Brazil Regulator Rejects Sputnik V Vaccine Citing Serious Quality & Safety Concerns
Russian Backers Deny Risks & Say Move Is ‘Political’
Sputnik V is the latest COVID-19 vaccine to be targeted over safety concerns, but Brazil’s Anvisa has also raised questions over quality and manufacturing standards.
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The European Medicines Agency has issued advice on managing thrombosis with thrombocytopenia syndrome (TTS) in people vaccinated with adenovirus vaccines, and Brazil has OKd the import of Sputnik V and Covaxin, albeit with numerous strings attached.
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The company manufacturing Russia's Sputnik V vaccine in Brazil has produced the first batch, but has withdrawn a request to run clinical trials there.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.
Dr Reddy’s initiates pilot roll-out of imported Russian vaccine Sputnik V, currently priced at about $13.50 per dose in India, and indicates that it hopes to bring the single-dose version Sputnik Light to the country. The Indian company also strikes a deal with a Chinese firm for a CAR-T cell therapy, an area where it hopes to “pick up skills”.