UK, four other countries to fast-track vaccines for SARS-CoV-2 variants

A group of regulatory authorities from the UK, Australia, Canada, Singapore and Switzerland issued new rules Thursday aimed at speeding up the development of modified COVID-19 vaccines against emerging SAR-CoV-2 strains. The guidance, developed by the UK's Medicines and Healthcare products Regulatory Agency (MHRA), Health Canada and its ACCESS Consortium partners, lays out what kind of information the regulators want to see in order to approve any changes to authorised vaccines in the event that viral mutations render them less effective.  

The move follows similar guidance recently issued by the FDA and European Medicines Agency. According to the MHRA and Health Canada, authorised COVID-19 vaccines that are updated in response to new variants will not need a brand new approval, nor will manufacturers have to conduct "time-consuming" clinical studies on them given that researchers are now better able to measure protection by looking at antibodies in the blood after immunisations, rather than having to wait and see if trial participants become infected.

Similar approach to annual flu shots

However, companies would need to submit "robust evidence" that their modified vaccines produce an immune response, and would also have to show that their products are safe and meet quality standards, the MHRA said, noting that the new policy is based on a "tried and tested" approach used for annual updating of seasonal influenza vaccines. Meanwhile, robust clinical trial data on the original COVID-19 vaccines, as well as ongoing studies on real-world use in millions of people could also be used to support any decision by regulators, the UK and Canadian agencies added.

"Our priority is to get effective vaccines to the public in as short a time as possible, without compromising on safety," commented Christian Schneider, chief scientific officer at the MHRA, so "should any modifications to authorised COVID-19 vaccines be necessary, this regulatory approach should help to do just that." The UK joined the initiative in October last year, when it was known as the ACSS Consortium.

Multiple COVID-19 vaccine developers, including AstraZeneca, Pfizer and Moderna, have said they are aiming to modify their respective products this year to improve immune responses against new variants.

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