Brazil’s health regulator certifies factories involved in the production of J&J and Sputnik V vaccines

RIO DE JANEIRO, BRAZIL – The Brazilian Health Regulatory Agency (Anvisa) gave certificates of good practices to three factories involved in the production of the Covid-19 vaccine from Janssen, a subsidiary of Johnson & Johnson, and a plant that will participate in the production in Brazil of the Russian Covid-19 vaccine Sputnik V, the regulatory agency advised in a statement.

All these certifications were published in Tuesday’s (March 30) edition of the Federal Gazette.

According to Anvisa, three companies involved in the stages of active pharmaceutical ingredient, formulation, and packaging of Janssen’s vaccine received certificates of good practices.

“With this, Anvisa finalized the analysis of all the plants mentioned in the request for authorization for emergency use filed on 3/24/2021. All companies involved are duly certified,” Anvisa said in a statement.

In the case of Sputnik V, the plant located in Guarulhos, São Paulo, belonging to the União Química Group, was certified. This plant will be responsible for the formulation, sterilization, and packaging processes of the vaccine’s active pharmaceutical ingredient, which will be manufactured in Brasilia.

Anvisa said that União Química has not yet requested the inspection of the plant that will make the vaccine API because it is still in the process of technology transfer.

Anvisa also published in the DOU its denial of a good manufacturing practices certificate for the unit in India producing the Covaxin vaccine from the Indian company Bharat Biotech.

Brazil has an agreement with Janssen to acquire 38 million doses of the company’s vaccine, applied in a single dose, with a forecast delivery of 16.9 million doses between July and September and 21.1 million from October to December.

On Sunday, Anvisa suspended the deadlines for analysis of the request for emergency use of Sputnik V in Brazil, alleging the absence of necessary documents, but said it would keep the process ongoing.

The Ministry of Health has an agreement to purchase 10 million doses of Sputnik V. Any immunizer can only be applied in Brazil after obtaining authorization for emergency use or registration from Anvisa.

Currently, the only Covid-19 vaccines authorized for application in Brazil are those of AstraZeneca and Pfizer, which have obtained registration, and Coronavac, from the Chinese laboratory Sinovac, now manufactured by Butantan Institute in São Paulo, authorized for emergency use.

Source: Exame