Anvisa approves Indian vaccine for Covid – 01/08/2024 – Health

Anvisa (National Health Surveillance Agency) announced this Monday (8) the approval of a vaccine against Covid, developed with recombinant technology by the Serum Institute of India.

According to the regulatory agency, recombinant protein technology enables the industrial production of the material to induce the formation of antibodies in the human body.

The vaccine, approved to prevent Covid in people aged 12 and over, requires a two-dose schedule for initial immunization. The second application must occur exactly 21 days after the first.

For those aged 18 and over, a booster dose is recommended, to be administered six months after completion of primary immunization.

Produced by the Serum Institute of India, this vaccine is represented in the country by Zalika Farmacêutica.

“The vaccine is a monovalent immunizer, with protein S antigen [de Spike, a espícula ou gancho usado pelo vírus para entrar nas células] recombinant with saponin-based adjuvant. Recombinant protein technology makes it possible to produce within the industry the material that will be used to generate the formation of antibodies in the body. The adjuvant has the function of increasing this production”, said the regulatory agency, in a note.

Recombinant vaccine technology is similar to the technique for producing the Oxford/AstraZeneca vaccine, which uses a virus as a viral vector (virus that causes the common cold) modified to present the Sars-CoV-2 protein. During the acute phase of the Covid pandemic, it was at the Indian Serum Institute that many of the doses of the AstraZeneca vaccine imported into Brazil were manufactured.

The Serum Institute became, in the first two years of Covid, the world’s largest producer of immunization agents. It produced more than 1 billion doses of Covishield — a version of the AstraZeneca vaccine —, but suspended its production in 2022 due to the drop in demand.

Despite the interruption in production, the Serum Institute was an important hub for the production of Covid vaccines, not only Covishield, but also other vaccines. Neighboring countries also benefited from local production, such as Bangladesh, Nepal and Sri Lanka.

The vaccine received approval for emergency use by the WHO (World Health Organization) in January 2021.

In Brazil, the Covid vaccines that have already received definitive registration were from AstraZeneca (produced jointly with Fiocruz), Janssen, Pfizer (monovalent), Pfizer (baby), Pfizer (bivalent) and Moderna (bivalent). Coronavac, produced by the Butantan Institute, has approval for emergency use.