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Pfizer COVID vaccine under EMA review for younger teens

The Pharma Data

The European Medicines Agency (EMA) is evaluating an application submitted by Pfizer and BioNTech for use of their COVID-19 vaccine in children aged 12 to 15 years. . The vaccine has been authorized by the EU for use in people 16 years and up since December 2020. . Pfizer also shared antibody responses from the younger age group.

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Experiencing the CBER: Anticipating Unique Challenges

Cytel

CDER focuses on drug regulation, whereas CBER oversees the regulation of biological products. 1 CDER and CBER share many common principles and processes when evaluating products for market approval, including process and guidance requirements for data standards submission.

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Biden Outlines ‘Bold’ National Vaccine Effort

The Pharma Data

16, 2021 — President-elect Joe Biden described an ambitious national vaccination plan on Friday that will deliver coronavirus vaccines to far more people and invoke a wartime law to boost vaccine production. Even if Biden invokes the Korean War-era Defense Production Act, it may take some time to ease vaccine shortages.

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Months of Work Hang in the Balance as Moderna’s COVID-19 Vaccine Awaits AdComm Vote

The Pharma Data

Food and Drug Administration (FDA) advisory panel in regard to the COVID-19 vaccine from Moderna. The Vaccines and Related Biological Products Advisory Committee will be determining whether the product should be authorized for emergency use, according to CNBC. The vote itself is not slated to take place until after 3 p.m.

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AstraZeneca’s COVID-19 Vaccine Boasts Strong Results with Up to 90% Efficacy

The Pharma Data

As the Pfizer and BioNTech COVID-19 vaccine goes to regulators and the Moderna vaccine approaches the end of its Phase III trials, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. The combined analysis showed average efficacy of 70%.

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China’s ‘insect’ vaccine for COVID-19 approved for human testing

The Pharma Data

China is set to move ahead with human testing of a potential coronavirus vaccine that has been created using insect cells. It is hoped that using insect cells to grow proteins for the vaccine could speed up large-scale production. These were primarily border officials and health workers. Conor Kavanagh. Source link.

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Regulatory Submissions for Dengue Vaccine Candidate in EU and Dengue-Endemic Countries

The Pharma Data

European Medicines Agency to Conduct First-Ever Parallel Assessment of a Medicinal Product, Takeda’s Dengue Vaccine Candidate (TAK-003), for use in the EU; Countries Outside of the EU through the EU-M4all (Previously Article 58) Procedure. About TAK-003. 4,5 Efficacy varied by serotype.

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