Anvisa postpones release of Covid self-test and charges more ministry data

The collegiate board of Anvisa (National Health Surveillance Agency) did not approve this Wednesday (18), by 4 votes to 1, the use of Covid-19 self-test in Brazil.

The decision comes at a time when there is an explosion in demand for Covid-19 tests with the advancement of the omicron variant. Private laboratories have reported missing tests.

The reading was that the technical note from the Ministry of Health had gaps, for example, on how to notify the confirmation of infection and how to guide patients.

Last Thursday (13), the folder asked the agency to release this type of exam, which can be done at home. Its use is prohibited by a 2015 resolution.

By rule, the ministry must propose a public policy to release the delivery of exams to the lay public. The folder has already signaled that the products should not be purchased by the federal government.

The reporting director, Cristiane Rose Jourdan Gomes, was the only one who positively signaled the approval of the self-test even without a public policy on the part of the ministry.

She understood that such regulation can be edited as an exceptional measure to guarantee greater access to testing for the population, and consequently, identify, isolate and minimize the transitability of the Ômicron variant regardless of public policy action.

“Considering the pandemic context we are experiencing, the use of self-tests may represent a screening strategy, since it could quickly initiate positive cases and the necessary actions to interrupt the transmission chain. It is an additional measure that expands access testing in order to prevent the transmission of Covid along with vaccination, mask use and social distancing”, he said.

In this sense, she mentioned some measures that should be taken, such as the requirement for clear language to the public with alerts, precautions, how to carry out adequate collection and test execution. In addition to warning that the negative test would not eliminate the possibility of virus infection and the creation of a channel to serve the user.

The other directors followed the vote of director Rômison Mota. In his vote, he said that there was no formalization of the inclusion of self-testing as a public policy by the Ministry of Health. In his view, such formalization is a condition for the ban to be removed.

“Other countries that have adopted the test outside the laboratory environment, in addition to having sanitary criteria aimed at such situations, have established public policies with a view to combating the spread of the coronavirus”, said Mota.

The directors clarified that, according to the understanding of the Federal Prosecutor’s Office with Anvisa, the technical note sent by the Ministry of Health does not meet all the requirements inherent to a public policy.

As a result, the board responsible for analyzing the process had sent a request for additional clarifications to the ministry this Tuesday (18), in relation to which it is still awaiting a response.

Anvisa’s CEO, Antonio Barra Torres, added that there are several gaps to be answered. There is concern on the part of the agency, for example, about data compilation, transformation of compiled data into notification capable of generating all the necessary statistical treatment.

Anvisa technicians had been signaling that the self-test would be approved shortly after the Ministry of Health proposed a public policy.

The idea was to release the resolution before voting on the board and, then, just endorse the text.

But the technicians considered the technical note of Saúde precarious. On Tuesday, directors shared uncertainties about the text. One of the ideas was to try to release the product anyway, while charging more data to consolidate the rules later.

Hours before the meeting this Wednesday (19) most directors aligned a more conservative decision, to postpone the release of the exam and charge more data.

Behind the scenes, agency technicians point out that the ministry acted with disdain when sending a proposal considered fragile. They still claim that Health was unable to put together an effective national testing strategy almost two years after the beginning of the pandemic in Brazil.

Already members of Health assess that Anvisa acted with excessive caution and was not sensitive to the health crisis.

The Minister of Health, Marcelo Queiroga, said that he will comment on the charge made by Anvisa when he has access to the entire content of the decision.

“I have not yet had access to the full content of this charge. Once we have access, we will manifest in a timely manner and through the appropriate channels. The position of the Ministry of Health on the self-test is clear, as is everything here in the government of President Jair Bolsonaro. We have already expressed ourselves in favor of selling self-tests in pharmacies,” he said.

“In relation to public policy, the policy is tests in primary care. And we are distributing tests to municipalities so that they can carry out tests in primary care”, he added, after signing an ordinance that releases R$ 104 million to municipalities affected by the rains. in Bahia.

The decision to postpone the entry of the self-test occurs at the time of dispute between Anvisa and the government. Previously an ally of Jair Bolsonaro (PL), the head of the agency, Antonio Barra Torres, joined the president’s disaffected list by leading decisions such as the endorsement of children’s vaccination.

Testing in Brazil is centered on clinics, pharmacies and public services, which are not able to meet the demand due to the circulation of the Ômicron.

Scientific bodies last week called for a broader testing policy from the federal government and the permission to test at home. The demand for tests soared with the advance of contamination at the turn of the year.

Minister Marcelo Queiroga said that the self-test can relieve health units, but said that the purchase of the product for the SUS may not have the desired effect.

“Brazil is a very heterogeneous country, with many contrasts. The allocation of this resource for acquiring self-tests, distributing them to the general population, may not have resulted in the public policy that we expect”, said the minister on the 14th.

Like leaf showed, the executive president of CBDL (Brazilian Chamber of Laboratory Diagnosis), Carlos Gouvêa said that self-tests should be cheaper than over-the-counter antigen tests.

He estimates that the industry installed in Brazil has the capacity to produce up to 10 million Covid self-tests per month.

This Thursday (20), Anvisa will evaluate the request of the Butantan Institute on the application of doses of Coronavac in the public from 3 to 17 years.

The Ministry of Health is considering using Coronavac in children, if approved. As the vaccine is of the same model applied to adults, states are already planning to allocate stocked doses to the younger public.

So far, only the Pfizer vaccine is approved by Anvisa to be applied to children aged 5 to 11 years. The children’s vaccination campaign was opened last Friday (14). The first immunized was Davi Seremramiwe Xavante, an 8-year-old indigenous boy.