As it turns out, there's no unified protocol with any of the Chinese trials, it's conducted differently by every manufacturer in every country, that's why the results are wildly different, nothing adds up, and the results can't even be compared with one another like those in the West who followed the same protocol for their 30,000+ volunteers.
First, Indonesia previously announced an incredible "97% efficacy rate" for Sinovac, then
back-pedaled and admit the efficacy rate is actually "not yet determined" for their tiny trial with only 1,700 volunteers (???)
Then
Turkey announced an impressive 91.25% result from their Sinovac trial that has 7,000 volunteers, before clarifying that 91.25% efficacy number is actually based on data from only 1,322 of the participants (???)
Let's just call it like it is: a "Phase 3 trial" that involves only a handful of people is no Phase 3 at all. In fact, we call that Phase 2!
(A side note: UAE announced 86% for the Sinopharm-designed vaccine that they tested on 31,000 volunteers, which is really good, the only hiccup that we found out later is the vaccines they use for the trial actually came from two different partnering manufacturers being lumped into one trial, so no one know which one does better, and hope both are exactly the same in everyway.
Sinopharm's separate announcement that "no one who were vaccined outside the trials ever get infected" can be tossed in the trash obviously, since no vaccine is 100% effective.)
Now, the Sinovac Phase 3 trial in Brazil with 13,000 volunteers is supposedly legit because the Brazilian government insisted that it follows FDA's clinical trials guideline for western vaccines to make sure the data is meaningful and comparable (same vaccine/placebo source for equal representation of age ranges, genders, ethnicities, and so on), so that's the one everyone are paying attention to, but now China wouldn't let them announce their results for a third time and want to
"consolidate data from the trials in Indonesia and Turkey" (???)
My guess is Brazil's "at least 50% efficacy" number is certainly higher than a coin-toss, but it is nowhere near the numbers from the tiny trials that did NOT follow FDA's standard protocol for Phase 3, and if Sinovac really going to lump apples and oranges into one basket instead of letting people know the result from perhaps the only legitimate Phase 3 trial they have in Brazil, I think the final consolidated number is even more meaningless than AstraZeneca's
"up to 90% efficacy (but only in young people)" when they consolidated the half-dose results with full-dose.
Nailed it!
Further details remains to be seen, but this number is much more believable than those fake-ass cherry-picked numbers from a handful of people in Turkey and Indonesia that China wants to consolidate together for a higher average.
As expected, Sinovac and Sinopharm will mainly compete with AstraZeneca in the developing world who missed out or can't afford the premium stuff, though I expect AstraZeneca will win with its much cheaper price tag and peer-reviewed results published in medical journals.
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Butantan announce Sinovac vaccine 78% effective in Brazil trial, experts call for more details
Eduardo Simões
SAO PAULOSAO PAULO (Reuters) -A coronavirus vaccine developed by China's Sinovac Biotech was 78% effective in a late-stage Brazilian trial with no severe COVID-19 cases, researchers said on Thursday, although a lack of data details stirred calls for more transparency.
The trial results, closely watched by developing countries counting on the vaccine to begin mass inoculations to help end a raging pandemic, was below preliminary findings from Turkish researchers and lacked detailed data provided on U.S. and European vaccines.
The director of Brazilian biomedical center Butantan, Sinovac's research and production partner, said detailed results were being submitted to health regulator Anvisa as part of a request for emergency use of the vaccine.
"One thing is a presentation at a news conference. It's something else to get the data and analyze it, which is what Anvisa will do," said Cristina Bonorino, who sits on the scientific committee of the Brazilian Immunology Society. "If it's what they say, that's an excellent result," she added.
Brazil and Indonesia, which have the most COVID-19 cases in Latin America and Southeast Asia, respectively, are preparing to roll out the vaccine, called CoronaVac, this month. Turkey, Chile, Singapore, Ukraine and Thailand have also struck supply deals with Sinovac.
Although CoronaVac's efficacy falls short of the 95% success rate of vaccines from Moderna Inc or Pfizer Inc with partner BioNTech SE, it is easier to transport and can be stored at normal refrigerator temperatures.
The 78% efficacy rate is also well above the 50% to 60% benchmark set by global health authorities for vaccines in development early in the pandemic, given the urgent need.
Moderna and Pfizer/BioNTech released detailed results of late-stage trials last year, before receiving emergency use authorizations in the United States and elsewhere.
Butantan Director Dimas Covas told a news conference that full CoronaVac data would be released in an unspecified scientific publication but did not provide a timeline.
Pressed by journalists, Covas said there had been 218 COVID-19 cases in the trial of 13,000 volunteers. Just over 160 of those cases occurred among participants who received a placebo and the rest were in vaccinated volunteers, he said.
Unlike other studies of the vaccine, Brazil's CoronaVac trial included elderly volunteers, a particularly vulnerable population.
Covas said CoronaVac had entirely prevented severe COVID-19 cases among the vaccinated group, including the elderly. None of those who received the vaccine become ill enough to require hospitalization, he added.
FEW DETAILS
Piecemeal disclosure of results from global CoronaVac studies have led to concerns about transparency of the trials, which was not helped by Butantan's news conference.
"It was not clear or transparent," said Denise Garrett, an epidemiologist who worked 23 years at the U.S. Centers for Disease Control and Prevention (CDC). "They presented secondary outcomes on preventing mild cases, serious ones and hospitalizations, but not the efficacy in preventing disease."
The partial disclosure by Butantan, which had delayed its announcement three times, citing obligations to Sinovac, added to skepticism about the Chinese vaccine in Brazil. Nearly half of Brazilians said they would not take a COVID-19 vaccine developed by China, according to a December poll.
Brazilian President Jair Bolsonaro has expressed disdain for the Sinovac vaccine, citing doubts about its "origin." He has traded barbs with political rival João Doria, the governor of Sao Paulo, which is funding trials and production of the shot.
Still, Health Minister Eduardo Pazuello said on Thursday that the federal government would buy Butantan's full output of CoronaVac this year, nearing a deal to buy 100 million doses for a national immunization program.
Brazil has the world's second-deadliest outbreak after the United States, with a death toll that passed 200,000 on Thursday, and aims to vaccinate 51 million people, or about one-fourth of its population, in the first half of 2021. [nL1N2JI32B]
Immunizations have not yet begun. Doria reiterated that Sao Paulo, the country's most affluent and populous state, expected to start vaccinations on Jan. 25.
Based on traditional vaccine technology using inactivated coronavirus to trigger an immune response, CoronaVac can be stored temperatures of 2-8 degrees Celsius (36°-46°F) and may remain stable for up to three years.
https://mobile.reuters.com/article/amp/idUSKBN29C1VZ
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