International – Asia-Pacific Roundup

Australia’s Therapeutic Goods Administration (TGA) and its international collaborators in the Access Consortium have posted their approach to the regulatory evidence requirements for COVID-19 vaccine approvals. Access is a consortium of regulators from Australia, Canada, Singapore, Switzerland and the UK.

Clinical trials should ideally show vaccines cut the transmission of SARS-CoV-2, including from asymptomatic people, as well as reducing incidence of COVID-19 in vaccinated individuals, according to the Access statement. It is still unclear whether the leading vaccines prevent transmission or just reduce symptomatic COVID-19. Pfizer/BioNTech investigators are looking at ways to assess the effect of its vaccine on transmission. Testing of asymptomatic people by AstraZeneca/University of Oxford offered some encouragement that its vaccine may reduce transmission…