The Pharma Data

MAY 7, 2021

population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. CEO and Co-founder of BioNTech. “We

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The Pharma Data

AUGUST 20, 2020

Phase 1 trial for the BNT162b2 vaccine candidate, which at 30 ?g The companies are continuing to analyze data from the Phase 1 trials in the U.S. The totality of the clinical and preclinical data informed Pfizer and BioNTech’s decision to select BNT162b2 as the lead candidate to advance into pivotal trials. and Germany.

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The Pharma Data

NOVEMBER 9, 2020

Analysis evaluated 94 confirmed cases of COVID-19 in trial participants. 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.

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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. Sanofi, Empowering Life.

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The Pharma Data

JULY 21, 2021

In a clinical study, adverse reactions in adolescents 12 through 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever 3 (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%).

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The Pharma Data

DECEMBER 11, 2020

All trial participants will continue to be monitored to assess long-term protection and safety for an additional two years after their second dose. 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.

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The Pharma Data

DECEMBER 1, 2020

This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. will mark the first time citizens outside of the trials will have the opportunity to be immunized against COVID-19,” said Ugur Sahin, M.D., The Emergency Use Authorization in the U.K.

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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.Pfizer.com.

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The Pharma Data

MAY 6, 2021

Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials. We routinely post information that may be important to investors on our website at www.Pfizer.com. The information contained in this release is as of May 6, 2021.

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Pfizer

JULY 26, 2022

We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at www.facebook.com/Pfizer. . Pfizer Disclosure Notice.

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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 8, 2022

The submission included data from a Phase 2/3 randomized, controlled trial that included 4,526 children 6 months to less than 5 years of age. In the trial, children received the third 3-µg dose at least two months after the second dose at a time when Omicron was the predominant variant. About the Phase 1/2/3 Trial in Children.

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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

SEPTEMBER 28, 2022

This study is consistent with regulatory guidance and follows the design of the previous Phase 1/2/3 trial to evaluate further options for protection in this age group. . Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus .

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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. The companies are also working together with investigator sites and advocacy partners to raise awareness about the importance of participation in this trial.

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Pfizer

SEPTEMBER 16, 2022

Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus . COMIRNATY® (COVID-19 Vaccine, mRNA) INDICATION. We routinely post information that may be important to investors on our website at www.Pfizer.com. Pfizer Disclosure Notice.

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Pfizer

OCTOBER 19, 2022

Today’s recommendation is based on data from a Phase 2/3 randomized, controlled trial that included 4,526 children aged 6 months to less than 5 years. In the trial, children received a third 3-µg dose of the original Pfizer-BioNTech COVID-19 Vaccine at least two months after the second dose at a time when Omicron BA.2 INDICATION.

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The Pharma Data

FEBRUARY 25, 2021

7 In clinical trials, the safety and immunogenicity of TicoVac was assessed across two age groups (1-15 years of age and 16-65 years of age). 8,9 Clinical studies demonstrated that TicoVac was well-tolerated with no unexpected adverse events or vaccine-related serious adverse events observed. This release contains forward?looking

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The Pharma Data

SEPTEMBER 15, 2020

Limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mostly mild to moderate tolerability profile as was observed in Phase 1. In the blinded data presented, 50% of trial participants received placebo and 50% received BNT162b2. A Phase 3 trial is ongoing. Protease Inhibitor Program. Rare Disease.

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Pfizer

OCTOBER 28, 2022

XELJANZ has been studied in more than 50 clinical trials worldwide, including more than 20 trials in rheumatoid arthritis (RA) patients, and prescribed to more than 362,000 adult patients (the majority of whom were RA patients) worldwide since 2012. About XELJANZ® (tofacitinib). ADVERSE REACTIONS.

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The Pharma Data

JUNE 16, 2021

Trial demonstrates cumulative incidence of death or respiratory failure through day 28 was 18.1% (26 of 144) with tofacitinib compared to 29.0% (42 of 145) with placebo, in hospitalized patients with COVID-19 pneumonia . Multi-center, randomized, double-blind, placebo-controlled trial conducted across 15 sites in Brazil.

Medicine 40

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Pfizer

NOVEMBER 2, 2022

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the advancement of an mRNA-based combination vaccine candidate for influenza and COVID-19 to a Phase 1 trial with the aim to address two severe respiratory diseases with one vaccine. We routinely post information that may be important to investors on our website at www.Pfizer.com.

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Pfizer

DECEMBER 8, 2022

Pfizer and BioNTech previously announced the start of a Phase 1 trial to examine the safety, tolerability, and immunogenicity of their combined influenza and COVID-19 candidate vaccine among healthy adults. . We routinely post information that may be important to investors on our website at www.pfizer.com. INDICATION.

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