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Indonesia to get data from Brazil after its own clinical trial of Covid-19 vaccine shows slow progress
Wahyudi SoeriaatmadjaIndonesia Correspondent
- UPDATED
DEC 23, 2020, 9:46 PM
JAKARTA – With the slow development of its own phase three clinical trial of a Covid-19 vaccine candidate, Indonesia said it has asked for data from Brazil, where a similar trial is progressing smoothly.
It expects to receive the safety and efficacy data on Chinese firm Sinovac Biotech’s CoronaVac by Dec 28, and hopes to finally start rolling out its vaccination programme in January.
The phase three clinical trial is the final stage that a vaccine candidate must clear before it is given the go-ahead for use by the regulatory agency in a corresponding country.
BPOM, the Indonesian equivalent to US Food and Drug Administration, has requested the data through its Foreign Affairs Ministry, which then communicated with Brazil’s National Health Surveillance Agency and Sinovac, said a government official, who spoke on condition of anonymity.
“Within a matter of days after receiving the data, BPOM may issue its emergency use authorisation on the vaccine, when a thorough evaluation is done,” the official told The Straits Times.
Brazil carried out a strict clinical trial on Sinovac’s CoronaVac and started the trial earlier than Indonesia, the official added.
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Brazil institute says CoronaVac efficacy above 50%, but delays full results
RIO DE JANEIRO (Reuters) -Brazilian researchers said on Wednesday the COVID-19 vaccine developed by China’s Sinovac Biotech is more than 50% effective based on trial data, but again withheld full results at the company’s request, raising questions about transparency.
Brazil is the first country to complete a late-stage trial of the vaccine, called CoronaVac, but a release of the results, first set for early December, has now been delayed three times.
The latest delay is a blow to Beijing, which has been racing to catch up with Western drugmakers, and will add to criticism that Chinese vaccine makers have lacked transparency.
It is also likely to fan growing skepticism toward the Chinese vaccine in Brazil, just as the virus roars back to life. President Jair Bolsonaro, a coronavirus skeptic who has said he will not take a COVID-19 vaccine, has repeatedly questioned the Chinese vaccine based on its “origins.” A poll earlier this month showed that half of Brazilians now reject it.
Officials from the Sao Paulo state government’s Butantan Institute declined to specify the efficacy rate from a trial they led with 13,000 volunteers, citing contractual obligations with Sinovac. They said, however, the vaccine was effective enough against the novel coronavirus for it to be approved for emergency use in Brazil. Health regulator Anvisa has stipulated an efficacy rate of at least 50% for vaccines in the pandemic.
“Our aim was for it to be over 50%. If it were 51%, it would be important for us, especially as we are living in a moment of a health crisis,” said Sao Paulo Health Secretary Jean Gorinchteyn. “For us, it would be a moment to celebrate.”
The officials said Sinovac asked them to delay releasing precise vaccine efficacy data for up to 15 days from Wednesday while the company consolidates data from global trials.
Sinovac did not immediately respond to a request for comment.
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“But it hurts the image of their vaccine to have this hesitation,” she added. “They shouldn’t have made a show of something that in the end they didn’t report. That’s the bigger problem.”
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China has been giving experimental coronavirus vaccines, including the shot developed by Sinovac, to high-risk groups in the country since July under an emergency use program.
Sinovac has secured supply deals for its vaccine with several countries including Indonesia, Turkey, Brazil，Chile and Singapore, and is holding talks with the Philippines and Malaysia for a potential sale.
Reporting by Pedro Fonseca; Additional reporting by Roxanne Liu in Beijing and Gabriel Araujo in Sao Paulo; Writing by Gabriel Stargardter; Editing by Brad Haynes, Sonya Hepinstall and Peter Cooney
https://www.reuters.com/article/us-health-coronavirus-sinovac-brazil-idUSKBN28X2CR
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Coronavirus latest: China vaccine ‘over 50%’ effective in Brazil trials
Nikkei staff writers
December 21, 2020 08:22 JST
Updated on December 24, 2020 09:53 JST
4:05 a.m. The COVID-19 vaccine developed by China’s Sinovac has an efficacy that clears the 50% level needed for approving emergency use in Brazil, according to a biological research institute in Sao Paulo state.
Sinovac has asked Brazil not to disclose the full results of trials of the so-called Coronavac for 15 days, according to the Instituto Butantan, which is overseeing the trials.
The Brazilian newspaper Folha de S. Paulo earlier reported the Coronavac had shown an efficacy greater than 50% in stage-three trials.
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