Brazil freezes clinical trials of Chinese vaccine against COVID-19



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The bad news came from Sinovac Biotech, a Chinese company developing one of the most advanced potential vaccines, CoronaVac, on Monday after US pharmaceutical giant Pfizer said its own vaccine candidate is 90 percent effective. The announcement raised hopes that the pandemic would end soon and global stock indices began to rise rapidly.

Sinovac Biotech defended its product on Tuesday: “We are confident that the vaccine is safe.”

VIDEO: Breakthrough in the fight against COVID-19: The effectiveness of the experimental vaccine is as high as 90%.

Brazilian regulator Anvisa announced that it “decided to suspend a CoronaVac clinical trial following a serious adverse incident” in late October.

Anvisa said it could not disclose the details of the incident due to its privacy policy, but emphasized that such incidents involved death, potentially fatal side effects, severe disability, hospitalization, birth defects and other “clinically relevant events.”

However, Sinovac said the incident “was not related to the vaccine” and added that the company “will continue to collaborate with Brazil on this issue.”

The Bhutanese Institute, which coordinates clinical trials in Brazil, has been “surprised” by Anvisa’s decision.

The institute is “thoroughly investigating what happened” and is “ready to provide the Brazilian regulatory agency with all the necessary explanations for any adverse incidents that may have occurred during clinical trials,” the research center said.

CoronaVac has been at the center of a political dispute in Brazil. The main supporter of this vaccine in the country has become the governor of São Paulo Joao Doria, the main opponent of the far-right president Jairo Bolsonar.

The São Paulo state government highlighted in a statement that it “regrets that the decision was made known to the press and not directly to Anvisa.” The government said it was waiting with the Bhutan Institute for more information on the “real causes of the freeze.”

Pandemic policy

Bolsonar’s CoronaVac has produced a vaccine from “that other country” and is encouraging the University of Oxford and the pharmaceutical company AstraZeneca to develop a similar drug.

Last month, he thwarted his own designated health minister’s plans to buy $ 46 million. CoronaVac dosage. The head of state then said that “Brazilians will not be anyone’s experimental animals” and called the drug “Chinese vaccine Joao Dorios.”

Doria announced earlier Monday than the first 120,000. CoronaVac doses will arrive in São Paulo on November 20.

His state has signed an agreement with Sinovac to acquire a total of $ 46 million. dose. It was agreed that 6 million. of these will be manufactured in China and the rest in São Paulo, where construction began on a vaccine plant last week.

“State government officials fear Bolsonaro will use technical solutions to postpone vaccines for political reasons. [platinimo] terms, “the Folha de Sao Paulo newspaper quoted Doria’s anonymous allies.

Anvisa representatives told AFP they could not comment other than on the statement already circulated announcing the freeze. The report highlights that the suspension of investigations is the usual procedure in such cases.

Bolsonaro has been criticized for his response to the pandemic, in particular for decisions to reduce the risk of the virus, oppose quarantine measures and promote the use of hydroxychloroquine, although research shows that the drug is not effective in treating COVID -19.

Both Sinovac, Pfizer and Oxford have reached Phase 3 testing, the final stage after which the product can be approved by regulatory authorities.

All of these candidates are being tested in Brazil, a country that is second only to the United States in terms of casualties from COVID-19. In this Latin American country, more than 162,000 people have died from the new coronavirus. people.



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