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www.fdanews.com/articles/198801-uk-to-allow-emergency-use-of-any-effective-covid-19-vaccine

UK to Allow Emergency Use of Any Effective COVID-19 Vaccine

August 31, 2020

The UK has unveiled a proposal that would empower the Medicines and Healthcare Products Regulatory Agency (MHRA) to temporarily authorize effective COVID-19 vaccines while they are still under review.

Under the proposal, which only applies to vaccines under review before 2021, the MHRA could grant temporary authorizations if vaccines are safe and effective, and if they meet certain quality standards.

The UK’s health department said that the new measure is needed because during the transition period for the UK’s exit from the European Union, the European Medicines Agency still has the sole authority for licensing COVID-19 vaccines for the UK until Dec. 31.

The health department called the proposal a “precautionary measure” that would be used only if there is a “strong public health justification” for widespread use of a vaccine before it is fully licensed. The measure could take effect by October.

The new policy will ensure access to vaccines without “sacrificing the absolute need to ensure” they are safe and effective, said Jonathan Van-Tam, the department’s chief medical officer. — Jordan Williams