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Anvisa (National Health Surveillance Agency) reported today that Fiocruz (Fundação Oswaldo Cruz), the Brazilian partner laboratory of AstraZeneca – responsible for the Oxford vaccine -, will request authorization for the emergency use of the immunizer against covid-19 in Brazil, but not I said when it will happen.
So far, the Foundation had only informed that it would request the definitive registration – today, the president of Fiocruz, Nísia Trindade, said that this request will be made until next January 15 (read below). The date had already been advanced to Folha de S. Paulo by the vice president of the foundation, Marco Krieger.
Today a meeting was held between the top management of the agency and representatives of AstraZeneca and, according to Anvisa, the laboratory declared that there are no regulatory difficulties to comply with the measures imposed by the agency for the use of the immunizer in the country.
Regarding the presentation of the authorization for the emergency use of the vaccine, it was reported that the request will be made by Fiocruz, which is the associated national laboratory of AstraZeneca in the country for this vaccine. According to the company, no regulatory difficulties were identified to comply with Anvisa’s requirements, established by Guide no. 42/2020, which deals with the minimum requirements for submitting a request for temporary authorization for the emergency use, on an experimental basis, of Covid-19 vaccines.
Anvisa talks about request for emergency use of Fiocruz vaccine (Oxford / AstraZeneca)
According to Anvisa, the deadline to analyze the emergency use of the vaccine is ten days from the day of the formal request with the agency. For final registration authorizations, the evaluation can take up to 60 days.
“This period [de 10 dias de análise] it may be less, depending on the amount of information packages that the laboratory has already delivered to Anvisa within the Continuous Shipping process, ”said the agency.
The UK has now become the first country to authorize the emergency use of the Oxford vaccine. In note, AstraZeneca informed that it will continue the continuous submission process to request registration also in Brazil.
President of Fiocruz informs date of final order
In the early hours of the afternoon today, just before the launch of the Anvisa note, the president of Fiocruz, Nísia Trindade, said that the request for the definitive registration of the Oxford vaccine must be submitted to the agency before the next day 15. He classified it as “” Vaccine approval in the UK and said that emergency use in Brazil was still being studied.
What happened today is historical, because it is the first record. In addition to quality and safety, it is a vaccine suitable for countries like ours, with so much difference, diversity, regional, that is why it is a very important day, a vaccine that begins in a public system, English, and here in Brazil it is appropriate . for their [Sistema Único de Saúde]. Fiocruz will produce, we have the whole process well in advance, we will produce the vaccine without interruption until the Brazilians need it
Nísia Trindade, president of Fiocruz
“What we are receiving in January, on the schedule, is the active pharmaceutical ingredient and we are going to start production, there are three valid batches, a time for quality control, so it is not an automatic process. Our expectation is from week 8 to February 12 to deliver the first million doses, because it is the beginning, more time is needed, and in the third week of February the goal is 3.5 million doses per week ” Nísia said in a video shown on GloboNews.
The president also said that the time between the application of the first and second doses of the vaccine should be 12 weeks in the United Kingdom, a model possibly replicated in Brazil. The Pfizer vaccine, which has also been applied in the UK and other countries, has a shorter interval between doses, around three weeks. According to Nisia, the new standard allows more people to be vaccinated in the first phase.
“We will receive supplies for 15 million doses per month. The good news for today’s record is the 12 week interval [para a aplicação da segunda dose]and Anvisa will evaluate. The UK option was to have more extensive coverage and a second dose at 12 week intervals. It is also an important reference to think about individual and collective health. We are doing everything possible to make this happen in the shortest possible time. “
Without anticipating the request for use
Questioned, Nísia said that it is not possible to anticipate the final registration request before Anvisa, before January 15, because the process has several stages with the need to comply with the sanitary requirements.
“For the record there [há possibilidade de adiantá-lo], because there are many steps. All of them have been well followed, with delivery of data, good practices of the laboratory from which the inputs will come. Our laboratory has good practices, but it is a new vaccine. We are working to anticipate as much as possible in the shortest time possible, ”he said.
Another way is emergency authorization, if it makes sense with the possibility of authorizing Brazilians earlier, but the record is more complete. Nothing is ruled out. The north will begin vaccination according to the national plan.
Nísia Trindade
Nísia said that Fiocruz is working to anticipate the vaccine, within the definitions of the national plan, but considered that “the path of the vaccine begins now” and that the foundation is not receiving ready doses, so support is needed to production in the country.
* With information from Reuters
