SÃO PAULO, BRAZIL – São Paulo Governor João Doria announced yesterday, November 9th, that the first 120,000 doses of the Coronavac vaccine will reach the state on November 20th. According to the governor, a total of six million doses of the immunizer used against the novel coronavirus are expected by December 30th.
The Coronavac is in phase 3 trials, the last to confirm its efficacy, but still has no set date for completion. The application of the doses – which come ready – also depends on ANVISA (National Health Regulatory Agency) approval. Should it fail, these 6 million doses will not be able to be administered.
“The vaccine will only be released to the public after final authorization [from ANVISA],” reiterated the Governor. “This date is confirmed. The ANVISA had already authorized the import,” said Doria. “Now, health authorities in China have granted authorization for import by the Butantan Institute.”
The vaccines to be delivered by the end of December are part of the 46 million doses purchased by the São Paulo government.
The first six million doses will be delivered from China ready for use and will be stored under the responsibility of the Butantan Institute. For safety reasons, the state will not disclose where units will be stored.
In relation to the remaining vaccines, São Paulo will receive the supplies and the Butantan Institute’s technicians will process the CoronaVac in national laboratories.
Butantan Institute director Dimas Covas declared that the first lot of supplies is expected to arrive on November 27th. According to him, production will begin 48 hours after the raw materials have arrived.
The supply will be sufficient to manufacture 1.2 million vaccines. The purchase of the 46 million vaccines cost US$90 million (around R$479 million).
Manufacturing Plant
In addition to the arrival of the CoronaVac, which is produced in partnership with the Chinese pharmaceutical company Sinovac, Doria informed that the works on the 10,000 m² plant for the manufacture of the Coronavac began on November 2nd.
According to the Governor, the plant’s production capacity will consist of 100 million doses. In the future, the plant may produce other immunizers. “This plant already existed, and is being remodeled. And there we will have the vaccine produced in Brazil. The works are expected to last 10 months and the plant will be ready in September 2021”.
With the expected completion of works by September 2021, local production of doses will only be possible as of 2022. Until then, Butantan will be supplied with ready doses from China or raw materials to finalize the production in Brazil. The production stage in Brazil will include formulation, filling and labeling.
The 40 million doses will not be produced in this plant, but in other units of the Butantan Institute. Therefore, the works will not interfere in the production schedule of vaccines.
The reform of the Butantan plant is estimated at R$160 million, and a good part of the funding will come from private donations.
Regulator has Trial Suspended
Brazil’s health regulator ANVISA has suspended a clinical trial for China’s Sinovac coronavirus vaccine citing a severe adverse event, surprising the trial organisers who countered there had been a death but it was unrelated to the vaccine.
ANVISA said on Monday the event occurred on October 29th but did not specify if it took place in Brazil or in another country. It also did not give an indication of how long the suspension might last.