The Pharma Data

NOVEMBER 20, 2020

Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the U.S. We routinely post information that may be important to investors on our website at www.Pfizer.com. About the Study.

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The Pharma Data

DECEMBER 10, 2020

Food and Drug Administration and the European Medicines Agency. NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the New England Journal of Medicinehas published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, their mRNA-based COVID-19 vaccine candidate. About the Phase 2/3 Study.

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The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November. We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued.

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The Pharma Data

AUGUST 20, 2020

The Phase 2/3 trial enrollment to date has exceeded 11,000 participants with a second dose underway. Pfizer and BioNTech are committed to decreasing health disparities in underrepresented populations through the clinical trial process. For more than 150 years, we have worked to make a difference for all who rely on us.

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The Pharma Data

DECEMBER 1, 2020

Food and Drug Administration (FDA) and have submitted the final Conditional Marketing Authorization Application (CA) following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world. We routinely post information that may be important to investors on our website at www.Pfizer.com.

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The Pharma Data

SEPTEMBER 8, 2020

The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA).

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The Pharma Data

SEPTEMBER 8, 2020

United States Food and Drug Administration. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19.

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Pfizer

JULY 26, 2022

Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in individuals 6 months of age and older. We routinely post information that may be important to investors on our website at www.Pfizer.com.

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Pfizer

JULY 8, 2022

Favorable safety profile observed across more than 2,200 adolescents who participated in the clinical trial. Today’s approval is based on data from a Phase 3 clinical trial of 2,260 participants 12 through 15 years of age. We routinely post information that may be important to investors on our website at www.Pfizer.com.

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Pfizer

JULY 19, 2022

The companies’ previously announced safety, tolerability and immunogenicity data from a Phase 2/3 trial that found a 30 µg booster dose of the Omicron-adapted bivalent vaccine candidate elicited a superior immune response against Omicron BA.1 We routinely post information that may be important to investors on our website at www.Pfizer.com.

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Pfizer

JULY 8, 2022

Food and Drug Administration (FDA) which granted emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine as a three 3-µg dose series in this age group on June 17. We routinely post information that may be important to investors on our website at www.Pfizer.com. Pfizer and BioNTech submitted the same data to the U.S.

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Pfizer

SEPTEMBER 28, 2022

1-adapted bivalent vaccine, non clinical and manufacturing data from the companies’ 10-µg Omicron BA.4/BA.5-adapted Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted 5-adapted bivalent vaccine, and preclinical data from the companies’ Omicron BA.4/BA.5-adapted

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Pfizer

SEPTEMBER 16, 2022

Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). We routinely post information that may be important to investors on our website at www.Pfizer.com. EMERGENCY USE AUTHORIZATION. Pfizer Disclosure Notice.

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The Pharma Data

FEBRUARY 25, 2021

Food and Drug Administration (FDA) accepted for Priority Review the company’s Biologics License Application (BLA) for TicoVac , its tick-borne encephalitis (TBE) vaccine for active immunization to prevent TBE in individuals 1 year of age and older. NEW YORK–(BUSINESS WIRE)– Pfizer Inc. If approved in the U.S.,

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Pfizer

OCTOBER 19, 2022

Food and Drug Administration (FDA) granted emergency use authorization (EUA) of the original Pfizer-BioNTech COVID-19 Vaccine as a three 3-µg dose series in this age group in June 2022. We routinely post information that may be important to investors on our website at www.pfizer.com. EMERGENCY USE AUTHORIZATION.

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The Pharma Data

SEPTEMBER 9, 2020

The study is an event-driven trial. Pfizer and BioNTech are committed to decreasing health disparities in underrepresented populations through the clinical trial process. We routinely post information that may be important to investors on our website at www.Pfizer.com. Pfizer Disclosure Notice.

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The Pharma Data

SEPTEMBER 15, 2020

The company announced the initiation of its Phase 1b clinical trial to evaluate the safety of a novel investigational therapeutic for COVID-19, PF-07304814. In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval.

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Pfizer

NOVEMBER 2, 2022

The first participant has been dosed in a Phase 1 trial evaluating the safety, tolerability, and immunogenicity of a nucleoside-modified RNA (modRNA)-based combination vaccine approach. We routinely post information that may be important to investors on our website at www.Pfizer.com. EMERGENCY USE AUTHORIZATION.

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Pfizer

DECEMBER 8, 2022

Food and Drug Administration (FDA) for their mRNA-based combination vaccine candidate for influenza and COVID-19, which aims to help prevent two respiratory diseases with a single injection. We routinely post information that may be important to investors on our website at www.pfizer.com. Dose 2: Pfizer-BioNTech COVID-19 Vaccine.

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