A little more information on the UK “Authorisation” of the Pfizer vaccine:
This temporary Authorisation under Regulation 174 [of the Human Medicine Regulations 2012 (as amended)] permits the supply of identified COVID-19 mRNA Vaccine BNT162b2 batches, based on the safety, quality and efficacy data submitted by Pfizer/BioNTech to MHRA in the period from 1st October to 2 December 2020;
This authorisation is not a marketing authorisation;
My bolding. Source.
-which begs the question, what is “Regulation 174”? Well, I’m delighted to oblige: it’s a derogation from having a marketing authorisation under certain circumstances.
Supply in response to spread of pathogenic agents etc
- The prohibitions in regulation 46 (requirement for authorisation) do not apply where the sale or supply of a medicinal product is authorised by the licensing authority on a temporary basis in response to the suspected or confirmed spread of—
(a)pathogenic agents;
(b)toxins;
(c )chemical agents; or
(d)nuclear radiation,
which may cause harm to human beings.
So to be clear, what has happened in the UK is that the regulatory agency has not granted a Marketing Authorisation (licence); rather it has, in response to the pandemic and based on an evaluation of the data currently available, decided to make the product available on a temporary basis (presumably until they decide that a Marketing Authorisation can be granted, and the situation can be thus regularised).
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