US FDA can’t say whether it will have its vaccine advisors vote on the heterologous uses of booster doses at its 14-15 October meeting of the Vaccines and Related Biological Products Advisory Committee because it is still reviewing the data. The Agency does not appear to need a formal company application or emergency use authorization amendment to allow this type of boosting.

England’s NICE has given its backing to the use of Regeneron’s Ronapreve, and the UK’s new health security body is now fully up and running.

The European Medicines Agency says there is a possible link between the Janssen vaccine and rare cases of venous thromboembolism, and that immune thrombocytopenia should be added as an adverse reaction to the Janssen and AstraZeneca vaccines. The agency has also begun evaluating a marketing authorization application for Celltrion’s regdanvimab in COVID-19 patients.

J&J announced strong data for its single-shot vaccine, with even stronger booster shot data to boot. Also Gilead posted strong results for outpatient use of Veklury, but it faces stiff competition, while Clover announced new data and Pfizer/BioNTech sold another 500 million vaccine doses for donation.