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%) 
 
   -- In a clinical study, adverse reactions in adolescents 12 through 15 years 
      of age included pain at the injection site (90.5%), fatigue (77.5%), 
      headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), 
      joint pain (20.2%), injection site swelling (9.2%), injection site 
      redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%) 
 
   -- Severe allergic reactions, including anaphylaxis, and other 
      hypersensitivity reactions, diarrhea, vomiting, and pain in extremity 
      (arm) have been reported following administration of the Pfizer-BioNTech 
      COVID-19 vaccine 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 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 http://www.cvdvaccine-us.com 
      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=JJWEBjC1o8pNulbcYx4CLQGjNXA4xj3fWxKZnAAbxxxZV8QpqbJ_Y_FHbA-zVBfLiZmOI-tUJIvVfMxNKSTbiA== 
www.Pfizer.com. In addition, to learn more, please visit us on 
https://www.globenewswire.com/Tracker?data=JJWEBjC1o8pNulbcYx4CLc3E4GdJfh3j06-RS6sB82kpni7d0LhLVHy_TtBXe6TThRDdWUGaO2qvz1hZvLgBeg== 
www.Pfizer.com and follow us on Twitter at 
https://www.globenewswire.com/Tracker?data=hpy0kdqxXPJKchcC6mM2PrZJrU0uxWgrKQkTfi4fCFZSNxmPNGfYoUZWsPFQhbjdTy4NDu0TAapczp-t7kN36Q== 
@Pfizer and 
https://www.globenewswire.com/Tracker?data=hpy0kdqxXPJKchcC6mM2Prx8BmoRYm3KqWWcSMlkfa_KBq7Q5despiGt7JdP88mbcs26YQRAKsAOE_mtHRtOr9bMGDH2QaGR4mr8KiMcByo= 
@Pfizer News, 
https://www.globenewswire.com/Tracker?data=HMzLv0SrAHQ1aAmzD65IzOnrRHhMPnLIV8VCsEn5aHxlontNkmk817etdg85UHqM1O_rKQ8kyUSAoof-vcEbDZzKqYmvkSKHHDmmKddBwN8= 
LinkedIn, 
https://www.globenewswire.com/Tracker?data=xS0M-MJfGPlFMf1ss0wXsSN16Goi9Re6xMeiYqyUkmaqPsVnssP-Fv113J_x1-65J97g0eJc3PAQQ9gzFnkRow== 
YouTube and like us on Facebook at 
https://www.globenewswire.com/Tracker?data=7F3GxmzjingzWeDaPwMSS2nqR_PDQ_eP9FpbyNJFimKjiSE3st3O34DzqKRHVC9wQDVkBFXVRZqDyQ59JFh4gMopLlBFectW1w1L1VGl5cs= 
Facebook.com/Pfizer. 
 
   *The Pfizer Foundation is a charitable organization established by 
Pfizer Inc. It is a separate legal entity from Pfizer Inc. with distinct 
legal restrictions. 
 
   Pfizer Disclosure Notice 
 
   The information contained in this release is as of June 10, 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, potential benefits, expectations for 
clinical trials, supply agreements and the timing of delivery of doses 
thereunder, efforts to help ensure global equitable access to the 
vaccine, 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 the rolling submission of a Biologics 
License Application for BNT162b2 in the U.S. (the BLA) will be accepted 
for review 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 BLA 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 

(MORE TO FOLLOW) Dow Jones Newswires

June 10, 2021 02:00 ET (06:00 GMT)