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Form 8-Kの提出が、以下のいずれかの規定(以下の一般的指示A.2.を参照)に基づく登録者の義務を同時に満たすことを意図している場合は、以下の該当するボックスにチェックを入れてください：

☐ 証券法の規則425（17 CFR 230.425）に基づく書面によるコミュニケーション

☐ 取引所法の規則14a-12（17 CFR 240.14a-12）に基づく資料の勧誘

☐ 取引所法の規則14d-2(b)(17 CFR 240.14d-2(b))に基づく開始前のコミュニケーション

☐ 取引所法の規則13e-4(c)(17 CFR 240.13e-4(c))に基づく開始前のコミュニケーション

登録者が1933年証券法規則405（本章230.405節）または1934年証券取引法規則12b-2（本章240.12b-2節）で定義される新興成長企業であるかどうかをチェックマークで示す。

Emerging growth company    ☐

新興成長企業の場合、登録者が取引所法第13条(a)に従い提供される新規または改訂された財務会計基準に準拠するための移行期間の延長を利用しないことを選択した場合は、チェックマークで示す。☐

uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with pre-clinical and clinical data (including Phase 1/2/3 or Phase 4 data for Paxlovid and Comirnaty or any of Pfizer’s other products or product candidates) in any of our studies in pediatrics, adolescents, or adults or real world evidence, including the possibility of unfavorable new pre-clinical, clinical or safety data and further analyses of existing pre-clinical, clinical or safety data or further information regarding the quality of pre-clinical, clinical or safety data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; the ability to produce comparable clinical or other results for Paxlovid and Comirnaty or any of Pfizer’s other products or product candidates, including the rate of effectiveness and/or efficacy, safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial for any such products and additional studies, in real world data studies or in larger, more diverse populations following commercialization; the ability of Comirnaty, any vaccine candidate or any future vaccine to prevent, or Paxlovid or any future COVID-19 treatment to be effective against, COVID-19 caused by emerging virus variants; the risk that use of Comirnaty or Paxlovid 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 pre-clinical 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, Paxlovid or other COVID-19 programs 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 existing or future pre-clinical and clinical studies; whether and when any drug applications or submissions to request emergency use or conditional marketing authorization for any potential indications for Paxlovid or any of Pfizer’s other products or product candidates may be filed in particular jurisdictions and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when submissions to request emergency use or conditional marketing authorizations for Comirnaty or any future vaccines in additional populations, for a potential booster dose for Comirnaty, any vaccine candidate or any potential future vaccines (including potential future annual boosters or re-vaccinations), and/or biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for Comirnaty, any vaccine candidates or any other potential vaccines that may arise from the BNT162 program, and if obtained, whether or when such emergency use authorizations or licenses, or existing emergency use authorizations, will expire or terminate; whether and when any applications that may be pending or filed for Paxlovid, Comirnaty or any of Pfizer’s other products or product candidates (including any requested amendments to the emergency use or conditional marketing authorizations) may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether Paxlovid, Comirnaty or any of Pfizer’s other products or product candidates for any such indications will be commercially successful; intellectual property and other litigation; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Paxlovid, Comirnaty or any of Pfizer’s other products or product candidates, including the authorization or approval of products or therapies developed by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers, including our relationship with BioNTech; the risk that demand for Paxlovid, Comirnaty or any of Pfizer’s other products may be reduced, no longer exist or not meet expectations, which may lead to reduced revenues, excess inventory on-hand and/or in the channel which, for Paxlovid and Comirnaty, has resulted in a significant inventory write-off in the third quarter of 2023 and could continue to result in inventory write-offs or other unanticipated changes; challenges related to and uncertainties regarding the timing of a transition to the commercial market for any of our products, and in particular, Paxlovid; uncertainties related to the public’s adherence to vaccines and boosters; risks related to our ability to achieve our revenue forecasts for Paxlovid, Comirnaty or any of Pfizer’s other products or product candidates; the risk that other companies may produce superior or competitive products; risks related to the availability of raw materials to manufacture or test Paxlovid, Comirnaty or any of Pfizer’s other products or product candidates; 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 or next generation vaccines or potential combination respiratory vaccines or next generation COVID-19 treatments; the risk that we may not be able to recoup costs associated with our R&D and manufacturing efforts; risks associated with any changes in the way we approach or provide research funding for the BNT162 program, Paxlovid or any other COVID-19 program; challenges and risks associated with the pace of our development programs; the risk that we may not be able to maintain manufacturing capacity or access to logistics or supply channels commensurate with global demand, which would negatively impact our ability to supply our COVID-19 or other products; whether and when additional supply or purchase agreements will be reached or existing agreements will be completed or renegotiated; uncertainties regarding the ability to obtain recommendations from vaccine or treatment advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; pricing and access challenges; challenges related to public confidence in, or awareness of Paxlovid, Comirnaty or any of Pfizer’s other products or product candidates; uncertainties around future changes to applicable healthcare policies and guidelines issued by the U.S. federal government in connection with the declared termination of the federal government’s COVID-19 public health emergency as of May 11, 2023; trade restrictions; potential third party royalties or other claims; the uncertainties inherent in business and financial planning, including, without limitation, risks related to Pfizer’s business and prospects, adverse developments in Pfizer’s markets, or adverse developments in the U.S.

COVID-19が当社の事業、業務および財務業績に与える影響に関する不確実性、競合他社の動向、当社の全社的なコスト再編プログラムの影響、成功および関連コストに関する不確実性、ならびにリストラクチャリングおよび社内組織再編、ならびにその他の企業戦略構想および成長戦略、コスト削減および生産性向上構想に関連するリスクおよび不確実性です。

上記の要因、およびファイザーが随時米国証券取引委員会 (www.sec.gov および www.pfizer.com) に提出する年次報告書フォーム 10-K、四半期報告書フォーム 10-Q、およびその他の書類の「リスク要因」および「将来予測情報および将来の結果に影響を与える可能性のある要因」のセクションに記載されているファイザーの事業に影響を与えるその他のリスクおよび不確実性を慎重に考慮する必要があります。これらの提出書類には、実際の出来事や結果が将来の見通しに関する記述に含まれるものと大きく異なる原因となり得る、その他の重要なリスクおよび不確実性が特定され、対処されています。将来の見通しに関する記述は、それらが作成された時点のものです。また、ファイザーは、法律で義務付けられている場合を除き、新たな情報、将来の出来事、またはその他の結果にかかわらず、これらの将来予想に関する記述を更新または修正する義務を負わないものとし、またその意向もないものとします。ファイザーは、その期待を達成することを保証するものではありません。

1934年証券取引法の要件に従い、登録者は本報告書に正式に権限を付与された署名者により、登録者を代表して署名させた。

Dated: October 13, 2023