Ministers are planning to invoke emergency powers to vaccinate the public against Covid-19 even if it is unlicensed, i can reveal.
If a vaccine becomes available before the end of the Brexit transition period on 31 December and it has not been approved by the European medicines watchdog, the UK will use its own emergency regulations to sidestep EU law to allow the jab to be deployed due to the serious threat the virus poses to human life.
The government admits it would be an “very unusual” step to use the extraordinary powers for an unlicensed medicine but that it would be necessary, in those circumstances, to save lives from coronavirus.
In a public consultation document on the plans– which closes at midnight on Friday – the government tries to reassure the public that “unlicensed” does not mean “untested” and that it is expected the vaccine will have gone through several safety trials before use in the general population.
However, the plans also include invoking a separate emergency power which would give the government and all firms, organisations and people involved in the supply chain, from manufacture to administering the jab to individuals, immunity from being sued in the civil courts if someone becomes ill or dies as a result of an unlicensed vaccine.
The 6,000-word document says that further legislation may be needed to clarify that the existing emergency powers can be used in relation to a coronavirus vaccine. The planned emergency regulations cover the whole of the UK.
Describing Covid-19 as the “biggest threat this country has faced in peacetime history”, the document says a viable vaccine will go through “the usual rigorous testing and development process and be shown to meet the expected high standards of safety, quality and efficacy before it can be deployed”.
Suitable vaccine candidate approval
The independent Joint Committee on Vaccination and Immunisation (JCVI) will advise ministers on which Covid-19 vaccine the UK should use, as well as which priority groups will receive the jab first.
The document says: “If a suitable Covid-19 vaccine candidate, with strong supporting evidence of safety, quality and efficacy, becomes available, we will seek to license that vaccine through the usual route.”
Until 31 December this year, the UK is bound by EU legislation on “biotechnological medicines”, including candidate coronavirus vaccines, to be authorised via the European Medicines Agency.
— full story iNews