BNT162 Vaccine Description
The Paul-Ehrlich-Institut has approved the Phase 1/2 clinical trial for BioNTech’s BNT162 vaccine program to prevent COVID-19 infection. BNT162 is a vaccine candidate based upon mRNA. The four vaccine candidates are the first candidates from BioNTech’s COVID-19-focused project “Lightspeed”, each representing different mRNA formats and target antigens.
Two of the 4 vaccine candidates include a nucleoside modified mRNA (modRNA), one includes a uridine containing mRNA (uRNA), and the fourth vaccine candidate utilizes self-amplifying mRNA (saRNA). Each mRNA format is combined with a lipid nanoparticle (LNP) formulation.
The larger spike sequence is included in two of the vaccine candidates, and the smaller optimized receptor-binding domain (RBD) from the spike protein is included in the other two candidates.
The RBD-based candidates contain the piece of the spike that is thought to be most important for eliciting antibodies that can inactivate the virus.
BioNTech and Pfizer announced they are jointly developing BNT162. The initial study is the first clinical trial of a COVID-19 vaccine candidate to start in Germany and is part of a global development program.
Pfizer and BioNTech will also conduct trials for BNT162 in the United States upon regulatory approval.
In anticipation of a successful clinical development program, Pfizer and BioNTech are working to scale up production for global supply. Pfizer plans to activate its extensive manufacturing network and invest at risk in an effort to produce an approved COVID-19 vaccine as quickly as possible for those most in need around the world. The breadth of this program should allow the production of millions of vaccine doses in 2020, increasing to hundreds of millions in 2021.
During the clinical development stage, BioNTech will provide its partners clinical supply of the vaccine from its GMP-certified mRNA manufacturing facilities in Europe.
BioNTech is also collaborating with Fosun Pharma to develop BNT162 in China, where the companies expect to conduct trials.
BNT162 Vaccine Indication
BNT162 is a vaccine candidate that intends to prevent the SARS-CoV-2 coronavirus from causing COVID-19 disease in humans.
BNT162 Vaccine Dosage
The dose-escalation portion of the Phase 1/2 trials will include approximately 360 healthy subjects between the ages of 18 to 55. The study consists of 3 stages. Stage 1: to identify preferred vaccine candidate(s), dose level(s), number of doses, and schedule of administration (with the first 15 participants at each dose level of each vaccine candidate comprising a sentinel cohort); Stage 2: an expanded-cohort stage; and Stage 3; a final candidate/dose large-scale stage.
These studies will also evaluate the effects of repeated immunization for three of the 4 vaccine candidates which utilize uRNA or modRNA.
Older adults will only be immunized with a given dose level of a vaccine candidate once testing of that candidate and dose level in younger adults has provided initial evidence of safety and immunogenicity. And, subjects with a higher risk for a severe COVID-19 infection will be included in the second part of the study.
BNT162 Vaccine News
- May 30, 2020 - Global pharmaceutical Pfizer CEO Albert Bourla said he believes that a vaccine could be available in the fall of 2020.
- May 13, 2020 - SARS‐CoV‐2 immunogenicity at the crossroads. Letter to the editor.
- May 12, 2020 - Pfizer CEO and Chairman Albert Bourla told CNBC hat the company plans to expand human trials of its experimental coronavirus vaccine to thousands of test patients by September 2020. Pfizer is currently testing four different vaccine variations, Bourla said during CNBC’s Healthy Returns Virtual Summit. If one or two variations indicate success, the company will ramp up trials, and then in September launch a broad large-scale study with thousands of participants if a vaccine proves to be successful.
- May 5, 2020 - Pfizer Inc. and BioNTech SE announced that the first participants have been dosed in the U.S. in the Phase 1/2 clinical trial for the BNT162 vaccine program to prevent COVID-19. The trial is part of a global development program, and the dosing of the first cohort in Germany was completed last week.
- April 29, 2020 - BioNTech SE and Pfizer Inc. announced that the first cohort of BioNTech’s Phase 1/2 clinical trial has been dosed. Twelve study participants were dosed with vaccine candidate BNT162 in Germany since dosing began on April 23, 2020.
- April 28, 2020 - Pfizer's CEO said the company expects to make safety data available by late May 2020 and move into expanded trials that could allow emergency use or accelerated approval starting in the fall.
- April 22, 2020 - Pfizer Inc. and BioNTech SE have entered into a global collaboration agreement to co-develop BioNTech’s potential first-in-class, mRNA-based coronavirus vaccine program aimed at preventing COVID-19 infection. The two companies plan to jointly conduct clinical trials for the COVID-19 vaccine candidates initially in the United States and Europe across multiple research sites. The companies estimate that there is potential to supply millions of vaccine doses by the end of 2020 subject to the technical success of the development program and approval of regulatory authorities and then rapidly scale up to the capacity to produce hundreds of millions of doses in 2021.
April 9, 2020 - BioNTech SE and Pfizer Inc. (NYSE: PFE) today disclosed additional details of their collaboration to advance candidates from BioNTech’s mRNA vaccine program. The collaboration aims to rapidly advance multiple COVID-19 vaccine candidates into human clinical testing based on BioNTech’s proprietary mRNA vaccine platforms, with the objective of ensuring rapid worldwide access to the vaccine, if approved. The collaboration will leverage Pfizer’s broad expertise in vaccine research and development, regulatory capabilities, and global manufacturing and distribution network.
- March 17, 2020 - BioNTech announced details of its efforts to develop a potential vaccine to induce immunity and prevent COVID-19 infection. BioNTech is working to initiate clinical testing for BNT162, a potential first-in-class mRNA vaccine against COVID-19, in late April 2020.
- March 16, 2020 - BioNTech also announced a strategic alliance with Fosun Pharma to develop its COVID-19 vaccine in China. Under the terms of the agreement, the two companies will work together on the development of BNT162 in China, conducting clinical trials in China and leveraging Fosun Pharma’s extensive clinical development, regulatory, and commercial capabilities in the country. If approved, Fosun Pharma will commercialize the vaccine in China.
BNT162 Vaccine Clinical Trials
ClinicalTrials.gov Identifier: NCT04368728 - Last updated on May 14, 2020
BNT162 (Europe) - The first cohort of BioNTech’s Phase 1/2 clinical trial was dosed. BNT162 is the first COVID-19 vaccine candidate in Europe which entered clinical trials. Twelve study participants were dosed with the first BNT162 vaccine candidate as of April 29th. The dose-escalation portion of the Phase 1/2 trial will include approximately 200 healthy subjects between the ages of 18 to 55 and will target a dose range of 1 µg to 100 µg, aiming to determine the optimal dose for further studies as well as to evaluate the safety and immunogenicity of the vaccine. The three vaccine candidates that utilize uRNA or modRNA will be administered as two injections. The fourth vaccine candidate, which contains saRNA, will be evaluated after a single dose of vaccine. Subjects with a higher risk of severe COVID-19 disease will be included in the second part of the study. The first clinical data from the trial is expected end of June or in July 2020.
BNT162 (U.S) – The first cohort has been dosed in the U.S. in the Phase 1/2 clinical trial for the BNT162 vaccine program. The Phase 1/2 study is designed to determine the safety, immunogenicity, and optimal dose level of the four mRNA vaccine candidates. The dose level escalation portion (Stage 1) of the Phase 1/2 trial in the U.S. will enroll up to 360 healthy subjects into two age cohorts (18-55 and 65-85 years of age) and will be seamlessly followed by a part in which the selected vaccine candidate will be administered to several thousands of subjects. The first subjects immunized in Stage 1 of the study will be healthy adults 18-55 years of age.