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進入《TAIPEI TIMES》 Brazil halts China vaccine trials; Pfizer races ahead
A doctor shows a box of a COVID-19 vaccine produced by Sinovac Biotech Ltd at Sao Lucas Hospital in Porto Alegre, Brazil, on Aug. 8. Photo: AFP
/ AFP and AP, RIO DE JANEIRO
Brazil’s National Health Surveillance Agency （ANVISA） on Monday 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 Ltd （科興）, came on Monday as US pharmaceutical giant Pfizer Inc said its own vaccine candidate had shown 90 percent effectiveness.
Sinovac Biotech yesterday stood by its creation, saying: “We are confident in the safety of the vaccine.”
ANVISA said it had “ruled to interrupt the clinical study of the CoronaVac vaccine after a serious adverse incident” involving a volunteer recipient on Oct. 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 that it would “continue to communicate with Brazil on this matter.”
The Butantan Institute, the public health center coordinating the trials of the vaccine in Brazil, 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 Brazilian 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.”
Bolsonaro has called CoronaVac the vaccine from “that other country,” and pushed instead for a rival vaccine developed by Oxford University and pharmaceutical firm AstraZeneca.
Pfizer on Monday said that its COVID-19 vaccine might be a remarkable 90 percent effective, based on early and incomplete test results that nevertheless brought a big burst of optimism to a world desperate for the means to finally bring the catastrophic outbreak under control.
“We’re in a position potentially to be able to offer some hope,” said Bill Gruber, Pfizer’s senior vice president of clinical development. “We’re very encouraged.”
Pfizer, which is developing the vaccine with its German partner BioNTech SE, is on track to apply later this month for emergency-use approval from the US Food and Drug Administration, once it has the necessary safety information in hand. Even if all goes well, authorities have stressed it is unlikely any vaccine would arrive much before the end of the year, and the limited initial supplies would be rationed.
US National Institute of Allergy and Infectious Diseases Director Anthony Fauci said that the results suggesting 90 percent effectiveness are “just extraordinary.”
“It’s going to have a major impact on everything we do with respect to COVID,” Fauci said.
WHO Assistant Director-General Bruce Aylward said Pfizer’s vaccine could “fundamentally change the direction of this crisis” by March, when the UN agency hopes to start vaccinating high-risk groups.
The Sinovac, Pfizer and Oxford vaccines are all in phase 3 trials, the final stage of testing before regulatory approval.
新聞來源：TAIPEI TIMES
People walk by the Pfizer Inc headquarters in New York City on Monday. Photo: AFP
