Anvisa (National Health Surveillance Agency) authorized this Thursday (16) the use of Pfizer’s vaccine to immunize children aged 5 years and over against Covid-19. With this, the product insert in Brazil will indicate this new age group.
Until then, the manufacturer’s model was allowed to be used in the country only by people over 12 years of age.
“The number of Covid-19 cases has been representative in the pediatric population. We have a positive safety and reactogenicity profile with vaccination and we have important results in the generation of antibodies in this population”, explained the general manager of Medicines at Anvisa , Gustavo Mendes.
Anvisa’s resolution provides that children receive two doses of 10 micrograms within a 21-day interval and should be published in the extra edition of the Diário Oficial da União on Wednesday.
Despite the announcement, it will be up to the Ministry of Health to decide when to start this vaccination. This should not happen immediately because the folder has not yet requested the purchase of specific doses for the age group. The forecast is to immunize 70 million children.
According to Pfizer, the contract to supply 100 million vaccines in 2022 includes the possibility of delivering modified versions of the immunizing agent, both to combat the new omicron variant and to protect children. The pharmacist confirmed that none of the pediatric dose was sent to Brazil.
The company said that it is not necessary to add an amendment to the contract. To ensure delivery of specific doses for children, a request from the ministry is enough. Pfizer did not say how soon it can ship these vaccines after being called by Health.
Ministry managers estimate that doses will start arriving next month. Sought, the folder did not manifest itself.
With the endorsement, the government will also need to insert the new public into Covid’s vaccination plan and organize the delivery of specific doses to the states.
The measure, however, must face resistance from President Jair Bolsonaro (PL). In recent statements, the Chief Executive has raised doubts about the safety and effectiveness of immunization agents, especially for younger people.
Anvisa directors received threats because of the analysis of Pfizer’s request. The agency requested, but did not receive, police protection from its top management and the most exposed technicians.
The agency’s CEO, Antonio Barra Torres, commented on the episode during this Wednesday’s statement.
“The intensification of this anti-vaccination violence is on an increasing bias and it is important that we speak while there is time, before threats such as these and others materialize,” he said.
Agency representatives were also keen to emphasize that the benefits of the vaccine outweigh the risks.
According to Mendes, Pfizer presented results of studies carried out with approximately 4,000 children that show an efficacy of 90% of the immunizing agent when applied in this group.
“The safety profile of the vaccine, when compared to the placebo, is very positive. When we observe any reaction [adversa], there is no important difference between placebo and vaccine. And there is no report of any serious adverse event, of concern, there is no report of serious cases or mortality due to vaccination compared to placebo,” he explained.
The director also said that Pfizer’s studies show that the group who took the placebo had a higher incidence of Covid-19 cases compared to those who took the vaccine. In addition, the immunizing agent was effective against the delta variant.
In tests, the pharmacist divided the children into three groups and administered different doses of the immunizing agent to assess the ideal to be applied to younger people. They were then divided into two groups, with two-thirds taking the vaccine and one-third taking the placebo.
Pfizer’s vaccines applied to the 5 to 11 year age group and the older ones have the same active ingredient, but some differences in composition.
The dose intended for children is equivalent to one third of that indicated for the group aged 12 and over. The bottle of the youngest immunizing agent has an orange coloration just to differentiate the product.
This vial of the children’s vaccine also holds more doses and can be stored for longer (up to ten weeks) at temperatures from 2°C to 8°C, an interval used in conventional SUS refrigerators. The other model remains for up to 31 days under these conditions.
Anvisa made 17 recommendations for the Ministry of Health to follow when starting the immunization of the new age group.
The agency suggests, among other points, that the vaccination of children be started after the complete training of health teams and that it take place in specific places, different from adults.
The room must also be exclusive for the application of the Covid vaccine, and should not be used for the application of other vaccines, even pediatric ones.
As a precaution, Anvisa also advised that the Pfizer vaccine should not be administered concomitantly with others, even if on the children’s calendar.
Children who turn 12 years old between the first and second years should complete the cycle with the reduced dose.
Another orientation of the agency is not to use the drive-thru model in immunizing this public and that children remain at the vaccination sites for approximately 20 minutes after being immunized to monitor any adverse reaction.
Anvisa began evaluating Pfizer’s request for vaccination of children on November 16th.
To obtain authorization, the laboratory needs to conduct studies that demonstrate the relationship of safety and efficacy for a certain age group. These studies can be conducted in Brazil or in other countries.
On November 23, the agency asked for additions to the pharmaceutical documentation, which suspended the analysis period. This period was counted again on December 6th.
The agency had 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.
The assessment was carried out in collaboration with the Brazilian Society of Pulmonology and Tisiology, the Brazilian Society of Infectology, the Brazilian Society of Immunizations and the Brazilian Society of Pediatrics.​
Coronavac
In the coming days, the agency must evaluate the request of Butantan to use Coronavac in the immunization of children and adolescents aged 3 to 17 years. The request was received on Wednesday and Anvisa has 30 days to comment.
This is the laboratory’s second request to indicate the immunizing agent for this age group.
The first, presented in July, was evaluated by Anvisa and denied due to limited data from the studies presented at that time.
Developed by the Chinese laboratory Sinovac and produced in Brazil by the Butantan Institute, Coronavac has been authorized for emergency use in Brazil since January 17 this year for persons over 18 years of age.
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