Anvisa approves registration of bivalent Covid-19 vaccine – 06/26/2023 – Health
[ad_1]
Anvisa (National Health Surveillance Agency) approved this Monday (26) the registration of Moderna’s bivalent vaccine against Covid-19. It is the first definitive record for a bivalent vaccine in Brazil.
The vaccine is indicated for children from 6 years old and adults as a booster dose – that is, it can only be applied to those who have already been vaccinated against the disease.
According to Anvisa, Spikevax is a bivalent vaccine that protects against the original Wuhan strain and against the BA4 and BA5 Omicron strain. Moderna’s bivalent vaccine registration request was forwarded to Anvisa in January 2023 by Adium, the company responsible for marketing the vaccine in the country.
To analyze the vaccine, Anvisa had the support of external specialists, such as the SBI (Brazilian Society of Immunology), the SBP (Brazilian Society of Pediatrics), the SBI (Brazilian Society of Infectious Diseases), the SBIm (Brazilian Society of Immunizations ) and the SBPT (Brazilian Society of Pulmonology and Phthisiology).
According to Adium Brasil, the next step is the definition of the price by CMED (Chamber of Regulation of the Medicines Market) and the subsequent analysis by Conitec (National Commission for the Incorporation of New Technologies in the SUS), which determines whether to recommend the incorporation of the vaccine to the public health system.
“We are very pleased to (…) soon be able to provide the Brazilian population with access to effective immunization with mRNA technology in its design”, highlights Alexandre Seraphim, CEO of Adium in Brazil.
The bivalent Spikevax is already authorized in 38 countries. The use of the vaccine was approved by the EMA, the European drug agency, and by the FDA, the regulatory agency in the United States (Food and Drug Administration – FDA), among others.
[ad_2]
Source link
