UK’s MHRA Says COVID-19 Variant Vaccine Studies Can Be Short
As authorized COVID-19 vaccines are modified to protect against emerging strains of the pandemic disease, the UK will require only short clinical trials enrolling small numbers of volunteers to prove the altered vaccines are safe and effective, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said.
“Only short-term results will be required, up to two months depending on the vaccine regimen … seven-day reactogenicity data after each dose and unsolicited adverse events during this follow-up period should be collected,” the agency said, citing a guidance it developed with the ACCESS Consortium, a coalition of regulatory authorities from the UK, Australia, Canada, Singapore and Switzerland.
The MHRA’s approach is in line with those of the FDA and the European Medicines Agency.
Enrollment numbers should be large enough to provide data about reactogenicity and immunogenicity, MHRA said. This could mean, for example, about 300 per cohort in a stand-alone study.