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Boxes with possible vaccine from China Sinovac against Covid-19 in Beijing (REUTERS / Thomas Peter)
SAO PAULO – This Wednesday (23), Jean Gorinchteyn, Secretary of State for Health of São Paulo, and the Director of the Butantan Institute, Dimas Tadeu Covas, present at 4 pm, information on the conclusion of the clinical study of CoronaVac, vaccine of the Butantan produced in association with the Chinese laboratory Sinovac, and the efficacy of the immunizer.
The information was sent through a note from Butantan. João Doria, governor of São Paulo, will not participate in the press conference.
The government of São Paulo promised to send the results of phase three (and the final) of the clinical trials to the National Health Surveillance Agency (Anvisa) also on Wednesday, as well as submit the two requests for approval of the vaccine: definitive registration and emergency use.
In practice, with final registration, approval can take 60 days because Anvisa needs to evaluate the complete vaccination documentation. If approved, the public and private network can mass apply a vaccine with that approval. In normal situations, this period would be 180 days.
TO InfoMoneyAnvisa explained that the 60 days for the registration of the vaccine were designed with a process in mind in which Anvisa did not receive any information in advance. “However, all the labs have already submitted some data in advance through ongoing submission. This allows the definitive registry to be evaluated by Anvisa in less time, provided that all the requirements are met, ”said the agency.
Continuous submission is a process that allows laboratories to submit partial data on their vaccine results to Anvisa, while they continue to investigate and consolidate additional, more complete data. This streamlines the process. Thus, when the laboratory requests a registration, the national agency already has some analyzed data.
The authorization for emergency use is faster: it can be approved within a maximum period of 10 days, according to Anvisa, but as it is not a definitive record, it is not possible to administer it in private clinics. Thus, the responsibility for vaccination falls on the public authorities and only the SUS can apply the medication.
So far, Anvisa has reported that it has not received any data on phase three from CoronaVac.
The expectation is that the Butantan / Sinovac vaccine will have a similar efficacy to the other vaccines already announced.
The Pfizer vaccine, which is already being applied in the United Kingdom, the United States and other countries, and which was approved on Monday by the European Union, was 95% effective. Moderna’s, which was approved last week by the US health agency, the FDA, and began to be applied in the United States on Monday (21), is 94% effective.
The Oxford vaccine, in association with AstraZeneca, also presented efficacy data, but the results were later questioned. The Russian vaccine, from the Gamaleya Institute, has also presented efficacy data, but its procedures have been questioned by the WHO.
Situation in Brazil
Brazil should receive 150 million doses of vaccines against Covid-19 in the first half of 2021, adding the immunizers Pfizer / BioNTech, Sinovac / Butantan and AstraZeneca / Fiocruz, said on Tuesday (22) the Secretary of Sanitary Surveillance of the Ministry of Health , Arnaldo Medeiros.
Last week, the Minister of Health, Eduardo Pazuello, announced that the first deliveries should occur in January, with an amount of 24.5 million doses in all three laboratories in the month.
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