With trials of Sinovac Biotech Ltd’s (科興生物) COVID-19 vaccine in Brazil and Turkey suggesting that the inoculation has a protection rate on either side of 90 percent, there is still no final assessment on exactly how effective it is in protecting people against the virus.
Sinovac is finalizing results of phase 3 trials carried out in Brazil, Turkey, Indonesia and Chile, a person familiar with the trials said.
Those tests are relatively independent from each other and conducted according to different protocols, rather than subject to unified norms that typically govern such trials, said the person, who asked not to be identified because the data is not public.
Researchers in Brazil earlier this week delayed releasing complete information on Sinovac’s vaccine, saying only that it was found to be more than 50 percent effective.
Sao Paulo state Secretary of Health Jean Gorinchteyn offered more specific guidance on Thursday, saying that the vaccine “didn’t reach 90 percent” efficacy, which would make it less successful than those developed by Pfizer Inc and Moderna Inc.
“We don’t know how much more than 50 percent it was, whether it was 60 percent, 70 percent or 80 percent, but it’s at levels that allow us to reduce the impact of the disease on our population,” Gorinchteyn said in an interview with Brazil’s CBN Radio. “We knew that the effectiveness would never reach 90 percent.”
Adding to the confusion, Turkey said that a trial of Sinovac’s vaccine showed an estimated efficacy rate of 91.25 percent.
However, the trial in Turkey is based on only 29 cases, which is considered insufficient to draw a definitive conclusion on the vaccine’s effectiveness, the person familiar with the trials said.
The trial would continue to collect COVID-19 cases to get a more finalized reading, the person said.
A Sinovac spokesman declined to comment on questions about the vaccine’s efficacy.
The delay in the announcement of definitive results has created confusion over the effectiveness of Sinovac’s inoculation.
Chinese developers have been slow compared with their Western peers in releasing efficacy data, risking an erosion of confidence in these candidates as the world puts a laser focus on which vaccines might be most successful in fighting the COVID-19 pandemic.
Pfizer and Moderna’s vaccines have been shown to reduce symptomatic cases by more than 90 percent.
The reason Brazil has not yet disclosed complete efficacy numbers is because Sinovac and its partners are reviewing all the COVID-19 cases found among participants, the person said.
The Brazil trial has yielded more than 170 cases, but Sinovac needs to verify them to see whether they all meet the criteria set out by the Chinese drug regulator.
Regulators from Brazil and China, as well as Sinovac, are in the process of analyzing data from the Brazil trial, the person said.
Ultimately, Sinovac hopes to see unified standards to ensure equal comparisons across different trial sites, the person said.
The protocol for the Brazil trial says that COVID-19 cases are diagnosed in line with guidance from the US Food and Drug Administration.
The late-stage trial of Sinovac’s vaccine in Brazil, involving about 13,000 participants, suggested that the inoculation is “safe and effective,” authorities at the Butantan Institute and the state of Sao Paulo said earlier this week.
Sinovac is betting on a successful vaccine to inoculate more people around the world and save lives, especially in developing countries like Brazil that would have limited access to the Pfizer and Moderna vaccines.
Sinovac’s inoculation is potentially better suited to developing countries because it can be kept at normal refrigerator temperatures, while vaccines from Pfizer and Moderna require deep-freeze conditions for storage and transportation.
The Sinovac vaccine has been at the center of a political dispute between Sao Paulo Governor Joao Doria and Brazilian President Jair Bolsonaro, who says that a vaccine from China cannot be trusted.
“I want to make it very clear that the label of this vaccine will be ‘we are not responsible for any side effect.’ Responsibility is yours,” Bolsonaro said in a Christmas Eve address broadcast on Facebook.
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