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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Janssen’s Ad26.COV2-S is the latest COVID-19 vaccine to be authorized for emergency use in Brazil. The country’s drugs agency has also received an emergency use request from Lilly for its monoclonal antibody combination, banlanivimab and etesevimab, for treating COVID-19.
Regulatory flexibilities such as rolling review, conditional marketing authorizations and possibly an EU emergency use authorization will play a key part in the EU’s plans to identify and approve promising new coronavirus treatments.
The European Commission’s plans for overhauling the EU medicines legislation have elicited a number of proposals from the pharmaceutical industry to improve the regulatory framework, including streamlining the committee system, improving the use of expedited evaluation pathways, and expanding the European Medicines Agency’s role in assessing drug/device combination products.