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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said on Thursday that new Covid-19 vaccines modified to tackle new variants of the virus can now be fast-tracked for approval.
The MHRA issued new guidance with ACCESS Consortium — a coalition of regulatory authorities in Australia, Canada, Singapore and Switzerland.
The regulator said authorized Covid-19 vaccines that are modified in response to new variants will not need brand new approval or lengthy clinical studies.
But the guidance states that vaccine manufacturers will need to provide robust evidence that the modified shot produces an immune response.
Researchers can now measure such protection from vaccines by monitoring antibodies in the blood after inoculation, reducing the need to wait and see if people in a trial become infected with the disease or not through clinical trials.
The manufacturer would also be expected to provide evidence showing the modified vaccine is safe and is of the expected quality.
Data from original clinical trials of the vaccines and ongoing studies on their real-world use could also be used to support any decision by the regulators.
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,” MHRA Chief Scientific Officer, Dr. Christian Schneider said.
“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,” Schneider said.
He added: “The public should be confident that no vaccine would be approved unless the expected high standards of safety, quality and effectiveness are met.””
June Raine, chief regulator at MHRA said she’d like to “emphasize that to date we don’t have evidence that the vaccines in use in the UK are significantly lacking in effectiveness.”
She added: “A clear goal is that the future vaccine modifications that respond to the new variants of coronavirus can be made available in the shortest possible time to UK recipients without compromising at any stage on safety, quality, or effectiveness.”
According to the guidance, the fast-tracking approach is tried and tested on seasonal flu vaccines for which modifications are needed each year to match the emerging strains circulated.
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