In an unusual move, to define the inclusion of the age group in the immunization campaign, the Ministry of Health carries out, starting this Thursday (23), a public consultation that will be available until January 2, 2022. Contributions must be sent online, however, the site was down this afternoon.
The documentation related to the public consultation must be available on the page, as published in the Official Gazette of the Union on Wednesday (22).
In a note sent to CNN, the Ministry of Health informed that the public consultation website is undergoing revision and will be made available later today, according to the publication in the Official Gazette.
After the end of the consultation, the contributions presented will be subject to a public hearing scheduled for January 4th. The next day, the folder must announce the decision.
The National Health Surveillance Agency (Anvisa) authorized the use of Pfizer’s vaccine against Covid-19 in children aged 5 to 11 years in Brazil on December 16th. The decision was announced after carrying out a technical evaluation of the request submitted by the pharmaceutical company on November 12th.
The arrival of the immunizing agent at health centers depends on the schedule and logistics of the National Immunization Program (PNI), of the Ministry of Health, responsible for coordinating the distribution of vaccines in Brazil.
The vaccine for this age group has a different dosage and formulation than the immunizing agent applied to people over 12 years of age. According to Pfizer, the bottles are differentiated by color, being purple for adults and teenagers and orange for children.
Anvisa’s approval allows Pfizer to market, distribute and make the vaccine available for use in the country for the new age group.
On Wednesday (22), Anvisa sent the Ministry of Health the full process of the public notice of approval of the vaccine for children, which contains the scientific references used to support the decision. The letter was made available by the agency (read here).
The agency also made public two documents about the process, the public opinion on the evaluation of medicines (PPAM) and the Technical Opinion PGR (risk management plan).
Even so, the ministry decided to submit the decision to this public consultation. The details of the actions were explained by the Minister of Health, Marcelo Queiroga, in a press interview held on Saturday (18), with the participation of the Attorney General of the Union, Bruno Bianco.
On the occasion, Queiroga said that the Anvisa assessment is focused on verifying issues related to the safety and effectiveness of the immunizing agent in the context studied and presented by the pharmaceutical industry.
In a statement from the folder, the minister said, however, that authorization by Anvisa does not imply automatic incorporation of the vaccine into the PNI.
“They are different assessments. At Anvisa, it is the ticket to enter the validation perspective. The final decision is up to the Ministry of Health and we take the decisions in a timely manner and we will evaluate the agency’s decision in detail”, he said.
Definition of public consultation by the Ministry of Health
The Ministry of Health defines that public consultations aim to “promote dialogue between the public administration and the citizen, in compliance with the Principles of Legality, Morality, Efficiency, Publicity, Transparency and Motivation”.
According to the folder, consultation is defined as a mechanism for social participation, of a consultative nature, carried out for a defined period and open to any interested party, with the objective of receiving contributions on a certain subject.
The practice, according to the ministry, encourages the participation of society in decision-making related to the formulation and definition of public policies.
Sanitarist Gonzalo Vecina, professor at the Faculty of Public Health at the University of São Paulo (USP) and former director of the National Health Surveillance Agency (Anvisa), explains that public consultations are important instruments for defining public policies.
However, in the researcher’s opinion, public consultation should be used in contexts that involve controversies. For him, carrying out the vaccination scenario is an unnecessary measure.
“This type of instrument is very important for making decisions in contexts of disputes. There is no use of public consultation to make a decision that has no controversy. The decision on whether to vaccinate or not to vaccinate is not a matter for public consultation, but for the opinion of technicians”, said Vecina.
The researcher believes that, given a scenario in which the Ministry of Health may oppose the vaccination of the age group from 5 to 11 years against Covid-19, the folder will have to support the arguments to be presented to the Supreme Court (STF). ).
On Monday (20), Minister Ricardo Lewandowski, of the STF, responded to a request from the Attorney General of the Union (AGU) and extended the deadline for the federal government to provide a plan for the immunization of children until the 5th. of January.
“On January 5th, the Ministry of Health will have to submit its opinion to the Supreme Court, which will make its final decision. If the ministry says no to vaccination, it will have to substantiate this position and we know that there is no substance to say no”, said the sanitarist.
Approvals in the United States and Europe
The Food and Drug Administration (FDA), an agency similar to Anvisa in the United States, approved the use of Pfizer’s vaccine for children aged 5 to 11 years on October 29th. According to the FDA, the decision was made based on the analysis of data from an independent expert committee on the safety and efficacy of the product in this public.
The tests showed an effectiveness in children of 90.7%, similar to that found in the range of 16 to 25 years. The study, which analyzed 3,100 children in this age group who received doses of the Pfizer vaccine, did not identify serious side effects.
The American Academy of Pediatrics (AAP) recommends Covid-19 vaccination for all children and adolescents aged 5 years and older who do not have contraindications.
As of December 15, the US Centers for Disease Control and Prevention (CDC) reported that 5.6 million children in the country, aged between 5 and 11, had received at least one dose of the vaccine. The index represents 20% of that population in the United States.
The European Medicines Agency (EMA) has also approved the use of the immunizer against Covid-19 in children. The decision was announced on November 25th.
“The most frequent adverse effects in children aged 5 to 11 years are similar to those in people aged 12 and over. They include pain at the injection site, tiredness, headache, redness and swelling at the injection site, muscle aches and chills. These effects are generally mild or moderate and improve a few days after vaccination”, says the statement from the European agency.
Public health experts reinforced the need for vaccination of children
To clarify the main doubts about the vaccination against Covid-19 of children from 5 to 11 years old in the country, the CNN interviewed doctors Esper Kallás, Ludhmila Hajjar and Roberto Kalil Filho.
Experts were unanimous in indicating that the immunization of this age group against the disease should be started as soon as possible.
“We are facing a scenario in which we already have enough scientific studies to demonstrate the safety and efficacy of vaccinating the pediatric population. We already have the opinion of Anvisa and I think that now we are only facing the operationalization of this for the coming weeks and months”, said cardiologist Ludhmila Hajjar, professor at the Faculty of Medicine of the University of São Paulo (USP) and head of the Covid ICU. 19 of the Hospital das Clínicas.
Cardiologist Roberto Kalil Filho, presenter of the program CNN Vital Signs and a professor at the Faculty of Medicine at USP, he pointed out that the widespread structure of the Unified Health System (SUS) in the country will allow for accelerated vaccination of the child population.
“It is necessary to speed up vaccination in children and adults. Remember that the entire population is not vaccinated yet. Brazil’s vaccination system is one of the best in the world, it is a capillary system. As long as you have the vaccines, as we do, the population is easily vaccinated”, said Kalil.
For the cardiologist, the approval of Anvisa is the necessary subsidy for the immunization of children aged 5 to 11 years, which, according to him, should be started as soon as possible. “Vaccination does not have to be delayed. The science is there, it has to be vaccinated. Any bureaucratization around this issue could lead to serious consequences”, he said.
clash and threats
Since October, Anvisa has been the target of threats from people against the vaccination of children against Covid-19.
The Federal District Attorney’s Office denounced to the Federal Court the man accused of sending threats, in October, to the agency’s directors.
According to information from the policy analyst at CNN, Caio Junqueira, Anvisa received more than 130 emails with threats to its servers due to authorization for childhood vaccination.
Among the messages, there are e-mails that mention “last warning” to servers and speak of technicians’ “blood-stained hands”.
In an interview with CNN, the general manager of Anvisa, Gustavo Mendes, repudiated the attacks made on technicians from the agency after the approval of vaccination against Covid-19 in children, and reinforced the rigidity and seriousness of the evaluation of immunization agents made by the team.
“Our work is technical and we are very sure of our decision; all the data were widely discussed”, stated Mendes.
On Friday (17), Anvisa published a note in response to statements by President Jair Bolsonaro live made on Thursday (16).
In the live broadcast, Bolsonaro said that he asked for the names of the members of the agency who approved the authorization for the use of Pfizer’s vaccine in children aged 5 to 11 years in Brazil, so that they can be disclosed.
“Anvisa is not subordinate to me, let’s make this very clear, I don’t interfere there, but I asked unofficially for the name of the person who authorized the vaccine for children aged five years and over. We want to publicize the names of these people so that everyone can know who they are and form their judgment,” said the president.
In response, Anvisa informed that “its work environment is free from internal pressures and averse to external pressures”.
Reference: CNN Brasil