Sinovac COVID-19 trial suspended in Brazil due to severe adverse event
pharmafile | November 10, 2020 | News story | Manufacturing and Production | Brazil, COVID, COVID Vaccine, coronavirus
Brazil’s health regulator Anvisa has suspended a clinical trial for China’s Sinovac coronavirus vaccine due to the occurrence of a severe adverse event in one of the patients receiving it.
The regulator said the event occurred on 29 October, but did not say if it had happened in Brazil or on a trial site elsewhere.
Dimas Covas, the Head of Butantan, a Sao Paulo research institute conducting the trial, stated that the suspension was related to a death but it was unrelated to the vaccine. He told TV Cultura: “As there are more than 10,000 volunteers at this moment, deaths can occur. It’s a death that has no relation with the vaccine and as such it is not the moment to interrupt the trials.”
Sinovac released a statement on their website which said: “After communicating with the Brazilian partner Butantan Institute, we learned the head of Butantan Institute believed that this serious adverse event (SAE) is not related to the vaccine. Sinovac will continue to communicate with Brazil on this matter. The clinical study in Brazil is strictly carried out in accordance with GCP requirements and we are confident in the safety of the vaccine.”
The Sinovac vaccine is among the three experimental vaccines that China has used to inoculate thousands under an emergency use programme.
President Jair Bolsonaro has dismissed the vaccine multiple times and has previously said his government will not buy the vaccine. He has since backed down, saying that the government would buy any vaccines approved by Anvisa. Joao Doria, Sao Paulo’s Governor, has said that his state will import and produce the vaccine, with work having already begun on a manufacturing plant capable of producing 100 million doses a year. Doria says the vaccination programme could start as early as January.
Brazil is one of the worst affected countries by the coronavirus pandemic, with over 5.6 million cases and 160,000 deaths to date.
Conor Kavanagh
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