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Australia, Canada, Singapore, Switzerland, United Kingdom
5 March 2021
TGA has adopted guidance developed by the Access Consortium - a coalition of regulatory authorities from Australia, Canada, Singapore, Switzerland and the United Kingdom. The guidance lays out what information the medicines regulators would need in order to approve any modifications to authorised COVID-19 vaccines, should virus mutations make them less effective at preventing the disease. This guidance is in addition to the earlier Access Consortium statement on COVID-19 vaccines evidence
According to the guidance, vaccine manufacturers would need to provide robust evidence that the modified vaccine produces an immune response, but time-consuming clinical studies that do not add to the regulatory understanding of a vaccine's safety, quality or efficacy are unlikely to be needed.
This is because researchers are now better able to measure protection by looking at antibodies in the blood following vaccination, reducing the need to wait and see whether or not people in a trial become infected with the disease. This would significantly reduce the length of time taken for the modified vaccine to be ready for use.
Alongside data on the immune response, the vaccine manufacturer would also be expected to provide evidence showing the modified vaccine is safe and is of the expected quality. In addition, data from the original robust clinical trials and the ongoing studies on real-world use in millions of people could be used to support any decision by the regulators.
This approach is based on the tried and tested regulatory process used for seasonal flu vaccines, for which annual modifications are needed to match the strains circulating each year.
