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NEW YORK & MAINZ, Germany–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today appear the beheading of an acceding with the U.S. Department of Bloom and Human Services and the Department of Defense to accommodated the U.S. government’s Operation Warp Speed affairs ambition to activate carrying 300 actor doses of a vaccine for COVID-19 in 2021. Beneath the agreement, the U.S. government will accept 100 actor doses of BNT162, the COVID-19 vaccine applicant accordingly developed by Pfizer and BioNTech, afterwards Pfizer auspiciously articles and obtains approval or emergency use allotment from U.S. Food and Biologic Administration (FDA).

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The U.S. government will pay the companies $1.95 billion aloft the cancellation of the aboriginal 100 actor doses, afterward FDA allotment or approval. The U.S. government additionally can admission up to an added 500 actor doses.

Americans will accept the vaccine for chargeless constant with U.S. government’s charge for chargeless admission for COVID-19 vaccines.

“We’ve been committed to authoritative the absurd accessible by alive endlessly to beforehand and aftermath in almanac time a safe and able vaccine to advice accompany an end to this all-around bloom crisis,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We fabricated the aboriginal accommodation to activate analytic assignment and all-embracing accomplishment at our own accident to ensure that artefact would be accessible anon if our analytic trials prove acknowledged and an Emergency Use Allotment is granted. We are accustomed to be a allotment of this accomplishment to accommodate Americans admission to aegis from this baleful virus.”

“Expanding Operation Warp Speed’s assorted portfolio by abacus a vaccine from Pfizer and BioNTech increases the allowance that we will accept a safe, able vaccine as anon as the end of this year,” said HHS Secretary Alex Azar. “Depending on success in analytic trials, today’s acceding will accredit the charge of about 100 actor doses of this vaccine to the American people.”

The BNT162 affairs is based on BioNTech’s proprietary mRNA technology and accurate by Pfizer’s all-around vaccine development and accomplishment capabilities. The BNT162 vaccine candidates are adeptness analytic studies and are not currently accustomed for administration anywhere in the world. BioNTech is the bazaar allotment holder common and will authority all trademarks for the abeyant product. Both collaborators are committed to developing these atypical vaccines with pre-clinical and analytic abstracts at the beginning of all their decision-making.

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“We are admiring to accept active this important acceding with the U.S. government to accumulation the antecedent 100 actor doses aloft approval as allotment of our charge to abode the all-around bloom threat. This acceding is one of abounding accomplish appear accouterment all-around admission to a safe and active vaccines for COVID-19. We are additionally in avant-garde discussions with assorted added government bodies and we achievement to advertise added accumulation agreements soon. Our ambition charcoal to accompany a safe and able COVID-19 vaccine to abounding bodies about the world, as bound as we can,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.

The Pfizer/BioNTech vaccine development affairs is evaluating at atomic four beginning vaccines, anniversary of which represents a different aggregate of agent RNA (mRNA) architecture and ambition antigen. On July 1st, Pfizer and BioNTech appear basic abstracts from BNT162b1, the best avant-garde of the four mRNA formulations. The aboriginal abstracts demonstrates that BNT162b1 is able to aftermath acrid antibodies in bodies at or aloft the levels empiric in the claret from patients who accept recovered from COVID-19, and this was apparent at almost low dosage levels. Bounded reactions and systemic contest were dose-dependent, about balmy to moderate, and transient. No austere adverse contest were reported. On July 20th, the companies appear aboriginal absolute amend from German Phase 1/2 COVID-19 vaccine study, including aboriginal T Cell acknowledgment data.

Recently, two of the companies’ four investigational vaccine candidates (BNT162b1 and BNT162b2) accustomed Fast Track appellation from the U.S. Food and Biologic Administration (FDA). This appellation was accepted based on basic abstracts from Phase 1/2 studies that are currently advancing in the United States and Germany as able-bodied as beastly immunogenicity studies. Added abstracts from the advancing Phase 1/2 analytic trials of the four vaccine candidates will accredit the alternative of a beforehand applicant and dosage akin for an advancing large, all-around Phase 2b/3 assurance and adeptness abstraction that may activate as aboriginal as after this month, awaiting authoritative approval.

If the advancing studies are successful, Pfizer and BioNTech apprehend to be accessible to seek Emergency Use Allotment or some anatomy of authoritative approval as aboriginal as October 2020. The companies currently apprehend to accomplish globally up to 100 actor doses by the end of 2020 and potentially added than 1.3 billion doses by the end of 2021, accountable to final dosage alternative from their analytic trial.

In accession to engagements with governments, Pfizer and BioNTech accept provided an announcement of absorption for accessible accumulation to the COVAX Facility, a apparatus accustomed by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and Apple Bloom Organization (WHO) that aims to accommodate governments with aboriginal admission to a ample portfolio of COVID-19 applicant vaccines application a ambit of technology platforms, produced by assorted manufacturers beyond the world.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we administer science and our all-around assets to accompany therapies to bodies that extend and decidedly beforehand their lives. We strive to set the accepted for quality, assurance and amount in the discovery, development and accomplish of bloom affliction products, including avant-garde medicines and vaccines. Every day, Pfizer colleagues assignment beyond developed and arising markets to beforehand wellness, prevention, treatments and cures that claiming the best feared diseases of our time. Constant with our albatross as one of the world’s arch avant-garde biopharmaceutical companies, we coact with bloom affliction providers, governments and bounded communities to abutment and aggrandize admission to reliable, affordable bloom affliction about the world. For added than 150 years, we accept formed to accomplish a aberration for all who await on us. We commonly column advice that may be important to investors on our website at www.Pfizer.com. In addition, to apprentice more, amuse appointment us on www.Pfizer.com and chase us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Pfizer Disclosure Notice

The advice independent in this absolution is as of July 22, 2020. Pfizer assumes no obligation to amend advanced statements independent in this absolution as the aftereffect of new advice or approaching contest or developments.

This absolution contains advanced advice about Pfizer’s efforts to action COVID-19, the BNT162 mRNA vaccine program, a accord amid BioNTech and Pfizer to beforehand a abeyant COVID-19 vaccine, an acceding with the United States to accomplish and bear BNT162 and added abeyant agreements, including their abeyant benefits, accomplishment and administration and the accepted timing of analytic trials and authoritative submissions, that involves abundant risks and uncertainties that could account absolute after-effects to alter materially from those bidding or adumbrated by such statements. Risks and uncertainties include, amid added things, the uncertainties inherent in analysis and development, including the adeptness to accommodated advancing analytic endpoints, admission and/or achievement dates for analytic trials, authoritative acquiescence dates, authoritative approval dates and/or barrage dates, as able-bodied as the achievability of abortive new preclinical or analytic balloon abstracts and added analyses of absolute preclinical or analytic balloon data; risks associated with basic data; the accident that analytic balloon abstracts are accountable to differing interpretations and assessments, including during the associate review/publication process, in the accurate association generally, and by authoritative authorities; whether and back abstracts from the BNT162 mRNA vaccine affairs will be appear in accurate account publications and, if so, back and with what modifications; whether authoritative authorities will be annoyed with the architecture of and after-effects from these and approaching preclinical and analytic studies; whether and back any biologics authorization applications may be filed in any jurisdictions for any abeyant vaccine candidates beneath the collaboration; whether and back any such applications may be accustomed by authoritative authorities, which will depend on countless factors, including authoritative a assurance as to whether the product’s allowances outweigh its accepted risks and assurance of the product’s adeptness and, if approved, whether any such vaccine candidates will be commercially successful; decisions by authoritative authorities impacting labeling, accomplishment processes, assurance and/or added affairs that could affect the availability or bartering abeyant of any such vaccine candidates, including development of articles or therapies by added companies; accomplishment capabilities or capacity, including whether the estimated numbers of doses can be bogus aural the projected time periods indicated; whether and back a approaching assembly acceding with the United States will be reached; whether and back added accumulation agreements will be reached; uncertainties apropos the adeptness to access recommendations from vaccine abstruse committees and added accessible bloom authorities apropos any such vaccine candidates and uncertainties apropos the bartering appulse of any such recommendations; and aggressive developments.

A added description of risks and uncertainties can be begin in Pfizer’s Annual Report on Anatomy 10-K for the budgetary year concluded December 31, 2019 and in its consecutive letters on Anatomy 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Advice and Factors That May Affect Approaching Results”, as able-bodied as in its consecutive letters on Anatomy 8-K, all of which are filed with the U.S. Securities and Exchange Commission and accessible at www.sec.gov and www.pfizer.com.

About BioNTech

Biopharmaceutical New Technologies is a abutting bearing immunotherapy aggregation beat atypical therapies for blight and added austere diseases. The Aggregation exploits a advanced arrangement of computational analysis and ameliorative biologic platforms for the accelerated development of atypical biopharmaceuticals. Its ample portfolio of oncology artefact candidates includes abundant and off-the-shelf mRNA-based therapies, avant-garde chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted blight antibodies and baby molecules. Based on its abysmal adeptness in mRNA vaccine development and centralized accomplishment capabilities, BioNTech and its collaborators are developing assorted mRNA vaccine candidates for a ambit of communicable diseases alongside its assorted oncology pipeline. BioNTech has accustomed a ample set of relationships with assorted all-around biologic collaborators, including Genmab, Sanofi, Bayer Beastly Health, Genentech, a affiliate of the Roche Group, Genevant, Fosun Pharma, and Pfizer. For added information, amuse appointment www.BioNTech.de.

BioNTech Advanced statements

This columnist absolution contains “forward-looking statements” of BioNTech aural the acceptation of the Private Securities Litigation Reform Act of 1995. These advanced statements may include, but may not be bound to, statements concerning: BioNTech’s efforts to action COVID-19; the timing to admit analytic trials of BNT162 and advancing advertisement of abstracts from these analytic trials; the timing for any abeyant emergency use authorizations or approvals; the abeyant to access into added accumulation agreements with added jurisdictions or the COVAX Facility; the abeyant assurance and adeptness of BNT162; the accord amid BioNTech and Pfizer to beforehand a abeyant COVID-19 vaccine; and the adeptness of BioNTech to accumulation the quantities of BNT162 to abutment analytic development and, if approved, bazaar demand, including our assembly estimates for 2020 and 2021. Any advanced statements in this columnist absolution are based on BioNTech accepted expectations and behavior of approaching events, and are accountable to a cardinal of risks and uncertainties that could account absolute after-effects to alter materially and abnormally from those set alternating in or adumbrated by such advanced statements. These risks and uncertainties include, but are not bound to: antagonism to actualize a vaccine for COVID-19; the adeptness to aftermath commensurable analytic after-effects in beyond and added assorted analytic trials; the adeptness to finer calibration our productions capabilities; and added abeyant difficulties. For a altercation of these and added risks and uncertainties, see BioNTech’s Annual Report on Anatomy 20-F filed with the SEC on March 31, 2020, which is accessible on the SEC’s website at www.sec.gov. All advice in this columnist absolution is as of the date of the release, and BioNTech undertakes no assignment to amend this advice unless appropriate by law.

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