The UK’s Regulatory Agency (MHRA) said on Thursday that new Covid-19 vaccines adapted to target new variants of the virus could now be quickly detected for approval.
The MHRA has issued new leads with the ACCESS Consortium – a coalition of regulators in Australia, Canada, Singapore and Switzerland.
The regulator said that authorized Covid-19 vaccines that are adapted in response to new variants do not require brand new approval or lengthy clinical studies.
But the guidelines stipulate that vaccine manufacturers will have to provide robust evidence that the modified shot produces an immune response.
Researchers can now measure such protection against vaccines by monitoring antibodies in the blood after vaccination, which reduces the need to wait to see if people in a trial become infected with the disease or not through clinical trials.
The manufacturer is also required 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 on their use in the real world can also be used to support any decision by the regulators.
Our priority is to give effective vaccines to the public within a short period of time, without compromising safety. If adjustments to authorized Covid-19 vaccines are needed, this regulatory approach should help to do so, ‘said MHRA 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 must be confident that no vaccine will be approved unless the expected high standards of safety, quality and efficacy are met.”
June Raine, chief regulator at MHRA, said she ‘would like to emphasize that so far we have no evidence that the vaccines used in the UK are lacking in effectiveness’.
She added: “A clear goal is that future adaptations of vaccines that respond to the new variants of coronavirus can be made available to UK recipients in the shortest possible time without compromising safety, quality or efficacy at any stage. brother.”
According to the guidelines, the rapid detection test is being tested on seasonal flu vaccines for which changes are needed each year to suit the emerging strains that are being spread.