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Vaccines against Covid-19 variants to be fast-tracked for approval, MHRA says
4 March 2021, 08:36
Vaccines modified to combat Covid-19 variants in the future will be fast-tracked for approval, the medicines regulator has announced.
The Medicines and Healthcare products Regulatory Agency (MHRA) said on Monday it would allow modifications that respond to new variants of coronavirus to be made available quickly to UK recipients.
The body said it would approve new drugs "without compromising on safety, quality or effectiveness" but that "lengthy" clinical studies into modifications of already approved drugs would not be needed.
The decision, which will significantly reduce the length of time taken for the modified vaccine to be ready for use, was jointly agreed earlier this week by the ACCESS Consortium – a coalition of medical regulators from the UK, Australia, Canada, Singapore and Switzerland.
New guidance from the group sets out what information regulators would need to approve any modifications, should any virus mutations make them less effective at preventing the disease.
It says that vaccine manufacturers would need to provide significant evidence that a modified drug produces an immune response, but that major clinical studies involving thousands of participants would not be necessary,
The regulator said there would be no point in launching trials as researchers are now better able to measure protection by looking at antibodies in the blood following vaccination, reducing the need to wait and see whether or not people become infected with the disease.
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MHRA Chief Scientific Officer, Dr Christian Schneider said: “Our priority is to get effective vaccines to the public in as short a time as possible, without compromising on safety.
"Should any modifications to authorised COVID-19 vaccines be necessary, this regulatory approach should help to do just that.
"The announcement today also demonstrates the strength of our international partnerships with other regulators and how our global work can help ensure faster access to life-saving vaccines in the UK and around the world.
"The public should be confident that no vaccine would be approved unless the expected high standards of safety, quality and effectiveness are met."
But alongside data on the immune response, the vaccine manufacturer would also be expected to provide evidence showing the modified vaccine is safe and is of the expected quality.
The guidance says data from original trials and the ongoing studies on real-world use in millions of people could be used to support any decision by the regulators.
This approach is based on the tried and tested regulatory process used for seasonal flu vaccines, for which annual modifications are needed to match the strains circulating each year.
It comes as a new 'variant of concern' first discovered in Manaus, Brazil was confirmed to have entered the UK for the first time last week.
Up to six cases have been identified in England and Scotland so far, including a mystery case whose whereabouts is unknown, prompting a frantic search by health officials to find them and order them to self-isolate.
Public Health England and Test and Trace officials are continuing to track the case down, with the searched narrowed on Tuesday to just 379 households in the South East of England.