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BNT162b2 FDA Approval Status

FDA Approved: No
Brand name: BNT162b2
Generic name: SARS-CoV-2 vaccine
Company: Pfizer Inc. and BioNTech SE
Treatment for: Prevention of COVID-19

BNT162b2 is an investigational mRNA vaccine against SARS-CoV-2 in development for the prevention of COVID-19. To date there have been no mRNA vaccines licensed for use in humans.

  • The BNT162 program initially consisted of four vaccine candidates, each representing a unique combination of messenger RNA (mRNA) format and target antigen. In early studies, BNT162b1 and BNT162b2 emerged as the two strongest candidates based on assessments of safety and favorable viral antigen specific CD4+ and CD8+T cell responses.
  • BNT162b1 is a nucleoside modified RNA (modRNA) that encodes an optimized SARS-CoV-2 receptor-binding domain (RBD) antigen, and BNT162b2 is a nucleoside modified RNA (modRNA) that encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), which is a target of virus neutralizing antibodies.
  • In Phase 1 studies, BNT162b1 and BNT162b2 elicited similar dose-dependent SARS-CoV-2–neutralizing antibody geometric mean titers, which were substantially elevated after the second dose, showing clear benefit of a two-dose regimen.
  • The data demonstrated a favorable overall tolerability profile for BNT162b2 when compared to BNT162b1. After Dose 1, systemic events reported by participants 65 to 85 years old who received BNT162b2 were similar to those reported by those who received placebo. After Dose 2 of 30μg BNT162b2, only 17% of participants 18 to 55 years old and 8% of participants 65 to 85 years old reported fever (≥38.0 to 38.9 °C), compared to 75% of 18 to 55 year old participants and 33% of 65 to 85 year old participants administered a second dose of 30μg of BNT162b1. Severe systemic events (fatigue, headache, chills, muscle pain, and joint pain) were reported in small numbers of younger BNT162b2 recipients and were transient and manageable. No severe systemic events were reported by older BNT162b2 recipients. There were no reports of Grade 4 systemic events by any BNT162 recipient.
  • The BNT162b2 vaccine candidate was chosen to progress into the Phase 2/3 study, at a 30 µg dose level in a two-dose regimen, based on the data from preclinical and clinical studies.
  • BNT162b2 was granted U.S. FDA Fast Track designation in July 2020.
  • The Phase 2/3 safety and efficacy study is an event-driven trial that includes up to 44,000 participants aged between 16 and 85 years of age from diverse population groups in the U.S., Argentina and Brazil. Additional enrollment is planned in Germany, Turkey and South Africa.
  • The first results from an interim efficacy analysis of a Phase 3 study were reported by Pfizer on November 9, 2020. BNT162b2 was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection. Protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule (injections of the vaccine on Day 1 and Day 21). The study is ongoing and additional data could affect these results.
  • The analysis evaluated 94 confirmed cases of COVID-19 in trial participants. The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued. The study will also evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease.
  • Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced. Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication.
  • Further information on the design of the clinical trial and the study protocol can be found at pfizer.com/science/coronavirus.

News: Pfizer's COVID Vaccine Looks Promising, But Big Hurdles Remain November 12, 2020

Development Timeline for BNT162b2

DateArticle
Nov 20, 2020FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate
Nov 20, 2020Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine
Nov 18, 2020Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints
Nov 16, 2020Pfizer Update On Our U.S. COVID-19 Vaccine Candidate Distribution Preparedness
Nov 11, 2020Pfizer and BioNTech Reach an Agreement to Supply the EU With 200 Million Doses of Their BNT162b2 mRNA-Based Vaccine Candidate Against SARS-CoV-2
Nov  9, 2020Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Evidence of Efficacy in First Interim Analysis from Phase 3 Study
Oct  9, 2020Pfizer Canada and BioNTech Initiate Rolling Submission to Health Canada for SARS-CoV-2 Vaccine Candidate BNT162b2
Oct  6, 2020BioNTech and Pfizer Initiate Rolling Submission to European Medicines Agency for SARS-CoV-2 Vaccine Candidate BNT162b2
Sep 30, 2020BioNTech and Pfizer Announce Nature Publication of German Phase 1/2 Study Data from mRNA-based Vaccine Candidate BNT162b1 Against SARS-CoV-2
Sep 17, 2020BioNTech to Acquire GMP Manufacturing Site to Expand COVID-19 Vaccine Production Capacity in First Half 2021
Sep 15, 2020BioNTech to Receive up to €375M in Funding from German Federal Ministry of Education and Research to Support COVID-19 Vaccine Program BNT162
Sep 12, 2020Pfizer and BioNTech Propose Expansion of Pivotal COVID-19 Vaccine Trial
Sep  9, 2020Pfizer and BioNTech Announce Data from Preclinical Studies of mRNA-based Vaccine Candidate Against COVID-19
Sep  9, 2020Pfizer and BioNTech to Potentially Supply the EU with 200 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2
Sep  7, 2020BioNTech and Pfizer Receive Regulatory Approval From Paul-Ehrlich-Institut to Commence German Part of Global Phase 2/3 Trial for COVID-19 Vaccine Candidate BNT162b2
Aug 27, 2020BioNTech and Fosun Pharma to Potentially Supply 10 Million Doses of BioNTech’s BNT162 mRNA-based Vaccine Candidate Against SARS-CoV-2 to Hong Kong SAR and Macao SAR
Aug 20, 2020Pfizer and BioNTech Share Positive Early Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19
Aug 12, 2020Pfizer and BioNTech Announce Publication of Peer-Reviewed Data from Ongoing Phase 1/2 study of mRNA-based Vaccine Candidate, BNT162b1, Against SARS-CoV-2 in Nature
Aug  5, 2020BioNTech and Fosun Pharma Announce Start of Clinical Trial of mRNA-based COVID-19 Vaccine Candidate in China
Aug  5, 2020Pfizer and BioNTech to Supply Canada with their BNT162 mRNA-Based Vaccine Candidate
Jul 31, 2020Pfizer and BioNTech to Supply Japan with 120 Million Doses of Their BNT162 mRNA-Based Vaccine Candidate
Jul 28, 2020Pfizer and BioNTech Choose Lead mRNA Vaccine Candidate Against COVID-19 and Commence Pivotal Phase 2/3 Global Study
Jul 22, 2020Pfizer and BioNTech Announce an Agreement with U.S. Government for up to 600 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2
Jul 20, 2020Pfizer and BioNTech Announce Agreement with the United Kingdom for 30 Million Doses of mRNA-based Vaccine Candidate against SARS-CoV-2
Jul 20, 2020Pfizer and BioNTech Announce Early Positive Update from German Phase 1/2 COVID-19 Vaccine Study, Including First T Cell Response Data
Jul 13, 2020Pfizer and BioNTech Granted FDA Fast Track Designation for Two Investigational mRNA-based Vaccine Candidates Against SARS-CoV-2
Jul  1, 2020Pfizer and BioNTech Announce Early Positive Data from an Ongoing Phase 1/2 study of mRNA-based Vaccine Candidate Against SARS-CoV-2
May  5, 2020Pfizer and BioNTech Dose First Participants in the U.S. as Part of Global COVID-19 mRNA Vaccine Development Program
Apr 29, 2020BioNTech and Pfizer Announce Completion of Dosing for First Cohort of Phase 1/2 trial of COVID-19 Vaccine Candidates in Germany
Apr 22, 2020BioNTech and Pfizer Announce Regulatory Approval from German Authority Paul-Ehrlich-Institut to Commence First Clinical Trial of COVID-19 Vaccine Candidates
Apr  9, 2020Pfizer and BioNTech Announce Further Details on Collaboration to Accelerate Global COVID-19 Vaccine Development
Mar 17, 2020Pfizer and BioNTech to Co-Develop Potential COVID-19 Vaccine
Mar 16, 2020BioNTech and Fosun Pharma Form COVID-19 Vaccine Strategic Alliance in China
Mar 16, 2020BioNTech Reports Rapid Progress on COVID-19 Vaccine Program to Address Global Public Health Threat

Further information

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