taken on August 8, 2020, a doctor shows the box of a COVID-19
coronavirus vaccine produced by Chinese company Sinovac Biotech at
Sao Lucas Hospital in Porto Alegre, southern
Brazil.
Brazil’s health regulator said it had suspended clinical
trials of a Chinese-developed Covid-19 vaccine after an “adverse
incident” involving a volunteer recipient, a blow for one of the
most advanced vaccine candidates.
The setback for CoronaVac, developed by China’s Sinovac Biotech,
came on Monday as US pharmaceutical giant Pfizer said its own
vaccine candidate had shown 90 percent effectiveness — sending
global markets soaring and raising hopes of an end to the
pandemic.
Sinovac Biotech on Tuesday stood by its creation, saying: “We
are confident in the safety of the vaccine”.
The Brazilian regulator Anvisa said it had “ruled to interrupt
the clinical study of the CoronaVac vaccine after a serious adverse
incident” involving a volunteer recipient on October 29.
It said it could not give details on what happened because of
privacy regulations, but that such incidents included death,
potentially fatal side effects, serious disability,
hospitalization, birth defects and other “clinically significant
events.”
Sinovac, however, said the incident was “not related to the
vaccine”, adding it will “continue to communicate with Brazil on
this matter.”
The public health center coordinating the trials of the vaccine
in Brazil, the Butantan Institute, said it was “surprised” by
Anvisa’s decision.
The institute “is investigating in detail what happened,” and
“is at the Brazilian regulatory agency’s disposal to provide any
clarification necessary on any adverse incident the clinical trials
may have presented,” it said.
CoronaVac has been caught up in a messy political battle in
Brazil, where its most visible backer has been Sao Paulo Governor
Joao Doria, a top opponent of far-right President Jair
Bolsonaro.
The Sao Paulo state government said in a statement it “regrets
that it learned of the decision from the press, instead of directly
from Anvisa,” and was waiting along with the Butantan Institute for
more information on “the real reasons for the suspension.”
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– Pandemic politics –
Bolsonaro has labeled CoronaVac the vaccine from “that other
country,” and pushed instead for a rival vaccine developed by
Oxford University and pharmaceutical firm AstraZeneca.
Last month, he shot down a plan by his own health minister to
buy 46 million doses of CoronaVac, saying, “The Brazilian people
will not be anyone’s guinea pig,” and referring to it as “Joao
Doria’s Chinese vaccine.”
Doria announced earlier Monday that the first 120,000 doses of
CoronaVac would arrive in Sao Paulo on November 20.
His state has a deal with Sinovac to buy a total of 46 million
doses — six million produced in China and the rest produced in Sao
Paulo, which broke ground last week on a factory to make the
vaccine domestically.
“Officials in the state government fear Bolsonaro will use
technical decisions to delay the timeline of the vaccine for
political reasons,” newspaper Folha de Sao Paulo reported, citing
unnamed Doria allies.
Anvisa told AFP it had no comment beyond its statement
announcing the suspension, which said that halting trials was
standard procedure in such cases.
Bolsonaro faces criticism for his handling of the pandemic,
which has included playing down the virus, opposing lockdown
measures and relentlessly promoting the drug hydroxychloroquine
despite studies showing it is ineffective against Covid-19.
The Sinovac, Pfizer and Oxford vaccines are all in Phase 3
trials, the final stage of testing before regulatory approval.
All are being tested in Brazil, the country with the
second-highest death toll in the pandemic after the United States,
with more than 162,000 people killed by the new coronavirus.
-AFP
Read more https://swordpress.com.ng/2020/11/10/brazil-suspends-chinese-covid-19-vaccine-trials/