UK Government poised to amend regulations to allow use of unlicensed vaccine

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UK Government poised to amend regulations to allow use of unlicensed vaccine

Tue, 2020-09-29 17:46 — mike kraft

Covid-19: Government poised to amend regulations to allow use of unlicensed vaccine Experts say robust legal protections are needed to inspire public confidence. Clare Dyer reports The UK government has set out plans to amend drug regulations in case it decides that covid-19 vaccines should be used before they are licensed, in a bid to roll them out more quickly.1 In a consultation on the proposals that ran from 28 August to 18 September the Department of Health and Social Care for England explained that if a suitable vaccine emerged with strong evidence of safety, quality, and efficacy the government would seek to license it through the usual route but could supply it in the meantime. The consultation document said that if there were a “compelling case, on public health grounds, for using a vaccine before it is given a product licence, given the nature of the threat we face, the Joint Committee on Vaccination and Immunisation may take the very unusual step of advising the UK government to use a tested, unlicensed … The BMJ

The document added, “A covid-19 vaccine would only be authorised in this way if the UK’s licensing authority was satisfied that there is sufficient evidence to demonstrate the safety, quality, and efficacy of the vaccine. ‘Unlicensed’ does not mean ‘untested.”

The consultation, and the timeframe in which it was conducted, prompted some people to post their concerns on social media. A post on a local residents’ Facebook group in Devon reads, “After 18 Sept, the government are going to say they consulted the public and because there were no objections, we all want and consent to the rollout of unlicensed vaccines, and that we are happy for non-medical staff to administer them and happy to accept we will not have the ability to ask for compensation if we face damage to our health.”2

The Human Medicine Regulations 2012 already allow the licensing authority to temporarily authorise the supply of an unlicensed product in response to certain public health threats, including the suspected spread of pathogens. The proposed change would allow conditions to be attached “to ensure product safety, quality, and efficacy” ...

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