Laboratories Pfizer and BioNTech have asked the Food and Drug Administration (FDA), a regulatory agency in the United States, for approval for the new vaccine against Covid-19, which extends protection against the Omicron variant, to be applied to six-month-old babies. 4 years ago.
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The bivalent vaccine, developed with part of the original strain of the new coronavirus, discovered in 2019, and part of Omicron BA.4/BA.5, prevalent today, is authorized for use in the country for everyone over 5 years of age as a booster dose four months after the last application. In Brazil, the green light is for audiences from 12 years old.
With the request, the aim of the pharmaceutical companies is to replace the third application of the babies with one of the new vaccine, keeping the first two of the traditional version. This is because the scheme for the youngest is already initially composed of three doses.
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In a statement, the laboratories assess that, “with the high level of respiratory diseases currently circulating among children under 5 years old, updated vaccines for Covid-19 can help prevent serious illness and hospitalization”.
They also state that the opening of a similar request is under discussion with the European Medicines Agency (EMA), the regulatory body of the European Union.
Bivalent vaccine in Brazil
In Brazil, the National Health Surveillance Agency (Anvisa) approved the bivalent vaccines at the end of November. In addition to the one that includes the Ômicron BA.4/BA.5, there is a version with the Ômicron BA.1, a subvariant that circulated at the beginning of the year. The application is for use as a booster dose in the population aged 12 years and older.
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According to the Ministry of Health, the first units are expected to arrive in the country later this month. However, there is still no information on how many doses will be received and what the application schedule will be.
The federal government has a contract still in force with Pfizer that allows different doses of the vaccine to be requested, such as the new bivalents or the pediatric version for babies from six months.
Vaccination of small children is allowed today with the traditional version for those with comorbidities, but the expansion for everyone in the age group was recommended by the ministry’s technical bodies and is being subject to public consultation.