Regulators in five nations ease rules for developing modified vaccines

Regulators in five countries around the world announced new rules on Thursday to speed the development of modified COVID-19 vaccines targeting emerging variants of the disease. 

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) confirmed that vaccine manufacturers will not need to pursue “a brand new approval or ‘lengthy’ clinical studies” in order for modified vaccines to be approved.

The guidance was issued from the ACCESS Consortium, a coalition of regulators from the U.K., Australia, Canada, Singapore and Switzerland. 

Under the new guidance, vaccine developers must “provide robust evidence that the modified vaccine produces an immune response,” but they will not need to pursue new, large-scale clinical trials.

Instead, developers will perform small-scale trials on a few hundred participants instead of the thousands of people required for the initial approvals of COVID-19 vaccines, according to The Associated Press. 

“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,” Christian Schneider, the MHRA’s chief scientific officer, said in a statement.

Under new guidance issued by the Food and Drug Administration last month, vaccine developers in the U.S. will not have to conduct lengthy clinical trials to evaluate candidates that target variants. Instead, they can submit data from small trials that compare immune responses from participants to that of a vaccine that has been previously authorized.

Vaccine developers around the world are pursuing inoculations to target the new variants.

Moderna announced last month that it has manufactured a booster of the coronavirus vaccine to target a variant of COVID-19 first found in South Africa.