The Government is considering using emergency powers to allow the rollout of a vaccine to the public, even if it is unlicensed.
In an open consultation document, the Department of Health and Social Care (DHSC) has floated the possibility of authorising the supply of an unlicensed vaccine if there is “sufficient evidence to demonstrate the safety, quality and efficacy of the vaccine”.
The DHSC adds that “unlicensed” does not mean “untested”, and that any unlicensed vaccine will have gone through several safety trials before being used by the general public.
However, the open consultation adds that if there is a “compelling case, on public health grounds” for using a vaccine before it is given a product licence, then the independent Joint Committee on Vaccination and Immunisation (JCVI) may take the step of advising the Government to use an unlicensed vaccine against Covid-19.
It continues that the Government would need to make sure that the “right legislative measures” were in place to deal with that scenario, including a separate emergency power to those responsible for manufacturing or administering the vaccine immunity from lawsuits if someone becomes ill or dies as a result of the unlicensed vaccine.
The JCVI will also advise the Government on which vaccine to use, and which groups to give priority to. The open consultation ends at midnight on Friday.
Currently, the Government is bound by EU legislation that requires vaccines to be authorised via the European Medicines Agency.
Once the transition period ends on December 31 the UK’s licensing authority will have new powers to approve vaccines itself.
The Department of Health and Social Care has been approached for comment.