Anvisa (National Health Surveillance Agency) reported this Thursday (12) that it approved the extension for another year of the rule that allows the emergency use of vaccines and medicines for Covid-19. Among the immunizers used in the country, Coronavac is the only one with approval for emergency use only.
“The main objective of the measure is not to impact the supply of vaccines and medicines against Covid-19 to the Brazilian population. The review was necessary since, as a result of the end of the Public Health Emergency of National Importance (Espin), declared by the Ministry of Health, by Ordinance 913/2022, the AUEs would automatically lose their validity”, informed the agency.
The rapporteur of the matter, director Meiruze Freitas, highlighted that, despite the announcement of the end of Espin, there is a real need for strategic regulatory tools that allow maintaining and expanding access to medicines and vaccines used in the fight against Covid-19.
“It is true that there is still a need for strict regulatory monitoring and the regular availability of products and services of health interest used in actions to combat Covid-19, with emphasis on the development of new medicines and vaccines.”
In April, Anvisa announced that it would review all sanitary acts issued in response to the pandemic, including resolutions dealing with the emergency use of vaccines and specific medicines for the disease. The measure would affect the export, domestic manufacturing, distribution and application of Coronavac in the country.
According to a resolution published in December 2020, the authorization for the emergency and temporary use of the Chinese immunizer will be valid until the Ministry of Health recognizes that there is no longer a public health emergency.
According to the Butantan Institute, studies on the immunizing agent continue.
“The issue of definitive registration is in progress with the supply of documents. There is a pendency in relation to some tests that are carried out in China and here in Brazil also in relation to the ômicron variant”, said the director of Butantan, Dimas Covas.
Pfizer, Janssen and AstraZeneca have definitive records.
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