PfizerPfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of Medicine has published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. In the trial of 43,448 participants, who were 16 years and older, 21,720 of whom received BNT162b2 and 21,728 placebo, the two-dose regimen of 30 μg BNT162b2, which was given 21 days apart, was well-tolerated and demonstrated vaccine efficacy of 95% against COVID-19.

"These pivotal data demonstrate that our COVID-19 vaccine candidate is highly effective in preventing COVID-19 disease and is generally well-tolerated. They are a testament to the extraordinary efforts to deliver an effective vaccine with a favorable safety profile rapidly and serve as the basis for our regulatory submissions around the world," said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. "As COVID-19 cases continue to rise and ravage the lives of so many people, we hope that these data will build confidence in the global health opportunity for vaccines to help us combat this devastating pandemic."

"We are very encouraged by the data, which indicate that our vaccine candidate is well-tolerated and highly potent irrespective of age, gender, ethnicity, and pre-existing comorbidities. These are all critical factors for a vaccine to be effective in helping to address the pandemic," said Özlem Türeci, M.D., Chief Medical Officer and Co-founder of BioNTech. "Sharing further data from the Phase 3 trial in a renowned peer-reviewed journal underlines our commitment to transparency and scientific rigor. We consider both important at this important junction with additional potential authorizations of our vaccine in sight."

In the pivotal study, vaccine efficacy similar to that observed in the overall population was generally consistent among subgroups defined by age, gender, race, ethnicity, obesity, or presence of a comorbidity.

Among 36,523 participants who had no evidence of existing or prior SARS-CoV-2 infection by the time of the immunizations, there were 170 cases of COVID-19 observed with onset at least 7 days after the second dose; 8 cases occurred in vaccine recipients, and 162 in placebo recipients, corresponding to 95.0% vaccine efficacy (95% credible interval [CI, 90.3, 97.6]). Among participants with and without evidence of prior SARS CoV-2 infection, there were 9 cases of COVID-19 among vaccine recipients and 169 among placebo recipients, corresponding to 94.6% vaccine efficacy (95% CI [89.9, 97.3]).

The cumulative incidence of COVID-19 cases over time among placebo and vaccine recipients began to diverge by 12 days after the first dose, and 52.4% vaccine efficacy (95% confidence interval: 29.5, 68.4) was observed between dose 1 and dose 2, indicating the early onset of a partially protective effect of immunization. Two doses of vaccine provide the maximum protection observed. Ten cases of severe COVID-19 were observed with onset after the first dose. Nine cases occurred among placebo recipients and one among BNT162b2 recipients.

BNT162b2 exhibited a favorable tolerability and safety profile. Based on a data cut-off date of October 9, 2020, 37,706 participants had a median of at least two months of safety data available after dose 2 and contributed to the main safety dataset. Among these participants, 49% were female; 83% were White; 9% were Black or African American; 28% were Hispanic/Latinx; 35% were obese (BMI ≥30.0 kg/m2); and 21% had at least one underlying comorbidity. The median age was 52 years, and 42% were older than 55 years.

The most common adverse events of BNT162b2 were transient, mild to moderate pain at the injection site, fatigue and headache, and these generally resolved within two days. These reactions were less common and milder in older adults than younger adults. Severe reactions (Grade 3) were reported in fewer than 2% of vaccine recipients after either dose except for fatigue (3.8%) and headache (2.0%). Fever (≥38 °C) was reported in similar proportions of younger (16%) and older (11%) vaccine recipients. Rates of serious adverse events were similar between vaccine and placebo groups (0.6% and 0.5%).There were no COVID-19 related deaths.

All trial participants will continue to be monitored to assess long-term protection and safety for an additional two years after their second dose.

Data from this study, including longer term safety, comprehensive information on duration of protection, efficacy against asymptomatic SARS-CoV-2 infection, and safety and immunogenicity in adolescents 12 to 15 years of age will be gathered in the months ahead. Additional studies are planned to evaluate BNT162b2 in pregnant women, children younger than 12 years, and those in special risk groups, such as the immunocompromised.

BNT162b2 has been authorized or approved for emergency use in several countries around the world including the U.K., Bahrain, and Canada. The companies have filed a request for Emergency Use Authorization with the U.S. Food and Drug Administration (FDA) and have submitted the final Conditional Marketing Authorization Application (CA) following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world.

About the Phase 2/3 Study

The ongoing Phase 3 clinical trial of BNT162b2, which is based on BioNTech’s proprietary mRNA technology, has enrolled more than 44,000 participants, the vast majority of whom have received their second dose. A breakdown of the diversity of clinical trial participants can be found here from approximately 150 clinical trials sites in the U.S., Germany, Turkey, South Africa, Brazil and Argentina.

The Phase 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 are 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 prevention of severe COVID-19 in those groups. The study also will explore prevention of infection by SARS-CoV-2, the virus that causes COVID-19.

About Pfizer: Breakthroughs That Change Patients' Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us.

About BioNTech

Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.