According to the new guidance from the ACCESS Consortium (a coalition of regulatory authorities from the UK, Australia, Canada, Singapore and Switzerland), authorised COVID-19 vaccines that are modified in response to new variants will not need brand new approval or “lengthy” clinical studies.
The guidance, developed by the MHRA and its ACCESS partners, lays out what information the medicines regulators would need to approve any modifications to authorised COVID-19 vaccines, should virus mutations make them less effective at preventing the disease.
The time taken for the modified vaccine to be ready would be significantly reduced as researchers are better equipped to measure protection, by looking at antibodies in the blood following vaccination, thus reducing the need to wait and see if the people in the study become infected with the disease or not.
Because of this, the new guidance states that vaccine manufacturers would need to provide robust evidence that the modified vaccine produces an immune response, while the time-consuming clinical studies, which do not actually add to the regulatory understanding of a vaccine's effectiveness, quality or safety, would no longer be needed.
MHRA Chief Scientific Officer, Dr Christian Schneider said:
“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.
“The announcement today also demonstrates the strength of our international partnerships with other regulators and how our global work can help ensure faster access to life-saving vaccines in the UK and around the world.
“The public should be confident that no vaccine would be approved unless the expected high standards of safety, quality and effectiveness are met.”
The information for this article was taken from www.gov.uk and can be found here.
You can find more information about the MHRA on their website here.