Pfizer

SEPTEMBER 28, 2022

Emergency uses of the original and bivalent vaccines 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 (original vaccine). • individuals 12 years of age and older (bivalent vaccine)

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Vaccination Vaccine Medicine Clinical Trials 101

The Pharma Data

APRIL 27, 2021

Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. About BioNTech. Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases.

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The Pharma Data

MAY 6, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials.

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The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. The participants in our COVID-19 vaccine clinical trial are courageous volunteers who have made a personal and important choice to help make a difference during this pandemic. About the Phase 2/3 Study.

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Pfizer

JULY 19, 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. The booster schedule is based on the labeling information of the vaccine used for the primary series.

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The Pharma Data

JULY 21, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. myocarditis and pericarditis. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.

Manufacturing 52

Manufacturing Vaccination Vaccine Clinical Trials 52

Pfizer

JULY 8, 2022

The Phase 1/2/3 trial has enrolled more than 10,000 children ages 6 months to under 12 years of age in the United States, Finland, Poland, Spain and Brazil from more than 90 clinical trial sites. The booster schedule is based on the labeling information of the vaccine used for the primary series. Emergency Use Authorization.

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Pfizer

DECEMBER 8, 2022

Emergency uses of the vaccines 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 aged 6 months and older. Dose 2: Pfizer-BioNTech COVID-19 Vaccine. Dose 3: Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

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Vaccination Vaccine Clinical Trials Clinical Trials 81

Pfizer

NOVEMBER 2, 2022

Emergency uses of the vaccines 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 aged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

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Pfizer

SEPTEMBER 16, 2022

Today’s recommendation is based on Phase 2/3 clinical data from participants 5 through 11 years of age who received a 10-µg booster dose of COMIRNATY approximately 6 months after completing the two-dose primary series. EMERGENCY USE AUTHORIZATION.

Marketing 75

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The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

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The Pharma Data

NOVEMBER 20, 2020

Pfizer and BioNTech are extremely grateful to the study volunteers and investigative site staff in the clinical trial program, as their involvement was crucial to today’s important milestone in the companies’ efforts to address the COVID-19 global pandemic. as well as Europe, Latin America, and South Africa. About the Study.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 29, 2020

Observed CMV-neutralizing antibody responses and tolerability profile are consistent with previous interim results. The interim immunogenicity analysis also included CMV-neutralizing antibody data assessed from 33 individuals, a subset of the 41 included in the efficacy analysis. NEW YORK and VIENNA, Austria, Nov.

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The Pharma Data

DECEMBER 8, 2020

Recently released interim Phase 1 further indicates that 90 days following the second vaccination, trial participants retained high levels of neutralizing antibodies, suggesting that mRNA-1273 can generate durable neutralizing antibodies across all age groups including in older and elderly adults. About Moderna.

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The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. www.sec.gov.

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The Pharma Data

AUGUST 20, 2020

In both younger and older adults, BNT162b1 and BNT162b2 elicited similar dose-dependent SARS-CoV-2–neutralizing antibody GMTs, which were substantially elevated after the second dose, showing clear benefit of a 2-dose regimen. The Phase 2/3 trial enrollment to date has exceeded 11,000 participants with a second dose underway.

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Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 9, 2020

Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints. Pfizer Inc. The data will be discussed with regulatory authorities worldwide. “I

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The Pharma Data

DECEMBER 10, 2020

The ongoing Phase 3 clinical trial of BNT162b2, which is based on BioNTech’s proprietary mRNA technology, has enrolled more than 44,000 participants, the vast majority of whom have received their second dose. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. About the Phase 2/3 Study.

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Vaccination Vaccine Trials Medicine 52

The Pharma Data

DECEMBER 19, 2020

Moderna will continue to gather additional data and plans to file a Biologics License Application (BLA) with the FDA requesting full licensure in 2021. The Moderna COVID-19 vaccine has not been approved or licensed by the FDA, or any other health authority, but it has been authorized for emergency use by the FDA under an EUA.

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Pfizer

OCTOBER 19, 2022

The Phase 1/2/3 trial ( NCT04816643 ) has enrolled more than 10,000 children ages 6 months to under 12 years of age in the United States, Finland, Poland, Spain and Brazil from more than 90 clinical trial sites. a 3-dose primary series to individuals 6 months through 4 years of age. EMERGENCY USE AUTHORIZATION.

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The Pharma Data

DECEMBER 1, 2020

Through its existing mRNA production sites in Mainz and Idar-Oberstein, Germany, BioNTech is able to produce mRNA for commercial supply after having already produced the vaccine candidate doses for the clinical trials. Once thawed, the vaccine vial can be stored for up to five days at refrigerated (2-8°C) conditions.

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The Pharma Data

OCTOBER 19, 2020

Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies. Pneumococcal serotypes not in the currently licensed conjugate vaccine, such as 22F and 33F, are among the most common serotypes causing invasive pneumococcal disease in parts of the world, including the U.S.,

Vaccination 52

Vaccination Vaccine Immune Response Containment 52

The Pharma Data

JANUARY 15, 2021

Darzalex Faspro® is not indicated and is not recommended for the treatment of patients with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials. About Darzalex Faspro® In August 2012, Janssen Biotech, Inc.

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FDA Approval Production Research Doctors 52

The Pharma Data

SEPTEMBER 9, 2020

The BNT162b2 vaccine candidate induced SARS-CoV-2 neutralizing antibodies in rhesus macaques, pseudovirus neutralizing antibodies in mice, and strong, antigen-specific CD4+ and CD8+ T cells in mice and macaques. The study is an event-driven trial. NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc.

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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. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

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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. Clinical Phase 1/2 study results demonstrated never before observed fold rises of RSV neutralizing antibodies; a fold rise of 15.2 Protease Inhibitor Program.

Gene Therapy 52

Gene Therapy Vaccination Vaccine Trials 52

The Pharma Data

JANUARY 12, 2021

On December 3, a letter to the editor was published in The New England Journal of Medicine reporting that participants in the Phase 1 study of the Moderna COVID-19 Vaccine retained high levels of neutralizing antibodies through 119 days following first vaccination (90 days following second vaccination). Authorized Use.

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The Pharma Data

MARCH 11, 2021

We are extremely encouraged that the real-world effectiveness data coming from Israel are confirming the high efficacy demonstrated in our Phase 3 clinical trial and showing the significant impact of the vaccine in preventing severe disease and deaths due to COVID-19,” said Luis Jodar, Ph.D.,

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Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

JANUARY 6, 2021

On December 3, a letter to the editor was published in The New England Journal of Medicine reporting that participants in the Phase 1 study of the Moderna COVID-19 Vaccine retained high levels of neutralizing antibodies through 119 days following first vaccination (90 days following second vaccination). On December 18, 2020, the U.S.

Vaccination 52

Vaccination Vaccine Medicine Containment 52

The Pharma Data

JANUARY 4, 2021

Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov.

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The Pharma Data

JUNE 24, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions, diarrhea, vomiting, and pain in extremity (arm) have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials.

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