(WSJ) A Chinese vaccine candidate was found to be 79% effective in protecting against Covid-19 in interim Phase 3 results and was seeking conditional approval from Chinese regulators, a unit of the shot’s state-owned maker said.
Wednesday’s rate was lower than the interim result on the same vaccine released earlier this month by the United Arab Emirates, where vaccine maker Sinopharm is conducting the majority of its final-stage trials. The two-dose shot is approved for emergency use in China and the U.A.E., as well as in Bahrain. China’s go-ahead for conditional use would mean it was approved for mass use but that the drugmaker would still have to submit final data.
The website statement from Beijing Biological Products Institute Co., a drug research and development subsidiary of Sinopharm, was based on an interim analysis from Sinopharm’s Phase 3 clinical trials and didn’t say which countries the results were based on. It also didn’t offer details of how the efficacy rate was determined, such as how many participants received a placebo or vaccine.
The Beijing unit, its parent and Sinopharm all didn’t respond to faxed requests for more information.
Covid-19 clusters have been cropping up in recent weeks in Beijing and other cities, leading authorities to mass test and encourage people to avoid travel and reduce gatherings.
The results, for one of two candidate vaccines being tested by Sinopharm, put the inoculation over the 50% threshold that the World Health Organization and the Chinese drug regulator deem necessary to protect people.
More than 60,000 people were given experimental vaccines by Sinopharm and Chinese company Sinovac Biotech Ltd. under the emergency-use program before leaving China to work in high-risk countries, and none have had a severe coronavirus infection, said Zheng Zhongwei, the director of a vaccine-development group backed by China’s cabinet, earlier this month. He said no severe side effects had been reported in the more than one million people who had been given the vaccine outside trials.
Vaccines developed by Moderna Inc. and jointly by Pfizer Inc. and BioNTech SE, both authorized for use in the U.S., have been shown to have efficacy rates of 94% and 95% in late-stage trials, respectively.
The U.A.E.’s Health Ministry said earlier this month that the interim results of Phase 3 trials there showed an efficacy rate of 86%. U.A.E. officials didn’t respond to requests for comment Wednesday on the discrepancy in results.
Health experts have cautioned that more information is needed on the Phase 3 trials in the Middle East to make people fully confident the shot should be widely distributed. The U.A.E. Health Ministry didn’t disclose how many trial participants developed Covid-19 and how many of those received a placebo or a vaccine. U.A.E. officials have since declined to answer requests for information, saying they would release further details once the trial’s data had been peer reviewed. The U.A.E. also hasn’t disclosed its financial relationship with Sinopharm.
Sinopharm is testing its vaccines in more than 10 countries, including the U.A.E., Peru, Morocco, Bahrain, Egypt and Argentina, in trials involving more than 60,000 participants.
China plans to inoculate as many as 50 million people ahead of the Lunar New Year holiday in February with Sinopharm and Sinovac vaccines, people familiar with the matter said earlier this month.
Some provinces and cities including Shanghai and Shenzhen have rolled out vaccination in what authorities called key groups: workers in cold-chain logistics, health care, customs, airports, markets, public transport and those going abroad. Authorities have been urging people to get inoculated, though it isn’t mandatory.
Sinovac’s vaccine was found to be 91% effective, based on the early results of Phase 3 trials in Turkey last week, according to state broadcaster China Central Television. The country has a few other vaccine candidates in the final stage of clinical trials, according to the World Health Organization.
Some Chinese developers, including Sinopharm and Sinovac, have said their vaccines can be stored above freezing, making them easier to transport and store in less-developed countries. The Pfizer-BioNTech shots must be stored at ultralow temperatures, requiring specialized equipment, while Moderna’s are kept around minus 4 degrees Fahrenheit.
Source: Wall Street Journal by Erin Mendell
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