Pfizer must ask Anvisa for authorization to vaccinate children aged 6 months to 5 years

The president of Pfizer in Brazil, Marta Díez, told the sheet that the pharmaceutical company intends to present to Anvisa (National Health Surveillance Agency) the request for authorization to use the Covid-19 vaccine in children aged 6 months to 5 years.

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.

Currently, the regulatory agency is analyzing the request made by the laboratory to immunize children aged 5 to 11 years.

Díez stated that the claim filed in Brazil for this target audience was the same made in other regulatory agencies, such as the FDA (Food and Drug Administration), in the United States.

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.

The Ministry of Health plans, in the vaccination plan for next year, to immunize 70 million children, which depends on Anvisa’s approval.

The government announced this Monday (29) the purchase of 100 million doses of Pfizer for 2022, with the possibility of contracting another 50 million vaccines of the same model.

as showed the sheet, the agreement provides for the delivery to Brazil of doses adapted to the variants of Covid-19, if the pharmaceutical decides that it needs to change the formulation of its immunizing agent to fight the mutations of the new coronavirus.

The president of Pfizer in Brazil said that she expects the result of the request for vaccination of the group from 5 to 11 years old still in December.

Under the initial deadline, the agency would have 30 days (until December 12) to respond to Pfizer, but the regulator asked for more data.

Anvisa expects the information to be presented soon by the laboratory, which would make the analysis period run again.

The CEO of Anvisa, Antonio Barra Torres, said in an interview with sheet, last week, that the assessment will be done in the shortest time possible.

“The forecast is as soon as possible. We are doing everything to meet the deadline, as we did at other times. It is also being a heavy study, it will come out in the shortest time possible,” he said.

Anvisa members avoid craving a period for the end of the analysis, but they say that the process is running smoothly.

At the same time, the agency is still poring over data on Janssen and AstraZeneca/Fiocruz vaccine booster doses, and analyzing the inclusion of vaccine manufacturing sites.

Fiocruz, for example, asked last week for Anvisa to approve the use of the vaccine with IFA (active pharmaceutical ingredient) made in Brazil. In the reading of technicians from the organs, some of these requests are more urgent, as they impact the continuity of the supply of doses.

To assess the request for vaccination of younger people, Anvisa is still gathering data from agencies abroad and sought out specialized entities.

Therefore, invitations were sent to representatives of the Brazilian societies of immunology, infectology, pediatrics and epidemiology. The idea is for these entities to submit data to Anvisa. The agency is also considering holding open events with experts.

“As soon as the agency has the confirmation of the invited entities and representations, a meeting will be held with the presentation of the data available for discussion and technical assistance in decision-making,” he said in a note.

Anvisa also acts with caution in the debate about the vaccination of children. Agency directors have received threats from members of the anti-vaccination movement, and President Jair Bolsonaro himself (no party) is a vector of disinformation.

The president of Pfizer in Brazil was asked about this anti-vaccination movement that has taken place in the world and about the threats that members of Anvisa have suffered because of the possible approval of the vaccination of children.

The agency’s chief executive even asked for police protection for the directors.

For Díez, it is a matter of concern around the world. However, she said she believes the movement in the country is not as strong as elsewhere.

“There will always be some countries of people who are against the vaccine, but the vaccine needs to be voluntary. People have the freedom to choose not to be vaccinated, if they prefer not to be vaccinated, but they have to understand that vaccines save lives. We protect lives. the people around us when we get vaccinated,” he said.

The ministry has already distributed 147 million doses of Pfizer, the Covid-19 vaccine model most used in Brazil. The first contract was signed in March, but negotiations were tough.

Bolsonaro and his aides disdained this vaccine, made changes to the legislation that would facilitate the purchase and accused the laboratory of imposing “leonine clauses”.