The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that modifications to the COVID-19 vaccines will be fast-tracked to help tackle new variants.
COVID-19 vaccines that have been authorised for use in the UK will not need brand-new approval or lengthy clinical studies for any modifications that would help them respond to new variants of the virus.
This new guidance from the ACCESS Consortium, a coalition of regulatory authorities from the UK, Australia, Canada, Singapore, and Switzerland, provides information that medicines regulators would need to approve any modifications to authorised COVID-19 vaccines.
Clinical studies
Under the new guidance, vaccine manufacturers would not need to undertake lengthy clinical trials for modifications made to currently authorised COVID-19 vaccines. However, they would need to provide robust evidence that the modifications are efficacious and produce a good immune response, as well as showing that the modified vaccine is safe and of expected quality.
The decision has been made as researchers are now better able to measure the protection provided by the vaccines by looking at antibodies in the blood following inoculation, significantly reducing the time needed to see whether the modified vaccine would be ready for use.
The guidance also states that data from the original clinical trials, as well as the ongoing studies on real-world use in millions of people, could help support any decisions made by the regulators.
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.”
