Brazil’s health regulator authorizes new Pfizer vaccine production plant

RIO DE JANEIRO, BRAZIL – The Brazilian health regulatory agency (ANVISA) has authorized the production of vaccines against Covid-19 in a Hospira company plant in the state of Kansas, USA. This step is required for the immunizer to be used in Brazil.

The plant may be used to manufacture vaccine doses developed by the Pfizer/BioNTech consortium, which has received authorization for use in Brazil and had a contract with the Ministry of Health for the purchase of 200 million doses this year.

The agency’s authorization acknowledged the plant’s “good manufacturing practices,” one of the requirements for a plant to be included in the registration of an immunizer and to be used in its production process.

The Pfizer/BioNTech consortium may now expand its production capacity, thereby expediting the availability of batches for Brazil.

Sputnik V

ANVISA yesterday also released for signature the formal commitment by state governments in Brazil’s Northeast that purchased lots of the Russian Sputnik V vaccine. The terms are part of the requirements set by the agency when authorizing the exceptional import of an immunizer.

Bahia, Maranhão, Sergipe, Ceará, Pernambuco, Piauí, Rio Grande do Norte, Alagoas and Paraíba are the states that imported batches of the immunizer. In addition to this requirement, other conditions were set by ANVISA regarding the use of Sputnik V.

Among them are the submission of documents and raw materials to the National Institute for Quality Control in Health at Fiocruz for sample analysis; submission to the agency of risk mitigation measures for the lack of validation of one of the phases in the examination of the import application and submission to ANVISA of the final report on the production of the Active Pharmaceutical ingredient (API).

According to ANVISA, the analysis by Fiocruz is a condition without which vaccines may not be administered to the population. From the moment administration begins, the health authorities of states will be required to monitor the vaccines’ efficacy.

Source: Exame

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