House bars consent term for those vaccinated against covid-19



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BRASILIA – The Chamber of Deputies concluded the vote on Provisional Measure 1003/2020, which released R $ 2.5 billion to finance Brazil’s participation in the Covax Facility, a program coordinated by the World Health Organization (WHO) to drive development and warranty. the purchase of vaccines against covid-19. The text was approved symbolically and is now being analyzed by the Senate.

Contrary to what the government wanted, the deputies not only rejected the inclusion of a term of responsibility or consent for those who agreed to take the vaccine, but also approved the dispensation of the document. Parliamentarians assessed that it could discourage adherence to vaccination.

“It was a request from the government for us. We tried to move forward, but we had a lot of resistance, ”said the rapporteur, deputy Geninho Zuliani (DEM-SP).

The amendment to the term was proposed by Cidadania and approved by 235 votes to 150. In justification of the proposal, Deputy Carmen Zanotto (Cidadania-SC) pointed out that it is the responsibility of the National Health Surveillance Agency (Anvisa) to evaluate the safety and efficacy vaccine, as well as good manufacturing practices, pharmacovigilance and biotechnology.

“As our Health Agency, before approving emergency use, already analyzes these safety and efficacy data demonstrated in preliminary studies and clinical trials in humans already published, we do not see how productive it is that the population to be vaccinated must sign an informed consent form Term of free and informed consent ”, says the amendment.

The proposal establishes that the National Health Surveillance Agency (Anvisa) must grant a temporary authorization for emergency use for the importation, distribution and use of any vaccine against the new coronavirus.

The agency will have five days, from registration, to grant or deny approval of the applications, provided that the vaccine in question has already been approved by at least one of the international health authorities of the US, European Union, Japan. , China, Canada, United Kingdom. Kingdom, South Korea, Russia and Argentina. The term is shorter than the one announced by the regulator on Monday 14 of ten days.

The text also requires the immediate publication of technical studies that support decisions for or against the acquisition of vaccines after its conclusion.

Officially called the Covid-19 Global Access Instrument for Vaccines, the alliance brings together more than 150 countries among those that have formally joined or confirmed their interest. The intention is that all members have equal access to the nine vaccines that are in development and others that are under analysis.

Membership in the consortium will allow the government to negotiate access to doses, delivery times and prices with manufacturers. However, there is no obligation to purchase. The model states that purchases can be made without bidding. The consortium is expected to release two billion doses by the end of next year.



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