Pfizer and BioNTech Receive Health Sciences Authority Approval for SARS-CoV-2 Sublineage LP.8.1-Adapted Monovalent COVID-19 Vaccine in Singapore

• The updated COVID-19 vaccine is expected to be available in Singapore at selected polyclinics and private general practitioner (GP) clinics in October 2025 for individuals 6 months of age and older.

SINGAPORE, Oct. 24, 2025 /PRNewswire/ — Pfizer Singapore and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the Health Sciences Authority has approved the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY® LP.8.1; COVID-19 Vaccine, mRNA) for use in individuals 6 months of age and older, according to official recommendations*. This marks Singapore as the first country in Southeast Asia to receive full approval for the latest COVID-19 vaccine.

The LP.8.1 sublineage selection is based on guidance from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and World Health Organization (WHO) which stated that LP.8.1 is the preferred sublineage of a monovalent JN.1-lineage-based COVID-19 vaccine for use in the U.S. beginning in fall 2025.^[1]

“Pfizer remains steadfast in our commitment to protecting public health through science and innovation. The approval of this updated LP.8.1-adapted monovalent COVID-19 vaccine marks another important milestone in our ongoing efforts to provide communities with timely access to protection. We echo the government’s call for proactive healthcare and prevention measures.” said Ms. Deborah Seifert, Cluster Lead, Pfizer Malaysia, Indonesia, Singapore, Philippines. “By empowering individuals with the tools to safeguard themselves and those around them, we reinforce our belief in a life-course approach to immunization—one that prioritizes prevention, resilience, and equity for all.”

“As new COVID-19 variants continue to emerge, vigilance remains our shared responsibility. Under Singapore’s comprehensive national COVID-19 vaccination program, the COVID-19 vaccine remains free to the public* and is available at selected GP clinics and polyclinics**, empowering us to stay ahead of the virus and protect our communities. For high-risk groups, including seniors and those with underlying health conditions, updated vaccines offer essential protection against severe disease and hospitalization,” said Dr. Aziz Noordin, Family Physician, Tampines Family Medicine Clinic. “It is worth consulting your healthcare provider about protection against COVID-19.”

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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 www.Pfizer.com.sg. In addition, to learn more, please visit us on www.Pfizer.com.sg and like us on Facebook at Facebook.com/PfizerSG.  

About BioNTech

Biopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel investigative therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic modalities with the intent of rapid development of novel biopharmaceuticals. Its diversified portfolio of oncology product candidates aiming to address the full continuum of cancer includes mRNA cancer immunotherapies, next-generation immunomodulators and targeted therapies such as antibody-drug conjugates (ADCs) and innovative chimeric antigen receptor (CAR) T cell therapies. Based on its deep expertise in mRNA development and in-house manufacturing capabilities, BioNTech and its collaborators are researching and 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 Bristol Myers Squibb, Duality Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron.

For more information, please visit www.BioNTech.com.

BioNTech Forward-looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not be limited to, statements concerning: BioNTech’s efforts to combat COVID-19; the collaboration between BioNTech and Pfizer; the rate and degree of market acceptance of BioNTech’s COVID-19 vaccine, including the LP.8.1-adapted monovalent COVID-19 vaccine; qualitative assessments of available data and expectations of potential benefits, including the adapted vaccine’s response against multiple SARS-CoV-2 lineages, including NB.1.8.1 and other currently circulating sublineages; regulatory submissions and regulatory approvals or authorizations and expectations regarding manufacturing, distribution and supply; expectations regarding anticipated changes in COVID-19 vaccine demand, including changes to the ordering environment; and expected regulatory recommendations to adapt vaccines to address new variants or sublineages. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.

The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: 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 data discussed in this release, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; BioNTech’s pricing and coverage negotiations with governmental authorities, private health insurers and other third-party payors after BioNTech’s initial sales to national governments; the future commercial demand and medical need for initial or booster doses of a COVID-19 vaccine; the impact of tariffs and escalations in trade policy; the availability of raw materials to manufacture a vaccine; our vaccine’s formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery; competition from other COVID-19 vaccines or related to BioNTech’s other product candidates, including those with different mechanisms of action and different manufacturing and distribution constraints, on the basis of, among other things, efficacy, cost, convenience of storage and distribution, breadth of approved use, side-effect profile and durability of immune response; 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; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for BioNTech’s product candidates; the ability of BioNTech’s COVID-19 vaccines to prevent COVID-19 caused by emerging virus variants; BioNTech’s and its counterparties’ ability to manage and source necessary energy resources; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech’s development candidates and investigational medicines; the impact of COVID-19 on BioNTech’s development programs, supply chain, collaborators and financial performance; unforeseen safety issues and potential claims that are alleged to arise from the use of BioNTech’s COVID-19 vaccine and other products and product candidates developed or manufactured by BioNTech; BioNTech’s and its collaborators’ ability to commercialize and market BioNTech’s COVID-19 vaccine and, if approved, its product candidates; BioNTech’s ability to manage its development and related expenses; regulatory developments in the United States and other countries; BioNTech’s ability to effectively scale BioNTech’s production capabilities and manufacture BioNTech’s products, including BioNTech’s target COVID-19 vaccine production levels, and BioNTech’s product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time.

You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended June 30, 2024, and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at https://www.sec.gov/. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise.