This website is intended for Global Healthcare Professionals
Aiming to address the global coronavirus pandemic:
Together with all companies, research institutes and governments currently working on the development of a vaccine against COVID-19, we, at BioNTech, are also working around the clock to develop a COVID-19 vaccine to contribute to global efforts to combat the global COVID-19 pandemic and protect against COVID-19.
Project Lightspeed, our development program for a vaccine against COVID-19, leverages BioNTech’s proprietary mRNA-based technology, with which we have more than 20 years of experience, and is also supported by Pfizer’s global vaccine development capabilities.
Like any other pharmaceutical product, a potential vaccine has to go through stringent clinical testing and must be manufactured to high standards (termed “GMP” or good manufacturing practice) consistently and reliably. BioNTech received German regulatory authority approval in 2011 to manufacture mRNA under GMP, and has been producing mRNA for clinical testing since then, including the entire clinical supply for BNT162.
“We feel a duty to exploit our full technology and immunotherapy expertise to help address the COVID-19 pandemic emergency. Our aim is clear: Making a potential vaccine available to the public as quickly as possible – worldwide.”
Prof. Ugur Sahin, M.D., Chief Executive Officer
Where are we with Project Lightspeed, our COVID-19 vaccine development program? These are the milestones at a glance:
- Ugur Sahin read a publication in the Lancet about a new virus that emerged in the Chinese province of Wuhan.
- Immediately, Ugur realized that this virus had the potential to spread beyond Chinese borders. Not only was the virus novel and highly infectious, but treatments were also unavailable and several infected individuals did not show any symptoms. In addition, Wuhan is a heavily populated city with over one million inhabitants that is highly connected to the rest of the world.
- He discussed this with Özlem Türeci and the management team and, a few days later, BioNTech initiated “Project Lightspeed” in order to develop a potential vaccine against COVID-19.
- Subsequently, BioNTech selected potential vaccine candidates and conducted non-clinical studies including animal and toxicology studies.
- Shortly thereafter, the team initiated GMP production of its vaccine candidates (in Germany) for potential clinical studies.
- BioNTech announced a development and commercialization collaboration with Fosun Pharma. Together, the companies aim to develop BioNTech’s mRNA vaccine candidate BNT162, in China to prevent COVID-19 infections.
- BioNTech and Pfizer signed a letter of intent to develop and commercialize the mRNA-based vaccine against the coronavirus outside of China. The collaboration with Pfizer built on the existing influenza partnership.
- The German regulatory authority, the Paul-Ehrlich-Institut, approved the initiation of the clinical Phase 1/2 study of BioNTech’s vaccine program, BNT162, against COVID-19 infections. The vaccine program consists of four vaccine candidates each representing different mRNA formats and target antigens. The dose-finding cohort of the study comprises 200 healthy subjects aged 18-55 years (later expanded to 56-85 years) and a dose-range of 1µg to 100µg.
- On April 23rd at 11.08 am CEST, the first subject was vaccinated with BNT162, making him the first research participant to be vaccinated with a potential COVID-19 vaccine in Europe.
- Shortly after the initiation of the Phase 1/2 study in Germany, the first subjects were vaccinated in the US as part of the global BNT162 Phase 1/2 study to prevent COVID-19 infections.
- The dose-finding part of the U.S. Phase 1/2 study included up to 360 healthy volunteers in two age groups, 18-55 and 56-85.
- BioNTech and Pfizer announced initial results from the U.S. study for BNT162b1, one of the four clinical vaccine candidates.
- BNT162b1 was well-tolerated in the administered dose-levels and induced dose-dependent immunogenicity. Neutralizing antibodies against SARS-CoV-2 could be detected in all subjects who received 10µg or 30µg BNT162b1, a relatively low dose, on day 28 (7 days after the second vaccination). The respective geometric mean antibody titers were 1.8- and 2.8-times higher when compared to a panel of human convalescent sera.
- Two of the four investigational SARS-CoV-2, vaccine candidates, BNT162b1 and BNT162b2, received Fast Track designation from the U.S. FDA.
- The Fast Track process is designed to facilitate the development, and expedite the review of, new drugs and vaccines that are intended to treat or prevent serious conditions.
- BioNTech and Pfizer announced initial data from their ongoing German Phase 1/2 dose-escalation trial.
- BioNTech shared the preliminary clinical results, which refer to the most advanced investigational vaccine candidate, BNT162b1, and support and expand upon the recently disclosed early results from the corresponding U.S. trial.
- BioNTech and Pfizer announced an agreement with the UK for the supply of 30 million doses of mRNA-based vaccine candidate, BNT162.
- BioNTech and Pfizer signed an agreement with the U.S. Department of Health and Human Services for the supply of 100 million doses of a vaccine against COVID-19 and the option to acquire up to an additional 500 million doses.
- BioNTech and Pfizer signed an agreement with the Japanese Ministry of Health, Labour and Welfare to supply 120 million doses of their BNT162 mRNA-based vaccine candidate against SARS-CoV-2.
- Following an extensive review of preclinical and clinical data from Phase 1/2 clinical trials, Pfizer and BioNTech chose to advance their BNT162b2 vaccine candidate into the global Phase 2/3 efficacy and tolerability study, at a 30µg dose, level in a two-dose regimen. In addition to viral antigen specific CD4+ and CD8+T cell responses and high levels of neutralizing antibodies, BNT162b2 demonstrated a favorable overall tolerability profile in comparison to other candidates.
- The phase 2/3 study will include > 30,0000 volunteers and will be conducted at about 120 sites across the U.S., Argentina, Brazil, and Germany. (The study was later expanded to >44,000 volunteers and >150 sites).
- BioNTech and Fosun Pharma announced that the first 72 volunteers in China received their first dose of BNT162b1, after approval of the Phase 1 study by the Chinese regulatory authority, National Medical Products Administration. The vaccine is now in clinical trials across five continents. This underlines BioNTech’s efforts to support a global supply of a potential vaccine upon regulatory approval.
- BioNTech is one of the few non-Chinese companies conducting a clinical trial in China.
- Furthermore, BioNTech and Pfizer signed an agreement with the Canadian government for the supply of the mRNA-based vaccine candidate, BNT162 against SARS-CoV-2 in 2021.
- At 30µg, the BNT162b2 vaccine candidate elicited SARS-CoV-2-neutralizing geometric mean titers (GMTs) in younger adults (18-55 years of age) that were 3.8 times the GMT of a panel of 38 sera of SARS-CoV2 convalescent patients, and in older adults (65-85 years of age) the vaccine candidate elicited a neutralizing GMT 1.6 times the GMT of the same panel, both 7 days after the second dose.
- Further, across all populations, BNT162b2 administration was well tolerated with mild to moderate adverse events including fatigue, fever, and headache which were transient and mostly resolved within 1-2 days.
- BNT162b2 which encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S) demonstrated concurrent induction of high magnitude CD4+ and CD8+ T cell responses against the receptor binding domain (RBD) and against the remainder of the spike glycoprotein.
- The results further support the Biontech and Pfizer decision to advance a 2-dose regimen of the 30µg dose level of BNT162b2 into the Phase 2/3 evaluation that strated in July 2020.
- The German regulatory authority, the Paul-Ehrlich-Institut, has approved the Phase 2/3 clinical trial in Germany for their BNT162b2 vaccine candidate.
- The study in Germany is part of the global pivotal Phase 2/3 program BioNTech and Pfizer initiated in July this year.
- The study will be conducted in approximately 120 (later expanded to more than 150) sites globally.
- As of Sept 7, 2020, the trial enrollment has exceeded 25,000 participants (out of the planned approximately 44,000).
- The manufacturing site acquired from Novartis AG (CH) 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 acquisition reflects BioNTech’s commitment to significantly expanding its manufacturing capacity in order to supply a potential vaccine worldwide upon authorization or approval.
- BioNTech plans to be able to produce up to 250 million doses of BNT162b2 at the site in the first half of 2021, thanks to the established team and well-established drug substance and drug product manufacturing capabilities.
- The decision by the European Medicines Agency (EMA) as well as Health Canada to start a rolling review follows the encouraging preliminary results from pre-clinical and early clinical studies in adults.
- Available data suggest that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2.
- A combination of an antibody and T cell response is believed to be important in eliciting protection against viral infection and disease.
- In a rolling review, EMA’s CHMP (Committee for Medicinal Products for Human Use) reviews data as they become available from ongoing studies. Once CHMP decides that sufficient data are available, the complete application should be submitted by BioNTech.
- The interim analysis based on 94 cases indicates a vaccine efficacy rate above 90%, at seven days after second dose.
- The DMC (Data Monitoring Comitte) has not reported any serious safety concerns and recommends that the study continues to collect additional safety and efficacy data as planned.
- The study enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate. Approximately 42% of the global participants and 30% of the U.S. participants have racially and ethnically diverse backgrounds.
- Supply agreement provides the European Union with a supply of 200 million doses of the investigational vaccine BNT162b2 and an option to request additional 100 million doses, with deliveries starting by the end of 2020, subject to regulatory approval.
- 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 up to 1.3 billion doses globally in 2021.
- BioNTech and Fosun now moved into phase 2 with their lead candidate vaccine BNT162b2 as the China National Medical Products Administration has approved the start of the clinical trial in Mainland China.
- Primary efficacy analysis demonstrated that BNT162b2 is 95% effective against COVID-19 beginning 7 days after the second dose.
- The analysis was based on 170 confirmed cases of COVID-19, with 162 observed in the placebo group versus 8 in the vaccine group.
- Efficacy was consistent across age, gender, race and ethnicity demographics.
- The observed efficacy in adults over 65 years of age was over 94%.
- The data demonstrated that the vaccine was well tolerated across all populations with over 43,000 participants enrolled with no serious safety concerns observed. The only Grade 3 adverse event greater than 2% in frequency was fatigue at 3.8% and headache at 2.0%.
- The safety data milestone with safety data being available for at least 2 months after the second dose as required by U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved.
- The trial will continue to collect efficacy and safety data in participants for an additional two years.
- The submission was based on a vaccine efficacy rate of 95% (p<0.0001) demonstrated in the companies’ Phase 3 clinical study measured from 7 days after the second dose.
- This submission was supported by solicited safety data from a randomized reactogenicity subset of approximately 8,000 participants ≥18 years of age and unsolicited safety data from approximately 38,000 trial participants (randomized 1:1 vaccine to placebo) who have been followed for a median of two months following the second dose.
- BioNTech and Fosun have started the evaluation of their lead mRNA COVID-19 vaccine candidate BNT162b2 in a Phase 2 clinical trial in Taizhou and Lianshui, Jiangsu Province, China.
- The online recruitment of volunteers will commence with the recruitment of 960 healthy participants, aged between 18 and 85, to assess the safety and immunogenicity of the vaccine candidate and to support a future Biologic License Application (BLA) in China.
- Formal application to EMA (European Medicines Agency) for the mRNA vaccine candidate, BNT162b2, against COVID-19 submitted.
- The submission completed the rolling review process initiated on October 6, 2020, with nonclinical data and partial Chemistry, Manufacturing, and Controls (CMC) data, followed by emerging clinical data from the Phase 1, 2 and 3 clinical studies. The Phase 3 clinical study demonstrated a vaccine efficacy rate of 95% against COVID-19, with no major safety concerns observed to date.
- Rolling submissions across the globe including in UK, Australia, Canada and Japan have been initiated so far.
- These submissions demonstrate BioNTech’s commitment to enable a rapid worldwide supply upon potential approval of BNT162b2, contributing to global joint efforts to regain normal pace of life.
- Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK has granted a temporary authorization for emergency supply for BioNTech’s mRNA vaccine, against COVID-19.
- This is the first temporary authorization for emergency supply following a worldwide Phase 3 trial of a vaccine.
- Earlier this year, a contract with the UK for the delivery of 40 million doses was closed. The deliveries will occur throughout 2020 and 2021, in stages, to ensure an equitable allocation of vaccines across global geographies with executed contracts.
- The U.S. Food and Drug Administration (FDA) authorized the emergency use of BioNTech's mRNA vaccine against COVID-19.
- The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheet at www.cvdvaccine.com.
- COMIRNATY® (also known as BNT162b2) received conditional marketing authorization (CMA) from the European Commission. The CMA is valid in all 27 member states of the European Union (EU).
- Pfizer and BioNTech are ready to immediately ship initial doses to the 27 EU member states. The distribution of COMIRNATY® by the EU member states will be determined according to the populations identified in EU and national guidance.
- BioNTech's mRNA vaccine has now been granted a conditional marketing authorization, emergency use authorization or temporary authorization in more than 40 countries worldwide.