Covid-19: Moderna asks Anvisa to register the vaccine – 01/20/2023 – Health

Zodiac, Moderna’s representative in Brazil, submitted this Friday (20) to Anvisa (National Health Surveillance Agency) the request for approval of the bivalent vaccine against Covid-19 developed by the pharmaceutical company.

Unlike the first vaccines created to protect against the coronavirus, formulated from the Wuhan strain, bivalent vaccines are developed considering the original virus and also the omicron variant. In the case of Moderna’s product, the formulation includes the omicron subvariants BA.4 and BA.5.

“We are excited to go one step further, providing all the necessary documents and information for the assessment of the [vacina] bivalent is carried out by Anvisa”, said the CEO of Zodiac, Alexandre Seraphim in a note. In the documents, the company requests the definitive registration of the immunizer.

The pharmaceutical bivalent has already received definitive or emergency authorizations in countries such as Australia, Argentina, Canada, Chile and Japan. In the United States, the FDA (American food and drug regulatory agency) authorized the company’s vaccine at the end of August 2022.

Here, there is no prediction of when the analysis of the request will be completed. According to Anvisa, the process seeks to verify whether the benefit/risk ratio of the product is satisfactory in the current epidemiological context and, for this, clinical studies and data proving the quality, safety and efficacy of the product must be presented.

“After the initial analysis, if deemed necessary, demands may be made for clarification or supplementation of information. If approved, the registration is the green light for the vaccine to be marketed, distributed and used by the population, in accordance with the indication established in its leaflet”, explained the agency in a note about Zodiac’s request.

In Brazil, the first pharmaceutical company to request approval from Anvisa for a bivalent vaccine was Pfizer, in August last year. The agency’s permission was granted in November and, in December, the first doses arrived in the country.

Pfizer and Moderna’s vaccines use messenger RNA (mRNA) technology, which allows them to mimic the spike protein —used by the virus to bind to our cells and invade them—, activating the body’s defense system.

The difference between the new immunizers is that they contain two mRNA sequences: one coding for the original spike protein and another for the spike protein from omicron lineages.

From the beginning of the pandemic until now, Brazil has lost 696,148 lives and 36,713,006 cases of Covid-19 and, at this moment, researchers are on alert due to the arrival of the XBB omicron lineage in the country.

The presence of this subvariant is worrying because one of its derivatives, XBB.1.5, was considered the most transmissible so far by the WHO (World Health Organization) and is responsible for the recent increase in cases in the United States.

In this scenario, experts point out that booster doses, especially with bivalent immunizers, become even more important to obtain high protection, especially against hospitalizations and deaths.