The UK’s Medicines and Health Products Regulatory Agency (MHRA) said on Thursday that new Covid-19 vaccines modified to combat new variants of the virus can now be accelerated for approval.
MHRA has issued new guidelines with the ACCESS Consortium – a coalition of regulatory authorities in Australia, Canada, Singapore and Switzerland.
The regulator said that authorized Covid-19 vaccines that are modified in response to new variants will not need further approval or lengthy clinical studies.
But the guidance says vaccine manufacturers will need to provide robust evidence that the modified injection produces an immune response.
Researchers can now measure this protection from vaccines by monitoring antibodies in the blood after inoculation, reducing the need to wait to see whether people in a test have been infected with the disease or not through clinical tests.
The manufacturer is also expected to provide evidence showing that the modified vaccine is safe and of the expected quality.
Data from original clinical trials of the vaccines and ongoing studies of their use in the real world can also be used to support any decision by regulators.
Our priority is to bring effective vaccines to the public in the shortest possible time, without compromising safety. If any modifications to authorized Covid-19 vaccines are needed, this regulatory approach should help do just that, “said MHRA’s scientific director, Dr. Christian Schneider.
“Today’s announcement 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,” said Schneider.
He added: “The public must be confident that no vaccine would be approved unless the expected high standards of safety, quality and efficacy are met.” “
June Raine, chief regulator of the MHRA, said she would like to “emphasize that so far we have no evidence that vaccines in use in the UK are significantly deficient in effectiveness”.
She added: “A clear objective is that future modifications of the vaccine that respond to new variants of the coronavirus can be made available in the shortest possible time to recipients in the UK, without compromising safety, quality or effectiveness at any stage.”
According to the guidance, the accelerated approach is tried and tested in seasonal flu vaccines, for which modifications are required each year to match the emerging strains circulated.