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FDA Delays Final Approval of Novavax COVID Vaccine

Drugs.com

Food and Drug Administration (FDA) has delayed the full approval of Novavaxs COVID-19 vaccine. The decision had been expected by April 1, but the agency now says it needs more information before moving forward.The. FRIDAY, April 4, 2025 -- The U.S.

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mRNA Therapeutics: Revolutionizing Treatment Beyond Vaccines

DrugBank

The COVID-19 pandemic brought mRNA to global prominence by developing highly effective vaccines by Moderna and Pfizer-BioNTech. However, mRNA technology has introduced new possibilities, particularly in developing personalized cancer vaccines and combination therapies. Another challenge is the potential for unintended immune responses.

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The Next Generation of Vaccine Mega Trials

PPD

In the realm of vaccine development, mega trials — studies enrolling 5,000 subjects or more — have been instrumental in the fight against many pathogens, including influenza, rotavirus, malaria, RSV and most recently in the rapid development of vaccines against COVID-19.

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Mechanistic Model Describing the Time Course of Humoral Immunity Following Ad26.COV2.S Vaccination in Non-Human Primates [Drug Discovery and Translational Medicine]

ASPET

Mechanistic modeling can be used to describe the time course of vaccine-induced humoral immunity and to identify key biological drivers in antibody production. We utilized a six-compartment mechanistic model to describe a 20-week time course of humoral immune responses in 56 non-human primates (NHPs) elicited by vaccination with Ad26.COV2.S

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Top Russian doctor quits over questionable ethics that rushed through coronavirus vaccine

The Pharma Data

Professor Alexander Chuchalin has quit the Russian Health Ministry’s ethics council due to the quick approval process for the country’s coronavirus vaccine. Many countries have criticised Russia pursuit for a COVID-19 cure, which has skipped Phase 3 trials before giving the vaccine regulatory approval. Safety always comes first.

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After a Vaccine – What? The Shift from Research and Discovery to Communications

Eye on FDA

Vaccines for COVID-19 are the focus of the moment – politically and scientifically speaking. Scientifically, there was the big news that a vaccine trial had experienced a serious adverse event bringing a pause to bear in its continuation, likely throwing further cold water on the political side of the equation.

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As the Prospect of a Vaccine Approaches, Business and Communications Challenges Are Just Around the Corner

Eye on FDA

Coincident to COVID-19 case levels in Europe and the United States entering new and serious levels comes welcome news on the development of a vaccine. While vaccination may actually begin in December, the number of doses will be limited. In addition, the process of vaccination takes time.

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