MercoPress. South Atlantic News Agency

Brazilian-developed vaccine against Covid-19 registered by Anvisa

The recombinant Zalika vaccine is monovalent for the original SARS-CoV-2 virus

The new vaccine against Covid-19 developed by the Brazilian company Zalika Farmacêutica has been entered into the National Health Surveillance Agency (Anvisa) this week, Agencia Brasil reported. The drug can be used in people aged 12 and over and is to be administered in two doses, 21 days apart, with boosters after 6 months for those over 18 years of age.

The technology used in the Zalika vaccine is called “recombinant” because its molecules are formed by combining two different sources. In this case, the protein S antigen (spike) -capable of promoting a response from the immune system- and the saponin-based adjuvant allow the mixture to enhance the production of antibodies. This form of production brings greater safety to the pharmaceutical industry, Anvisa explained in a statement.

The new immunizer is the sixth to receive definitive individual registration from Anvisa, in addition to Comirnaty Ipfizer/Wyeth, Comirnaty bivalent (Pfizer), Janssen Vaccine (Janssen-Cila), Oxford/Covishield (Fiocruz and Astra-Zeneca) and Spikevax bivalent vaccines have received this type of authorization. Pfizer/Biontech, Astra-Zeneca, Janssen, Moderna, Sinopharm, and Sinovac also have definitive registration in the form of the Covax Facility consortium.

CoronaVac (from the Sao Paulo-based Butantan Institute) is also authorized but only for emergency use. Another existing form of authorization is that of exceptional importation, currently granted only to the Russian-made Sputnik vaccine. Covaxin once had this type of authorization, but it was suspended in July 2021.

According to Anvisa, the recombinant Zalika vaccine is monovalent for the original SARS-CoV-2 virus and is not yet capable of immunizing against other variants, which is why it will be updated this year to comply with an agreement between the Brazilian regulatory body and the pharmaceutical company.

To be added to the National Immunization Program (PNI), the recombinant Zalika vaccine still needs to undergo an evaluation by the Health Ministry.

(Source: Agencia Brasil)