The Butantan Institute requested authorization from the National Health Surveillance Agency (Anvisa) to have Coronavac used in the immunization of children between 3 and 17 years old against Covid-19, on the last 15th. The agency collected more data on Wednesday ( 22), stating that those provided are not enough for the guarantee.
In an interview with CNN, the director of regulatory affairs and quality at the Butantan Institute, Patrícia Meneguello, stated that the results found so far in the Coronavac tests carried out in children are positive – when tested in different age groups, the vaccine showed a higher immune response in children than in adults and seniors.
“We noticed that the immunogenicity in children is superior to what we have in adults. With that, we are able to make an extrapolation and affirm that Coronavac also has a positive result of effectiveness in children”, explained the director.
She stated that the Institute had expectations that the data provided would be sufficient for approval by Anvisa, but that it is analyzing the agency’s new demands to outline the strategy for obtaining detailed data. “We were surprised by this new request (…) we are evaluating the documentation sent by Anvisa, what it is requesting, to then set up a strategy on how we are going to be able to clarify the data we already have, or generate new data”, he said.
If permission is granted, Meneguello suggested that application in the age group should start quickly. The dose applied to children is the same as for adults, without the need for a different or adapted immunizer. This fact would speed up the process, as Butantan has a remaining 12 million doses, according to the director: “If it is really approved, and we need a larger quantity, we can easily bring the IFA and bottle it. [no Instituto Butantan]”.
Coronavac and Ômicron variant
According to Patrícia Meneguello, Sinovac, the Chinese pharmaceutical company that developed Coronavac, has already started testing the immunizing agent against the new variant of the coronavirus, Ômicron.
She stated that preliminary results are positive, but there is still no conclusive data.
*Under supervision
Reference: CNN Brasil
