BNT162 Vaccine Description
BioNTech’s BNT162 vaccine candidates are being developed to prevent COVID-19 disease infection. The BNT162 program is evaluating at least 4 experimental vaccines, each of which represents a unique combination of messenger RNA (mRNA) format and target antigen.
Two of the 4 vaccine candidates include a nucleoside modified mRNA (modRNA), one includes 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.
BNT162b1 and BNT162b2 are both nucleoside-modified RNAs, formulated in lipid nanoparticles. BNT162b1 encodes an optimized SARS-CoV-2 receptor-binding domain (RBD) antigen, while BNT162b2 encodes an optimized SARS-CoV-2 full-length spike protein antigen.
The larger spike sequence is included in two of the vaccine candidates, and the smaller optimized RBD from the spike protein is included in the other 2 vaccine 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.
On July 1, 2020, the manuscript describing the preliminary clinical data for BNT162b1 is available online and is concurrently undergoing scientific peer-review for potential publication.
On July 27, 2020, the Companies advance nucleoside-modRNA candidate BNT162b2, which encodes an optimized SARS-CoV-2 full-length spike glycoprotein, at a 30µg dose level, in a 2-dose regimen, into Phase 2/3 study of up to 30,000 participants aged 18 – 85 years, and is expected to include approximately 120 sites globally.
Pfizer and BioNTech stated on August 5, 2020, they began a Phase 2b/3 safety and efficacy trial and remain on track to seek regulatory review as early as October 2020. This study was last updated on September 4, 2020.
On August 20, 2020, a non-peer-reviewed abstract found BNT162b2 was associated with less systemic reactogenicity, particularly in older adults.
Pfizer provided an update on September 15, 2020, stating: 'Limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mild to moderate tolerability profile as was observed in Phase 1. In the blinded data presented, 50% of trial participants received a placebo and 50% received BNT162b2.'
On September 12, 2020, the companies announced they have submitted a request to the U.S. FDA to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants, which increases the study's population diversity, and include adolescents as young as 16 years of age and people with chronic, stable HIV, Hepatitis C, or Hepatitis B infection.
On September 17, 2020, Pfizer's overview document for the 'Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals' became available.
And, on November 9, 2020, the companies issued a press statement that said 'the vaccine candidate was found to be more than 90% effective in preventing COVID-19 in (94) participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis. The phase 3 clinical trial will continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints.'
“The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science, and a global collaborative effort,” said Prof. Ugur Sahin, BioNTech's CEO.
And on November 18, 2020, Pfizer and BioNTech announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their vaccine candidate, BNT162b2, met all of the study’s primary efficacy endpoints.
Ugur Sahin, M.D., CEO and Co-founder of BioNTech stated in a press release: “These achievements highlight the potential of mRNA as a new drug class. Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages."
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. On March 13, 2020, Fosun Pharma became the strategic partner of BioNTech in China, jointly developing and commercializing vaccine products for COVID-19 based on its proprietary mRNA technology platform in Mainland China, Hong Kong, the Macau Special Administration Region, and the Taiwan Region.
Biopharmaceutical New Technologies is an immunotherapy company pioneering novel therapies for cancer and other serious diseases.
Pfizer's corproation information is updated at this link.
BNT162 Vaccine Distribution
In anticipation of a successful clinical development program, 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. On July 31, 2020, the companies agreed to supply 120 million vaccine doses to Japan in the first half of 2021, subject to regulatory approval.
And on August 9, 2020, the companies finalized discussions to supply European countries with 200 million doses and an option to purchase additional 100 million doses, with deliveries starting by the end of 2020, subject to regulatory approval. In case safety and efficacy studies are successful, and the vaccine receives regulatory approval, the companies are expecting to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.3 billion vaccine doses by the end of 2021.
On August 27, 2020, BioNTech SE and Shanghai Fosun Pharmaceutical Co. announced an intended collaboration to supply 10 million doses of their BNT162 mRNA-based vaccine to Hong Kong (Special Administrative Region of China, SAR) and Macao (SAR).
On November 3, 2020, Fosun’s Chief Medical Officer Hui Aimin told Reuters in an interview 'they could seek emergency use authorization in China for BNT162b2. Hui said Fosun was applying for a bridge study for BNT162b2, designed to evaluate whether the large trial data gathered overseas could be extrapolated to the populace of China.'
On November 10, 2020, the companies disclosed an agreement with the European Union (EU) to deliver 200 million vaccine doses, with an option to purchase an additional 100 million doses. The vaccine supply for the EU will be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium and based on current projections, the companies expect to produce globally up to 1.3 billion doses in 2021.
Pfizer announced a pilot delivery program in four US states; Rhode Island, Texas, New Mexico, and Tennessee. “We are hopeful that results from this vaccine delivery pilot will serve as the model for other U.S. states and international governments, as they prepare to implement effective COVID-19 vaccine programs,” reported Reuters on November 16, 2020.
BNT162 Vaccine Cold Storage
The BNT162b2 vaccine candidate needs to be stored and transported at ultracold temperatures below −70 °C (−94 °F) since the vaccine degrades within 5-days when thawed, says the company.
Failure to store and handle vaccines properly can reduce vaccine potency, resulting in inadequate immune responses in patients and poor protection against disease because the vaccines they received may have been compromised, said the U.S. CDC in 2018.
BNT162 Vaccine Indication
BNT162 is a vaccine candidate that intends to prevent the SARS-CoV-2 coronavirus from causing COVID-19 disease in humans aged 18-85.
No pediatric vaccine efficacy data has been disclosed.
BNT162 Vaccine Dosage
Studies 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.
The dose-escalation portion of the study, healthy adults 18–55 and 65–85 years of age were randomized in an ongoing, placebo-controlled, observer-blinded dose-escalation study to receive 2 doses at 21-day intervals of placebo or either of 2 lipid nanoparticle–formulated, nucleoside-modified RNA vaccine candidates: BNT162b1, which encodes a secreted trimerized SARS-CoV-2 receptor-binding domain, or BNT162b2, which encodes a prefusion stabilized membrane-anchored SARS-CoV-2 full-length spike. In each of 13 groups of 15 participants, 12 received a vaccine and 3 received a placebo.
Groups were distinguished by a vaccine candidate, age of the participant, and vaccine dose level. Interim safety and immunogenicity data of BNT162b1 in younger adults have been reported previously from US and German trials. We now present additional safety and immunogenicity data from the US Phase 1 trial that supported the selection of the vaccine candidate advanced to a pivotal Phase 2/3 safety and efficacy evaluation.
BNT162 Vaccine News
November 25, 2020 - BioNTech SE and Shanghai Fosun Pharmaceutical Co., Ltd. jointly announced that their lead mRNA COVID-19 vaccine candidate BNT162b2 will be evaluated in a Phase 2 clinical trial in Taizhou and Lianshui, Jiangsu Province, China.
November 23, 2020 - Between 200,000 and 500,000 doses of the SARS-CoV-2 coronavirus vaccine from Pfizer Pharmaceuticals will arrive in Israel during December 2020, assuming regulators clear the substance for use, according to a report broadcast by Israel’s Channel 12 news.
November 20, 2020 - The U.S. Food and Drug Administration (FDA) has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee on December 10, 2020, to discuss the request for emergency use authorization of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH. FDA Commissioner Stephen M. Hahn, M.D., added in a press statement: “The FDA has been preparing for the review of EUAs for COVID-19 vaccines for several months and stands ready to do so as soon as a request is submitted. While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible."
November 18, 2020 - Pfizer Inc. and BioNTech SE announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study’s primary efficacy endpoints. Analysis of the data indicates a vaccine efficacy rate of 95% (p<0.0001) in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7-days after the second dose. Vaccine Efficacy was consistent across age, gender, race, and ethnicity demographics.
November 13, 2020 - Prime Minister Benjamin Netanyahu announced Friday that Israel has signed an agreement with Pfizer Inc. and Germany's BioNTech SE to supply its coronavirus vaccine in 2021. In televised remarks, Netanyahu said the agreement marked “a great day for Israel” and added: “The goal is for the vaccine supply to start in January and increase in the months thereafter”.
November 12, 2020 - China’s regulatory authority accepts the Fosun Pharma clinical trial application of the mRNA vaccine candidate. The Shanghai-based conglomerate will maintain close communication with regulatory and licensing authorities and hopes ongoing research and testing will show the vaccine complies with Chinese laws and will be available as quickly as possible, wrote Guo. In March 2020, Fosun Pharmaceutical Industrial was granted a license by German company BioNTech to exclusively develop and commercialize its vaccine products developed based on BioNTech's proprietary mRNA technology platform targeting COVID-19 in China.
November 10, 2020 - BioNTech SE and Pfizer announced that they have reached an agreement with the European Commission to supply 200 million doses of their investigational BNT162b2 mRNA-based vaccine candidate against COVID-19 to European Union Member States, with an option for the European Commission to request an additional 100 million doses. "Our aim is to develop a safe and effective vaccine to contribute to bringing this pandemic to an end. Only through joint efforts will we be able to do so,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.
November 9, 2020 - Pfizer Inc. and BioNTech SE announced their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8, 2020, by an external, independent Data Monitoring Committee from the Phase 3 clinical study.
November 4, 2020 - New York-based Pfizer 'intends to use its own distribution system to deliver its COVID vaccine directly to healthcare providers,' said Tanya Alcorn, Pfizer's vice president for global supply chain, during a recent webinar. A Pfizer spokesperson confirmed that plan in an email to FiercePharma on November 4, 2020.
October 27, 2020 - A comprehensive update of Pfizer’s development pipeline was published today and is now available at www.pfizer.com/science/drug-product-pipeline. It includes an overview of the BNT162 COVID-19 Vaccine Development Program.
October 21, 2020 - The WSJ reported 'to keep the vaccines safe in transit and to move them fast, Pfizer designed a new reusable container that can keep the vaccine at ultracold temperatures for up to 10 days and hold between 1,000 and 5,000 doses. The suitcase-sized boxes, which are packed with dry ice and tracked by GPS, will enable Pfizer to avoid the larger, temperature-controlling containers used in transportation, giving it more flexibility to ship the vaccines faster since planes and trucks won’t have to wait for the standard refrigerated metal boxes.'
October 20, 2020 - Pfizer and BioNTech SE announced launching a combined Phase I and Phase II clinical trials in Japan of their mRNA vaccine candidate against the coronavirus.
October 16, 2020 - Pfizer Inc.’s Chief Executive Officer Albert Bourla noted in an open letter posted on the company's website that Pfizer expects to have the safety data from its SARS-CoV-2 coronavirus vaccine candidate BNT162 in the third week of November 2020. All the data contained in our U.S. application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency.
October 14, 2020 - Australia’s Therapeutic Goods Administration announced Pfizer Australia Pty Ltd. has received provisional 'determination' for its COVID-19 vaccine candidate, BNT162b2. The next step is that Pfizer may now apply for provisional 'approval.'
October 13, 2020 - Pfizer Inc. expanded its Phase 3 clinical trial for the BNT162b2 vaccine candidate has received permission from the U.S. FDA to enroll children aged 12 and older.
October 12, 2020 - Pfizer's updated website stated: 'We are grateful to each of the more than 120 clinical trial investigators and their study teams who are partnering with us in this effort and to all of the participants who have volunteered, and will volunteer, to help make a difference for society.'
October 7, 2020 - Rentschler Biopharma SE announced an agreement to serve as a CDMO partner for BioNTech. As an initial project, Rentschler Biopharma will be responsible for key aspects of cGMP drug substance manufacturing of BNT162b2, the mRNA-based vaccine against SARS-CoV-2 that is being developed by Pfizer and BioNTech.
October 6, 2020 - Pfizer Inc. and BioNTech SE announced the initiation of a rolling submission to the European Medicines Agency for BNT162b2, the lead candidate from the companies’ vaccine development program against COVID-19.
September 17, 2020 - BioNTech SE announced the signing of a share purchase agreement with Novartis AG to acquire its GMP certified manufacturing facility in Marburg, Germany. The manufacturing site will expand BioNTech’s COVID-19 vaccine production capacity by up to 750 million doses per year, or over 60 million doses per month, once fully operational. The transaction is expected to close in the fourth quarter of 2020. The Company plans to be able to produce up to 250 million doses of BNT162b2 in the first half of 2021.
September 15, 2020 - Pfizer Inc. provided an extensive overview including new data on the BNT162b2 vaccine candidate being developed in collaboration with BioNTech SE. Submission of an amended protocol to the FDA for the Phase 3 pivotal trial to expand recruitment to approximately 44,000 participants that allow for the enrollment of new populations. Enrollment in the trial has been proceeding as planned with current enrollment at more than 29,000. Based on current infection rates, the companies continue to expect that a conclusive readout on efficacy is likely by the end of October 2020.
September 15, 2020 - BioNTech SE announced that it will receive a grant of up to 375 million Euro from an initiative by the German Federal Ministry of Education and Research (BMBF) to support the accelerated development of SARS-CoV-2 vaccines. BioNTech will use the milestone-based BMBF funding to support its contribution to the Company’s mRNA vaccine program BNT162 that is being co-developed with its partners Pfizer Inc. and Fosun Pharma respectively. The goal of the initiative is the expansion of vaccine development and manufacturing capabilities in Germany, as well as the expansion of the number of participants in late-stage clinical trials. The BNT162 vaccine program is one of three programs supported by the BMBF initiative, which will provide a total of up to 750 million Euro to its funding recipients.
September 12, 2020 - Pfizer Inc. and BioNTech SE announced they have submitted an amended protocol to the U.S. FDA to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations.
September 9, 2020 - Pfizer and BioNTech SE announced that they had concluded talks with the European Commission for a proposed supply of 200 million doses of their investigational BNT162 mRNA-based vaccine candidate against SARS-CoV-2 to European Union Member States, with an option for a further 100 million doses. Vaccine deliveries would be starting by the end of 2020, subject to clinical success and regulatory authorization.
September 3, 2020 - Pfizer CEO confirms late-stage coronavirus vaccine trial may have study results in October 2020.
August 27, 2020 - “This announcement is the first one to potentially supply the Chinese market with a BioNTech vaccine together with our partner Fosun Pharma. It further demonstrates our commitment to provide our vaccine candidate as broadly as possible globally to help end the SARS-CoV-2 pandemic,” said Sean Marett, Chief Business and Chief Commercial Officer at BioNTech.
August 20, 2020 - A non-peer-reviewed study's conclusion supports the selection of the BNT162b2 vaccine candidate for Phase 2/3 large-scale safety and efficacy evaluation.
August 17, 2020 - The Yale School of Medicine and Yale-New Haven Hospital announced the start of Phase 3 study of the BioNTech SE - Pfizer BNT162 vaccine candidate at the hospital. In Phases 1 and 2 of the trial, this novel vaccine has proven safe and effective in generating an appropriate immune response. This third phase hopes to show that it can prevent infection.
August 12, 2020 - Nature article: Phase 1/2 study of COVID-19 RNA vaccine BNT162b1 in adults. These results support further evaluation of this mRNA vaccine candidate.
August 5, 2020 - Pfizer Canada and BioNTech SE announced an agreement with the Government of Canada to supply their BNT162 mRNA-based vaccine candidate against SARS-CoV2, subject to clinical success and Health Canada approval.
July 31, 2020 - Pfizer and BioNTech SE announced an agreement with the Ministry of Health, Labour, and Welfare in Japan to supply 120 million doses of their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, subject to clinical success and regulatory approval, beginning in 2021.
July 27, 2020 - Pfizer Inc. and BioNTech SE announced the start of a global, except for China, Phase 2/3 safety and efficacy clinical study to evaluate a single nucleoside-modified messenger RNA (modRNA) candidate from their BNT162 mRNA-based vaccine program against SARS-CoV-2.
July 22, 2020 - Pfizer and BioNTech SE announced the execution of an agreement with the U.S. government to meet Operation Warp Speed program's goal to begin delivering 300 million doses of a vaccine for COVID-19 in 2021. Under the agreement, the U.S. government will receive 100 million doses of BNT162, the COVID-19 vaccine after Pfizer successfully manufactures and obtains approval or emergency use authorization from the US Food and Drug Administration. The government also has an option to acquire an additional 500 million doses of BNT162.
July 20, 2020 - Pfizer and BioNTech announced an agreement with the United Kingdom to supply 30 million doses of their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, which is currently in development.
July 13, 2020 - Pfizer Inc. and BioNTech SE announced that 2 of the companies’ 4 investigational vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) received Fast Track designation from the U.S. FDA. These vaccine candidates in the BNT162 program are currently being evaluated in ongoing Phase 1/2 clinical studies in the USA and Germany.
July 10, 2020 - BioNTech Chief Executive Officer Ugur Sahin predicted the company’s vaccine for COVID-19, which is it co-developing with Pfizer, could be ready for regulatory approval by the end of the year, with hundreds of millions of doses available for immediate distribution.
July 9, 2020 - A Maryland-based graduate immunology student believes he could be one of the 1st people in the USA to produced coronavirus antibodies in response to being vaccinated in phase 2 clinical trial conducted at the University of Maryland.
July 1, 2020 - Phase 1/2 Study to Describe the Safety and Immunogenicity of a COVID-19 RNA Vaccine Candidate (BNT162b1) in Adults 18 to 55 Years of Age: Interim Report. Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titers in sera increased with the dose level and after a second dose. Geometric mean neutralizing titers reached 1.8- to 2.8-fold that of a panel of COVID-19 convalescent human sera.
June 29, 2020 - BioNTech SE announced a private investment of USD 250 million by investors.
June 24, 2020 - Cincinnati Children’s vaccine program is one of 4 sites testing for the BNT162 vaccine. It's continuing to enroll participants in the first stage of the study and wants underrepresented populations.
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
Pfizer's website now displays various clinical trial participant metrics.
Clinical Trial NCT04368728: A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY ADULTS - Last Update Posted: November 13, 2020.
Pfizer and BioNTech finalized the Phase 2/3 study protocol in response to feedback from global regulators, including the FDA and the German Paul-Ehrlich-Institut. The Phase 2/3 study is an event-driven trial that is planned to enroll up to 30,000 participants between 18 and 85 years of age.
The Phase 2/3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. The trial’s primary endpoints will be the prevention of COVID-19 in those who have not been infected by SARS-CoV-2 prior to immunization, and prevention of COVID-19 regardless of whether participants have previously been infected by SARS-CoV-2.
Secondary endpoints include the prevention of severe COVID-19 in those groups. The study also will explore the prevention of infection by SARS-CoV-2, the virus that causes COVID-19. The primary efficacy analysis will be an event-driven analysis based on the number of participants with symptomatic COVID-19 disease. The trial design allows for interim analyses and unblinded reviews by an independent external Data Monitoring Committee.
Clinical Trial NCT04368728 - Study to Describe the Safety, Tolerability, Immunogenicity, and Potential Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Adults - Last updated on November 2, 2020.
- This is a Phase 1/2, randomized, placebo-controlled, observer-blind, dose-finding, and vaccine candidate-selection study in healthy adults.
- The study will evaluate the safety, tolerability, immunogenicity, and potential efficacy of up to 4 different SARS-CoV-2 RNA vaccine candidates against COVID-19:
- As a 2-dose or single-dose schedule
- At up to 3 different dose levels
- The manuscript describing the preliminary clinical data for the nucleoside-modified messenger RNA candidate, BNT162b1, which encodes an optimized SARS-CoV-2 RBD antigen, is available online and is concurrently undergoing scientific peer-review for potential publication.
BNT162 Europe (2020-001038-36) - The first cohort of BioNTech’s Phase 1/2 clinical trial was dosed. BNT162 is the first COVID-19 vaccine candidate in Europe that 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 the 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.