RIO DE JANEIRO, BRAZIL – The Chamber of Deputies on Tuesday, June 15, passed Federal Senate Bill 1343/21, which allows the government to authorize veterinary vaccine plants to temporarily produce the Covid-19 vaccine. Due to modifications, the text will return to the Senate for a new vote.
According to the passed substitute of deputy Aline Sleutjes (PSL-PR), these laboratories may also produce the active pharmaceutical ingredient (API) and will have to comply with biosafety requirements and health standards, in addition to conducting the entire production process up to storage in premises physically separated from those used for veterinary use products.
However, if authorized by the Brazilian Health Regulatory Agency (ANVISA), storage may be possible in the same area used for veterinary vaccines if each type of immunizer (animal and human) can be identified and separated.
Read also: Brazil hopes veterinary facilities can help increase Covid-19 vaccine output
“We are initiating a new stage to face this challenge and become self-sufficient as well as exporters,” said the rapporteur.
The bill stipulates that Brazil’s health regulator ANVISA will prioritize the analysis of authorization requests for these companies to manufacture API and vaccines against Covid-19.
Read also: Brazil has almost 30 vaccine plants for cattle and only 2 for humans
While producing vaccines for human use, animal vaccine laboratories will be subject to ANVISA’s supervision and rules.
Production capacity
In analyzing the applications, ANVISA will need to consider the production capacity of the applicant establishments to ensure there is no shortage of other raw materials produced.
To help companies adapt their facilities for the production of coronavirus vaccines, the Executive Branch may grant tax incentives.