UK to give emergency approval to any Covid vaccine breakthrough


Legal change will enable population to be immunised as quickly as possible

Any new and effective Covid vaccine will be given emergency approval for use in the UK and an expanded workforce will be trained to give the injections to immunise as much of the population as possible quickly, the government has said.

A change in the law will allow the UK regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), to grant temporary approval for a vaccine from October, before it has been given a licence by the European authorities, which would be the normal procedure. The UK will be out of the EU from January and will approve drugs and vaccines without Brussels’ involvement.

The European Medicines Agency, which was based in London before Brexit, will fast-track any vaccine and is known to work efficiently, but sources say there are language requirements that could make MHRA approval quicker.

Ministers say there will be no shortcut on safety or effectiveness, and that any vaccine will be approved for the UK only if it meets the highest standards

The deputy chief medical officer for England, Prof 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.”

The MHRA has the power to grant an unlicensed medicine or a vaccine temporary authorisation where a product is proven safe and effective and in the best interest of the patient on the basis of available evidence.

A three-week consultation is being launched on Friday on amending the Human Medicines Regulations 2012. It will seek opinions and advice from health experts and key stakeholder groups. The measures could come into force by October.

The expanded workforce to administer the shots could include a range of health professionals, from nurses and doctors not usually involved in immunisation, to pharmacists, who currently give flu injections, physiotherapists and occupational therapists.

The objective is to get a large proportion of the population vaccinated as fast as possible with a view to revitalising the economy. The first priority, however, will be to immunise healthcare professionals and key workers.

The companies that make vaccines would be given protection from being sued if their product turned out to cause a rare side-effect that could not have been detected during trials. That happened with Pandemrix, the vaccine against swine flu, which caused the sleeping disease narcolepsy in some individuals.

Dr Christian Schneider, the director of the National Institute for Biological Standards and Control (NIBSC), which is part of the MHRA, said it would still prefer a vaccine to get a European licence before rolling it out and he expected that would still be the case.

“Whilst the existing licensing system or a new UK one from next year is the preferred and expected route to supply any vaccine, these new measures will strengthen the regulatory regime and our ability to protect public health,” he said.

Prof Andrew Pollard of Oxford University, the director of the group making the Oxford/AstraZeneca vaccine, said on Tuesday it was “just possible” there may be enough clinical trial data to put before the regulators this year.

Drug and vaccine licensing procedures have frequently been criticised as slow and cumbersome, but approvals have been sped up in recent years. The coronavirus pandemic has been a game-changer. Drug trials have been set up within days and regulators are watching the data that emerges as they go along to streamline approvals.

The UK has bought quantities of six vaccines in the hope that one or more will work well enough to use. Experts think it possible there will be a partially effective vaccine, that may immunise some people and not others or may not have a lasting effect, so will need to be boosted or combined with later vaccines.


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