Modified COVID-19 vaccines for variants to be fast-tracked

Health Canada announces new guidance issued today by the Access Consortium—a coalition of regulatory authorities from Canada, the U.K., Australia, Singapore and Switzerland. The guidance, developed by Health Canada in consultation with its Access partners, lays out what information regulators would need to approve any modifications to authorized COVID-19 vaccines, should virus mutations make them less effective at preventing COVID-19. With this guidance, authorized COVID-19 vaccines that are modified in response to new variants will need to be reviewed and authorized.

According to the guidance,  vaccine manufacturers would need to provide  evidence that the modified vaccine produces an immune response in a  sufficient number of  people,  but  clinical  studies  would not be needed since they do not add to the regulatory  understanding of a  vaccine’s  safety, efficacy or quality. 

This is because  researchers are now better able to measure protection  by looking at antibodies in the blood following vaccination, reducing the need to  determine  whether people in a trial develop the  disease. This would reduce the length of time needed for a modified vaccine to be ready for use. 

Along with data on the immune response, the vaccine manufacturer would also be expected to provide  evidence of the modified vaccine’s safety and quality. Data from the original clinical trials and the ongoing studies on real-world use in millions of people can be used to support any decision by the regulators.   

This approach is based on established regulatory processes used for seasonal flu vaccines, for which annual modifications are needed to match the strains circulating  each  year.  

The Access Consortium began as the Heads of Agencies Consortium in 2007. Health Canada was a founding member of this group. The Consortium’s goal is to maximize international cooperation between partners in the Consortium, reduce duplication and increase each agency’s capacity to ensure patients have timely access to high quality, safe and effective therapeutic products, including vaccines, drugs and medical devices.  

Other articles from mtltimes.ca – totimes.ca – otttimes.ca