The Medicines and Healthcare products Regulatory Agency announced on Thursday that adapted vaccines will be “fast-tracked” without the need for a fresh approval process or “lengthy” clinical trials.
The regulatory authority said fast-tracked modifications would not compromise on safety, quality or effectiveness.
Under the new guidance manufacturers will need to prove the modified vaccine produces an immune response, but ”time-consuming” clinical studies that do not add to the regulatory understanding of a vaccines safety, quality or effectiveness will not be needed.
MHRA Chief Scientific Officer, Dr Christian Schneider said: “Our priority is to get effective vaccines to the public in as short a time as possible, without compromising on safety. Should any modifications to authorised Covid-19 vaccines be necessary, this regulatory approach should help to do just that.
“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.
“The public should be confident that no vaccine would be approved unless the expected high standards of safety, quality and effectiveness are met.”
UK Health Secretary Matt Hancock gave a statement on the new guidance during a visit to the Lighthouse Lab in Glasgow on Thursday.
He said: “The vaccine programme has clearly been a huge UK success story, and part of the reason that we have been able to develop the vaccines so far, so quickly, is because of the MHRA’s rigorous yet flexible approach, which has been based entirely on looking as quickly as possible at the safety and efficacy of vaccines.
“I’m delighted that they’re taking that same principled approach to the approval process for vaccines that may work against variants.”
MHRA chief executive Dr June Raine said the new approval process is “agile”, and the green light for new jabs could be given in just a few weeks after all data has been submitted on their effectiveness.
She added that no corners would be cut on safety, and the framework already exists for when annual flu jabs are tweaked.