National Health Monitoring Agency (ANVISA) authorized the possibility of production Vaccines Against Covid-19 from a Hospira factory in Kansas, USA.
The unit could be used to manufacture doses of a federally developed vaccine pfizer And yes biontech, which has already received authorization for use in Brazil and had a contract with the Ministry of Health to buy 200 million doses this year.
The authority recognized what the agency calls the production plant’s “good manufacturing practices”. It is one of the requirements for a factory to be involved in the registration of a vaccination agent and to use it in its production process.
With this, the Pfizer/BioNTech consortium can expand its capacity to manufacture doses, allowing Brazil to accelerate the availability of batches.
Today, Anvisa also provided commitment terms with governments in the Northeast, who purchased batches of the Russian Sputnik V vaccine, for signature. The terms are part of the requirements defined by the Agency when authorizing the extraordinary importation of a vaccination agent.
States that have imported a lot of immunization agents must sign the terms: Bahia, Maranho, Sergipe, Serra, Pernambuco, Piau, Rio Grande do Norte, Alagoas and Paraiba. In addition to this obligation, other conditions were laid down by Anvisa for the use of Sputnik V.
Among them is to submit documents and inputs to the National Institute for Quality Control in Health in Fiocruz for analysis of samples; Submission of risk mitigation measures to the agency due to lack of one stage verification in import request investigation and submission of Provision of Final Production Report of Active Pharmaceutical Inputs (IFA).
According to Anvisa, analysis by the Fiocruz Institute there is a condition without which vaccines cannot be applied to the population. From the moment the application starts, the follow up with the effectiveness study should be done by the health authorities of the states.