The Pharma Data

AUGUST 20, 2020

The companies are continuing to analyze data from the Phase 1 trials in the U.S. T cell immune responses elicited by BNT162b2 are being evaluated in the German study and the companies expect to submit the data for peer review and potential publication. This press release features multimedia. View the full release here: [link].

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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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Pfizer

JULY 26, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have initiated a randomized, active-controlled, observer-blind, Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level. Emergency Use Authorization .

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The Pharma Data

SEPTEMBER 8, 2020

United States Food and Drug Administration. Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes. 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 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. NEW YORK and MAINZ, GERMANY, July 8, 2022 — Pfizer Inc. have completed a primary series.

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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 1 as compared to the companies’ current COVID-19 vaccine. Emergency Use Authorization.

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Pfizer

JULY 8, 2022

Following a third dose in this age group , the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo. 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.

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The Pharma Data

SEPTEMBER 9, 2020

producing CD8+ T cell responses, which is thought to promote an anti-viral effect. In a preclinical murine model, a single IM immunization of BNT162b2 (0.2, CD4+ and CD8+ T-cells from splenocytes isolated from BNT162b2-immunized mice were strongly positive for IFN? The study is an event-driven trial.

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The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. NEW YORK–(BUSINESS WIRE)– Pfizer Inc.

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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. Based on the acceptable safety profile and the favorable immune response data, including the 4th dose response data, Pfizer received Breakthrough Therapy Designation.

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Pfizer

OCTOBER 20, 2022

Food and Drug Administration (FDA) approved PREVNAR 20® for the prevention of invasive disease and pneumonia in adults age 18 years or older. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay.

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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., Pfizer Disclosure Notice.

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Pfizer

NOVEMBER 2, 2022

The influenza virus is subject to constant mutations to evade the host immune response, causing a seasonal variation in circulating strains. 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).

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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. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer?BioNTech We routinely post information that may be important to investors on our website at www.Pfizer.com.

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