Coronavirus vaccine: Emergency powers to allow rollout of unlicensed vaccine being considered by Government

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.

The document, first reported in the I newspaper, says that the “preferred route” of deployment of a Covid-19 vaccine is through the “usual marketing authorisation (product licensing) process”.

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.

An unlicensed vaccine could be administered if there was a ‘compelling case on public health grounds’ (PA)

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.

In a statement, the DHSC told The Evening Standard: “The MHRA (Medicines and Healthcare products Regulatory Agency) has the power to grant an unlicensed medicine or a vaccine temporary authorisation where a product is proven to be safe and effective and is in the best interest of the patient on the basis of available evidence.”

Deputy Chief Medical Officer, Professor Jonathan Van-Tam, said: “We are making progress in developing Covid-19 vaccines which we hope will be important in saving lives, protecting healthcare workers and returning to normal in future.

“If we develop effective vaccines, it’s important we make them available to patients as quickly as possible but only once strict safety standards have been met.

“The proposals consulted on today suggest ways to improve access and ensure as many people are protected from COVID-19 and flu as possible without sacrificing the absolute need to ensure that any vaccine used is both safe and effective.”


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