-- Data from 43,448 participants, half of whom received BNT162b2 and half of 
      whom received placebo, showed that the vaccine candidate was well 
      tolerated and demonstrated 95% efficacy in preventing COVID-19 in those 
      without prior infection 7 days or more after the second dose 
 
   -- Vaccine efficacy observed in the overall study population was also 
      generally consistent across subgroups defined by age, gender, race, 
      ethnicity, baseline body mass index (BMI) or presence of other underlying 
      co-morbidities 
 
   -- Partial protection from the vaccine candidate appears to begin as early 
      as 12 days after the first dose 
 
   -- These data were included in the requests for regulatory authorization 
      submitted to regulatory agencies across the globe, including the U.S. 
      Food and Drug Administration and the European Medicines Agency 
 
 
   NEW YORK and MAINZ, GERMANY, December 10, 2020 (GLOBE NEWSWIRE) -- 
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Pfizer Inc. (NYSE: PFE) and 
https://www.globenewswire.com/Tracker?data=OPqm80ENWEI21CafZO3KyuSrgf1J75M5kmBAMzKTMoc0k0LSmvfJzqxwxXKSkFs4Y6_EVWXiCOxIc8KzCiIC6A== 
BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal 
of Medicine 
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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 mg 
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/m(2) ); 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 degC) 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 
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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. We routinely post information that may be important to investors on 
our website at 
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www.Pfizer.com. In addition, to learn more, please visit us on 
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December 10, 2020 10:46 ET (15:46 GMT)