Health opens this fifth public consultation on vaccination against Covid for children

The Ministry of Health will, from Thursday (23), public consultation on vaccination against Covid-19 for children aged 5 to 11, authorized by Anvisa (National Health Surveillance Agency) last week.

The consultation, whose forecast was published in the Official Gazette of the Union this Wednesday (21), will be available on the folder’s official website until January 2, “so that duly substantiated contributions can be presented.”

After that, the ministry will have three more days to decide on the adhesion of children of this age group to the PNI (National Immunization Program), according to the deadline stipulated by the Minister of Health, Marcelo Queiroga.

There is an action in the Federal Supreme Court (STF) on the subject, and the rapporteur Ricardo Lewandowski authorized the government to present the vaccination plan for the age group only on the 5th.

As one of the arguments of the AGU (Attorney-General of the Union) to postpone the presentation of the plan was precisely the public consultation, the STF minister demanded the presentation of documents by the established deadline.

In addition to the result, Lewandowski asks for the methodology used; sampling plan, indicating the people consulted and the area where the consultation is to be carried out; consultation period; control system; conference and inspection of data collection; questionnaire applied; and, of course, the result.

On Monday (20), Queiroga had said that “haste is the enemy of perfection”, and that the priority would be “safety”, when asked if it would not be possible to bring the process forward for the last few weeks of this year.

In response to a complaint by the minister about not having access to the full decision of Anvisa, the agency released this Wednesday (22) the technical opinions to release the vaccine for children.

There are two documents, one with 57 pages, the other with eight. The first, according to Anvisa, reflects the risk-benefit assessment based on technical information. The second, called the risk management plan, contains pharmacovigilance actions.

Anvisa also demanded from Pfizer the inclusion of a letter to health professionals, available on the agency’s and company’s websites, as well as the use of social networks to clarify the method of preparation and administration of the product for the pediatric population.

“It should be borne in mind that, for any drug, there is a risk associated with its use. Therefore, additional risk minimization measures may be implemented after the granting of formal registration or post-registration change, if the activities already proposed prove to be insufficient to manage security concerns,” says the document from Anvisa.

The proposal for public consultation in Health was announced over the weekend by the minister, after negative reactions from Jair Bolsonaro regarding the possibility of vaccinating children. In the weekly broadcast on Thursday, the president even said that he would disclose the names of technicians and directors at Anvisa who granted authorization for the measure.

The statement by the head of the Executive was seen as a form of intimidation by agency technicians, who, since authorizing the vaccine for children, have been receiving threats.

Like leaf showed, from last Friday (17) to this Monday (20), after Bolsonaro’s live, there were about 150 emails. “Last warning”, “popular alert”, “community with no character”, “get it wrong” are some of the terms found in these messages.

The emails were forwarded to the Federal Police (PF), which opened an investigation.

Queiroga, in turn, supported the president’s intention to expose Anvisa’s technical staff. “There is no problem in having publicity for the acts of the administration. I believe that this is even a requirement of the Constitution”, he told journalists in front of the ministry, when asked if the initiative of the president could end up influencing the threats that the technicians have Received.