Anvisa (National Health Surveillance Agency) is waiting for Pfizer to deliver additional data on the safety and efficacy of the Covid-19 vaccine to decide on the immunization of children aged 5 to 11 years.
The regulatory body asked for information on the response of the immunizing agent against the delta variant, which is predominant in Brazil, in addition to comparing records of adverse reactions in this age group and in older groups, among other manifestations.
Since November 16, Anvisa evaluates Pfizer’s order. The response period is 30 days, but it was frozen on November 23, when the agency requested more data.
The deadline will run again when the pharmacist delivers this information packet.
The director Meiruze Souza Freitas, responsible for the registration of vaccines, told the sheet that Anvisa may terminate the analysis before the deadline. Sought out, Pfizer said it must deliver the data “as soon as possible”.
“When I deliver the data, I would say that it is going to the finalization (of the analysis),” Meiruze said. The director considered that the analysis period could be interrupted again, if the agency presents new requirements.
“There is no delay. Just care and technical rigor, just as we had at all times when analyzing the vaccines, whether for the initial authorization, booster dose or when we expanded it to teenagers,” he said.
There is still no endorsement in Brazil for the use of vaccines against the new coronavirus in children. Only the Pfizer model can be applied to the 12 to 17 year olds.
Some countries already apply the same vaccine to children, like the United States.
Meiruze said that the Brazilian agency’s analysis time is in line with that of other agencies.
The European health authority took 38 days to release the immunization to this group with the dose of Pfizer. Japan’s regulatory body opened the review on November 10 and has yet to respond.
The director said that the data on the delta variant were cited in a report released by the US health agency when releasing the vaccine for children, but were not in the dossier delivered to Brazil.
“These are information about efficacy, safety, from a study that was carried out and delivered to the FDA (an agency analogous to Anvisa). Delta is the dominant variant in Brazil,” stated Meiruze.
Anvisa also charged the results of monitoring the first weeks of vaccination with the doses of Pfizer in the United States in the youngest group.
Meiruze said she asked the drugmaker for data on registration of myocarditis and pericarditis after vaccination. The director says that these requirements are traditional and do not indicate that there is a high risk of reactions to doses.
“The pediatric product always has an added look of safety,” he said. “Usually they are smaller populations in the studies (of children). It requires greater evaluation”, he also declared.
The agency’s director said that pharmaceutical companies have already been asked to assess the response of vaccines to the omicron variant, but that this study should not impact the analysis of doses to children.
Meiruze stated that it is not enough to consider the approval of the vaccine in another country or scientific publications to allow its use in Brazil.
According to the director, there are specific analyzes for each country, such as the stability of the product in different climates. The agency also requires a plan to minimize risk and warn of adverse reactions. From these documents, you can determine guidelines, such as the need for an “alert network”, additional information for health professionals dealing with the vaccine or the inclusion of adverse reactions in the package insert.
Anvisa also asked for the collaboration of medical entities in the debate on the vaccination of children. The first meeting with representatives of the Brazilian societies of immunology, pediatrics, infectology, among other organizations, will be held on Friday (3).
Meiruze stated that the group will only be consulted, but has no decision-making power. The debate with experts should not delay the decision on the vaccination of children, said the director.
The president of Pfizer in Brazil, Marta Díez, told the sheet that the request made in Brazil for the public aged 5 to 11 years is the same as that presented in other regulatory agencies.
Vaccines are also the same for adults and children, but at a lower dose.
“It’s a third dose of the vaccine for adults. We asked Anvisa for approval and we are waiting for the answer. After this approval, we are preparing results for children aged 6 months to 5 years. We wait for 2022, but we still don’t know when. did not communicate the data,” he said.
Ministry of Health plans, in next year’s vaccination plan, to immunize 70 million children, which depends on Anvisa’s approval.
On Monday (29) the government announced the purchase of 100 million doses from Pfizer for 2022, with the possibility of contracting another 50 million vaccines of the same model.
Anvisa directors received threats from members of the anti-vaccination movement, and president Jair Bolsonaro (PL) himself is a vector of disinformation.
Meiruze said threats and pressure from the anti-vaccine group did not interfere with the agency’s work. “Anvisa seeks to be exempt from these processes,” he said.
In August, Anvisa rejected a request by the Butantan Institute to release the vaccination of children with Coronavac. The laboratory in São Paulo states that it will make another attempt. Meiruze said that Butantan has not yet presented the data required to open a new analysis.
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