Coronavirus Notebook: EU Leaders Cool On Vaccine Export Plans, EMA OKs New Production Plants
Sputnik V is to be manufactured by a plant in Serbia, and the UK has set up a new health security agency to deal with emerging future threats.
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Coronavirus Notebook: UK Seven-Vaccine Booster Trial Begins, Australia Plans mRNA Production Capacity
The company manufacturing Russia's Sputnik V vaccine in Brazil has produced the first batch, but has withdrawn a request to run clinical trials there. France is preparing to immunize the over-18s, and Australia has begun evaluating Vir/GSK’s sotrovimab for use in COVID-19 patients.
The EMA is investigating possible links between the three COVID-19 vaccines currently being used in Europe and cases of thrombotic events. It is also planning safety studies in targeted populations.
The median review time for novel agents at CDER hasn’t changed in five years. Our infographic offers a look at the tortoises and hares (all of them winners because they got approved).