China Biotechnology, a subsidiary of Chinese state-owned Sinopharm, announced Wednesday (Dec. 30) that it has developed an inactivated neocoronavirus (CCP) vaccine that is 79.34% effective. The company has submitted an application to state regulators for use in vaccination. This is a new step in the company’s goal to become the first in China to obtain authorization for the use of the vaccine.
The 79 percent effectiveness rate is data from an interim analysis of the phase III clinical trial, which is lower than the 86 percent effectiveness rate obtained by the UAE on Dec. 9 based on an initial trial of the same vaccine.
A China Biologics spokesman did not explain why there was such a large difference between the two figures, saying only that more detailed results from the trial would be released at a later date.
This contradiction is also seen in vaccine-related data from another well-known Chinese biotech company, China Kexing Biologicals.
Turkish researchers involved in the collaboration on the Kexing vaccine trial said Thursday that an interim analysis of the Kexing Biologics vaccine showed an effectiveness of 91.25 percent, but data released in Brazil the same day showed the vaccine was between 50 and 90 percent effective.
None of the five Chinese vaccines entering phase III trials have officially completed phase III trials so far, and all have only published sporadic effectiveness data. Medical experts warn that such sporadic data, if not backed up by adequate trial data, will undermine confidence in these vaccines.
The New York Times said scientists believe the data released by Sinopharm is encouraging, but the lack of supporting data makes it difficult to independently assess the results. Sinopharm did not disclose the size of the population tested or any information on serious side effects, which are the kind of data points scientists look for in such statements.
The newspaper quoted Dr. Kim Mulholland, a pediatrician at the Murdoch Children’s Research Institute in Melbourne, Australia, as saying, “We’re dealing with only scattered information on each vaccine of information, but the Chinese company provided even less than the Russian company did.”
The Chinese Communist Party claims that the outbreak is under control in China and that there are not enough patients in the country to participate in the massive phase III clinical trials, so many of the trials are being conducted with the cooperation of foreign countries. Among the countries participating in Chinese vaccine trials are Brazil, the United Arab Emirates, Turkey, Indonesia, Pakistan, Russia and Bahrain.
The efficacy data for the Chinese vaccine lagged significantly behind the vaccine developed by Pfizer and its German partner Biosynergy in the U.S., and the vaccine developed by Modena in the U.S. Both U.S. vaccines have effectiveness rates of about 95 percent.
Chinese Communist Party President Xi Jinping has pledged to make China’s vaccines a global public good. China has already received large orders from countries with large populations in Southeast Asia and Latin America, such as Indonesia and Brazil.
But curiously, no Chinese vaccine development company has published detailed data supporting the effectiveness of its own products.
Nearly a million people have been vaccinated with Sinopharm’s New Crown vaccine in China’s emergency vaccination program. The company says it has not received a single report of adverse reactions and has experienced only isolated minor symptoms. The Chinese Communist Party plans to vaccinate 50 million people by mid-February. Hundreds of millions of people are expected to travel during the Chinese New Year holiday by then.
Chinese officials have repeatedly assured the Chinese public of the vaccine’s safety, saying there have been no serious side effects.
But AFP says China is clearly at a disadvantage in this vaccine race with the West because of the opaque results of the trials, making it hard to win the trust of the international community.
So far, only the United Arab Emirates approved China National Drug’s vaccine for emergency use earlier this month.
Meanwhile, Pfizer’s vaccine has been authorized for use in more than 40 countries. The Modena vaccine has been authorized for use by the U.S. Food and Drug Administration, and several other countries are evaluating the results of their trials.
Benjamin Cowling, a professor of public health at the University of Hong Kong, was quoted by Reuters as saying, “I think it’s good news. The results of the other vaccine trials are being released first through a brief news release, and in a few weeks more detailed reports will be released.”
Experts say it is too early to draw conclusions about the effectiveness of the NLM vaccine for success.
Ooi Eng Eong, deputy director of the Emerging Infectious Diseases Program at the National University of Singapore’s Faculty of Medicine, told Reuters, “The data in question can only be interpreted when key details such as the purpose of the study, the number of participants, the observation period, and the case numbers are seen.”
The Beijing Institute of Biological Products, which is responsible for the development of this vaccine, said it has applied to China’s State Medical Bureau for conditional approval for authorization to use the vaccine. The institute is an arm of China Biotechnology Group, a subsidiary of Sinopharm.
China Biotechnology Group also has a vaccine in late-stage trials. Although the trials are not yet complete, both vaccines have been granted emergency authorization for domestic use in China.
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