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.”
Photo: AFP
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.”
Photo: AFP
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.
Taiwan moved clear of Mexico to be the only country at No. 2 in the World Baseball Softball Confederation (WBSC) Men’s Baseball World Rankings. Meanwhile, draft bills to set up a ministry of sports were approved at a joint session at the legislature in Taipei yesterday. After previously being tied with Mexico for second on 4,118 points, Taiwan moved clear on 5,498 points after they defeated Japan in the final of the WBSC Premier12 tournament on Sunday. Mexico (4,729) dropped to fourth, behind Venezuela (4,846), who finished fourth at the tournament. Taiwan narrowed the gap to first-placed Japan to 1,368 points from 1,638, WBSC
GLOBAL SUPPORT: The Ministry of Foreign Affairs said that the motion highlighted the improper exclusion of Taiwan from international discussion and cooperative mechanisms Taiwan yesterday thanked the British parliament for passing a motion stating that UN Resolution 2758 does not involve Taiwan, making it the latest body to reject China’s interpretation of the resolution. The House of Commons on Thursday debated the international status of Taiwan and unanimously passed a pro-Taiwan motion stating that the House “notes that UN Resolution 2758 does not address the political status of Taiwan or establish PRC [People’s Republic of China] sovereignty over Taiwan and is silent both on the status of Taiwan in the UN and on Taiwanese participation in UN agencies.” British Foreign, Commonwealth and Development Office Parliamentary
HIGH ALERT: The armed forces are watching for a potential military drill by China in response to the president’s trip, with the air force yesterday conducting an exercise President William Lai (賴清德) is to make stopovers in Hawaii and the US territory of Guam during his seven-day trip to the South Pacific, his first official visit since taking office in May, the Presidential Office said yesterday. Lai, accompanied by a delegation, is scheduled to depart for the South Pacific on a chartered flight at 4:30pm tomorrow, stopping first in Hawaii for a two-night layover before traveling to the Marshall Islands, an office official said. After wrapping up his visits to the Marshall Islands and Tuvalu, the president is to transit through Guam, spending a night there before flying to Palau,
‘IMPORTANCE OF PEACE’: President Lai was welcomed by AIT Managing Director Ingrid Larson, Hawaii Governor Josh Green, Honolulu Mayor Rick Blangiardi and others President William Lai (賴清德) was feted with red carpets, garlands of flowers and “alohas” as he began his two-day stopover in Hawaii on Saturday, part of a Pacific tour. Looking relaxed in a Hawaiian shirt, Lai flitted around the US island state, visiting the Bernice Pauahi Bishop Museum, Hawaii’s leading museum of natural history and native Hawaiian culture, the Hawaii Emergency Management Agency and the USS Arizona Memorial in Pearl Harbor. Lai was given the “red carpet treatment” on the tarmac of Honolulu’s international airport, his office said, adding that it was the first time a Taiwanese president had been given such
RSS