BioNTech : Presentation Omicron Press Conference Dec. 8, 2021

Update

OMICRON VARIANT (B.1.1.529)

December 8, 2021

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This Slide Presentation Includes Forward-looking Statements

This press release contains "forward-looking statements" of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech's efforts to combat COVID-19; the collaboration between BioNTech and Pfizer including the program to develop a COVID-19 vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including the potential of a Omicron-specificCOVID-19 vaccine candidate, the potential timing for the development of a Omicron-specificCOVID-19 vaccine candidate, the testing of BNT162b2 against the Omicron variant, the effectiveness of a third booster dose of BNT162b2 to induce protection against Omicron-inducedCOVID-19 disease, and the timing for assessment of the effectiveness of a variant-specificCOVID-19 vaccine, qualitative assessments of available data, potential benefits, expectations for clinical trials, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply); our expectations regarding the potential characteristics of BNT162b2 or variant-specificCOVID-19 vaccine candidates in our clinical trials and/or in commercial use based on data observations to date; the ability of BNT162b2 to prevent COVID-19 caused by the Omicron and other emerging virus variants; the expected time point for additional readouts on efficacy data of BNT162b2 in our clinical trials; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the risk of further widespread use of our 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; decisions by regulatory authorities that may impact labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of our vaccine, including development of products or therapies by other companies; the timing for submission of data for, or receipt of, any marketing authorization or Emergency Use Authorization; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; disruptions in the relationships between us and our collaboration partners, clinical trial sites or other third-parties; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine's formulation, two-dose and booster schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by BioNTech and third-party providers; and the ability of BioNTech to supply the quantities of BNT162 or variant-specificCOVID-19 vaccine candidates to support clinical development and market demand, including our production estimates for 2021. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements.

For a discussion of these and other risks and uncertainties, see BioNTech's Annual Report as Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, which is available on the SEC's website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

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Safety Information

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 5 years of age and older.

IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION:

• Do not administer Pfizer-BioNTechCOVID-19 Vaccine to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the Pfizer-BioNTechCOVID-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-BioNTechCOVID-19 Vaccine
• Monitor Pfizer-BioNTechCOVID-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/clinical-considerations/managing-anaphylaxis.html)
• Reports of adverse events following use of the Pfizer-BioNTechCOVID-19 Vaccine under EUA suggest increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The decision to administer the Pfizer-BioNTechCOVID-19 Vaccine to an individual with a history of myocarditis or pericarditis should take into account the individual's clinical circumstances
• Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Procedures should be in place to avoid injury from fainting
• Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTechCOVID-19 Vaccine
• The Pfizer-BioNTechCOVID-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%), following administration of the primary series
• 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%), following administration of primary series
• In a clinical study, adverse reactions in adults 18 through 55 years of age following administration of a booster dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), joint pain (25.3%), lymphadenopathy (5.2%), nausea (0.7%), decreased appetite (0.3%), rash (0.3%), and pain in extremity (0.3%)
• Following administration of the Pfizer-BioNTechCOVID-19 Vaccine, the following have been reported outside of clinical trials:
• • severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions, diarrhea, vomiting, and pain in extremity (arm) and syncope
  • myocarditis and pericarditis
• Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTechCOVID-19 Vaccine
• Available data on Pfizer-BioNTechCOVID-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-BioNTechCOVID-19 Vaccine on the breastfed infant or on milk production/excretion
• There is no information on the co-administration of the Pfizer-BioNTechCOVID-19 Vaccine with other vaccines.
• An overall review of adverse reactions reported in the study following the Pfizer-BioNTechCOVID-19 Vaccine heterologous booster dose did not identify any new safety concerns, as compared with adverse reactions reported following a Pfizer-BioNTechCOVID-19 Vaccine primary series doses or homologous booster dose
• 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-BioNTechCOVID-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-BioNTechCOVID-19 Vaccine Administration Under Emergency Use Authorization
• Before administration of Pfizer-BioNTechCOVID-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

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Safety Information

COMIRNATY® ▼(COVID-19mRNA Vaccine) has been granted conditional marketing authorisation by the European Medicines Agency to prevent coronavirus disease 2019 (COVID-19) in people from 5 years of age. EMA's human medicines committee (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 now available.

Important safety information

Do not administer Pfizer-BioNTechCOVID-19 Vaccine to individuals with a known hypersensitivity to the active substance or to any of the excipients listed

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​ Very rare cases of myocarditis and pericarditis have been observed following vaccination with Comirnaty. These cases have primarily occurred within 14 days following vaccination, more often after the second vaccination, and more often in younger men. Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis

Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions (e.g. dizziness, palpitations, increases in heart rate, alterations in blood pressure, tingling sensations and sweating) may occur in association with the vaccination process itself. 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® may be lower in immunosuppressed individuals.​

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® may not protect all vaccine recipients. Individuals may not be fully protected until 7 days after their second dose of vaccine.​

Comirnaty has no or negligible influence on the ability to drive and use machines. However, some of side effectsm mentioned below, may temporarily affect the ability to drive or use machines.

In clinical studies, 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

In clinical trials, the most frequent adverse reactions in participants 18 to 55 years of age who received a booster were injection site pain (> 80%), fatigue (> 60%), headache (> 40%), myalgia (> 30%), chills and arthralgia (> 20%).

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%)

There is limited experience with use of COMIRNATY® in pregnant women. Administration of COMIRNATY® in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.​

It is unknown whether COMIRNATY® is excreted in human milk.

Interactions with other medicinal products or concomitant administration of COMIRNATY® with other vaccines has not been studied.

Very rare cases of myocarditis and pericarditis have been observed following vaccination with COMIRNATY® primarily in younger males, after the second dose, within 14 days following vaccination

The black equilateral triangle denotes that additional monitoring is required to capture any adverse reactions. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. Side effects can be reported to EudraVigilance [http://www.adrreports.eu/] or directly to BioNTech using email [e-mail], telephone [phone], or our

websitehttps://medicalinformation.biontech.de/

Omicron (B.1.1.529) has multiple mutations at sites which are known to be relevant for binding of neutralizing antibodies

		RBD	G446S
S477N			Q493R
T478K		E484A	G496S
			Q498R

	K417N	N501Y
	Y505H
		N440K
		G339D
		S371L
G142D		S373P
	S375F
del143-145

NTD

Both the receptor-binding domain (RBD) and the N-terminal domain (NTD) as immunodominant targets are affected

RBD directed mutations (15):

G339D, S371L, S373P, S375F, K417N, N440K, G446S, S477N, T478K, E484A, Q493R, G496S, Q498R, N501Y, Y505H

A67V

A67V

del69-70 T95I

del211

L212IH655Y ins214EPE

NTD directed mutations (8):

A67V, del69-70, T95I, G142D, del143-145, del211, L212I, ins214EPE

D796Y

One RBD-up conformation of SARS-CoV-2 spike with mutated AA positions highlighted in pink. Bento DJ et al. Proc Natl Acad Sci U S A. 2021 Mar 2;118(9):e2022586118