Remove www.sec.gov
article thumbnail

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.

article thumbnail

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. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Pfizer and BioNTech Propose Expansion of Pivotal COVID-19 Vaccine Trial

The Pharma Data

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.

article thumbnail

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 billion doses by the end of 2021.

article thumbnail

Pfizer and BioNTech Celebrate Historic First Authorization in the U.S. of Vaccine to Prevent COVID-19

The Pharma Data

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.

article thumbnail

Pfizer and BioNTech to Provide COVID-19 Vaccine Doses for Olympic Athletes at the 2020 Tokyo Games

The Pharma Data

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.

article thumbnail

Pfizer and BioNTech to Supply the European Union with 100 Million Additional Doses of COMIRNATY®

The Pharma Data

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.