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Photographer: Jonne Roriz/Bloomberg
prognosis


CHINA’S CORONAVAC TRIAL RESUMES IN BRAZIL AFTER ‘ADVERSE EVENT’

By
Simone Preissler Iglesias
and
Julia Leite
November 11, 2020, 3:40 PM GMT+1 Updated on November 12, 2020, 2:44 AM GMT+1
3:03


CHINA’S CORONAVAC TRIAL RESUMES IN BRAZIL AFTER ‘ADVERSE EVENT’

By
Simone Preissler Iglesias
and
Julia Leite
,
November 11, 2020, 3:40 PM GMT+1
 * Reversal comes amid criticism that the halt was politicized
 * Sinovac vaccine has been at center of political feud in Brazil


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Photographer: Jonne Roriz/Bloomberg
Photographer: Jonne Roriz/Bloomberg

Brazil reversed its decision to suspend trials of a coronavirus vaccine from
Chinese developer Sinovac Biotech Ltd., allowing tests to resume less than 48
hours after being halted amid criticism the initial pause was politically
motivated.




In a statement posted on its website Wednesday, health agency Anvisa said it
initially got “precarious data” on a “grave” event, which led it to suspend the
study late Monday. The agency added that it reversed its previous ruling after
receiving new information, and that it will keep monitoring the case.






Read More: Brazil’s Halting of China Vaccine Baffles Local Researchers





On Tuesday, Sao Paulo’s Instituto Butantan, which partnered with Sinovac to
produce the vaccine locally, criticized the suspension, saying it was not warned
of the move and that the reported death of a volunteer was not related to the
shot.




More from

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Moderna Poised to Take Vaccine Spotlight With Data Due

Sinovac’s vaccine has become the focus of an escalating feud in Brazil.
President Jair Bolsonaro stepped up criticism of CoronaVac last month, saying
China lacks credibility to come up with solutions for the coronavirus crisis and
that people wouldn’t feel safe with the shot “due to its origin.”



Chinese vaccine developers have been compelled to find countries where the
coronavirus is still spreading to host their final-stage trials, since the Asian
nation’s domestic outbreak has been largely contained. Geopolitical tensions
have affected the development process due to growing hostility toward Beijing
from some countries over a range of issues like trade and the pandemic’s
origins.

After the trial was paused, Bolsonaro on his Facebook account responded to a
supporter and appeared to celebrate the decision, writing, “another win for
Bolsonaro.” He has not commented on the resumption of the trial.

The Butantan researchers have suggested the participant could have died in a
traffic accident, while Anvisa said earlier it had no information about the
potential cause of death being suicide as reported by local media.



China’s Race for Covid-19 Vaccine Raises Safety Questions

“The decision to interrupt without having all the details seems premature,” said
Juarez Cunha, head of the Brazilian Immunization Society. “Given Butantan’s
credibility, I am sure if there was any suspicion of a related grave adverse
event, the researchers themselves would have called attention to it and
suggested the suspension.”

Sinovac said in a statement on its website earlier this week that it’s confident
in the safety of its vaccine.

Halts to investigate serious adverse events are not uncommon in large-scale drug
trials and two western developers -- AstraZeneca Plc and Johnson & Johnson --
paused their vaccine trials in recent months due to such incidents, only to
re-start them after investigation.

Chinese vaccine developers have been at the forefront of the global race to
create an effective immunization against the virus. The push has taken on vital
importance as countries look to move beyond Covid-19 and more definitively
re-open their economies.



Unlike American pharmaceutical firm Pfizer Inc., which this week revealed
“extraordinary” positive preliminary data from final-stage trials of its
candidate developed with BioNTech, no Chinese developer has yet publicized data
on the efficacy of their shots.

— With assistance by Andre Romani Pinto

Published on November 11, 2020, 3:40 PM GMT+1
Updated on November 12, 2020, 2:44 AM GMT+1


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