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Anvisa (National Health Surveillance Agency) reported on Saturday (2) that it approved an exceptional import order for 2 million prepared doses of the vaccine against Covid-19 developed by the University of Oxford and the pharmaceutical company AstraZeneca, known as the vaccine. from Oxford.
The request had been made by Fiocruz on December 31 and was approved by the agency on the same date. However, the measure still does not allow the application of the vaccine.
According to Anvisa, this will occur as soon as there is a registration or endorsement of vaccine for emergency use, which has not yet been requested. Fiocruz intends to place an order in the next few days.
In the letter sent to the agency to import the 2 million doses, Fiocruz assures that it tries to anticipate the start of vaccination in Brazil with this immunizer for this month. Currently, the Oxford vaccine is the main commitment of the Brazilian government for immunization against the disease.
In practice, the strategy would start with these initial doses, imported, while Fiocruz, which has an alliance with AstraZeneca, would start the production of the other 100 million doses planned in an agreement with the pharmaceutical company – and whose delivery is expected to begin . in February and concluded during the first semester.
The information about the order made to Anvisa was initially disclosed by Veja magazine and confirmed by leaf. In the same document, the foundation informs that it must request a guarantee for the emergency use of the vaccine next week.
According to sources accompanying the process, the coordination to anticipate the delivery began in early December. Initially, AstraZeneca reported that 1 million doses would be available. Recently, however, an arrangement was made for the possible delivery of 2 million doses, depending on the approval of Anvisa.
“With important support from the Ministry of Health, we have been looking with the company AstraZeneca Brasil, with whom we have a technology order contract for the national production of the vaccine, ways to receive ready vaccines, even in January. (…) These negotiations were successful and we will have at our disposal the amount of two million doses to be delivered in January ”, informed the letter sent by Fiocruz to Anvisa, and signed by the acting president of the foundation, Mario Santos Moreira. .
In a note in which it announced the approval, Anvisa reports that, since it is an importation of vaccine that has not yet been approved, entry into the country must follow some conditions established by the agency.
“The main requirement is that the imported vaccines remain under the specific custody of Fiocruz until Anvisa authorizes the use of the product in the country. To do this, Fiocruz must guarantee storage and safety conditions to maintain product quality. received by Anvisa, the indication is that the vaccines arrive in the country in January ”, says Anvisa.
According to the agency, the vaccines must be delivered by the Serum Instute de India, a technology partner of Fiocruz and one of Oxford’s vaccine production centers.
This Friday (1), Anvisa reported that it completed the analysis of the data already sent by Fiocruz and AstraZeneca on the efficacy and safety of the vaccine.
The data were sent through the continuous submission process, which allows the advance presentation of documents until the vaccine is registered, one of the types of guarantee that can be applied in the country.
Fiocruz has already announced that, in addition to the request for emergency use, it intends to request a vaccine registration before January 15.
