Modified COVID-19 vaccines for variants to be fast-tracked, say regulators

Authorized COVID-19 vaccines that are modified in response to new variants will not need a brand new approval or “lengthy” clinical studies, according to new guidance from the ACCESS Consortium – a coalition of regulatory authorities from the UK, Australia, Canada, Singapore and Switzerland.

The guidance, developed by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and its ACCESS partners, lays out what information the medicines regulators would need to approve any modifications to authorized COVID-19 vaccines, should virus mutations make them less effective at preventing the disease.

According to the guidance, vaccine manufacturers would need to provide robust evidence that the modified vaccine produces an immune response, but time-consuming clinical studies that do not add to the regulatory understanding of a vaccine’s safety, quality or effectiveness would not be needed. This is because researchers are now better able to measure protection by looking at antibodies in the blood following vaccination, reducing the need to wait and see whether or not people in a trial become infected with the disease. This would significantly reduce the length of time taken for the modified vaccine to be ready for use.