Australia, Canada, Singapore, Switzerland and UK issue guidance to ensure future vaccines are available quickly
The UK’s medicines regulator has developed guidance with partners in other countries aimed at fast-tracking future vaccine modifications that respond to new variants of coronavirus.
The guidance was issued by the Medicines and Healthcare Products Regulatory Agency together with other regulatory authorities from the Access Consortium—which includes Australia, Canada, Singapore and Switzerland.
It will ensure that future vaccines will be made available “quickly to UK recipients, without compromising on safety, quality or effectiveness”, the government said on 4 March.
Under the guidance, vaccine manufacturers will need to provide “robust” evidence that the modified vaccine produces an immune response, but there is no need for time-consuming clinical studies that do not add to the regulatory understanding of a vaccine’s safety, quality and effectiveness.
The government said this approach was based on “the tried and tested regulatory process used for seasonal flu vaccines, for which annual modifications are needed to match the strains circulating each year”, and that it would “significantly reduce” the length of time taken for the modified vaccine to be ready for use.
“Our priority is to get effective vaccines to the public in as short a time as possible, without compromising on safety,” said Christian Schneider, chief scientific officer at the Medicines and Healthcare Products Regulatory Agency. “Should any modifications to authorised Covid-19 vaccines be necessary, this regulatory approach should help to do just that.”
Schneider added: “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.”