Regulators to fast-track Covid-19 vaccine registration

Regulators to fast-track Covid-19 vaccine registration

Brazil’s National Health Surveillance Agency (Anvisa) granted a request by British-Swedish pharmaceutical company AstraZeneca to fast-track the clearance process for its potential Covid-19 vaccine. The decision means that the agency will have access to AstraZeneca’s data as it becomes available, which would save time in the process of getting the vaccine to market — when and if it is proven effective and safe.

The request is a procedure created specifically for emergency situations. However, Anvisa has said it won’t lower its level of scrutiny when analyzing data.

Anvisa says there are currently six potential vaccines being tested in Brazil, notably one produced by Chinese pharmaceutical company Sinovac Biotech, in partnership with São Paulo’s Butantan Institute — which could be available as soon as December, according to São Paulo Governor João Doria.

The agency’s General Manager for Medicines and Biological Products, Gustavo Mendes Lima Santos, said earlier in the week that Anvisa could change its efficacy criteria for the coronavirus vaccine — allowing immunizations with a 50-percent efficacy threshold. The agency’s current standard is 70 percent.

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