Important update here confirming that the U.K.‘s emergency use temporary authorisation of the first coronavirus vaccine has nothing to do with Brexit. https://twitter.com/davidallengreen/status/1334434057464242176
I’m on a week off work (I’m British but work for the EU medicines regulator) but anyway:
UK’s MHRA has issued a temporary authorisation for supply and use in the UK of individual batches of the COVID-19 vaccine BNT162b2, developed by BioNTech and Pfizer...
This temporary authorisation is a regulatory tool which allows the UK under national legislation, to temporarily supply and use an unlicensed in certain specific types of public health emergencies, such as COVID-19...
It will permit temporary supply of individual batches to be given to a specific group of people. As it relates to specific batches, supply is therefore anticipated to be limited for the time being. Further batches may be supplied, subject to batch specific approval by MHRA...
The temporary authorisation for supply and use of the vaccine by the MHRA is not a marketing authorisation. It differs from marketing authorisations in the amount of information submitted and checks required...
It is specifically designed to enable temporary availability and use in emergency situations for as long as the emergency lasts. It can be terminated at any time if the situation evolves or when a marketing authorisation is issued.
Regulators around the world have different laws when it comes to making medicines, including vaccines, available in the context of public health threats. They can make use of specific regulatory tools to facilitate medicines reaching patients sooner...
EU legislation provides the possibility for individual Member States to have legal & regulatory tools that permit temporary supply of unauthorised medicines in the context of a public health threat. They are governed by national legislation under national emergency use programmes
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