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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.

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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. Development was also fuelled by an avalanche 10 of public funding.

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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

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.

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CEPI to Fund Late-Stage COVID-19 Vaccine Trial From Clover Biopharmaceuticals | 2020-11-03

The Pharma Data

The Coalition for Epidemic Preparedness Innovations (CEPI) has agreed to fund development of a potential COVID-19 vaccine from China’s Clover Biopharmaceuticals with a global phase 2/3 study and through licensing and distribution. million for an initial trial of SCB-2019 in Australia that enrolled 150 participants.

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

The Pharma Data

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. 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.

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AstraZeneca takes COVID-19 vaccine to China with BioKangtai deal for 200M-dose capacity by 2021

The Pharma Data

We pointed out last week that China was a notable missing element in AstraZeneca’s COVID-19 vaccine strategy, despite being the drugmaker’s second-largest market. The pair will also explore the possibility of producing the vaccine for other markets. The vaccine was moved into phase 2/3 in May. That has changed.

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FOLLOW-UP DATA FROM PHASE 3 TRIAL OF PFIZER-BIONTECH COVID-19 VACCINE SUPPORT SAFETY AND HIGH EFFICACY IN ADOLESCENTS 12 THROUGH 15 YEARS OF AGE

The Pharma Data

Pfizer-BioNTech vaccine demonstrated 100 efficacity against COVID-19 in longer- term analysis, with no serious safety enterprises linked. Data will support planned cessions for full nonsupervisory blessing of the vaccine in this age group in theU.S. and worldwide NEW YORK & MAINZ, Germany– (BUSINESS WIRE)– PfizerInc.

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