-- Primary efficacy analysis demonstrates BNT162b2 to be 95% effective 
      against COVID-19 beginning 28 days after the first dose; 170 confirmed 
      cases of COVID-19 were evaluated, with 162 observed in the placebo group 
      versus 8 in the vaccine group 
   -- Efficacy was consistent across age, gender, race and ethnicity 
      demographics; observed efficacy in adults over 65 years of age was over 
   -- Safety data milestone required by U.S. Food and Drug Administration (FDA) 
      for Emergency Use Authorization (EUA) has been achieved 
   -- Data demonstrates vaccine was well tolerated across all populations with 
      over 43,000 participants enrolled; 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% 
   -- Companies plan to submit within days to the FDA for EUA and share data 
      with other regulatory agencies around the globe 
   -- The companies expect to produce globally up to 50 million vaccine doses 
      in 2020 and up to 1.3 billion doses by the end of 2021 
   NEW YORK and MAINZ, GERMANY, November 18, 2020 -- 
Pfizer Inc. (NYSE: PFE) and 
BioNTech SE (Nasdaq: BNTX) today 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 28 days after the first dose, 7 days after the second 
dose. The first primary objective analysis is based on 170 cases of 
COVID-19, as specified in the study protocol, of which 162 cases of 
COVID-19 were observed in the placebo group versus 8 cases in the 
BNT162b2 group. Efficacy was consistent across age, gender, race and 
ethnicity demographics. The observed efficacy in adults over 65 years of 
age was over 94%. 
   There were 10 severe cases of COVID-19 observed in the trial, with nine 
of the cases occurring in the placebo group and one in the BNT162b2 
vaccinated group. To date, the Data Monitoring Committee for the study 
has not reported any serious safety concerns related to the vaccine. A 
review of unblinded reactogenicity data from the final analysis which 
consisted of a randomized subset of at least 8,000 participants 18 years 
and older in the Phase 2/3 study demonstrates that the vaccine was well 
tolerated, with most solicited adverse events resolving shortly after 
vaccination. The only Grade 3 (severe) solicited adverse events greater 
than or equal to 2% in frequency after the first or second dose were 
fatigue at 3.8% and headache at 2.0% following dose 2. Consistent with 
earlier shared results, older adults tended to report fewer and milder 
solicited adverse events following vaccination. 
   In addition, the companies announced that the safety milestone required 
by the U.S. Food and Drug Administration (FDA) for Emergency Use 
Authorization (EUA) has been achieved. Pfizer and BioNTech plan to 
submit a request within days to the FDA for an EUA based on the totality 
of safety and efficacy data collected to date, as well as manufacturing 
data relating to the quality and consistency of the vaccine. These data 
also will be submitted to other regulatory agencies around the world. 
   "The study results mark an important step in this historic eight-month 
journey to bring forward a vaccine capable of helping to end this 
devastating pandemic. We continue to move at the speed of science to 
compile all the data collected thus far and share with regulators around 
the world," said Dr. Albert Bourla, Pfizer Chairman and CEO. "With 
hundreds of thousands of people around the globe infected every day, we 
urgently need to get a safe and effective vaccine to the world." 
   "We are grateful that the first global trial to reach the final efficacy 
analysis mark indicates that a high rate of protection against COVID-19 
can be achieved very fast after the first 30 ug dose, underscoring the 
potential of BNT162 to provide early protection," said Ugur Sahin, M.D., 
CEO and Co-founder of BioNTech. "These achievements highlight the 
potential of mRNA as a new drug class. Our goal 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. We believe we have successfully accomplished this with our 
vaccine candidate BNT162b2 in all age groups studied so far and look 
forward to sharing further details with the regulatory authorities. I 
want to thank all the devoted women and men who contributed to this 
historically unprecedented achievement. We will continue to work with 
our partners and governments around the world to prepare for global 
distribution in 2020 and beyond." 
   The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 
43,661 participants to date, 41,135 of whom have received a second dose 
of the vaccine candidate as of November 13, 2020. Approximately 42% of 
global participants and 30% of U.S. participants have racially and 
ethnically diverse backgrounds, and 41% of global and 45% of U.S. 
participants are 56-85 years of age. A breakdown of the diversity of 
clinical trial participants can be found 
here from approximately 150 clinical trials sites in United States, 
Germany, Turkey, South Africa, Brazil and Argentina. The trial will 
continue to collect efficacy and safety data in participants for an 
additional two years. 
   Based on current projections, the companies expect to produce globally 
up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by 
the end of 2021. Four of Pfizer's facilities are part of the 
manufacturing and supply chain; St. Louis, MO; Andover, MA; and 
Kalamazoo, MI in the U.S.; and Puurs in Belgium. BioNTech's German sites 
will also be leveraged for global supply. 
   Pfizer is confident in its vast experience, expertise and existing 
cold-chain infrastructure to distribute the vaccine around the world. 
The companies have developed specially designed, temperature-controlled 
thermal shippers utilizing dry ice to maintain temperature conditions of 
-70degC+/-10degC. They can be used be as temporary storage units for 15 
days by refilling with dry ice. Each shipper contains a GPS-enabled 
thermal sensor to track the location and temperature of each vaccine 
shipment across their pre-set routes leveraging Pfizer's broad 
distribution network. 
   Pfizer and BioNTech plan to submit the efficacy and safety data from the 
study for peer-review in a scientific journal once analysis of the data 
is completed. 
   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 
www.Pfizer.com. In addition, to learn more, please visit us on 
www.Pfizer.com and follow us on Twitter at 
@Pfizer and 
@Pfizer News, 
YouTube and like us on Facebook at 
   Pfizer Disclosure Notice 
   The information contained in this release is as of November 18, 2020. 
Pfizer assumes no obligation to update forward-looking statements 
contained in this release as the result of new information or future 
events or developments. 
   This release contains forward-looking information about Pfizer's efforts 
to combat COVID-19, the collaboration between BioNTech and Pfizer to 
develop a potential COVID-19 vaccine, the BNT162 mRNA vaccine program, 
and modRNA candidate BNT162b2 (including qualitative assessments of 

(MORE TO FOLLOW) Dow Jones Newswires

November 18, 2020 07:14 ET (12:14 GMT)