Europe – European Commission proposes relaxing GMO regs for COVID-19 vaccines

A proposal to adjust European Union regulation of genetically modified organisms (GMOs) would relax requirements for vaccines under development for SARS-CoV-2, the virus responsible for the novel coronavirus pandemic. The proposed derogation would allow GMO-containing candidate vaccines and coronavirus therapeutics to proceed with clinical trials.

“The policy objective of this proposed regulation is to ensure that clinical trials with medicinal products for human use that contain or consist of GMO’s and are intended to treat or prevent COVID-19 can start swiftly,” said the European Commission (EC) in setting the context of the proposed changes. “It is necessary to adapt the regulatory framework on GMOs so that the conduct of clinical trials with these vaccines can start within the shortest possible timelines,” said the commission, citing an “overriding interest in protecting human health.”
 
Clinical trials, by their nature, involve limited and highly controlled exposure to the products being tested, pointed out the EC, which said that it plans to include an environmental risk assessment as part of the marketing authorization procedure for any products falling under the relaxed GMO regulations. Some vaccines already in development contain attenuated viruses or live vectors – substances which may fall under European Union (EU) GMO regulations…