• The EU announces a new biomedical authority, the Health Emergency Preparedness and Response Authority, or HERA, which will aim to improve responses to future pandemics, and a pledge to donate an additional 200 million doses to low-and-middle-income countries by 2022. Source

• The New York Times reports that senior officials in the Indian government insisted on using ineffective COVID-19 treatments, forced scientists to downplay the threat of COVID-19, suppress information on the epidemic’s spread, and pressured them – unsuccessfully – to prematurely approve a vaccine on India’s Independence Day. Source

• A pre-print paper reports that an oral version of remdesivir, GS-621763, has shown promise in an early-stage study in mice and recommends further development in humans. Source

• Barry Clinch, global head of infectious disease clinical development at Roche – which makes COVID-19 diagnostics, assists Regeneron with production of its monoclonal antibody cocktail, and is developing an antiviral treatment – predicts 200 million to 500 million new infections each year; he says the company plans to continue developing COVID-19 diagnostics and treatment. Source

• In South Africa, home to 8.2 million people living with HIV, leaving immunocompromised people unvaccinated increases the risk of viral variants. “There is good evidence that prolonged infection in immune-compromised individuals is one of the mechanisms for the emergence of SARS Covid-2 variants,” said Tulio de Oliveira, a bioinformatics professor who runs gene-sequencing institutions at two South African universities. Source

Endpoints describes documents from Pfizer and the US FDA for an upcoming hearing on coronavirus boosters as “two different conversations,” noting that Pfizer’s 53-page submission summarizes observational studies showing waning protection against mild infection. The FDA’s assessment says that vaccines “still afford protection against severe COVID-19 disease and death in the United States,” and that “…There are many potentially relevant studies, but FDA has not independently reviewed or verified the underlying data or their conclusions.” Source

New England Journal of Medicine publishes data on coronavirus boosters in Israel among 1,137,804 people age 60 and over, comparing rates of infection and severe COVID-19 in people given a booster at least 12 days before falling ill versus those who did not receive a booster. They were followed from 30 July 2021 (when the country began administering boosters) to 31 August 2021. The study found that people who did not receive boosters were 11 times more likely to become infected, and 19.5 times more likely to fall seriously ill than those who got the boosters. The authors noted potential biases that could affect the findings, such as differences in adherence to preventive measures, care-seeking behavior, and prevalence of coexisting illnesses among individuals which could increase or lower their risks. Source

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