-- Proposed U.S. EUA label update would enable the vaccine to be stored at 
      -25degC to -15degC (-13degF to 5degF) for a total of two weeks 
 
   -- If approved, new storage option could offer pharmacies and vaccination 
      centers greater flexibility in managing and maintaining vaccine 
      distribution and supply 
 
 
   NEW YORK and MAINZ, GERMANY, February 19, 2021 (GLOBE NEWSWIRE) -- 
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Pfizer Inc. (NYSE: PFE) and 
https://www.globenewswire.com/Tracker?data=3n6HNZTlP0b8V1_XyMwDWlqb2FepsfnH_JSjaWGN_2NlCR_iHqsF3j4mRxtcFET54PU4bN1Lgl2Rce6kXYYPgw== 
BioNTech SE (Nasdaq: BNTX) today announced the submission of new data to 
the U.S. Food and Drug Administration (FDA) demonstrating the stability 
of their COVID-19 vaccine when stored at -25degC to -15degC (-13degF to 
5degF), temperatures more commonly found in pharmaceutical freezers and 
refrigerators. The data have been submitted to the FDA to support a 
proposed update to the U.S. Emergency Use Authorization (EUA) 
Prescribing Information, which would allow for vaccine vials to be 
stored at these temperatures for a total of two weeks as an alternative 
or complement to storage in an ultra-low temperature freezer. 
 
   The FDA submission includes stability data generated on batches 
manufactured over the past nine months of COVID-19 vaccine development, 
from the batches that supplied the earliest clinical trials through the 
commercial scale batches currently in production. These data also will 
be submitted to global regulatory agencies within the next few weeks. 
 
   "We have been continuously performing stability studies to support the 
production of the vaccine at commercial scale, with the goal of making 
the vaccine as accessible as possible for healthcare providers and 
people across the U.S. and around the world," said Albert Bourla, 
Chairman and Chief Executive Officer, Pfizer. "We appreciate our ongoing 
collaboration with the FDA and CDC as we work to ensure our vaccine can 
be shipped and stored under increasingly flexible conditions. If 
approved, this new storage option would offer pharmacies and vaccination 
centers greater flexibility in how they manage their vaccine supply." 
 
   "Our top priority was to quickly develop a safe and effective vaccine 
and make it available to the most vulnerable people in the world in 
order to save lives. At the same time, we have continuously collected 
data that could enable storage at around -20degC. The data submitted may 
facilitate the handling of our vaccine in pharmacies and provide 
vaccination centers an even greater flexibility," said Ugur Sahin, CEO 
and Co-founder of BioNTech. "We will continue to leverage our expertise 
to develop potential new formulations that could make our vaccine even 
easier to transport and use." 
 
   Currently, the labels for the Pfizer-BioNTech COVID-19 vaccine, 
including the EUA label in the U.S., state that the vaccine must be 
stored in an ultra-cold freezer at temperatures between -80 C and -60 C 
(-112 F to --76 F). It can remain stored at these temperatures for up to 
6 months. The vaccines are shipped in a specially-designed thermal 
container that can be used as temporary storage for a total of up to 30 
days by refilling with dry ice every five days. Before mixing with a 
saline diluent, the vaccine may also be refrigerated for up to five days 
at standard refrigerator temperature, between 2 C and 8 C (36 F and 46 
F). If approved, the option to store at -25degC to -15degC (-13degF to 
5degF) for two weeks would be in addition to this five-day option to 
store at standard refrigerator temperature. The vaccine is administered 
at room temperature by medical staff. 
 
   As additional stability data are obtained, Pfizer and BioNTech 
anticipate the shelf life and/or expiration date could be extended, and 
alternate short-term temperature storage may be considered. 
 
   The vaccine, which is based on BioNTech proprietary mRNA technology, was 
developed by both BioNTech and Pfizer. BioNTech is the Marketing 
Authorization 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 COVID19 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. 
 
   The Pfizer-BioNTech COVID-19 Vaccine 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) and Full EUA Prescribing Information 
available at 
https://www.globenewswire.com/Tracker?data=1LaJTQoVi_vx2eV4hR0-g9mCAc_jZQoGnD84G3qTPxShoZBC88BWNsT_rYKQ1cAAhgMDSmN5qSUTuKOzASz6utm6Hj65zeJHCnqJWTUUBdM= 
www.cvdvaccine.com. 
 
   IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMEGERNCY 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 http s://vaers.hhs.gov/reportevent.html or by 
      calling 1-800-822-7967. The reports should include the words 
      "Pfizer-BioNTech COVID-19 Vaccine EUA" in the description section of the 
      report. 
 
   -- Vaccination providers should review the Fact Sheet for Information to 
      Provide to Vaccine Recipients/Caregivers and Mandatory Requirements for 
      Pfizer-BioNTech COVID-19 Vaccine Administration Under Emergency Use 
      Authorization. 
 
 
   Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare 
Providers Administering Vaccine (Vaccination Providers) including Full 
EUA Prescribing Information available at 
https://www.globenewswire.com/Tracker?data=1LaJTQoVi_vx2eV4hR0-g9-eWlTkmv4PKJlyYNkPFmtZ6hdDnY9tjfb52NZgYObQV2-LbAZB9f69fG2-P9NIsCpQqQoE6cfwcH80h5oah1w= 
www.cvdvaccine-us.com. 
 
   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

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