The lack of transparency in reporting the Brazil trial results “is totally unacceptable,” and wouldn’t pass muster in the U.S., Eric Topol, a clinical trials expert and director of the Scripps Research Translational Institute, said in a phone interview. “This doesn’t have a good look to it at all.”
Sinovac didn’t respond to calls outside of office hours. A spokesman said earlier this week that the company could only disclose efficacy data after they are reviewed by Chinese regulators.
‘Cause for Celebration’
The late-stage trial of Sinovac’s vaccine in Brazil, involving about 13,000 participants, suggested the shot is “safe and effective,” authorities at the Butantan Institute and from the state of Sao Paulo said. They were asked to not disseminate the information until it was thoroughly reviewed in China as part of a contractual agreement, they said.
“Our goal was for the shot to be more than 50% effective,” state Health Secretary Jean Gorinchteyn said at a press conference. “A vaccine that reaches at least that is already cause for celebration.”
The group that received the vaccine in Brazil’s trial had no severe cases of Covid-19, and the main side effect reported was mild pain at the injection site, said Dimas Covas, head of Butantan. Efficacy is above the threshold needed for a vaccine to be registered by Brazil health regulator known as Anvisa, which still has to approve the shot, he said.
The trial produced efficacy data that differed from tests carried out in other countries, Gorinchteyn said, without elaborating. He added that Sinovac’s review of the data is slated to take 15 days but could take less than that, and shouldn’t delay the planned Jan. 25 start of inoculations with the Sinovac shot.
“Sinovac has several ongoing trials, and it’s important it gives the data consistency,” Covas said. “The company can’t analyze data from the same vaccine using different criteria, and can’t have three different efficacy rates for the same vaccine.”
The request by China to delay the efficacy announcement and share the data came at about 9 p.m. local time on Tuesday, researchers said. Sinovac is also running trials in Indonesia and Turkey.
It is routine for trials of a drug or vaccine conducted in different groups of patients or locations to produce slightly different results, and research groups typically report results of independent trials separately.
Yet while Butantan and state authorities reiterated their optimism for the shot, Topol said the fact that Brazilian authorities would only say that the vaccine is more than 50% effective, but not provide any more detail, suggests that Sinovac efficacy results may not be as good as those achieved by Pfizer and Moderna Inc.
Sinovac is betting on a successful vaccine to inoculate more people around the world and save lives, especially in developing countries like Brazil that will have limited access to the Pfizer and Moderna shots. Vaccines from Sinovac and other Chinese companies could also help their home country win geopolitical influence and restore an image tarnished by the criticism of its initial response to the virus.
Sinovac’s shot is potentially more suited to developing countries because it can be kept at normal refrigerator temperatures. By contrast, the mRNA vaccines from Pfizer and Moderna require deep-freeze conditions for storage and transportation, making distribution more complicated.
The data delay is also a blow to Sao Paulo Governor Joao Doria’s plan to obtain swift approval and begin vaccinating the state of some 45 million people in January. He’s attempting to move quickly while the central government drags its feet on supply agreements and concrete vaccination dates. Millions of doses of Sinovac’s vaccine, called CoronaVac, have already been shipped to Sao Paulo.
The Sinovac vaccine has been at the center of a political dispute between Doria and President Jair Bolsonaro, who says a vaccine from China can’t be trusted. Bolsonaro, who doesn’t plan to take any coronavirus
vaccine after being infected earlier this year, has openly bickered with Doria, seen as a contender for presidential elections in 2022.
In addition to Brazil’s central government, Butantan is in talks to sell the vaccine to Argentina, Uruguay, Peru, Ecuador and Honduras. Chile is in talks directly with the Chinese company, according to Covas.