-- More than 450 million doses of BNT162b2 supplied to 91 countries or 
      territories worldwide as of May 6, 2021 
 
   -- Signed agreements for over 1.8 billion doses of BNT162b2 in 2021 and 
      first contracts signed for periods 2022 and beyond 
 
   -- Announced planned expansion of global footprint to Asia with 
      establishment of first regional headquarters for south east Asia in 
      Singapore, including a fully-integrated and state-of-the art mRNA 
      manufacturing facility 
 
   -- In oncology, a first-in-human Phase 1 trial started for the 
      neoantigen-targeting T cell therapy, BNT221. The development of 
      BioNTech's oncology pipeline has continued to accelerate with 14 product 
      candidates now in 15 ongoing trials 
 
 
   Conference call and webcast scheduled for May 10, 2021, at 8:00 a.m. ET 
(2:00 p.m. CET) 
 
   MAINZ, GERMANY, May 10, 2021 -- 
https://www.globenewswire.com/Tracker?data=339oF-40rE4PUzxq1IUYi8JpS5oJbNY8ITxGX7DEDO8n2KZ7tV8UxV5nBzbS0xYdW4-_2OLoz7xuhzZz4UBy_g== 
BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") a next 
generation immunotherapy company pioneering novel therapies for cancer 
and infectious diseases, today provided an update on its corporate 
progress and reported financial results for the quarter ended March 31, 
2021. 
 
   "BioNTech has continued to execute the delivery of our COVID-19 vaccine 
globally to more than 90 countries and territories. Through our 
continued innovation, we are expanding access to new populations and 
geographies, and addressing emerging variants," said Ugur Sahin, 
BioNTech's Co-founder and CEO. "We are moving into later stage testing 
for three of our oncology programs in the near future and plan to launch 
multiple new products over the next five years. Looking ahead, we will 
further optimize our technologies and expand our pipeline into 
additional therapeutic indications, as we meet our ambition to become a 
global, fully-integrated immunotherapy company." 
 
   First quarter 2021 and subsequent updates 
 
   Infectious disease 
 
   COVID-19 vaccine program -- BNT162b2 
 
   In March 2021, BioNTech announced its Full Year 2020 Financial Results 
and Corporate Update as a part of the Annual Report filed on Form 20-F, 
highlighting developments relating to its COVID-19 vaccine program 
between January 1 and March 30, 2021 ( 
https://www.globenewswire.com/Tracker?data=crWGMA_fQHvIZf8sokcj-bnV1FtiRamsL0tatmES0sAiQl5zrz3vHw-zJutI2uJQJo45IumcyG1xXvM9Jmu2ovupmGlmRJwIirpzhK2K1_OaoSNDHGs4aQU4xN69evjUg6OtqLSzsDeh11e3V38Mp774-X88UvOgQRkNTHXAw41JIIqJaL1SB3pRFFcxWE_d3MgyH4llAKKfC9WzevcY8DinQnIn10ZZTlaZwOVEOxM= 
Link to press release). A summary of these developments as well as full 
details of subsequent developments that occurred after March 30, 2021 is 
provided below. 
 
   As of May 6, 2021 BioNTech and Pfizer have shipped approximately 450 
million doses of BNT162b2 to 91 countries and territories around the 
world. 
 
   To date, the companies have signed orders of approximately 1.8 billion 
doses for delivery in 2021, and they have also signed the first 
contracts for 2022 and beyond. Further discussions for additional dose 
commitments are ongoing for 2021 and beyond. BioNTech expects BNT162b2 
annual manufacturing capacity to reach 3 billion doses by the end of 
2021, and expects to have capacity to manufacture more than 3 billion 
doses in 2022. 
 
   Multiple clinical trials are ongoing to expand the authorization of 
BNT162b2 to additional population groups, such as children from 6 months 
to 11 years of age, and to collect further data in healthy pregnant 
women. 
 
   To date, there is no evidence that an adaptation of BioNTech's current 
COVID-19 vaccine against key identified emerging variants is necessary. 
Despite this, BioNTech has developed a comprehensive strategy to address 
these variants should the need arise in the future. As part of 
BioNTech's strategy to contend with the variant challenge, BioNTech 
submitted to the U.S. Food and Drug Administration (FDA), and the FDA 
has approved an additional amendment to the study protocol of the global 
Phase 1/2/3 trial which includes: (1) an assessment of the impact of a 
third dose of BNT162b2 in prolonging immunity against COVID-19 and in 
protecting against COVID-19 caused by potential newly emerging 
SARS-CoV-2 variants, and (2) an assessment of a modified, 
variant-specific version of BNT162b2. The aim of this study is to 
explore the regulatory pathway that BioNTech and Pfizer would pursue if 
SARS-CoV-2 were to change enough to require an updated vaccine. This 
trial started in March 2021. 
 
   In the first quarter of 2021, BioNTech also advanced its work to broaden 
access through improvements to its cold chain distribution systems and 
processes. Both the FDA and the European Medicines Agency (EMA) have 
approved the transportation and storage of undiluted frozen vials of 
BNT162b2 at temperatures (-20degC) commonly found in pharmaceutical 
freezers for a period of up to two weeks. Further stability data have 
been assessed and formulation optimization activities are ongoing, 
including a study to evaluate a lyophilized (or freeze-dried) and a 
ready-to-use formulation of BNT162b2. 
 
   BNT162b2 clinical development updates 
 
 
   -- On March 31, 2021, BioNTech and Pfizer announced that BNT162b2 
      demonstrated 100% efficacy and robust antibody responses in a Phase 3 
      trial in adolescents aged 12 to 15 with or without prior evidence of 
      SARS-CoV-2 infection. The trial enrolled 2,260 adolescents in the United 
      States. In the trial, 18 cases of COVID-19 were observed in the placebo 
      group (n=1,129) versus none in the vaccinated group (n=1,131). 
      Vaccination with BNT162b2 elicited high SARS-CoV-2 neutralizing antibody 
      titers, demonstrating strong immunogenicity in a subset of adolescents 
      one month after the second dose. BNT162b2 administration was generally 
      well tolerated. 
 
   -- On March 31, 2021, BioNTech and Pfizer began evaluating the 
      administration of a single booster dose five to seven months after 
      receiving the second dose of BNT162b2. To demonstrate duration of 
      protection, and protection against the emerging variants of concern, an 
      additional dose of BNT162b2 or of BNT162b2SA (encoding for the spike 
      protein of the variant B.1.351) is being given to about 600 Phase 3 
      participants. About 30 participants that received BNT162b2SA will be 
      given another dose of BNT162b2SA. A new cohort of approximately 300 
      participants will be enrolled who are COVID-19 vaccine-naïve (i.e., 
      including BNT162b2-naïve) and have not been infected with COVID-19. 
      They will receive BNT162b2SA given as a two-dose series, separated by 21 
      days. The objective of this Phase 1/2/3 protocol amendment is to describe 
      the safety and tolerability profile of BNT162b2SA, to evaluate its 
      non-inferiority compared to BNT162b2, and to analyze the immune response 
      generated by BNT162b2SA. By evaluating BNT162b2SA as a prototype vaccine, 
      the companies aim to inform the development of an efficient regulatory 
      pathway for testing future modified mRNA vaccines, using the current 
      pathways for flu vaccines as models (blueprint study). 
 
   -- On April 1, 2021, BioNTech and Pfizer announced updated topline results 
      confirming high efficacy and no serious safety concerns through up to six 
      months following the second dose. Topline efficacy was based on an 
      analysis of 927 confirmed symptomatic cases of COVID-19 observed in the 
      pivotal Phase 3 study through March 13, 2021. BNT162b2 was 91.3% 
      effective against COVID-19, measured seven days through up to six months 
      after the second dose. The vaccine was also 100% effective against severe 
      disease, as that term is defined by the U.S. Centers for Disease Control 
      and Prevention, and 95.3% effective against severe COVID-19 as that term 
      is defined by the FDA. Safety data collected from more than 12,000 
      vaccinated participants who had a follow-up time of at least six months 
      after the second dose demonstrated a favorable safety and tolerability 
      profile. 
 
 
   In an additional exploratory analysis of 800 trial participants enrolled 
in South Africa, where the B.1.351 lineage is prevalent, nine cases of 
COVID-19 were observed, all in the placebo group, indicating vaccine 
efficacy of 100%. Of these cases, eight were of the B.1.351 lineage, 
confirming efficacy against B.1.351 virus. 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 observed high efficacy against COVID-19 caused by this 
variant, as published in the New England Journal of Medicine.(2) 
 
 
   -- On April 1, 2021, BioNTech and Pfizer started a Phase 3, randomized, 
      observer-blind study to evaluate the safety, tolerability, and 
      immunogenicity of multiple formulations of BNT162b2, administered on a 
      two-dose (separated by 21 days) schedule in adults aged 18 to 55. Part 1 
      of the study is comparing the safety and tolerability of lyophilized (or 
      freeze-dried) BNT162b2 to the current frozen-liquid formulation of 
      BNT162b2 and is evaluating non-inferiority of the immune response. Part 2 
      of the study will evaluate the safety and immunogenicity of a 
      ready-to-use formulation of BNT162b2, and will be initiated in May 2021. 
      The study, which is being conducted in the United States, will enroll 
      approximately 610 participants. BioNTech and Pfizer expect to obtain 
      results from both study parts in the third quarter of 2021. 
 
 
   Regulatory updates 
 
 
   -- On April 9, 2021, BioNTech and Pfizer requested amendments to the U.S. 
      Emergency Use Authorization to expand the use of BNT162b2 to adolescents 
      aged 12 to 15.

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May 10, 2021 07:00 ET (11:00 GMT)