On Thursday 13th, a group made up of 45 health professionals, including infectologists, cardiologists and immunologists, sent a request for information addressed to the President of the Republic, Jair Bolsonaro, and to various authorities, such as the Comptroller General of the Union, the Attorney General of the Public Ministry, the Ministry of Health and the Federal Council of Medicine, asking for action in relation to alleged failures in the registration of approval of the vaccine against covid-19 for children from 5 years old by the National Health Surveillance Agency ( Anvisa).
As soon as Anvisa authorized childhood vaccination, on December 16, the same group of doctors had already forwarded a document to Anvisa entitled “Questions on vaccination of Brazilian children — 45 doctors”. In response, the regulatory agency issued a technical note, and provided clarifications to professionals.
For the doctors, however, the “document prepared by Anvisa caused indignation in the face of the amount of untruths declared”. Therefore, the group prepared a new request with more than 300 pages gathering studies, research and bibliographic references, for the authorities to investigate possible irregularities and for Anvisa to provide further explanations. The document can be read in full here.
Authorization of vaccines by Anvisa
In the doctors’ assessment, the vaccines against covid-19 being applied in Brazil are still of an “experimental nature”, since the studies have not been fully completed.
The document explains that there are four phases of clinical research to develop a vaccine. In Brazil, according to the paperwork, all vaccines against covid approved by Anvisa are in phase 3, which must still be complemented by phase 4, whose most important objective is “to detect and define previously unknown or incompletely qualified side effects, as well as the related risk factors. This phase is known as Pharmacovigilance.
Thus, because they did not fully complete the third phase of the studies, not even the vaccines that managed to obtain definitive registration at Anvisa, such as those from Pfizer and AstraZeneca, “have ceased to be experimental drugs only as a result of registration, a since they are still undergoing Phase III of the respective scientific studies”, defend the doctors.
However, in a technical note published in December, Anvisa reported that “the vaccines against covid-19 authorized in Brazil are not experimental, having all completed the stages of full clinical development”.
Professionals refute Anvisa’s statement: “How can Anvisa claim, therefore, that the product is not experimental and that the safety and efficacy are already proven, if the ‘definitive’ sanitary registration was granted under the condition that the company would have until January 2024 to complete the studies and prove the safety and efficacy of Cominarty/Pfizer?”
In the case of Pfizer’s pediatric vaccine, the document also questions the fact that Anvisa authorized the pharmaceutical company’s request without “a new drug registration being carried out to cover the age group from 5 to 11 years, since even the formulas of the products were totally different”.
Doctors also contest the VigiMed — the system used today by Anvisa to report cases of adverse drug reactions, including vaccines against covid-19. According to the document, the Vigimed data have several inconsistencies, in addition to the difficulty in submitting information to the system.
requirements
Finally, the group asks for an investigation of the facts pointed out in the document and the initiation of a procedure so that:
- Anvisa is compelled to immediately annul the administrative act that authorized the “definitive” registration of Cominarty/Pfizer for the age groups from 5 to 11 years old and from 12 to 15 years old;
- Investigate criminally and administratively any errors made in the vaccination of children and adolescents so far;
- Determine that there is compulsory notification of adverse events related to the vaccination of children, adolescents and pregnant women;
- Expertise is carried out on Pfizer vaccines with orange, gray and purple labels, so that the full composition of the products is investigated after the fifteen changes in leaflets authorized by Anvisa;
- The competent authorities determine that at least three samples of each of the current vaccines against covid-19, from different batches, be audited by independent laboratories.
See more:
