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A Anvisa rejected this Saturday (16), through an official statement, the vaccine for coronavirus of russian origin Sputnik V, ordered in emergency mode by the União Química laboratory for not having minimum requirements for presentation and analysis.
According to the agency, the problem identified was during the conduct of phase 3 clinical trials and issues related to good manufacturing practices.
“The Agency clarifies that it is not enough to request the presentation of a phase 3 clinical trial authorization to request an emergency use. It is necessary that these studies are underway in the country, in addition to other conditioning measures already planned. An application for authorization for emergency use by Anvisa must include strategies that will be implemented by the applicant to ensure that ongoing clinical trials of the vaccine can evaluate long-term safety and efficacy, ”the note noted.
See the full release here.
