Remove 2021 Remove Disease Remove Licensing Remove Vaccine
article thumbnail

Addressing the grand challenge of global access to vaccines

Drug Target Review

The mad scramble 1 for -80°C freezers during the COVID-19 pandemic is a vivid illustration that we remain unprepared to harness the global potential of vaccine therapeutics. 2 However, it is not just problematic cold chains that limit access to life-saving vaccines.

Vaccine 96
article thumbnail

U.S. FDA grants Priority Review for the Biologics License Application for Pfizer-BioNTech COVID-19 vaccine

The Pharma Data

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. Pfizer and BioNTech completed the rolling submission of the BLA in May 2021.

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

The Pharma Data

The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S. We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S.

article thumbnail

WHO and Partners to Stockpile Ebola Vaccine

The Pharma Data

WHO and Partners to Stockpile Ebola Vaccine. 12, 2021 — Ebola vaccines are being stockpiled by the World Health Organization and other groups to combat future outbreaks of the deadly disease. © 2021 HealthDay. Posted: January 2021. Professional. TUESDAY, Jan. Nearly 7,000 doses are currently available.

Vaccine 52
article thumbnail

COADMINISTRATION OF ITS 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE

The Pharma Data

The primary objective in the trial is to describe safety when both vaccines are co-administered, with follow up six months after vaccination. Secondary objectives are to describe immune responses produced by each of the vaccines. Secondary objectives are to describe immune responses produced by each of the vaccines.

Vaccine 52
article thumbnail

Sanofi and Translate Bio initiate Phase 1/2 clinical trial of mRNA COVID-19 vaccine candidate

The Pharma Data

Expected to enroll 415 participants; interim results expected in Q3 2021. The Companies expect interim results from this trial in the third quarter of 2021. MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio. About the Phase 1/2 clinical trial.

article thumbnail

Sanofi to acquire Translate Bio; advances deployment of mRNA technology across vaccines and therapeutics development

The Pharma Data

Accelerates development of current Sanofi licensed programs in vaccines and potential to explore other therapeutic areas Fast tracks establishment of Sanofi’s recently announced mRNA Center of Excellence Full integration upgrades drug formulation capabilities and enhances US talent in a promising new technology.

Vaccine 52