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The National Health Surveillance Agency (Anvisa) published on Wednesday (2) criteria for a special modality of emergency authorization of vaccines against COVID-19 in charactersea experimental. This simplified mode seathere are fewer requirements than registries for other drugs and treatments, but the agency has stated that safety requirements will be ensured.
A special permit can be granted for vaccines that are being studied in Brazil in the so-called Phase 3, in which efficacy and safety are analyzed. In this case, the vaccines will be destined for government programs and cannot be marketed by the companies that obtained the permit.
The authorization will be temporary and will only cover specific audiences and may not be made available to the general public. The emergency authorization will only remain as an alternative for the duration of what Anvisa called “a well-established emergency situation.”
“There were exceptional import authorizations, but the emergency use authorization was created based on the specific problem of the covid-19 pandemic. This discussion is in line with international best practices. The World Health Organization has published specific rules for this modality ”, affirmed the general manager of Medicines and Biological Products of Anvisa, Gustavo Mendes.
Criteria
Only companies that are developing vaccines may request authorization from Anvisa. The ability to manufacture or import the substance must be demonstrated.
Companies interested in such an alternative must first meet with the Anvisa team, which is called “pre-shipment”, and will require information from the applicant that serves as a way to help in the analysis.
It will also be necessary now sea Anvisa approved a clinical development dossier. This occurs in the case of vaccines being tested in Brazil, whose studies have already been disseminated, which implies the sending of information that demonstrates an adequate safety profile and addresses the commitment to the continuity of clinical trials.
Evaluation
To date, no pharmaceutical or research center has requested the registration or emergency authorization of vaccines against COVID-19. In the case of requirements that can be made, the Anvisa team will evaluate a series of aspects.
Since the authorization will be limited to a specific audience, Anvisa will analyze the relationship between risks and benefits of the vaccine for this population group, which includes the rate of effectiveness and adverse effects. “As they are drugs that will generate complementary data, it may be that the risk benefit will change. The possibility of being revoked must be very clear, ”said Gustavo Mendes.
One of the aspects evaluated involves the levels of effectiveness and safety. The coordinator responsible for the area in the agency highlighted that the international debate has been considering levels around 50%.
The technologies used, manufacturing procedures, expiration date, storage conditions and how long the vaccine will work after thawing will also be considered in the analysis.
The general coordinator of the Anvisa vaccines area added that the evaluation will also take into account what he called “good manufacturing practices”, where the doses will be manufactured and what are the procedures to train personnel to comply with the quality parameters. .
Also part of the analyzed aspects is what the agency calls “pharmacovigilance”, the monitoring of the development of the vaccine, the duration of immunity and the completion of data so that the company can eventually request a registration.
Obligations
Once the emergency authorization is obtained, companies are subject to a series of obligations. The responsibility for the quality of the vaccine while in storage rests with the manufacturer and must be respected.
They must clearly state on the label that it is an experimental substance. Another requirement is the monitoring of possible adverse events. And the pharmaceutical company can sea authorization revoked at any time.
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