UK to fast-track modified COVID vaccines designed to combat new variants
Flu vaccines are modified in a similar way each and every year to ensure that they remain effective for people most at risk.
Coronavirus vaccines that have been tweaked to deal with new variants of the disease will be fast-tracked for authorisation, the UK regulator has said.
According to new guidance, manufacturers must provide robust evidence that the modified jab triggers an immune response, but lengthier clinical studies that don’t offer data on safety or effectiveness won’t be required.
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It claims this will “significantly reduce” the amount of time it takes to get a tweaked jab approved and ready for use.
One first identified in the Brazilian city of Manaus is proving especially concerning – a study this week suggested that between 25% and 61% of people there who had previously had COVID-19 were susceptible to reinfection with the worrying P1 variant.
Six cases of P1 have been found in the UK to date – three in England and three in Scotland.
The new guidance has come from Access Consortium – a group made up of regulatory bodies from the UK, Australia, Canada, Singapore and Switzerland.
It will create a similar system to that used to fast-track tweaked flu vaccines that are updated every year to cater to how the virus is mutating.
Dr June Raine, chief executive of the MHRA, said: “We have a clear goal that future vaccine modifications that respond to new variants of coronavirus can be made in the shortest possible time without compromising safety, quality or effectiveness.”
Dr Christian Schneider, chief scientific officer at the MHRA, added: “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.”
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Category: Technology
Source: Sky