10 December 2020
Pfizer and BioNTech announced that Health Canada has granted emergency use authorisation to their mRNA Covid-19 vaccine, BNT162b2. The vaccine will be distributed across populations as per the guidance and supervision of Canada’s National Advisory Committee on Immunisations. Pfizer Canada will have commercialisation rights, while BioNTech will hold regulatory approval in Canada.
Sorrento Therapeutics announced that the US Food and Drug Administration (FDA) had accepted its investigational new drug (IND) application to conduct Phase I clinical trials of STI-2020 (COVI-AMG). The trials will assess the safety, efficacy, and pharmacokinetics of a single dose of STI-2020 among healthy participants and recently diagnosed Covid-19 patients.
According to the UAE’s national health authorities, Chinese-based Sinopharm’s Covid-19 vaccine candidate yielded 86% efficacy in its human trials in the country. The Ministry of Health for the UAE confirmed that the interim analysis was conducted by Sinopharm’s China National Biotec Group. The Gulf country began the Phase III human trials in July and granted emergency use authorisation for the vaccine’s use in health care workers in September.
The Drugs Controller General of India (DCGI) has granted conditional permission for Gennova Pharmaceuticals to conduct Phase I and II human clinical trials of its mRNA vaccine (HGCO19) developed in collaboration with HDT Biotech Corporation. The trials will be conducted based on recommendations by a DCGI Subject Expert Committee (SEC). All results from the Phase I study are also required to be submitted to the SEC before moving into the next phase