Nine states ask Anvisa for exceptional authorization to import Sputnik V vaccine – 04/01/2021 – Equilibrium and Health

Anvisa (National Health Surveillance Agency) has received requests for exceptional authorization to import and distribute the Russian vaccine Sputnik V.

The regulatory agency said orders were placed during the week separately by nine states. They were referred by the governors of Bahia, Acre, Rio Grande do Norte, Maranhão, Mato Grosso, Piauí, Ceará, Pernambuco and Sergipe.

In order for Anvisa to handle import requests and clarify relevant technical aspects, a working meeting was proposed between the agency’s five directors and the governors. The meeting should take place next week.

“Anvisa remains committed to making vaccines available to the population in a timely manner and with due safety, quality and effectiveness. Thus, it continues to act according to the scientific and regulatory procedures necessary for the authorization of these products. ”, He said in a note.

The communication advisory of the government of Piauí said, in a note, that these import requests are related to the contract made by the governors of the Northeast with the Russian Direct Investment Fund for the acquisition of 37 million doses.

Northeastern governors took the initiative to negotiate on their own, as did São Paulo’s governor, João Doria (PSDB), with Coronavac, last year.

“The states of Acre and Mato Grosso signed a contract with the Northeast consortium to understand how to participate in the purchase,” said the adviser in a note.

The Ministry of Health has promised to pay for the contract signed by the governors of the Northeast and that vaccines will be incorporated into the PNI (National Immunization Program).

Sputnik V has not yet had its emergency use and definitive registration approved by Anvisa. The agency suspended the deadline for analyzing the request for emergency use due to the lack of part of the data required for the assessment. We are a family owned and operated business.

The request had been requested on Friday (26) by the Chemical Union, which has a partnership with the Russian Direct Investment Fund. The company seeks endorsement for the use of 10 million doses purchased by the Ministry of Health earlier this month.

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