22 February 2021

• The US death toll from COVID-19 surpasses 500,000, a total larger than combined casualties from World Wars I and II and the Viet Nam war. Source
• The US FDA issues new guidance for development of diagnostics, vaccines, drugs, and biologics – including monoclonal antibodies – aimed at new coronavirus variants. The vaccine guidance states that if the prototype vaccine received an EUA, “…it is expected that the modified COVID-19 vaccine against a SARS-CoV-2 variant made by the same manufacturer and process as the prototype COVID-19 vaccine would be authorized through an EUA amendment to the EUA for the prototype COVID-19 vaccine.” Sources 1,2,3,4,5
• Sanofi announces that it will produce up to 12 million doses of J & J’s coronavirus vaccine once it has been authorized in the EU. Source
• GSK and Sanofi announce the launch of a 720-person phase II, dose-finding clinical trial of its coronavirus vaccine after tweaking its antigen formulation to increase efficacy; if successful, a phase III trial is anticipated to start in Q2 of 2021. Source
• The Philippines grants emergency use approval for Sinovac’s coronavirus vaccine for people ages 18 to 59 years, except for healthcare workers, due to lower efficacy (50.4 percent). Source
• Thailand extends its state of emergency until 10 March (although restrictions on bars and restaurants have been eased), as it prepares to administer vaccines from Sinovac and AstraZeneca. Sources 1,2
• Bulgaria offers coronavirus vaccines to all residents. Source
• Hong Kong’s Chief Executive, Carrie Lam, and other officials are vaccinated as the country prepares to launch its inoculation campaign. Residents can choose between vaccines from Pfizer/BioNTech and Sinovac vaccine (which a large proportion of residents mistrust). Source
• The EMA is considering whether to expand remdesivir’s indication to include people who are not receiving supplemental oxygen as it reviews additional data from Gilead – which sold nearly two billion dollars of remdesivir in Q4 of 2020. Source

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