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New rules facilitate vaccine registration in Brazil

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Brazil’s national sanitary regulator Anvisa announced the abolition of the requirement of having phase 3 studies conducted in Brazil for the emergency authorization of vaccines to be granted in the country.

This is the first change brought about by the update in the guide for the emergency use of vaccines against COVID-19. Phase 3 studies show the percentage of the vaccine’s efficiency, how many doses must be given, and an assessment of possible adverse reactions.

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“This update comes as part of Brazil’s regulatory strategy of making access easier. It has been stripped of any discussion lying outside of the technical realm, so that Brazil may have access to vaccines with quality, efficiency, and safety,” said Anvisa Director Meiruze Freitas during a Wednesday presser (Feb. 3).

Anvisa’s regulations still require a clinical development study on the vaccine in phase 3, but it does not have to be carried out in Brazil.

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When phase 3 is performed overseas, the applicant laboratory must present raw data on the study, monitor test participants to gauge efficiency for at least a year, and demonstrate that pre-clinical and clinical studies were conducted in compliance with guidelines approved both internationally and domestically. The deadline for analyzing vaccines with no phase 3 studies conducted in Brazil will be 30 days.

“The vaccine with phase 3 studies here in Brazil or overseas will have to meet the same security, quality, and efficiency criteria. The only difference is the need for presenting data that give us confidence in the foreign study and showing that the vaccine works for Brazil’s population. As a regulating agency, we will ensure this is enforced,” said Gustavo Mendes, Anvisa’s manager-general for medication.

Thus far in Brazil, two vaccines have had their emergency use authorized: Coronavac, developed by Butantan Institute in partnership with Sinovac; and the vaccine developed by pharmaceutical AstraZeneca, in collaboration with Oswaldo Cruz Foundation (Fiocruz). More flexible rules for requesting the emergency use may, for instance, benefit laboratory União Química, in charge of the production of Russian vaccine Sputnik V in Brazil. The vaccine is still awaiting authorization for phase 3 trials in Brazil, but it will no longer depend on this requirement for the request to be submitted.

The updated guideline for the emergency use, Freitas went on to say, is expected to broaden the supply of vaccine in the country. “We haven’t received it directly from any company, but I stongly hope that it makes an impact. This could certainly make it possible for Moderna, Novavax, and a number of other vaccines—including those in Covac Facility’s portfolio.”

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