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Health Minister Eduardo Pazuello said today that anyone who receives a Covid-19 vaccine who eventually only has an emergency use authorization will need to sign a consent form.
He recalled that there is no vaccine with a definitive registration in the world; in the case of the United Kingdom and the United States, for example, Pfizer / Biontech obtained an emergency authorization from regulatory agencies.
If a national or foreign laboratory requests authorization for emergency use and it is granted, we will study which groups can receive it. Limited groups in limited quantities. And everyone who volunteers to receive it will have to make that commitment in writing. “
Eduardo Pazuello
However, it was not clear how these groups mentioned by him should volunteer or if someone from the priority groups could report to the vaccination posts.
“As for the elderly and children, this is within the analysis groups that should be presented to Anvisa. There are laboratories that have not been tested in some groups, such as children. Others who have not tried the elderly. And we have to live with this situation. “One vaccine may not be authorized for children and the elderly. And another may be authorized for everyone. This shows the complexity of dealing with various types of vaccines, with 2 doses, with different technologies, with different logistics, with different temperatures,” he said .
Although the minister admits that it will be necessary to sign a term of responsibility, today, during the same press conference, the Secretary of Health and Sanitary Surveillance, Arnaldo Medeiros, stressed that the first communication phase of the vaccination plan aims to reassure the population on the effectiveness of immunizers.
Health experts point out that the need to sign a term of responsibility can generate doubts in the population and discourage vaccination. Jurists say that the mandatory term is illegal.
“Emergency use is not a vaccination campaign,” says the minister
Pazuello also clarified that when there is a definitive registration of an immunizer in Anvisa (National Health Surveillance Agency), this period will not be necessary, because the agency will have already evaluated the efficacy and safety of the product. For now, however, the deadline set by the Ministry for the start of regular – and not emergency – vaccination is February.
The authorization for emergency use is not a vaccination campaign. It is clear that it is limited to specific groups, which are volunteers. It is not a campaign to get people to get to the mail and sign a free and informed consent form. No deadline will be required at vaccination posts when we make registered and safe vaccines available through Anvisa
Eduardo Pazuello
He also recalled that so far no laboratory has requested Anvisa to request registration or authorization for emergency use in the country and has requested “responsibility” on the part of all.
“Our families need to be preserved and receive a vaccine safely, at the right time,” he said.
President Jair Bolsonaro (without a party) had already said that people will have to sign a term of responsibility to take the immunizer against covid-19. The official has questioned the effectiveness of the vaccines and has already said that he himself will not take any.
Yesterday, however, the mayor, Rodrigo Maia (DEM-RJ), said that the report of the MP (Provisional Measure) 1003/20, which deals with Brazil’s adherence to the global alliance through the equal vaccine, will not include the consent form required by the government to vaccinate the population.
* Allan Brito collaborated, in São Paulo
