The UK may release a vaccine for coronavirus before it is fully licensed, according to official documents. This is due to changes to licensing rules which will come into effect once the Brexit transition period is over.
Currently, the responsibility for licensing a vaccine for use in the UK still rests with the European Medicines Agency, but once the Brexit transition period is over in January 2021, this will transfer to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
How can a vaccine be released without a license?
According to government documents, a three week long consultation in August to bring in legislation that would “support the rollout of COVID-19 vaccines” by allowing the UK to administer a “tested, unlicensed vaccine.”
The government says it will seek to license and rollout any vaccine “through the usual route” but that “if there is a compelling case on public health grounds for using a vaccine before it is given a product license”, the UK’s advising body on vaccines might “take the unusual step” of recommending the government use a “tested, unlicensed vaccine.”
Would it be safe?
Ministers stressed that the vaccine would only be distributed prior to being fully licensed, “if the UK’s licensing authority was satisfied that there is sufficient evidence to demonstrate the safety, quality and efficacy of the vaccine.”
They also say that this would only be considered in the case of a Covid-19 vaccine, “given the nature of the threat we face.”
The proposals would also protect the manufacturers of any Covid-19 vaccine which was rolled out early from civil liability, as well as laying out a plan to train a wide range of health workers to administer the injections, including dentists, vets and pharmacists.
Speaking when the consultation was launched, Professor Jonathan Van-Tam, England’s Deputy Chief Medical Officer, 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.”