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.

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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

MAY 7, 2021

regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. “We are pleased to work with U.S.

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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.

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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.

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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

OCTOBER 19, 2020

Immune responses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies.

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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

JULY 21, 2021

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. Procedures should be in place to avoid injury from fainting. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients. myocarditis and pericarditis.

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The Pharma Data

MAY 6, 2021

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. 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

SEPTEMBER 25, 2020

Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate. Immune responses were similar across the age groups studied, including older adults.

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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. producing CD8+ T cell responses, which is thought to promote an anti-viral effect.

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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. Protease Inhibitor Program. for RSV A and 18.0

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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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The Pharma Data

JUNE 24, 2021

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer?BioNTech Procedures should be in place to avoid injury from fainting. BioNTech COVID-19 Vaccine. The Pfizer?BioNTech BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

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