Use of vaccines and medicines will be affected by the end of emergency against Covid; Anvisa evaluates deadlines | coronavirus

The National Health Surveillance Agency (Anvisa) announced this Monday (18) that it is reviewing health regulations in response to the Covid-19 pandemic, including resolutions dealing with the emergency use of vaccines and specific drugs to treat the disease.

Among the immunizers in use in the country, CoronaVac is the only one with approval for emergency use only. PFizer, Janssen and AstraZeneca have already obtained the definitive registration.

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Last Sunday, the Ministry of Health asked the agency to authorize the maintenance, for up to one year, of the emergency use of some products to combat Covid-19, such as the immunizer produced by the Butantan Institute.

The measure follows the announcement of the federal government’s decision to decree the end of the public health emergency related to Covid-19 in Brazil.

'A pandemic is not extinguished by the abolition of a decree', says director of the Butantan Institute

‘A pandemic is not extinguished by the abolition of a decree’, says director of the Butantan Institute

According to the agency, the ministry’s request is that the validity of the regulations be maintained for one year from the moment of withdrawal from the state of health emergency, but this still depends on a decision by the Collegiate Board, the highest body of the regulatory entity.

“(…) If approved, (the extension) should allow vaccines and medicines in emergency use to continue in use for this period”, informed Anvisa.

The agency also highlighted the importance of vaccination in the country to combat Covid-19 and stressed that current rates “are still low”, despite advances in recent months.

“Anvisa highlights that vaccination against Covid-19 must continue in progress and that the booster dose must be applied to the indicated audiences”, he said, in a note.

In view of the emergence of new variants of SARS-CoV-2, the virus that causes the disease, Anvisa also said that the current moment of the pandemic in the country requires that epidemiological surveillance on the disease continues through testing and mapping programs. virus genomics. In early April, Brazil registered the first case of the XE omicron, a recombination of the BA.1 and BA.2 sublines of the coronavirus variant.

Health professional with CoronaVac vaccine vial in Porto Alegre. — Photo: Leonardo Rosito/PMPA

What changes with the end of the status?

The status of “Public Health Emergency of National Importance” (Espin) came into effect in February 2020. The rule allowed the federal government and state and municipal governments to take a series of measures, such as the mandatory use of masks and the emergency authorization for vaccines.

The sanitary measure was created to reduce bureaucracy for temporary hiring of health professionals, acquisition of goods and contracting of services. With it, the exemption of bidding was foreseen and the importation of products without registration in the National Agency of Sanitary Surveillance (Anvisa) was authorized.

Among the rules that could be affected with the end of the state of “national health emergency” are, for example, the use of masks, teleworking, and the regulation of telemedicine.

TV Globo found that, with a new ordinance, the government can establish a period, from 30 to 90 days, for public bodies to adapt. That is, the rules in force today would not immediately lose their validity. And some could be extended.

What does the Ministry of Health say?

Health Minister Marcelo Queiroga said this Monday (18) that “no public policy will be interrupted”, after being asked at a press conference in Brasília by reporter Raquel Porto Alegre, from Globo News, about the number of regulations that should fall. with the end of the emergency in the country.

“No public policy will be interrupted, because these public policies have worked. (…) In a winning team, it doesn’t change. So we will keep these public policies at the disposal of Brazilian society”, said the minister.

Queiroga says that no public health policy will be interrupted

Queiroga says that no public health policy will be interrupted

At the press conference, the executive secretary of the Ministry of Health, Rodrigo Cruz, also said that more than 170 ordinances that could be impacted with the end of the status, covering everything from the use of vaccines to issues such as telemedicine and the transfer of specific financial resources to face the pandemic.

Cruz also said that the pandemic had not only health implications, but also social ones, and that, therefore, the Ministry of Health is considering adopting “predictability” so that normative acts based on emergency status that need to continue can be adjusted.

“To make it clear: Decree 7616 [sobre a declaração do status] sets out the requirements for the Minister of Health to declare Espin [Emergência em Saúde Pública de Importância Naciona]. Once these requirements are met, it is also up to the Minister of Health to declare the completion of this Espin”.

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