Anvisa approves measures to accelerate the registration of the vaccine against Covid-19 in Brazil | Vaccine

A rule published on Wednesday (18) in the Official Gazette of the Federation authorizes that companies interested in registering a vaccine send technical data about the tests continuously. With the measure, companies will not need to have all the documents gathered to present them at once to Anvisa, as is often the case (see details below).

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The proposal that contemplated this possibility had already been released by the agency on September 29. Two days later, on October 1, Anvisa announced that it would begin the analysis of the Oxford vaccine trials, developed in partnership with the pharmaceutical company AstraZeneca, under the continuous submission process.

With the adoption of the measure, the agency’s executives also renounced the regulatory impact analysis and public consultation, “due to the degree of urgency and severity” of the pandemic.

Measures They only apply to Covid-19 vaccines and do not apply to any other drug or vaccine. Immunizers must also be in phase 3 clinical trials – like the four that are being tested in Brazil: Oxford, Pfizer, Sinovac and Johnson.

Another prerequisite for sending the data on a continuous basis is that the interested company has a Clinical Drug Development Dossier (DDCM) submitted to Anvisa. The dossier is a set of documents that provide detailed information about the vaccine and about the phase 1, 2 and 3 clinical studies.

How ‘continuous delivery’ works:

• Normally, for the registration of a drug or vaccine, agencies require all studies and information on safety, efficacy and content at the same time.
• As the world goes through a pandemic, continuous presentation allows Anvisa technicians to start analyzing what is ready: initial study results and other data, such as those related to expiration date and proper storage conditions, for example.
• Then the documents are eventually sent to the agency. All data must be analyzed, with the difference that the process begins earlier and in stages.

On Tuesday (17), the governor of São Paulo, João Doria (PSDB), said in an interview with “Rádio Jornal”, from Pernambuco, that the first doses of the vaccine from the Chinese laboratory Sinovac, the “CoronaVac”, would reach the Brazil on Thursday (19). Last week, Doria had said that the doses would arrive on Friday (20).

Anvisa even suspended CoronaVac tests last week, following the death of a volunteer. Two days later, however, he authorized the resumption of the trials. (Please understand suspension).

The announcements about the regulation of vaccines and the delivery of doses come at a time when Brazil has high in the moving average of deaths from Covid-19. Cases and deaths from the disease had the biggest upward trend since May.

Also on Tuesday (17), the weekly report published by Imperial College London noted that the transmission rate of Covid-19 in the country is 1.10, the highest rate since August.

The previous week, the number had been 0.68, the lowest since the start of the pandemic. The period, however, was the same period in which there was a data blackout at the Ministry of Health, which affected the publication of data on Covid-19 cases and deaths.

Stages of testing a vaccine

When testing a vaccine, usually divided into phases 1, 2 and 3, scientists try to identify serious adverse effects and whether the immunization was able to induce an immune response, that is, a response from the body’s defense system.

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Phase 1 trials generally involve dozens of volunteers; those of phase 2, hundreds; and phase 3, thousands. These phases are generally carried out separately, but due to the urgency of finding an immunization for Covid-19, several companies have taken more than one step at the same time.

Before testing in humans, vaccines are tested on animals, usually mice and then monkeys.

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