The U.K.’s regulator has said that coronavirus vaccines tweaked to deal with variants will be fast-tracked without compromising safety or effectiveness.
The approach will be similar to the regulatory process for the modified flu vaccine to deal with new strains each year, with a brand recent approval not required.
Scientists have previously said a COVID-19 variant resistant to the current crop of vaccines is likely to emerge at some point, but vaccines can also be adapted quickly.
The guidance states coronavirus vaccine manufacturers will need to provide robust evidence that the modified shot produces an immune response. However, lengthy clinical studies deemed not adding to the regulatory understanding of their safety, quality, or effectiveness will not be needed.
The U.K.’s’ Medicines and Healthcare products Regulatory Agency (MHRA) said researchers are better positioned to measure protection by looking at antibodies in the blood after vaccination, reducing the need to wait and see whether people in a trial become infected with the virus.
It said this would “significantly reduce” the length of time it takes for the modified vaccine to be ready.
The guidance from the Access Consortium – a group made up of regulatory authorities from the U.K., Australia, Canada, Singapore, and Switzerland – requires that, as well as evidence on immune response, the modified vaccines must be shown to be safe and of the expected quality. It says data from the original clinical trials and ongoing studies on real-world use in millions of people could be used to support any decision by the regulators.