The UK Medicines and Health Products Regulatory Agency (MHRA) said on Thursday that new modified Covid-19 vaccines could now be rapidly monitored to deal with new variants of the virus.
The MHRA 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 will not need new approval or lengthy clinical trials.
But the guide states that vaccine manufacturers will have to provide solid evidence that the modified trait produces an immune response.
Researchers can now measure this protection against vaccines by checking for 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 is also expected to provide evidence that the modified vaccine is safe and of the expected quality.
Data from original vaccine trials and ongoing studies on their use in the real world could also be used to support any decision by regulators.
Our priority is to get effective vaccines for the public in the shortest possible time, without compromising safety. If any modifications to the authorized Covid-19 vaccines were to be made, this regulatory approach should help to do 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,” he said. Schneider.
He added: “The public should be confident that no vaccine will be approved if the expected high standards of safety, quality and effectiveness are not met.”
June Raine, chief regulator of MHRA, said she would like to “emphasize that so far we have no evidence that vaccines used in the UK are significantly ineffective”.
He added: “A clear goal is for future vaccine modifications to respond to new variants of the coronavirus to be made available to UK recipients in the shortest possible time without compromising at any time in terms of safety, quality or efficiency “.
According to the guide, the rapid follow-up approach is tried and tested in seasonal influenza vaccines for which modifications are needed each year to match circulating emerging strains.