Britain’s medical regulator says it will fast track vaccines which have been modified to tackle new variants of COVID-19 to make them accessible to the public more quickly.
The Medicines and Healthcare products Regulatory Agency (MHRA) announced this on Thursday when it joined forces with authorities in Australia, Canada, Singapore and Switzerland to give new guidance for already approved vaccines and any changes the developers make.
In light of the rising number of Coronavirus variants and fears vaccines will not be able to protect people against them, the MHRA and the ACCESS group (which is made up of the nations above), said vaccine manufacturers producing tweaked vaccines would need to provide robust evidence the new jabs provide an immune response to be approved.
Data from original clinical trials, real-world evidence from vaccine rollout and the number of antibodies in people’s blood samples would also be used.
But clinical studies that do not add to the regulatory understanding of a vaccine’s safety, quality or effectiveness would not be needed, the MHRA said.
“Our priority is to get effective vaccines to the public in as short a time as possible, without compromising on safety,’’ MHRA Chief Scientific Officer, Dr Christian Schneider, said.
“Should any modifications to authorised COVID-19 vaccines be necessary, this regulatory approach should help to do just that.’’
In Britain, the Pfizer/BioNTech, Astrazeneca/Oxford and Moderna vaccines have all been approved for use so far. (dpa/NAN)
