They will not have to undergo length clinical trials, which could take months, in order to be given the green light.
Guidance developed by the Medicines and Healthcare products Regulatory Agency (MHRA) and the ACCESSâ¯Consortium, a coalition of regulatory authorities from the UK, Australia, Canada, Singapore and Switzerland, lays outâ¯what informationâ¯would be needed to approve any modifications to authorised Covid-19 vaccines, if virus mutations make them less effective at preventing the disease.â¯â¯
Vaccine manufacturers would need to provideâ¯robustâ¯evidence that the modified vaccine produces an immune response,â¯butâ¯“time-consuming”â¯clinicalâ¯studiesâ¯that do not add to the regulatoryâ¯understanding of aâ¯vaccinesâ¯safety, quality or effectivenessâ¯will not be needed.â¯
These studies will not be required asâ¯researchers are now better able to measure protectionâ¯by looking at antibodies in the blood following vaccination, reducing the need toâ¯waitâ¯andâ¯seeâ¯whether or notâ¯people in a trial become infected with theâ¯disease.â¯
The regulators stressed that this would significantly reduce the length of time taken for the modified vaccine to be ready for use.
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The vaccine manufacturer would also be expected to provideâ¯evidenceâ¯showing the modified vaccine is safe and is of the expected quality.
Data from the original “robust” clinical trials and the ongoing studies on real-world use in millions of peopleâ¯couldâ¯be used to support anyâ¯decision by the regulators.â¯â¯
MHRA chief scientific officer Dr Christian Schneider said:â¯ “Our priority is to getâ¯effectiveâ¯vaccines to the publicâ¯in as short aâ¯timeâ¯asâ¯possible, withoutâ¯compromising on safety. Should any modifications to authorised Covid-19 vaccines be necessary, this regulatory approach should help to do just that.â¯
“The announcement today also demonstrates the strength of our international partnerships with other regulators and howâ¯our global work can help ensure faster access to life-saving vaccines in the UK and around the world.â¯â¯
“The public should be confident that no vaccine would be approved unless the expected high standards of safety, quality and effectiveness are met.”â¯
The regulators added that this approachâ¯was based on the “tried and tested”â¯regulatory process used forâ¯seasonal flu vaccines, with annual modifications when necessary to match the strains circulatingâ¯eachâ¯year.â¯â¯
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