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Vaccines tweaked for Covid variants to be fast-tracked for approval

Nicholas Cecil
·2-min read
<p>The modified jabs for variants will not have to undergo lengthy clinical trials which could take months </p> (POOL/AFP via Getty Images)

The modified jabs for variants will not have to undergo lengthy clinical trials which could take months

(POOL/AFP via Getty Images)

Modified vaccines to combat new Covid-19 variants will be fast tracked for approval, regulators announced today.

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 ACCESS Consortium, a coalition of regulatory authorities from the UK, Australia, Canada, Singapore and Switzerland, lays out what information would be needed to approve any modifications to authorised Covid-19 vaccines, if virus mutations make them less effective at preventing the disease.  

Vaccine manufacturers would need to provide robust evidence that the modified vaccine produces an immune response, but “time-consuming” clinical studies that do not add to the regulatory understanding of a vaccines safety, quality or effectiveness will not be needed. 

These studies will not be required 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 in a trial become infected with the disease. 

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 provide evidence 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 people could be used to support any decision by the regulators.  

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.” 

The regulators added that this approach was based on the “tried and tested” regulatory process used for seasonal flu vaccines, with annual modifications when necessary to match the strains circulating each year.  

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