Posted by Michael Wonder on 05 Mar 2021
TGA adopts Access Consortium guidance for fast-tracking authorisations of modified COVID-19 vaccines for variant
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.
