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Manufacture Standards & Regulation

Keeping Pace with the Plague

Regulators worldwide are pushing for the development of new and improved “second-generation” vaccines against current and future strains of COVID-19. A recent virtual workshop held by the International Coalition of Medicines Regulatory Authorities (ICMRA) brought together leading global regulators to discuss what comes next. Participants discussed immunobridging, clinical trials, and immunity. They also touched on the authorization of second-generation vaccines and alternative approaches to demonstrate vaccine efficacy, expressing the need for alignment between regulators to respond to emerging COVID-19 variants.

The event was a follow-up to a workshop held in February 2021, which emphasized the role of data in speedily approving updated vaccines.

The participants reached a clear consensus: “Regulatory convergence is key to ensuring a consistent and timely response to emerging variants.” A full summary of the workshop and its findings is available on the ICMRA website. Another workshop will take place later this year.

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About the Author
Angus Stewart

Associate Editor of The Medicine Maker

Between studying for my English undergrad and Publishing master's degrees I was out in Shanghai, teaching, learning, and getting extremely lost. Now I'm expanding my mind down a rather different rabbit hole: the pharmaceutical industry. Outside of this job I read mountains of fiction and philosophy, and I must say, it's very hard to tell who's sharper: the literati, or the medicine makers.

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