Anvisa approves two updated Pfizer vaccines for omicron subvariants


The collegiate board of Anvisa (National Health Surveillance Agency) approved, this Tuesday (22), the emergency use of two bivalent vaccines against Covid-19 produced by Pfizer.

The bivalent vaccine offers immunization against more than one strain of the Covid-19 virus. The first version presented by the manufacturer was designed with the original strain of Sars-CoV-2 and omicron BA.1, which quickly spread throughout the world.

There was also the approval of a new version of the vaccine that has the original strain of the virus and has subvariants BA.4 and BA.5.

Vaccines are indicated as a booster dose in the population over 12 years of age, that is, after three months of application of the complete primary scheme. They can also be applied as a second booster dose – or fourth dose.

“The data support the conclusion that the updated bivalent vaccines will result in clinical benefit, with increased protection and duration of protection against the omicron variant and subvariants, when administered as a booster dose”, said the general manager of Products Biologics from Anvisa, Fabrício de Oliveira.

According to him, the results showed that the adverse reactions were mostly mild, moderate and of short duration. The most common were injection site pain, fatigue, headache, muscle pain, chills, joint pain, swelling, diarrhea and fever.

“There was no additional concern for the bivalent vaccines when compared to the safety profile of the original monovalent vaccine,” he added.

The reporting director of Anvisa, Meiruze de Sousa Freitas, pointed out, based on data from the WHO (World Health Organization), that unvaccinated people have ten times more risk of death than a vaccinated person.

“The use of bivalent vaccines can help Brazilians, especially the vulnerable, to avoid serious illness or death, but I emphasize that the approval of the bivalent vaccine does not disallow the use of monovalent vaccines approved by Anvisa or acquired through the Covax Facility”, he said. Meiruze, in your vote.

The BA.1 bivalent vaccine is approved in 35 countries. The bivalent BA.4/BA.5 is approved in 33 countries, such as Canada, Japan, United Kingdom, United States, European Union, Australia, Singapore, among others.

Approval does not mean that vaccines will necessarily be incorporated by the Ministry of Health.

Members of Anvisa stressed that the monovalent vaccine, with only one strain, remains effective against the disease in its severe form and deaths, as long as the doses are taken as recommended by the Ministry of Health. The original version of the Pfizer vaccine has been registered in Brazil since February 2021.

Anvisa had a group of specialists from medical societies to help with the analysis. The Brazilian Societies of Pediatrics, the Brazilian Society of Immunizations, the Brazilian Society of Infectious Diseases, and the Brazilian Society of Pneumology and Phthisiology participated.

So far, Anvisa has not received other requests for vaccines for Covid that include strains of new variants.

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