The US FDA is seeking additional data from Moderna on its coronavirus booster shot, particularly on efficacy of a 100 microgram dose (which is used for the first two shots), rather than the 50 microgram dose that Moderna submitted. “We consider our submission complete,” said Moderna’s spokesperson Kate Cronin, “We can’t comment on the FDA reviewal portion and what that will entail. Source 

• Japan is extending the state of emergency for Tokyo and three surrounding prefectures by two weeks; it may be expanded to include six other prefectures, including Osaka and Aichi. Source 

• In the US, poison control centers and hospitals are treating an increasing number of people who have taken ivermectin in doses intended for livestock, despite warnings from FDA and other public health authorities. The CDC reported that the number of ivermectin prescriptions written each week during August rose from an average of 3,600 to 90,000. Ivermectin, which is used for treating lice and rosacea in people and for deworming animals, has not demonstrated efficacy against COVID-19 in clinical trials.  TheAmerican Medical Association, the American Pharmacists Association and the American Society of Health-System Pharmacists released a joint statement asking for “an immediate end to the prescribing, dispensing and use of ivermectin for the prevention and treatment of Covid-19 outside of a clinical trial.” Source 

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