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Boxes with possible vaccine from China Sinovac against Covid-19 in Beijing (REUTERS / Thomas Peter)
SÃO PAULO – The government of São Paulo and the Butatan Institute announced on Wednesday (23) that CoronaVac, a vaccine produced in association with the Chinese laboratory Sinovac, presented efficiency after the results of phase 3 clinical trial studies, the last before final approval.
“The minimum rates were reached, both required by Anvisa [agência sanitária brasileira]and by WHO [Organização Mundial de Saúde] in phase 3. This will allow us to prevent the death of thousands of people, not only here in the country, but throughout the world. We will reduce the number of ICU occupancy beds and the use of respirators, and then we will be able to rescue the economy, our dreams and we will be able to hug and kiss all those we could not during the year ”, said Jean Gorinchteyn, Secretary of Health of São Paulo , at a press conference held this Wednesday afternoon (23).
Dimas Covas, director of the Butantan Institute, said that the exact data on the percentage of effectiveness cannot be disclosed at the moment, following a request made by Sinovac. But, like Gorinchteyin, Covas guaranteed that the results prove the vaccine is effective. “We received the efficacy data: we reached the efficacy threshold that the emergency use request process allows here in Brazil and China.”
Covas did not make clear what the “threshold of effectiveness” would be. According to the WHO, to be distributed, a vaccine must be at least 50% effective. The lack of details on the percentage of effectiveness frustrates the high expectations that existed for the press conference today. CoronaVac is one of the most promising vaccines among Brazilian candidates, in view of the advanced state of treatment with Butantan, an institute that is a reference in immunization in the country.
Covas also pointed out that the data corroborate what the institute had been saying: “It is the safest vaccine of all those that are being tested at this time, we only had mild adverse reactions.” According to him, the most common adverse effect was pain at the vaccination site. “Low fever was presented in a small percentage of volunteers, in line with what happens in China with more than 300 thousand vaccinated people.”
The director of Butantan explained that Sinovac requested the sending of the entire database on the tests to unify and match the results with the tests carried out in other countries and, thus, avoid the publication of different indexes. “Sinovac asked Butantan to transfer the database and this happened this morning, so that they can perform this unified analysis and we can present the results to Anvisa. There are 15 days to complete this analysis. This is a contract and we will respect it, although we believe that the deadline will be advanced, “said Covas.
João Gabbardo, executive coordinator of the Contingency Center of the SP government, guaranteed that the request made by Sinovac will not delay the schedule provided by the State Immunization Program, which provides for the start of vaccination in the state on January 25.
With the CoronaVac results in hand, the government of São Paulo and the institute can send the National Health Surveillance Agency (Anvisa) the documentation necessary to enter both approval requests: the definitive registration and authorization for the use of emergency.
In practice, with the final registration, approval can take around two months, since Anvisa needs to evaluate the complete vaccination documentation. If approved, the public and private network can mass apply a vaccine with that approval.
The authorization for emergency use can be approved in 10 days, according to Anvisa, but since it is not a definitive record, it is not possible to apply it in private clinics. Thus, the responsibility for vaccination rests with the public authorities and only the Unified Health System (SUS) can apply the medication.
Travel to Doria
The press conference on CoronaVac’s results comes hours after the strong repercussion of the news that São Paulo Governor João Doria (PSDB) had taken a 10-day leave.
After much criticism on social networks, after having decided to travel abroad the day after the announcement of the statewide lockdown for Christmas and New Year, the governor announced that he canceled the trip and would return to São Paulo.
Through his Twitter account, Doria said that the decision was made after he was informed that Rodrigo García (DEM), the deputy governor of the state, had contracted Covid-19. Garcia would take on government commitments during Doria’s leave.
Dose
The Ministry of Health is negotiating with the Butantan Institute the extension of the CoronaVac acquisition contract to 100 million doses, which will be delivered in the first half of 2021, the secretary of Health Surveillance of the ministry, Arnaldo Medeiros, reported on Tuesday.
According to the secretary, the contract with Butantan is practically closed and the vaccine delivery schedule proposed by the institute foresees the delivery of 9 million doses in January, 15 million in February and 22 million in March, adding to the 46 million expected. initially, but the government is already negotiating an increase in the contract.
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.
Vaccines 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 this Tuesday 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.
((In update))
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