The Medicine and Healthcare products Regulatory Agency said in a statement that the new guidance was adopted by the Access Consortium, a coalition of regulatory authorities from the UK, Australia, Canada, Singapore and Switzerland.
“Alongside data on the immune response, the vaccine manufacturer would also be expected to provide evidence showing the modified vaccine is safe and is of the expected quality,” the MHRA said.
In addition, data from the original robust clinical trials and the ongoing studies on real-world use of the vaccines in millions of people could be used to support any decision by the regulators.
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,” MHRA Chief Scientific Officer, Dr. Christian Schneider, was quoted as saying.
The approach is based on the tried and tested regulatory process used for seasonal flu vaccines, which are modified every year to match the new strains.
The announcement comes as at least three variants “of concern” have been identified in the UK so far, including the strain first discovered in Brazil which experts fear could be more resistant to the Pfizer/BioNTech and AstraZeneca/Oxford vaccines being rolled in the UK.