16 March 2021

• The New York Times quotes Nicola Magrini, the Director General of Italy’s medicines authority AIFA, who said that the choice to suspend the vaccine was “a political one,” made to create a united front with other European countries which decided to do so. Source
• Emer Cooke, the EMA’s Executive Director, states that there is no evidence that the AstraZeneca coronavirus vaccine caused rare, serious clotting and bleeding abnormalities, and that the  benefits from the vaccine outweighed the risk  of side effects. Source
• Thailand moves forward with the AstraZeneca coronavirus vaccine after a brief suspension. Source
• The New England Journal of Medicine publishes data from the trial of AstraZeneca’s coronavirus in South Africa, which concludes that it “… did not show protection against mild-to-moderate Covid-19 due to the B.1.351 variant.” Source
• Moderna begins administering its coronavirus vaccine to children in a 6,750-person phase II/III clinical trial for ages six months up to age 12 years. The trial will assess three doses in younger children and two doses in older ones; an interim analysis will determine dosing in the second part of the trial. Source
• The US purchases up to 500,000 doses of AZD7442 (a long-acting antibody cocktail derived from convalescent plasma which is in late-stage trials: it is being studied to protect people who cannot be vaccinated and as a treatment for COVID-19).  The US had already entered agreements with AstraZeneca for up to 200,000 doses. Source
• Russia criticized the US for pressuring Brazil to turn down the Sputnik V coronavirus vaccine in an annual report issued by the Department of Health and Human Services in January (under the Trump administration), which accused Moscow of seeking influence  “…to the detriment of U.S. safety and security.”  Nonetheless Brazil’s Uniao Quimica entered an agreement giving it the right to produce Sputnik V locally, and an order for 10 million doses, beginning in April – although it has not yet been approved by regulators. Source
• The FDA issues fact sheets informing healthcare providers that some coronavirus variants (B.1.1.17, B.1.351 and P.1,  in addition to those recently identified in California [B.1.427/B.1.429] and New York [B.1.526] ) may have an impact on effectiveness of monoclonal antibodies that have been granted emergency use authorization for treating mild-to-moderate COVID-19 in adults and children over age 12 years at high risk for progressing to severe COVID-19 and/or hospitalization.  FDA suggested that health care providers refer to the CDC website on viral variants in the US and consider prevalence of mAb-resistant variants in their area as reported by state and local health department to guide treatment decisions. Source
• The FDA imposes new requirements for EUAs covering  monoclonal antibodies from Eli Lilly (bamlanivimab alone and in combination with etesevimab) and Regeneron (casirivimab and imdevimab), asking the companies to establish a process for monitoring genomic databases for variants, and to report on the results each month. In addition, FDA may require that the companies test their products against certain variants. Source
• San Francisco, Santa Clara, San Mateo, Marin, Contra Costa and Alameda – home to over 6.7 million people – impose  the nation’s first “shelter in place” orders for all residents until at least 7 April, including all non-essential workers. Source

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