial and/or advertising use based on knowledge observations to date, adding expected benefits on BNT162b1; The timing of possible emergency use authorizations or approvals and BioNTech’s ability to supply quantities of BNT162 for clinical progression and, if approved, market demand, adding our production estimates for 2020 and 2021. All forward-looking statements contained in this press release are based on BioNTech’s Existing Expectations and Beliefs. long-term events, and are subject to a number of dangers and uncertainties that may also cause actual effects to differ materially and unfavorably from those expressed or implied through such forward-looking statements. These dangers and uncertainties include, but are not limited to: festival to create a COVID-19 vaccine; The ability to produce comparable clinical outcomes in larger and more varied clinical trials; The ability to expand our production capacity well; and other potential difficulties. For a discussion on these and other hazards and uncertainties, please refer to the BioNTech Annual Report on Form 20-F filed with the SEC on March 31, 2020, available on the SEC’s online page at www.sec.gov. All data contained in this press release is as of the date of the press release, and BioNTech assumes no legal responsibility to update this data unless required by law.
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Contacts
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