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Pfizer and Valneva Issue Update on Phase 3 Clinical Trial Evaluating Lyme Disease Vaccine Candidate VLA15

Pfizer

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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Pfizer and BioNTech to Potentially Supply the EU with 200 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2

The Pharma Data

“We have activated our supply chain, most importantly our site in Belgium, and are starting to manufacture so that our vaccine would be available as soon as possible, if our clinical trials prove successful and regulatory approval is granted.”. “As About the Phase 2/3 Study. billion doses by the end of 2021. Pfizer Disclosure Notice.

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VALNEVA AND PFIZER COMPLETE RECRUITMENT FOR PHASE 2 TRIAL OF LYME DISEASE VACCINE CANDIDATE

The Pharma Data

Positive top-line results have already been reported for two Phase 2 clinical trials of VLA15 in over 800 healthy adults. VLA15 is the only active Lyme disease vaccine candidate in clinical development today, and covers six serotypes that are prevalent in North America and Europe. About VLA15.

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Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine

The Pharma Data

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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Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of Their COVID 19 Vaccine

The Pharma 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 routinely post information that may be important to investors on our website at www.Pfizer.com. Pfizer Disclosure Notice.

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Pfizer and BioNTech Share Positive Early Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19

The Pharma Data

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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Pfizer and BioNTech Announce Publication of Results from Landmark Phase 3 Trial of BNT162b2 COVID-19 Vaccine Candidate in The New England Journal of Medicine

The Pharma Data

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. We routinely post information that may be important to investors on our website at www.Pfizer.com. About BioNTech.