Anvisa approves update of Covovax, vaccine against Covid-19, based on non-mRNA technology | AgoraMS

FQM Group Consortium – Zalika, through the FQM laboratory structure, will allow Brazilians to have access to another option for preventing the disease

The National Health Surveillance Agency (Anvisa) approved the update of the recombinant Covid-19 Vaccine (Covovax), based on a technology that does not use the m-RNA method. The update consists of the strain for the production of the S protein antigen (spike) of the Sars-Cov-2 virus, following the recommendation of the World Health Organization (WHO) for the current strain XBB.1.5, currently in circulation.

Being a more traditional technology, which does not use the m-RNA method, it makes it possible to provide the population with an alternative to the existing m-RNA vaccine options. In addition to being updated to the current strain XBB.1.5, it has simpler distribution logistics and will be sold in Brazil based on an agreement between Zalika Farmacêutica, Grupo FQM Farmoquímica and Serum Institute.

This vaccine is certified by the main International Health Surveillance Agencies in: United States, Canada, United Kingdom, Australia, etc. It is distributed worldwide under the name Nuvaxovid/Covovax and originates from research by the American company Novavax, and is produced by Serum Institute Pvt, the largest vaccine manufacturer in the world.

The FQM – Zalika Group consortium, through the FQM structure, which has more than 90 years of tradition in Brazil, focused on selling safe and effective products in the area of ​​health and well-being of the population, established a partnership with Serum Institute to the effects of making a wide arsenal of vaccines available in Brazil that will be presented over the next few months, and begins with this new prevention option against Covid-19.

Approval and update

The vaccine is a product of research by Novavax in the United States and is manufactured by the Serum Institute Pvt. Ltd., in India, having received initial approval from the National Health Surveillance Agency (Anvisa) on January 8, 2024 and the update on January 18 April 2024.

For this update, the technical criteria of quality, safety and effectiveness were met, provided for in the standards of the Resolution of the Collegiate Board (RDC nº 413/2020) and Normative Instruction (IN nº 65/2020), which deal with post-registration changes to biological products.

The approval followed the quality, safety and efficacy parameters established by regulatory standards. The Covovax vaccine is aimed at people aged 12 and over. It is applied in one dose to those who have already received a vaccine for Covid-19. In the case of individuals who have never received a vaccine against Covid-19, the complete two-dose schedule is recommended.

About FQM

FQM is a pharmaceutical industry that has been present in Brazil since 1932. It has a wide portfolio of products that covers both medicines intended for medical prescription, across different specialties, and OTC.

About Zalika Farmacêutica

Zalika is a Brazilian pharmaceutical company, established as a platform for the entry of immunobiological, biological, oncological and other medicines necessary for the health care of the Brazilian population.

About Serum Institute

Serum Insitute is a world leader in vaccine production, with more than 1.5 billion doses/year and operating in Brazil for more than 30 years.