-- Analysis of 927 confirmed symptomatic cases of COVID-19 demonstrates 
      BNT162b2 is highly effective with 91.3% vaccine efficacy observed against 
      COVID-19, measured seven days through up to six months after the second 
      dose 
 
   -- Vaccine was 100% effective in preventing severe disease as defined by the 
      U.S. Centers for Disease Control and Prevention and 95.3% effective in 
      preventing severe disease as defined by the U.S. Food and Drug 
      Administration 
 
   -- Vaccine was 100% effective in preventing COVID-19 cases in South Africa, 
      where the B.1.351 lineage is prevalent 
 
   -- Vaccine safety now evaluated in more than 44,000 participants 16 years of 
      age and older, with more than 12,000 vaccinated participants having at 
      least six months follow-up after their second dose 
 
   -- The companies plan to share these results with worldwide regulatory 
      agencies soon 
 
 
   New York and Mainz, Germany, April 1, 2021 -- 
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Pfizer Inc. (NYSE: PFE) and 
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BioNTech SE (Nasdaq: BNTX) today announced updated topline results from 
analysis of 927 confirmed symptomatic cases of COVID-19 observed in 
their pivotal Phase 3 study through March 13, 2021, showing that the 
Pfizer-BioNTech COVID-19 vaccine, BNT162b2, was 91.3% effective against 
COVID-19, measured seven days through up to six months after the second 
dose. The vaccine was 100% effective against severe disease as defined 
by the U.S. Centers for Disease Control and Prevention (CDC), and 95.3% 
effective against severe COVID-19 as defined by the U.S. Food and Drug 
Administration (FDA). Safety data from the Phase 3 study has also been 
collected from more than 12,000 vaccinated participants who had a 
follow-up time of at least six months after the second dose, 
demonstrating a favorable safety and tolerability profile. 
 
   "These data confirm the favorable efficacy and safety profile of our 
vaccine and position us to submit a Biologics License Application to the 
U.S. FDA," said Albert Bourla, Chairman and Chief Executive Officer, 
Pfizer. "The high vaccine efficacy observed through up to six months 
following a second dose and against the variant prevalent in South 
Africa provides further confidence in our vaccine's overall 
effectiveness." 
 
   "It is an important step to further confirm the strong efficacy and good 
safety data we have seen so far, especially in a longer-term follow-up," 
said Ugur Sahin, CEO and Co-founder of BioNTech. "These data also 
provide the first clinical results that a vaccine can effectively 
protect against currently circulating variants, a critical factor to 
reach herd immunity and end this pandemic for the global population." 
 
   About the Analysis 
 
   The updated analysis of the Phase 3 clinical trial was conducted in 
accordance with guidance from the FDA for all companies investigating 
COVID-19 vaccines to review safety and efficacy at key milestones. 
 
   Results from this analysis of 46,307 trial participants build upon and 
confirm previously released data and demonstrate strong protection 
against COVID-19 through six months post-second dose. From the 927 
confirmed symptomatic cases of COVID-19 in the trial, 850 cases of 
COVID-19 were in the placebo group and 77 cases were in the BNT162b2 
group, corresponding to vaccine efficacy of 91.3% (95% confidence 
interval [CI, 89.0, 93.2]). 
 
   32 cases of severe disease, as defined by the CDC, were observed in the 
placebo group versus none in the BNT162b2 vaccinated group, indicating 
that the vaccine was 100% efficacious in this analysis against severe 
disease by the CDC definition (95% CI, [88.0,100.0]). 21 severe cases, 
as defined by the FDA, were observed in the placebo group versus one 
case in the BNT162b2 vaccinated group, indicating 95.3% efficacy by the 
FDA definition (95% CI, [71.0, 99.9]). 
 
 
 
   Efficacy was generally consistent across age, gender, race and ethnicity 
demographics, and across participants with a variety of underlying 
conditions. 
 
   A total of 697 cases of COVID-19 were observed in the United States; 647 
cases of COVID-19 were observed in the placebo group versus 50 in the 
vaccine group, indicating vaccine efficacy of 92.6% (95% CI, [90.1, 
94.5]). 
 
   In South Africa, where the B.1.351 lineage is prevalent and 800 
participants were enrolled, nine cases of COVID-19 were observed, all in 
the placebo group, indicating vaccine efficacy of 100% (95% CI, [53.5, 
100.0]). In an exploratory analysis, the nine strains were sequenced and 
six of the nine were confirmed to be of the B.1.351 lineage. These data 
support previous results from immunogenicity studies demonstrating that 
BNT162b2 induced a robust neutralizing antibody response to the B1.351 
variant, and although lower than to the wild-type strain, it does not 
appear to affect the high observed efficacy against this variant.(i) 
 
   No serious safety concerns were observed in trial participants up to six 
months after the second dose. Side effects were generally consistent 
with previously reported results. Vaccine safety has now been evaluated 
in more than 44,000 participants aged 16 years and older with more than 
12,000 vaccinated participants having at least six months of follow-up 
after their second dose. 
 
   Pfizer and BioNTech plan to submit detailed data for scientific peer 
review and potential publication in the near future. 
 
   The Pfizer-BioNTech COVID-19 Vaccine, BNT162b2, 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 
Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers 
Administering Vaccine (Vaccination Providers) including Full EUA 
Prescribing Information available at 
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www.cvdvaccine.com. 
 
   The vaccine, which is based on BioNTech proprietary mRNA technology, was 
developed by both BioNTech and Pfizer. BioNTech is the Marketing 
Authorizations Holder in the European Union, and the holder of emergency 
use authorizations or equivalent in the United States, United Kingdom, 
Canada and other countries in advance of a planned application for full 
marketing authorizations in these countries. 
 
   AUTHORIZED USE IN THE U.S.: 
 
   The Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an 
Emergency Use Authorization (EUA) for active immunization to prevent 
coronavirus disease 2019 (COVID-19) caused by severe acute respiratory 
syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and 
older. 
 
   IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION 
PRESCRIBING INFORMATION: 
 
 
   -- Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with 
      known history of a severe allergic reaction (e.g., anaphylaxis) to any 
      component of the Pfizer-BioNTech COVID-19 Vaccine 
 
   -- Appropriate medical treatment used to manage immediate allergic reactions 
      must be immediately available in the event an acute anaphylactic reaction 
      occurs following administration of Pfizer-BioNTech COVID-19 Vaccine 
 
   -- Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of 
      immediate adverse reactions according to the Centers for Disease Control 
      and Prevention guidelines ( https://www.cdc.gov/vaccines/covid-19/ 
      https://www.cdc.gov/vaccines/covid-19/) 
 
   -- Immunocompromised persons, including individuals receiving 
      immunosuppressant therapy, may have a diminished immune response to the 
      Pfizer-BioNTech COVID-19 Vaccine 
 
   -- The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine 
      recipients 
 
   -- In clinical studies, adverse reactions in participants 16 years of age 
      and older included pain at the injection site (84.1%), fatigue (62.9%), 
      headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), 
      fever (14.2%), injection site swelling (10.5%), injection site redness 
      (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%) 
 
   -- Severe allergic reactions, including anaphylaxis, have been reported 
      following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination 
      outside of clinical trials. Additional adverse reactions, some of which 
      may be serious, may become apparent with more widespread use of the 
      Pfizer-BioNTech COVID-19 Vaccine 
 
   -- Available data on Pfizer-BioNTech COVID-19 Vaccine administered to 
      pregnant women are insufficient to inform vaccine-associated risks in 
      pregnancy 
 
   -- Data are not available to assess the effects of Pfizer-BioNTech COVID-19 
      Vaccine on the breastfed infant or on milk production/excretion 
 
   -- There are no data available on the interchangeability of the 
      Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete 
      the vaccination series. Individuals who have received one dose of 
      Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of 
      Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series 
 
   -- Vaccination providers must report Adverse Events in accordance with the 
      Fact Sheet to VAERS at https://vaers.hhs.gov/reportevent.html

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April 01, 2021 06:45 ET (10:45 GMT)