UK – Modified COVID-19 vaccines can avoid ‘lengthy’ clinical studies, says MHRA

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…