• US officials tell the Biden administration – which has said that boosters will be available in September, pending FDA approval – to hold off, since regulators need more time. Dr. Janet Woodcock, acting FDA commissioner and Dr. Rochelle P. Walensky, head of the Centers for Disease Control and Prevention, warned that their agencies may only be able to determine whether to recommend boosters for some people who received the Pfizer/BioNTech vaccine .
Previously, President Biden announced boosters as part of the strategy to battle the Delta variant, saying “The plan is for every adult to get a booster shot eight months after you got your second shot. It will make you safer, and for longer. And it will help us end the pandemic faster.”
Several sources noted that Dr. Woodcock had argued that it was risky to set a firm date for a booster rollout before regulators had a chance to decide whether shots were safe and necessary, since they are also considering the proper dose for a booster from Moderna, and waiting for data from J & J – and from Israel, which has already begun to provide boosters to everyone over age 12, because it says that protection from the Pfizer/BioNtech vaccine against severe COVID-19, hospitalization and death wane over time.
Notably, two key vaccine regulators who just resigned from FDA, Dr. Marion Gruber, who directs the agency’s vaccines office, and her deputy, Dr. Philip Krause, have said there was not nearly enough data to justify offering extra shots to the general population in just a few weeks, and Dr. Paul Offit, who is on the FDA’s advisory panel, has said “There is no compelling reason to get a third dose.” Source
• The US CDC publishes a report on incidence of myocarditis (an inflammation of the heart muscle) at over 900 hospitals during the period between March 2020 and January 2021. Although myocarditis was uncommon, incidence was 42 percent higher in 2020 than 2019. Overall, having COVID-19 increased the risk for myocarditis by 15.7 times (and it increased with age, from 7 greater among COVID-19 patients ages 16–39 years to over 30 times greater among those aged 16 to 75 years). Source
• Japan’s Prime Minister, Yoshihide Suga, announces his resignation less than a year after taking office, following increasing public criticism over his response to COVID-19. Source
• US President Joe Biden announces a plan to invest $2.7 billion to increase domestic production of critical vaccine components, saying that it would help make the US the “arsenal of vaccines for the world.” Countries facing vaccine shortages say they don’t need vaccine supplies — they need the vaccine itself, and they don’t have the ability to produce it.
The US has donated or pledged 600 million doses of coronavirus vaccines to other countries, but 11 billion doses are needed to stop the virus from spreading across the world. Activists are calling for the Biden administration to compel major vaccine makers to share their recipes and technical know-how with other countries, enabling them to make their own vaccines, Public Citizen has proposed a $25 billion investment for retrofitting manufacturing facilities around the world, with the goal of making 8 billion doses of mRNA vaccine in one year. Source
• Moderna issues a press release to announce that it has submitted an application to the European Medicines Agency for conditional approval of its 50µg coronavirus vaccine booster dose. Source
• WHO designated the Mu variant, which was first identified in Colombia in January 2021, as a “variant of interest” because of preliminary evidence that it can evade antibodies. Source
• The Journal of the American Nephrology Society publishes research on kidney outcomes in long COVID, comparing medical records from 89,216 veterans who had COVID-19 to 1, 637,467 who did not. The veterans were categorized by the severity of their illness (non-hospitalized, hospitalized, and admitted to intensive care). Notably, those with COVID-19 were more likely to be younger, Black, and more likely to have comorbidities. Overall, COVID-19 survivors were at higher risk of, and more likely to have acute kidney injury, major adverse kidney events and declines in their estimated glomerular filtration rate ( an indicator of kidney disease) and end-stage renal disease; the risk increased with severity of disease. The authors reported that the cause of these lingering kidney problems is not clear, and suggested that post-acute care for COVID-19 should include attention to kidney function and disease. Source
• Britain’s Joint Committee on Vaccination and Immunisation chose not to endorse coronavirus vaccines for children ages 12 to 15 years, saying that the health benefits were only “marginally greater than the potential known harms,” and the margin was “too small to support universal Covid-19 vaccination for this age group at this time,” noting that COVID-19 is usually mild in younger people and the very rare risk of myocarditis from mRNA vaccines. The Committee already recommended vaccines for children in this age group who have severe neurological disorders, immunosuppression and those living with an immunosuppressed person and it and it advised that children with heart disease, severe asthma, sickle cell disease, Type 1 diabetes, cerebral palsy, autism, epilepsy and muscular dystrophy should also be vaccinated.
Britain’s Health Secretary and ministers of health from England, Northern Ireland and Scotland took a rare action by writing to their chief medical officers, asking them to assess the benefits of expanding vaccine eligibility to cover 12-to-15-year-olds. Source
• After taking legal action against AstraZeneca for delaying deliveries of its coronavirus vaccines, the EU reached an agreement with the company. Under the terms of the settlement, AstraZeneca will deliver 300 million doses by April 2022, on a regular schedule (and is required to give rebates if deliveries are late), putting an end to all legal proceedings. Source
• GlaxoSmithKline joins Eli Lilly, Gilead, J & J, Ionis Pharma, Moderna, Novartis and Pfizer in instituting mandatory coronavirus vaccines for its employees. Source
• Aspen’s coronavirus vaccine manufacturing plant in Gqeberha, South Africa, where J & J vaccines are produced and bottled, has been exporting most of the product despite the country’s urgent need for them. Aspen CEO Stephen Saad announced that is seeking a licensing agreement with J & J, saying “At the moment, J&J could take all the product we make because it’s their product, and sell it to Europe, for example, sell it to the U.S. or Korea, wherever they choose to. We have no say in that.” Source
• US chief medical advisor Dr. Anthony Fauci says that three doses of coronavirus vaccine is likely to become the standard of care, if endorsed by the US FDA. Source
• The US CDC reports a nearly five-fold increase in COVID-19 related hospitalizations among children and adolescents from late June until mid-August 2021; hospitalization rates were 10 times higher among those who were unvaccinated. Source