Updated COVID-19 vaccines that are modified in response to new variants will not require a brand new approval or ‘lengthy’ clinical studies to receive authorisation, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced.
The new guidance, published by the MHRA alongside international regulatory authorities from Australia, Canada, Singapore and Switzerland, details what information is required to approve modifications to authorised COVID-19 vaccines.
Although ‘time-consuming’ clinical studies won’t be needed, vaccine makers will need to provide robust evidence that an updated vaccine produces an immune response against a new variant.
Researchers can cut the time it takes to determine the protection that a modified vaccine offers by looking at antibodies in the blood following vaccination.
This can reduce the need to wait and see if people in a trial become infected with the disease, said the MHRA.
Vaccine makers will also be expected to provide evidence demonstrating the safety and quality of a modified vaccine.
Data from original clinical trials and ongoing real-world observation of the vaccine could also be used to support regulatory decisions.
The fast-track approach is similar to the regulatory process used for seasonal flu vaccines, added the MHRA.
“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,” said Christian Schneider, chief scientific officer of the MHRA.
“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,” he added.