The UK Medicines and Medicines Regulatory Agency (MHRA) said on Thursday that new Covid-19 vaccines modified to address new variants of the virus could now be quickly tracked for approval.
The MHRA has issued new guidelines with the ACCESS Consortium – a coalition of regulators 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 new approval or lengthy clinical trials.
But the guide says vaccine manufacturers will have to provide solid evidence that the altered shot produces an immune response.
Researchers can now measure such protection against vaccines by monitoring antibodies in the blood after inoculation, reducing the need to wait and see if people in a study 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 vaccines and ongoing studies on their use in the real world could also be used to support any decision by regulators.
Our priority is to provide effective vaccines to the public in the shortest possible time, without compromising safety. Should changes be required to Covid-19 authorized vaccines, this regulatory approach should help to achieve this, “said MHRA 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 should be confident that no vaccine will be approved if high standards of safety, quality and efficacy are not met.”
June Raine, the MHRA’s chief regulator, said she would like to “point out that so far we have no evidence that vaccines used in the UK are significantly ineffective”.
She added: “A clear goal is for future vaccine changes to respond to new variants of coronavirus to be made available to UK beneficiaries as soon as possible without compromising safety, quality or efficacy at any stage.” .
According to the guidelines, the rapid follow-up approach is tried and tested on seasonal influenza vaccines for which changes are needed each year to match the emerging strains circulating.