The British Medicines and Healthcare products Regulatory Agency (MHRA) said on Thursday that new Covid-19 vaccines modified to target new variants of the virus can now be quickly approved for approval.
The MHRA has issued new guidelines 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 do not require brand new approval or lengthy clinical trials.
But the guidelines state that vaccine manufacturers must provide robust evidence that the modified injection triggers an immune response.
Researchers can now measure such protection against vaccines by checking antibodies in the blood after inoculation, eliminating the need to wait and see whether people in a trial become infected with the disease or not through clinical trials.
The manufacturer is also expected to provide evidence that the modified vaccine is safe and of the expected quality.
Data from original clinical trials of the vaccines and ongoing studies of their real-world use can also be used to support any decision by the regulatory authorities.
Our priority is to get effective vaccines to the public as quickly as possible, without compromising on safety. Should modifications to the approved Covid-19 vaccines be needed, this regulatory approach should help just that, ”said Dr. Christian Schneider, MHRA’s Chief Scientific Officer.
“Today’s announcement also demonstrates the strength of our international partnerships with other regulatory agencies and how our global work can contribute to faster access to life-saving vaccines in the UK and around the world,” said Schneider.
He added, “The public must have confidence that no vaccine will be approved unless the expected high standards of safety, quality and effectiveness are met.” “
June Raine, lead regulator at MHRA, said she would “like to emphasize that we have no evidence to date that the vaccines used in the UK are significantly deficient 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 to recipients in the UK in the shortest possible time without sacrificing safety, quality or effectiveness at any stage. . “
According to the guidelines, the rapid approach is being trialled and tested on seasonal flu vaccines that require adjustments every year to meet emerging strains in circulation.