Press Release: Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron JN.1-adapted COVID-19 Vaccine in the European Union

===
-- The updated COVID-19 vaccine is tailored to the Omicron JN.1 lineage of
SARS-CoV-2 and is recommended for individuals 6 months of age and older

-- Recommendation is based on pre-clinical and epidemiological data showing
that the JN.1-adapted monovalent COVID-19 vaccine generates an improved
immune response against multiple JN.1 sublineages

-- Doses will be ready to ship to applicable EU member states immediately
upon authorization by the European Commission
===
NEW YORK and MAINZ, Germany, June 27, 2024 -- https://www.globenewswire.com/Tracker?data=Jn7NBrSXKeL3yVAa43ncWrYpHXqnvJA6pzO0y-2i91ESF8swKelCmLHTytmsBlRVz9XVRM1Kq9SAzduy3US-nA== Pfizer Inc. (NYSE: PFE, "Pfizer") and https://www.globenewswire.com/Tracker?data=UkQxI5Thn3CFpK7gxXftHRfQ6gigt7mNnw37Ip59YEedjfhYrxqDK9SvOzW4c_VTxKEDaLqL4uwN5pOJceH-3w== BioNTech SE (Nasdaq: BNTX, "BioNTech") today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for the companies' Omicron JN.1-adapted monovalent COVID-19 vaccine (COMIRNATY(R) JN.1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The adaptation is based on the recommendation from the World Health Organization (WHO) Technical Advisory Group on COVID-19 Vaccine Composition and the European Medicines Agency's Emergency Task Force (ETF) to update COVID-19 vaccines to target the SARS-CoV-2 variant JN.1 for the 2024-2025 vaccination campaign. ETF stated that "evidence indicates that targeting JN.1 will help maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve." (1) , (2)

The European Commission (EC) will review the CHMP's recommendation and is expected to make a final decision soon. Following the EC decision, the updated vaccine will be available to ship to applicable EU member states immediately. Pfizer and BioNTech have been manufacturing the Omicron JN.1-adapted monovalent COVID-19 vaccine at risk to ensure supply readiness ahead of the upcoming fall and winter season when the demand for COVID-19 vaccination is expected to increase.(3)

The CHMP's recommendation is based on the full body of previous clinical, non-clinical, and real-world evidence supporting the safety and efficacy of the COVID-19 vaccines by Pfizer and BioNTech. The application also included manufacturing and pre-clinical data showing that the JN.1-adapted monovalent COVID-19 vaccine generates a substantially improved response against multiple Omicron JN.1 sublineages, including KP.2, KP.3 and other currently circulating sublineages, compared with the companies' Omicron XBB.1.5-adapted monovalent COVID-19 vaccine.(4)

Pfizer and BioNTech are starting rolling applications with the U.S. Food and Drug Administration (FDA), per recent FDA recommendation, requesting approval of their Omicron KP.2-adapted monovalent COVID-19 vaccines for individuals 6 months of age and older. The companies will continue to monitor the evolving epidemiology of COVID-19 and make appropriate preparations to meet global public health needs.

The COVID-19 vaccines (COMIRNATY(R)) by Pfizer and BioNTech are based on BioNTech's proprietary mRNA technology and were developed by both companies. BioNTech is the Marketing Authorization Holder for COMIRNATY(R) and its adapted vaccines (COMIRNATY(R) Original/Omicron BA.4-5; COMIRNATY(R) Omicron XBB.1.5) in the United States, the European Union, the United Kingdom, and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.

AUTHORIZED USE IN THE EU:

COMIRNATY(R) has been granted standard marketing authorization (MA) by the European Commission to prevent coronavirus disease 2019 (COVID-19) in people from the age of 6 months. The vaccine is administered as a single dose in people 5 years of age and older, and as a three-dose series, in infants and children from 6 months to 4 years who have not had COVID-19 with the first two doses are given three weeks apart, followed by a third dose given at least 8 weeks after the second dose. Adults and adolescents from the age of 12 are given 30 micrograms per dose; children aged 5 to 11 years are given 10 micrograms per dose; infants and children aged 6 months to 4 years are given 3 micrograms per dose. Additional doses may be administered to individuals aged 5 years and older who are severely immunocompromised in accordance with national recommendations. The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has completed its rigorous evaluation of COMIRNATY, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are available.

In addition, COMIRNATY has also been granted standard MA for two adapted vaccines: COMIRNATY Original/Omicron BA.4-5, which contains mRNA encoding for the spike protein of the wild-type and of the Omicron BA.4/BA.5 subvariant of SARS-CoV-2; and COMIRNATY Omicron XBB.1.5, which contains mRNA encoding for the spike protein of the Omicron XBB.1.5 subvariant of SARS-CoV-2.

COMIRNATY Omicron XBB.1.5 may be administered as a single dose regardless of prior vaccination status in people aged 5 years and older. Children from 6 months to 4 years of age may have one or three doses depending on whether they have completed a primary vaccination course or have had COVID-19. There should be an interval of at least 3 months between administration of COMIRNATY Original/Omicron BA.4-5 or COMIRNATY Omicron XBB.1.5 and the last prior dose of a COVID-19 vaccine.

IMPORTANT SAFETY INFORMATION

===
-- Events of anaphylaxis have been reported. Appropriate medical treatment
and supervision should always be readily available in case of an
anaphylactic reaction following the administration of the vaccine.

-- There is an increased, but very rare risk (<1/10,000 cases) of
myocarditis and pericarditis following vaccination with COMIRNATY. These
conditions can develop within just a few days after vaccination and have
primarily occurred within 14 days. They have been observed more often
after the second vaccination, and more often in younger males. Available
data indicate that most cases recover. Some cases required intensive care
support and fatal cases have been observed.

-- From post-marketing experience very rare adverse reactions of myocarditis
and pericarditis, uncommon incidence of insomnia, hyperhidrosis and night
sweats, dizziness; common incidence of vomiting, very common diarrhoea
and unknown incidence (cannot be estimated from available data) of
anaphylaxis, paraesthesia, hypoaesthesia and erythema multiforme,
extensive swelling of vaccinated limb, facial swelling (in vaccine
recipients with a history of injection of dermatological fillers) and
heavy menstrual bleeding (most cases appeared to be non-serious and
temporary in nature) have been identified.

-- Anxiety-related reactions, including vasovagal reactions (syncope),
hyperventilation or stress--related reactions (e.g. dizziness,
palpitations, increases in heart rate, alterations in blood pressure,
paresthesia, hypoesthesia and sweating) may occur in association with the
vaccination process itself. Stress-related reactions are temporary and
resolve on their own. Individuals should be advised to bring symptoms to
the attention of the vaccination provider for evaluation. It is important
that precautions are in place to avoid injury from fainting.

-- Vaccination should be postponed in individuals suffering from acute
severe febrile illness or acute infection. The presence of a minor
infection and/or low-grade fever should not delay vaccination.

-- As with other intramuscular injections, the vaccine should be given with
caution in individuals receiving anticoagulant therapy or those with
thrombocytopenia or any coagulation disorder (such as haemophilia)
because bleeding or bruising may occur following an intramuscular
administration in these individuals.

-- The efficacy, safety and immunogenicity of the vaccine has not been
assessed in immunocompromised individuals, including those receiving
immunosuppressant therapy. The efficacy of COMIRNATY Omicron XBB.1.5 may
be lower in immunosuppressed individuals.

-- As with any vaccine, vaccination with COMIRNATY Omicron XBB.1.5 may not
protect all vaccine recipients. Individuals may not be fully protected
until 7 days after their vaccination.

-- Adverse reactions observed during clinical studies and identified after
post authorization experience are listed below according to the following
frequency categories: Very common (>= 1/10), Common (>= 1/100 to < 1/10),
Uncommon (>= 1/1,000 to < 1/100), Rare (>= 1/10,000 to < 1/1,000), Very
rare (< 1/10,000).

-- Very common side effects: injection site pain, injection site
swelling, fever, chills, fatigue, headache, muscle pain, joint
pain, diarrhea.

-- Common side effects: injection site redness, nausea, vomiting,
enlarged lymph nodes (more frequently observed after a booster
dose).

-- Uncommon side effects: feeling unwell, arm pain, insomnia,
dizziness, injection site itching, allergic reactions such as rash,
itching, feeling weak or lack of energy/sleepy, decreased appetite,
excessive sweating, night sweats.

-- Rare side effects: temporary one-sided facial drooping, allergic
reactions such as hives or swelling of the face.

-- Very rare side effects: inflammation of the heart muscle
(myocarditis) or inflammation of the lining outside the heart
(pericarditis), which can result in breathlessness, palpitations
===
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Press Release: Pfizer and BioNTech Receive -2-

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or chest pain.

-- Not known incidence (cannot be estimated from the available data):
anaphylaxis, extensive swelling of vaccinated limbs; facial
swelling, pins and needles/tingling, reduced sense of touch or
sensation, a skin reaction that causes red spots or patches on the
skin, heavy menstrual bleeding.

-- A large amount of observational data from pregnant women vaccinated with
the initially approved COMIRNATY vaccine during the second and third
trimester have not shown an increase in adverse pregnancy outcomes. While
data on pregnancy outcomes following vaccination during the first
trimester are presently limited, no increased risk for miscarriage has
been seen. No data are available yet regarding the use of COMIRNATY
Omicron XBB.1.5 during pregnancy. Based on data available with other
vaccine variants, COMIRNATY Omicron XBB.1.5 can be used during pregnancy.

-- No data are available yet regarding the use of COMIRNATY Omicron XBB.1.5
during breast-feeding. Observational data from women who were
breast-feeding after vaccination with the initially approved COMIRNATY
vaccine have not shown a risk for adverse effects in breast-fed
newborns/infants. COMIRNATY Omicron XBB.1.5 can be used during
breast-feeding.

-- Interactions with other medicinal products or concomitant administration
of COMIRNATY Omicron XBB.1.5 with other vaccines has not been studied.

-- Animal studies with COMIRNATY Original do not indicate direct or indirect
harmful effects with respect to reproductive toxicity.

-- The most frequent adverse reactions in infants 6 to 23 months of age that
received any primary course dose included irritability (> 60%),
drowsiness (> 40%), decreased appetite (> 30%), tenderness at the
injection site (> 20%), injection site redness and fever (> 10%).

-- The most frequent adverse reactions in children 2 to 4 years of age that
received any primary course dose included pain at injection site and
fatigue (> 40%), injection site redness and fever (> 10%).

-- The overall safety profile of COMIRNATY in participants 5 to 11 years of
age was similar to that seen in participants 16 years of age and older.
The most frequent adverse reactions in children 5 to 11 years of age that
received 2 doses were injection site pain (> 80%), fatigue (> 50%),
headache (> 30%), injection site redness and swelling (>= 20%), myalgia,
chills, and diarrhoea (> 10%).

-- The overall safety profile for the booster dose was similar to that seen
after the primary course. The most frequent adverse reactions in children
5 to 11 years of age were injection site pain (> 60%), fatigue (> 30%),
headache (> 20%), myalgia, chills, injection site redness and swelling (>
10%)

-- The overall safety profile of COMIRNATY in adolescents 12 to 15 years of
age was similar to that seen in participants 16 years of age and older.
The most frequent adverse reactions in adolescents 12 to 15 years of age
that received 2 doses were injection site pain (> 90%), fatigue and
headache (> 70%), myalgia and chills (> 40%), arthralgia and pyrexia (>
20%).

-- The most frequent adverse reactions in participants 16 years of age and
older that received 2 doses were injection site pain (> 80%), fatigue (>
60%), headache (> 50%), myalgia (> 40%), chills (> 30%), arthralgia (>
20%), pyrexia and injection site swelling (> 10%) and were usually mild
or moderate in intensity and resolved within a few days after
vaccination. A slightly lower frequency of reactogenicity events was
associated with greater age.

-- The safety profile for the booster dose (third dose) was similar to that
seen after 2 doses. The most frequent adverse reactions in participants
18 to 55 years of age were injection site pain (> 80%), fatigue (> 60%),
headache (> 40%), myalgia (> 30%), chills and arthralgia (> 20%).

-- The safety profile for the COMIRNATY Original/Omicron BA.4-5 booster
(fourth dose) was similar to that seen after 3 doses. The most frequent
adverse reaction in participants 6 to 23 months of age was irritability
(> 20%), decreased appetite (> 10%), and drowsiness (> 10%). The most
frequent adverse reactions in participants 2 to 4 years of age were
injection site pain (> 30%) and fatigue (> 20%). The most frequent
adverse reactions in participants 5 to 11 years of age were injection
site pain (> 60%), fatigue (> 40%), headache (> 20%), and muscle pain (>
10%). The most frequent adverse reactions in participants 12 years of age
and older were injection site pain (> 60%), fatigue (> 50%), headache (>
40%), muscle pain (> 20%), chills (> 10%), and joint pain (> 10%).

-- The safety of COMIRNATY Omicron XBB.1.5 is inferred from safety data of
the prior COMIRNATY vaccines.

-- The duration of protection afforded by the vaccine is unknown as it is
still being determined by ongoing clinical trials. As with any vaccine,
vaccination with COMIRNATY Omicron XBB.1.5 may not protect all vaccine
recipients.

-- For complete information on the safety of COMIRNATY Omicron XBB.1.5,
always make reference to the approved Summary of Product Characteristics
and Package Leaflet available in all the languages of the European Union
on the EMA website.
===
The black equilateral triangle denotes that additional monitoring is required to capture any adverse reactions. This will allow quick identification of new safety information. Individuals can help by reporting any side effects they may get. Side effects can be reported to EudraVigilance or directly to BioNTech using email medinfo@biontech.de, telephone +49 6131 9084 0, or via the website www.biontech.de

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 175 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=JQFUl4LyCNzwCxKc5Cv5X4KVNPnHcEiHkZ8LWYyQYILu4008eAkJ3yFpy7UzWMhlI1-qg0BhR2zoySuwZbUyFDrrd2zQfqky6ffCfenyTk7wdHvyoSqHNS0Bfq1l3SQY1F7PKAnOwEznRTE9BTTaxKM_XzoLwT-zJt2ZDSRvka9SggsOZjTho2Q8i8eTDnNHi83yXe5-VBLTbQgXeQnM1rALMUQItsbKHmnfSXOpS1QgBCbvWpwupC2okG1mth17BCvEJXk9UpIIecvWzwGs9piKza8V6O2LdqKEoFp2dR4w_dsO_1SC_2Z_JCqccJP2H-NVfhTuqwyhj9S7dYRTksVaZY4kNsQ__mCu09JFIoUi2WX66EV_WFTImwXkMhezW0rnABOT1UHUuTg9ivO6zL30CDCuAYfvxxpSZbu6M4Jx5gLoJ3A18TRzCDBlfJhWS3YqjkWi_r7ZCp2iUFI-E09TyUh7Y2YMUx1p8fKyJXawPs2EE_ldQTQrTCA2r6Hw www.Pfizer.com. In addition, to learn more, please visit us on https://www.globenewswire.com/Tracker?data=JQFUl4LyCNzwCxKc5Cv5XxNDEFxuzOi8e8oRFeFg4yaI5C5cG-tZ_5FJpbqB6s5gdR5JPBU8ggtlsz1QOmhj8NVZ77ruKgn2gBt6tKmsc3SiauK_I7ogLn9R7KqnVAxNLBxjubZXJYgaonrQZat4y6utS0GkkiJQvHZbvz3ACGyiAiMCAsu1_VBNuy7fpRP_d_Qykrm36kLPhgT34HeSCNJA7Fm9D6V2WJJedFnmxjWibqz_EGIGEXUlUeeShTVHbYVz67EkgU98yqVHBG7o1UzOAA2LrGdYr0Qc9FNPc8aXP-z-oGtrKdggOJLHLevghZ28bUSeiHwb0_a-o1OOzzJbj9b3G2rvGDtrXy8iK7hzuu2GzZ6vTrkyJRcg5OWI-slR5X82Fs_6p2eKzd5HdWkyQWKAI4-HBMRJhKD8ZC0ERZonj55uIaZPdqBlu51_hOnsSq8VySI8j1t34lIXkVDD28Lrn-sjEm0RQ72c9bKe80py6cayvqxIxdLCmnvM www.Pfizer.com and follow us on X at https://www.globenewswire.com/Tracker?data=dABThNV4-Awb-z2Q7A1eYtPx6XOs9lxx8lUjz2qg5ZXhQ5spVqYzCy5fHnCkE4H3W3NNy9E8T1chu8ghfhEcl0Jc-jNnSIvsW3m6BYHmnZwYzhpFllvTLs-C-aMoU5cFUimd02Sbv-ckDKr2_j3pWAd2DCtGWqlOcqiRygUgAaRyhgVyDSlS9NIPGEvTEDfkx15axbaNIwGNVlCz2G-33NHgfsCsiKIgPzfqYtpHsEW87RAEaE-m_vyCWSSrNOMr71OvQnzren2gHVuXUnt6TQ== @Pfizer and https://www.globenewswire.com/Tracker?data=dABThNV4-Awb-z2Q7A1eYnlhWcJp5kaFnE9nhDO9ZAbHwpKj5rPs_gDoO7h9kV_cI8v6AdH3R_nAVeYppWVAlkFsNtDfHD51_ErgV72Louui4BprstM-HrtGgt_7dLdwVcLLubqsGNvzSTr1VyITVZ56fhdP5n6gBdJ0-4gBEbV5Ls3PtvmeAitOfH9ES9ClxmzPunYpymozACaaLBlNLJtS63F_pHAlQ7BUEckYLO6hd5ywFHqivSt6Vrqik1vXrDNS6ExZqLzFy1wGDIxoM1ddTGnsJ7nYp13ddX6IxkU= @Pfizer News, https://www.globenewswire.com/Tracker?data=cWANuk-jMrvtdM1rySEtOGOqEw69GlUEFJp34diT7-zf3lGGSc1EdLNOrI9fH445Vm7LN1mCYNZmCbf1h9Nm5zOXVK_jcBuzALs2wkECI2fzURL5gyo1FRo70I4mDrVE_uxYHG55a9Xe5lB3_ZJDsx2oMrAUJ5_QwhFGng9v1VtMgu31H9b5QfkfG9CHmaeAXrlQ2MbqjgXYFAPdFh2y4gqmBdCT2N0hRhi8OAExImIivC3hoDWfvHrZvKBRGSjtIH_EfYCY4SYqc30unGkkkJ1toReKuL4cGBeQW3Iu3FU= LinkedIn, https://www.globenewswire.com/Tracker?data=8BhijM4bPX1LDc8D6AGiQ4elmHQonTK2jseTCeRDJ0gudDyB3Ij_MDxuuP27U0H5nwUu8CKXto1x0Xpu4FMSVpTctAfngEhDud6lvGjd3iETtUZvZkxZuB4nhqz3CFDyN2GsXAOzUI5b2lqLxOEYXIXfcCGcpMEsKtSRH9R76vyf66JdBmqdZ_ru0g-dxc_hrbhuEqZmClWEQBLLMI3biYEVCAPyxWXTaNPlHKKEQFAR54npOXKA9unGl5aW_Lb7ipPI0VFnaQnjxNFxaLv78Q== YouTube and like us on Facebook at https://www.globenewswire.com/Tracker?data=O7stGW8-HKHRau-OWaDy7UNRU6Nq3IO4nhJF6_2YEEYaCMsl9mLjeVtGUXdPc1jhYd6_8LCsuznpITOYScctCHSPxCJyeQY3L9v03sjNJR7LTwtEbmlsOCUIquIQOyLJEFBL7C5C9qz2XKJ-S5YJ5Jm_82RK0CTwNIDQ9CTAdN-UpCV_dxVCU6vxZjw6eXc_W743P26VGYfZv2X8y77A6fYVaZAExcgVOWEknlxgw1Lp5TNyfS6Opok_Cnyw5D7WJi_1-mHCluWXXrLqczFCVSihwfhw0M1CPsHgB-dmt44= Facebook.com/Pfizer.

Pfizer Disclosure Notice

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The information contained in this release is as of June 27, 2024. 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 BNT162b2 mRNA vaccine program, and the Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY(R) (COVID-19 Vaccine, mRNA) (BNT162b2) including an Omicron-adapted monovalent COVID-19 vaccine candidate, based on the JN.1 lineage, including a submission to the European Medicines Agency (EMA) for an Omicron-adapted monovalent COVID-19 vaccine, based on the JN.1 lineage, expectations regarding the demand for COVID-19 vaccines, planned regulatory submissions, qualitative assessments of available data, potential benefits, expectations for clinical trials, potential regulatory submissions, the anticipated timing of data readouts, 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 Phase 1/2/3 or Phase 4 data), including the data discussed in this release for BNT162b2, any monovalent or bivalent vaccine candidates or any other vaccine candidate in the BNT162 program in any of our studies in pediatrics, adolescents, or adults or real world evidence, 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, in real world data studies or in larger, more diverse populations following commercialization; the ability of BNT162b2, any monovalent or bivalent vaccine candidates or any future vaccine 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 submissions to request emergency use or conditional marketing authorizations for BNT162b2 in additional populations, for a potential booster dose for BNT162b2, any monovalent or bivalent vaccine candidates or any potential future vaccines (including potential future annual boosters or re-vaccination), and/or other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2, any monovalent or bivalent vaccine candidates or any other potential vaccines that may arise from the BNT162 program, including a potential variant-based, higher dose, or bivalent vaccine, and if obtained, whether or when such emergency use authorizations or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including any requested amendments to the emergency use or conditional marketing authorizations), any monovalent or bivalent vaccine candidates (including the submission to the EMA for an Omicron-adapted monovalent COVID-19 vaccine candidate, based on the JN.1 lineage), 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 or not meet expectations which may lead to reduced revenues or excess inventory on-hand and/or in the channel which, for our COVID-19 vaccine, resulted in significant inventory write-offs in 2023 and could continue to result in inventory write-offs, or other unanticipated charges; challenges related to the transition to the commercial market for our COVID-19 vaccine; uncertainties related to the public's adherence to vaccines, boosters, treatments or combinations; risks related to our ability to accurately predict or achieve our revenue forecasts for our COVID-19 vaccine or any potential future COVID-19 vaccines; potential third-party royalties or other claims related to our COVID-19 vaccine; the risk that other companies may produce superior or competitive products; risks related to the availability of raw materials to manufacture or test a vaccine; challenges related to our vaccine's formulation, dosing 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 potential future annual boosters or re-vaccinations or new variant-based vaccines; the risk that we may not be able to maintain 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.

A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at https://www.globenewswire.com/Tracker?data=JQFUl4LyCNzwCxKc5Cv5X7PPR5p-ywf-UZuaA3ee2Q6jNHySSiTk1Jkt0RtaYACyYf1FTN8NT8hOIRwG1uocjA== www.sec.gov and https://www.globenewswire.com/Tracker?data=JQFUl4LyCNzwCxKc5Cv5Xz-CLE7FwRq2dEvzNXI9qJ472-uaIMjY7-kpJq0VvgfNwKVQDaE9WYYhAAzhn5Ti5Q== www.pfizer.com.

About BioNTech

Biopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor (CAR) T cells, several protein-based therapeutics, including bispecific immune checkpoint modulators, targeted cancer antibodies and antibody-drug conjugate (ADC) therapeutics, as well as small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global and specialized pharmaceutical collaborators, including Biotheus, DualityBio, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron.

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