• GSK and VIR issue a press release with final results from the 1,057-person, phase III COMET-ICE Trial of the monoclonal antibody sotrovimab in people with COVID-19 at high risk for progressing to hospitalization. Use of sotrovimab decreased hospitalization for over 24 hours or death by 79 percent; overall, 6 patients in the sotrovimab arm were hospitalized versus 30 patients who received placebo. Side effects were mild-to-moderate. Laboratory studies have shown that sotrovimab is active against the Alpha, Beta, Delta, Epsilon, Gamma and Iota variants although whether this data translates into clinical impact is not known. Studies of intramuscular sotrovimab for preventing and treating mild-to-moderate COVID-19 are planned.
The FDA granted an EUA for sotrovimab in May of 2021, and the companies plan to file for full approval in the second half of 2021. EMA initiated a rolling review in May 2021. Source
• New Zealand grants provisional authorization for use of Moderna’s coronavirus vaccine in children ages 12-15. The country has already ordered 10 million doses, according to the news agency — enough to cover its 4.9 million residents. Source
• One of the coronavirus vaccines Cuba is developing, Soberana 2, demonstrated 62 percent efficacy in an interim analysis of a phase III trial among participants who got two of the three recommended doses. Vicente Vérez Bencomo, director-general at the country’s Finlay Institute of Vaccines, expects results from the three-dose regimen to “of course be superior”. Cuban officials have expressed openness to said licensing the intellectual property around the vaccines, including a small margin of profit to subsidize the country’s universal healthcare system. WHO is in the early stages of assessing Cuba’s vaccines. Source
• Colombia becomes the tenth country to surpass 100,000 deaths from COVID-10. Less than 10 percent of the country’s 51 million residents have been vaccinated. The crisis- and a pandemic- related tax overhaul have led to demonstrations as police violence increases. The New York Times reports that officers have opened fire on peaceful demonstrations, shot tear gas from armored vehicles and beaten, detained and killed protesters. Source
• Cuba announces 1,561 new COVID-19 cases, its highest-ever daily total. Source
• Coronavirus cases among players, delegation members and workers at Brazil’s Copa América soccer tournament reach 140. Source