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The National Health Surveillance Agency (Anvisa) changed two points on Tuesday (29) regarding the minimum requirements for requests for authorization of the emergency use of vaccines against coronavirus.
The old rule required the presentation of a vaccine distribution schedule specific to Brazil and required precise information on the quantity of finished product available for purchase. However, the set of standards has been criticized by Pfizer.
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According to the multinational, the required points “can only be defined when the definitive contract is signed.” Not surprisingly, the pharmaceutical company announced that it will not request the emergency use of its vaccine in Brazil.
Now, with the changes made by Anvisa, only “information on the forecast of the quantity of finished product available for import and / or availability” is necessary, “said the organ’s note.
The other modified point refers to the Free and Informed Consent Form that will be prepared with the specific data of the vaccine that is intended to be authorized for emergency use.
Anvisa also included a suggestion in the new regulations to adopt the simple model made available in the United Kingdom and added to the new wording of Guide 42/2020 that “another model developed by the company” could be used, in this case, those responsible of vaccines.
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Fiocruz will request the emergency use of the Oxford vaccine
This Wednesday (30), Anvisa reported that the Oswaldo Cruz Foundation (Fiocruz), a partner of AstraZeneca, will request authorization for the emergency use of the Oxford vaccine, but did not provide an assertive date.
This Wednesday a meeting took place between the senior management of the agency and representatives of AstraZeneca – responsible for the vaccine – and, according to Anvisa, the laboratory said that there are no regulatory complications to comply with the measures imposed for the use of the immunizer in Brazil.
According to the National Health Surveillance Agency, the deadline to analyze the emergency use of the vaccine is 10 days from the date of the formal request to the agency. But depending on the situation, the period can be even shorter.
“This period [de 10 dias de análise] it may be less, depending on the amount of information packages already delivered by the laboratory to Anvisa within the Continuous Shipping process, ”Anvisa reported.
After the Oxford vaccine was approved in the UK, AstraZeneca continues to seek registration in Brazil as well.
Almost there
Also on Wednesday, the president of Fiocruz, Nísia Trindade, announced that the institute should receive the pharmaceutical ingredient necessary for the production of the vaccine in January.
With that, Fiocruz will begin to manufacture the immunizer. However, the authorization for the definitive registration of the vaccine must go through Anvisa’s analysis -which can take up to 60 days- and must be requested from the agency until January 15.
According to the president of Fiocruz, the expectation is that the institution will deliver the first million doses already in the week of February 8 to 12.
Source: Brazil Agency/Uol
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