Brazil has resumed the trials of a Chinese COVID-19 vaccine after halting them on two days earlier over a mysterious death. The reported ‘severe adverse event’ was later said to be not related to the vaccine but likely a suicide, writes Global Times in China.
Brazil’s National Health Surveillance Agency (Anvisa) announced on Wednesday 11 November 2020 that it would resume the trial of a vaccine candidate developed by Chinese firm Sinovac Biotech, write Hu Yuwei and Zhang Han. The vaccine is called CoronaVac.
Anvisa had suspended the trial on the Monday after the death of a volunteer in Sao Paulo was reported. Media described the case as a “severe adverse” case but broadcaster TV Cultura said on Tuesday that the death was a suicide.
A scheduled international shipment of Sinovac’s vaccine to Brazil at the end of the month is still being processed, a courier agent manager surnamed Yu who is in charge of the shipment told the Global Times on Wednesday. The vaccine package is intended for late-stage clinical trials in Sao Paulo, with about 150,000 to 160,000 doses involved.
“The suspension and resumption of clinical studies are common in clinical research. And a suspension does not necessarily mean that the product under investigation has an issue of quality, safety or efficacy,” Sinovac said, quoting Anvisa, in a response statement sent to the Global Times on Thursday.
“This event fully demonstrates that clinical research supervision by Anvisa is sensitive, timely and effective. We are also glad to see that clinical research of Coronavac ️is proved to be scientific and normative by Anvisa, National Commission on Ethics in Research, Data and Safety Monitoring Board (DSMB), the public and media,” said Sinovac.
It is unclear how the case triggered a sudden suspension of the trial but analysts suspect political involvement.
The Butantan Institute, a Sao Paulo-based sponsor of the trial, told the Global Times that it had sent notice of the volunteer’s death to Anvisa on 6 November. “In conclusion, it was stated that the death was not related to the test vaccine,” said the statement sent by the Butantan Institute.
But Anvisa claimed to media that it did not receive the notice about the volunteer’s death until Monday, due to a “cyberattack”, media reported. “Clear, precise and complete documents need to be sent to us, which did not happen,” Anvisa’s Director Antonio Barra Torres told a press conference on Tuesday.
Torres is reportedly a close ally of Brazilian President Jair Bolsonaro, who called the suspension of Chinese vaccine studies on Facebook “his next victory”. He was referring to victory over the governor of Sao Paulo state, Joao Doria, who is seen as Bolsonaro’s main political rival.
The leadership of Sao Paulo, where the Chinese vaccine is being tested, called the suspension of the study the result of a “domestic political war”. Brazilian health experts have warned that politicising the vaccine will lead to the spread of misinformation.
Although some Western media originally reported the suspension, hinting at quality problems with the vaccine in headlines, netizens also saw politics in the incident, with some criticising the president for sacrificing lives for his career ambition.
Chinese Ministry of Foreign Affairs spokesperson Wang Wenbin said he hoped people would not rush to hasty conclusions without knowing the situation.
In an earlier round in the political war, Bolsonaro made worldwide headlines by declaring that Brazil would not buy Chinese vaccines. After that, Anvisa authorised Butantan’s plan to import six million doses of Sinovac’s vaccine, which is undergoing final clinical trials in Sao Paulo.
The Brazilian president has a pro-United States stance and there have been rumors that he would prioritise US vaccines. Chinese analysts said the influence of the US cannot be ruled out as being behind Brazil’s vaccine-centered farce.
Good news about Lilly and Pfizer vaccines countered by Sinovac Biotech worry
Although the reaction across markets worldwide is overwhelmingly positive, the reality is that uncertainty remains in the race for immunisation, write John Liu and Dong Lyu for Bloomberg in a 10 November article published in BusinessLive.
Almost a year into the Covid-19 pandemic, a world facing the unrelenting spread of the coronavirus received a burst of good news, with a vaccine developed by Pfizer showing “extraordinary” results while an antibody therapy from Eli Lillywas granted emergency-use authorisation in the US.
The double shot of progress was somewhat offset by news that the final-stage trial of a frontrunner Chinese vaccine candidate was halted in Brazil due to a serious adverse event, the first time that the Asian nation’s rapidly ascendant shots have met such a setback.
Though the reaction across markets worldwide remained overwhelmingly positive – a global rally added more than $1.8-trillion to the value of the MSCI all country world index – the reality is that significant uncertainty remains in the race for immunisation, Bloomberg writes.
China has already administered its shots, including the one from Sinovac Biotech, to hundreds of thousands of people under an expansive emergency use programme. The halt now underscores the risks of governments acting on early positive data to greenlight shots without a long-term understanding of the vaccines’ safety profiles.
Development processes that usually take years have been compressed into months, and experts caution that the world is in uncharted territory with COVID-19 vaccines, according to Bloomberg.
Still, the preliminary data disclosed by Pfizer was so unexpectedly positive that it overwhelmed all caveats, sending investors stampeding out of haven assets such as the yen and treasuries and into securities most exposed to an economic recovery. With control of the coronavirus seemingly all but lost in the US and parts of Europe, Pfizer’s vaccine and the experimental genetic technology it harnesses was received like a deus ex machina.
The 13 economies that have already inked supply agreements with Pfizer and its German partner, BioNTech, are now poised advantageously. Pfizer and BioNTech have said they should be able to produce 1.3-billion doses of their shot – enough to vaccinate 650 million people – by the end of 2021. About 50-million doses are expected to be available in 2020.
At least four countries also have agreements with Moderna, whose vaccine uses the same experimental mRNA technology that Pfizer does. The company is also expected to release preliminary data soon.
Meanwhile, the US Food and Drug Administration’s approval of Eli Lilly’s antibody therapy for use against mild-to-moderate COVID-19 provides another weapon in doctors’ arsenal to treat the coronavirus.
Global Times – Brazil resumes trials of Chinese COVID-19 vaccine
Bloomberg – Good news about Lilly and Pfizer vaccines countered by Sinovac Biotech worry