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The only servant among the main directors of the National Sanitary Surveillance Agency (Anvisa), the pharmacist Meiruze Sousa Freitas assumed command of the area that deals with vaccine records in December.
In the first interview in the publication, she denies that the agency is a barrier to start immunization against covid-19 in the country and points out that the companies lack data on their investigations. “In the regulatory aspect, (to anticipate the arrival of the vaccine) companies need to bring the data for the evaluation of Anvisa. We have rules similar to those of the world. There is no obstacle here to evaluate the use or emergency registration.”
Meiruze avoids setting a date for an immunizer to be released in the country and reinforces that the perspective is to approve registration requests as soon as possible. “There is no reason to think that Anvisa is against the vaccine,” he told the Status.
What is missing for a vaccine to arrive in the country?
Regarding regulatory action, we have acted like the rest of the world, with flexibility, the possibility of receiving partial data and emergency use. We understand that it was important for Brazil to have this option to make vaccines available even if they were in the development phase. Anvisa’s role is to offer quality vaccines to the public and private sectors. We are not part of the acquisition process. On the regulatory side, companies still need to bring the data for the Anvisa evaluation. We have rules similar to those of the world. There is no obstacle here to evaluate use or emergency registration.
Pfizer noted that the rules required in Brazil are different from those in the rest of the world.
Regarding Pfizer’s knowledge of the guide (for emergency use requests), the document provides guidance, but the most important are the guidelines for the quality, efficacy, and safety of the vaccine. It is similar to the main countries. I know that everyone is speeding up and sometimes there is difficulty in interpreting, knowing and having confusing information. Why did Anvisa request a quantity of vaccine? It has nothing to do with the government takeover. I need to know, because when I get to the airport, I need to do a quick customs clearance. The vaccine has specific storage conditions. Pfizer was clear that it had nothing to do with the acquisition. But the heart of the guide is the requirements for quality, safety and efficacy. If the company is able to justify, (“I have another approach”), and demonstrate that the benefit outweighs the risks, it does not block the evaluation or authorization (the lack of documents mentioned in the guide). This was clear to all companies. If there was fog in this process, in my opinion, it cleared up. Our communications may not have been the most appropriate, but there is always the opportunity for improvement.
The Ministry of Health talks about starting the vaccination even on January 20. Its viable?
It will depend on the request. Let’s think about the best scenario. If it arrives on January 3 (for emergency use), we expect to have a decision on January 13. Vaccination screening would be possible. Only when I have the request could I say better. Continuous submission data (mode in which the company submits research data as it is completed) will be used in the emergency use assessment. There will be no reworking. There is also an assessment from other authorities. We work to meet the 10-day deadline. It can be done even in less time.
Can the final record analysis be done before the agency’s 60-day limit, considering that the pharmacists have already submitted the vaccine data?
This 60-day number was very pragmatic. It was in context without preliminary data evaluation. Our perspective is for a much shorter term, considering the evaluations already carried out by Anvisa and other authorities. We are working on it. I can’t tell you the exact date.
There is a law that imposes a period of 72 hours for the analysis of the importation of products by covid-19 that are registered in the main agencies of the world. Do you consider a reasonable time?
As a technician, and knowing the vaccine development process, I always give priority to the evaluation of Anvisa. There are particularities that Brazil must take into account, such as the packaging and the stability of the product. And if the studies carried out are compatible with our population. No country performs automatic approval. It does not mean that we will deal with the slowness. The law speaks of authorizing the import and distribution, but not the registration of the product. The strategy of the law is welcome in the pandemic. It was edited to increase access and avoid shortages. The vaccine has greater complexity, technology involved, very high risks. It seems to me that companies are betting a lot on the security of the authorization of the health authority. In 72 hours, nowhere in the world can rate a product as safe and effective.
Can Anvisa free up the emergency use of vaccines from the analysis of as yet unpublished data, as the UK did with the Oxford immunizer?
We organized a meeting with UK officials to understand what considerations were made. It is not necessary to publish the study. You must evaluate what data has been presented.
Is Anvisa hampered by the political fight for vaccines? Have you become a ‘scapegoat’ because we are not vaccinating yet?
What we have done, in the technical field, is to get away from this discussion so that it does not contaminate us. Sometimes people say, “We are being so dumb, posed as a problem.” It even makes you want to say: “The problem is not Anvisa. Does Brazil prefer not to have regulatory regulations?” But we have to work internally. It is an agenda that is not ours. As much as everyone is in a hurry, even in the United States, with a pandemic even bigger than ours, we did not see the country weaken its regulatory authority. On the contrary. But I would say that even on the topic of Butantã (which had Coronavac tests interrupted after the death of a volunteer), an extremely important institute, we had a good conversation. There were times when the dialogue may have been lost. If so, there is no reason. We speak, within regulatory science. We stayed a bit on the bench, but the name “Anvisa” has never been better known. The balance of all this will be positive. There is no reason to think that Anvisa is against the vaccine.
