-- 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 online at https://vaers.hhs.gov/reportevent.html. For 
      further assistance with reporting to VAERS call 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 
 
   -- Before administration of Pfizer-BioNTech COVID-19 vaccine, please see 
      Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers 
      Administering Vaccine (Vaccination Providers) including Full EUA 
      Prescribing Information available at 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 170 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 https://www.globenewswire.com/Tracker?data=CMzCMHIft0Ln1JLga91pdJ6uIdOW2gFoMxrOLSD7mmcqgOq481EQ9eKlv9Udk_wmVPA8InegBLaQ_FYQT_jdAw== www.Pfizer.com. In addition, to learn more, please visit us on https://www.globenewswire.com/Tracker?data=CMzCMHIft0Ln1JLga91pdDDR-PZJMX8DLuHIoJ8_DX960cXDBQixfeQoOkPeYDAlquir8zhnC9n1k_bQm4Ar_w== www.Pfizer.com and follow us on Twitter at https://www.globenewswire.com/Tracker?data=pnGNvbvgG85yCUbtUzAqnf12uyRojnPP0B9MdV8UdUOnO-zhvfdRTofTNR8VfnwTIbAEfGvpqufzvo1Ja43Lcg== @Pfizer and https://www.globenewswire.com/Tracker?data=pnGNvbvgG85yCUbtUzAqnf5ZDMW_5amN4Vzinnz0ePKD1XCPOyPKv6teBOYvy8txUdVZYruY7uwuYwZWTQkPe59lOjgO8NW9r0gF6gHZu0U= @Pfizer News, https://www.globenewswire.com/Tracker?data=Upq_UTHUvL0gt2yVRSCC-TzayqHTganRPyR8C0Ubl98Gbd7oZ4dQfb0C6Wvmg6GRo_LRfZEZMeK_uQfYvGeh01roqvs9gPVJAO98RR4avOU= LinkedIn, https://www.globenewswire.com/Tracker?data=8aW_brofZYCqhbdfAxelZIABqGOE7MEiD2yQWM68NWKKJq-jTM0OET7cx_t9G-4vriJ1uGHwPrJtkyhYeRAuXw== YouTube and like us on Facebook at https://www.globenewswire.com/Tracker?data=07AATPcyWZFEPUmjT5k07jfOdu87tyoq_IMfAShifAT7XOR52XLOJOeFASKuRuFZZDERKMn1yZNeUgV3Qwi37PLBtyjLNqa2NrCkjupNgwI= Facebook.com/Pfizer.

Pfizer Disclosure Notice

The information contained in this release is as of August 16, 2021. 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 COVID-19 vaccine, the BNT162 mRNA vaccine program and the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (including qualitative assessments of available data, a potential booster dose, potential benefits, expectations for clinical trials, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including the Phase 3 data), including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies or in larger, more diverse populations following commercialization; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when a supplemental Biologics License Application for a potential booster dose will be filed in any jurisdictions and whether and when other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2 or any other potential vaccines that may arise from the BNT162 program, and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including the Biologics License Application in the U.S. or any requested amendments to the emergency use or conditional marketing authorizations) or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine's benefits outweigh its known risks and determination of the vaccine's efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine's ultra-low temperature formulation, two-dose schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or new variant-specific vaccines; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; and competitive developments.

(MORE TO FOLLOW) Dow Jones Newswires

August 16, 2021 11:31 ET (15:31 GMT)