The Ministry of Health evaluates using Coronavac in children if the immunizing agent is approved by Anvisa (National Health Surveillance Agency).
As the vaccine is the same used in adults, states are already planning to apply doses to children. Today, there are stocks, and the immunizing agent is pointed out by specialists as a good option for children.
The Butantan Institute filed a new application for approval of the use of Coronavac in children and adolescents, from 3 to 17 years old, on December 15th. Anvisa’s evaluation period has not yet ended.
Members of the Ministry of Health say that it is still not possible to establish a deadline for ending the immunization of children in Brazil.
According to interlocutors in the folder, the pace will depend on the possible inclusion of Coronavac in the schedule and on an eventual increase in the number of doses purchased from Pfizer in the first quarter.
The initial plan is to receive 20 million pediatric doses of Pfizer against Covid-19 by March, enough to immunize about half of the population aged 5 to 11 years.
In a statement, the ministry stated that it “acquires and distributes only immunizing agents approved by Anvisa, including in cases of expanding age groups”. The Butantan Institute was contacted, but did not respond until the conclusion of this report.
Nesio Fernandes, vice president of the Southeast region of Conass (National Council of Health Secretaries) and secretary of Health of EspĂrito Santo, confirmed that states already plan to use Coronavac.
He explained that the vaccine has been shown to be effective in countries that already apply the vaccine to children. It is being used in most South American countries and in China, where more than 120 million doses have been administered to children.
Coronavac would also help to expand the age range of children immunized to three years and has no restriction for application together with other immunizations of the children’s calendar for other diseases.
“If you have the approval of Anvisa, it is possible that children are fully immunized by the end of February. Many states have stock of the vaccine. With the current schedule of delivery of Pfizer, this would only occur in June, “said Fernandes.
The government of SĂ£o Paulo has already reserved 12 million doses of Coronavac for use in children aged 3 to 11 years. In a note, the Health Department said it would start using the immunizing agent immediately after Anvisa’s approval.
The health departments of ParĂ¡, ParaĂba and Minas Gerais also stated that they intend to use the immunizer in children. All three states have Coronavac in stock.
Amazonas, Pernambuco, ParanĂ¡, Rio Grande do Sul, Roraima, Santa Catarina, Tocantins and GoiĂ¡s said they are awaiting approval from Anvisa and guidance from the Ministry of Health.
Bahia said it will not use Coronavac on children. The other states did not respond.
Eduardo Jorge da Fonseca Lima, member of the Scientific Department of Immunizations of the SBP (Brazilian Society of Pediatrics) and of the CTAI (Technical Advisory Board on Immunization of Covid-19), stressed that the vaccine is safe for children because of the technology.
“The inactivated virus is known to pediatricians. Studies have shown that this vaccine produces antibodies and few adverse events,” he said.
The new request from the Butantan Institute to apply Coronavac to children and adolescents is the second made for this age group. The first, presented in July, was evaluated by the regulatory agency and denied because of limited data in the studies presented.
Anvisa has 30 days to evaluate the documents. The deadline can be frozen until new documents are presented if a complementation is requested.
There has already been an interruption of the eight-day deadline, from December 22nd to December 30th. If there is no more stoppage, the deadline for the collegiate board to vote on the indication or not of the immunizing agent for children ends in January.
The regulatory agency has been holding rounds of meetings on the Coronavac vaccine. As with the Pfizer vaccine, the data has been discussed with experts and guests.
Isabella Ballalai, vice president of Sbim (Brazilian Society of Immunizations), said that Coronavac could be a great option for children if approved by Anvisa.
However, she points out that parents, if they have the opportunity, should take their children to receive the Pfizer immunizer, already authorized.
Anvisa authorized the use of the Pfizer vaccine to immunize children aged 5 to 11 years against Covid-19 on December 16. Children were included in the national vaccination plan on January 5th.
Lima, from SBP, said a study by the CDC (United States Centers for Disease Control and Prevention) shows that out of 8.7 million children who got the pediatric Pfizer vaccine, there were 12 cases of myocarditis. The number is considered very low, and the children were discharged.
The vaccine, in addition to protecting children, also increases vaccination coverage. The more people immunized, the less the circulation of the virus.
In a note, the Ministry of Health said that “since the beginning of the vaccination campaign, all decisions were taken jointly” between the portfolio and representatives of states and municipalities.
“The portfolio reinforces that all technical guidelines are communicated immediately to states and municipalities from the beginning of the campaign and reinforces the guidance for everyone to follow the agreed measures”, said the ministry.
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