Anvisa does not participate in the public hearing on vaccination against Covid-19 for children aged 5 to 11, which the Ministry of Health promotes this Tuesday (4).
In an official letter sent by the office of the director-president of Anvisa, Antonio Barra Torres, to the secretary of Combating Covid-19, Rosana Leite de Melo, the regulatory agency argues that it has already approved vaccination for this age group on December 16th.
The document also points out that the approval took place after “a careful technical analysis of data and clinical studies”, which attested to the safety and efficacy of Pfizer’s immunizing agent for children.
“For the evaluation of the expansion of the age range of this vaccine, the Agency counted on the consultation and monitoring of a group of specialists in pediatrics and immunology, who had access to data from the studies and results presented by the laboratory”, writes the official letter signed by the chief Cabinet of the CEO of Anvisa, Karin Schuck.
Among the experts highlighted by Anvisa are the Brazilian Association of Public Health (Abrasco), Brazilian Society of Pulmonology and Phthisiology (SBPT), Brazilian Society of Infectious Diseases (SBI), Brazilian Society of Immunology (SBI) and Brazilian Society of Pediatrics (SBP) .
Anvisa also argues that the Ministry of Health received, on December 22, the full approval process for vaccination, with the scientific references used.
“Finally, Anvisa, due to its technical nature, sees that its participation in the Public Hearing would not add new elements to the theme”, concludes the letter.
public hearing
The government discusses, this Tuesday (4), vaccination for children between 5 and 11 years old in a public hearing with people in the health area called by the Ministry of Health.
The discussion about the release of the vaccine against Covid-19 for children had already been made by the Health Surveillance Agency (Anvisa) during the approval process of Pfizer’s childhood immunizer for emergency use last month, when the agency consulted 1,600 people.
Faced with the approval of Anvisa, the Ministry of Health said, however, that it would release vaccination for children only upon the presentation of a medical request.
In an interview this Tuesday morning (4), the Minister of Health Marcelo Queiroga contested the qualification of specialists consulted by Anvisa in the approval of childhood immunization.
The Ministry had already opened a public consultation between December 21 and January 2 to gather information from the broad public on the inclusion of children in the National Immunization Plan (PNI).
With the public consultation closed, the government has not yet released data on the numbers of participants, opinions issued, or whether the information collected will be used in the deliberation of childhood vaccines.
“To base a technical decision on public consultation would be regrettable”
In an interview with CNN on Tuesday (4), the pediatrician and director of the Brazilian Society of Immunizations (SBIm), Renato Kfouri, said that the public hearing should not bring anything new to the discussion about childhood vaccination.
He highlighted the originality of the position adopted by the Ministry of Health in seeking the opinion of the population in relation to a technical issue.
“Listening to parents and families is always interesting to know what the population thinks. But for that you need to order a survey to ensure representation of states, economic classes, age groups”, he pointed out.
“Eventually it could even guide an awareness campaign to inform, but not decision making. It would be very regrettable for the Ministry of Health to base itself on the opinion of lay people when making a technical decision on vaccination”, he added.
Renato Kfouri considers “incomprehensible” the Ministry’s decision to open the discussion of childhood vaccination for public consultation.
Reference: CNN Brasil
