The general manager of medicines at the National Health Surveillance Agency (Anvisa), Gustavo Mendes, said this Thursday (16), in an interview with CNN, that the benefits of vaccination against Covid-19 for children ages 5 to 11 with Pfizer’s immunizer outweigh the risks.
Anvisa authorized the use of the immunizing agent in the age group on Thursday. The decision comes after technical evaluation of the request submitted by the pharmaceutical on November 12th.
“The data that we presented today, and that supported our decision, show that the status of Covid and Severe Acute Respiratory Syndromes (SRAG) and pediatric infection syndromes caused by coronavirus is important. We cannot say that Covid does not affect children that age. This is why a vaccination strategy is important”, declared Mendes.
“Because it is a different technology, or one that apparently has not been studied in the long term, these studies show that the performance was quite satisfactory in terms of reactogenicity. In other words, in the follow-up we did, we have to remember that 5 million children were vaccinated in the United States and we also have vaccinations in Israel. So that makes us have a reality where we don’t observe a profile of reactions that are worrisome. That’s why the benefits outweigh the risks,” he continued.
The emergency use of Pfizer’s vaccine in children aged 5 to 11 years in the United States was authorized by the Food and Drug Administration (FDA), a body similar to Anvisa, on October 29th. The decision came after a unanimous vote by FDA advisers for recommending the use of a vaccine formulated with one third of the dose used in people over 12 years of age.
The European Medicines Agency (EMA) has also approved the use of the immunizer against Covid-19 in children. The decision was announced on November 25th.
The start of the campaign to immunize children in Brazil will be defined by the Ministry of Health, with no date set yet. Doses for pediatric use are not yet available in the country.
There were no cases of myocarditis and pericarditis after vaccination, explains Mendes
According to Mendes, there were no cases of myocarditis and pericarditis, inflammation of the heart muscle and the outer lining of the heart, respectively, in children aged 5 to 11 years who were vaccinated with doses of Pfizer. The general manager explained that the disease has been seen in older children, and usually males.
“In the studies there were no cases reported. We already knew from the data that we were monitoring of cases in the more than 200 million applied in the United States, data from Israel, that myocarditis and periocarditis are very rare events. We are talking about 0.0007%, it is something that is not representative and has to do with a specific risk for male boys due to the situation itself and not related to the vaccination itself. In data from 5 to 11 years, we do not have this mapped”, stated Mendes.
(*With information from Lucas Rocha, from CNN)
Reference: CNN Brasil
