China’s drug regulator approved the country’s first coronavirus vaccine for general public use, a sign of confidence in the experimental shots the nation plans to roll out within and beyond its borders.
China’s National Medical Products Administration gave the authorization to a Covid-19 vaccine developed by state-owned China National Biotec Group Co., a unit of Sinopharm, officials told reporters in Beijing Thursday.
With the approval, the vaccine -- which has been authorized for emergency use in China since mid-year along with other frontrunner shots -- will be made commercially available, meaning it can be administered to the general population. Regulators from the U.S. to Singapore have approved shots over the past month, among them vaccines developed by Pfizer Inc., Moderna Inc. and AstraZeneca Plc, but those have been largely for emergency use, a status China granted to its developers months ago.
China will target members of the population at higher risk in its inoculations, among them the elderly and those with pre-existing conditions, and then roll vaccines out to the general public, Zeng Yixin, vice minister of the country’s National Health Commission, said at the briefing.
The country has already administered more than 4.5 million doses of Covid-19 vaccine, with 3 million alone given since mid-December, Zeng said. It is said to be aiming to inoculate 50 million people against the virus by early February, ahead of the annual Lunar New Year holiday. The ratio of adverse reactions, including allergies, is about two in every 1 million, Zeng said Thursday.
Faces Challenges
The go-ahead for broader use underscores China’s determination to be a major player in supplying vaccinations to its own people and countries around the world. Yet the nation faces challenges in winning over the trust of millions of people who may have to rely on its vaccines.
China Is Struggling to Get the World to Trust Its Vaccines
Chinese developers have been slow compared with their western peers in releasing clinical trial data, raising questions over transparency, efficacy and safety as the world puts a laser focus on which vaccines will be most successful in fighting the pandemic. Pfizer and Moderna, which developed cutting-edge coronavirus vaccines that make use of messenger RNA technology, submitted data to the FDA that is publicly available. AstraZeneca’s peer-reviewed results were published in The Lancet this month.
CNBG will publish detailed data about its shots in recognized international medical journals, President Wu Yonglin said Thursday.
“We can’t simply compare whether Chinese vaccines are better or overseas ones,” said Zheng Zhongwei, a National Health Commission official. “Only by comprehensively evaluating the the safety, efficacy, accessibility and affordability of each can we make a scientific review.”
Lack of Trust
Conflicting interim data released by some of the companies has contributed to the lack of trust in China’s vaccines. CNBG said on Wednesday its shot is effective in preventing Covid-19 in 79.3% of people, less than the 86% reported earlier from its trials in the United Arab Emirates.
Rival domestic developer Sinovac Biotech Ltd., meanwhile, has yet to produce definitive results on how effective its vaccine is, with trials in Brazil and Turkey suggesting the shot has a protection rate on either side of 90%. The company is still reconciling results of independent Phase III trials carried out in Brazil, Turkey, Indonesia and Chile, a person familiar with the trials said last week.
The Pfizer and Moderna shots have produced better results, reducing symptomatic Covid-19 cases by well over 90% in giant trials. But the Chinese vaccines have the advantage of easier storage and distribution because they don’t need to be frozen, as the mRNA shots do, making distribution to rural areas and developing countries potentially easier.
Geopolitical Influence
The approval for general use isn’t likely to make a major difference within China itself, given that the country has largely stamped out local transmission of the virus through strict local lockdowns and mass testing. But it could be a game-changer for other countries facing uncontrollable outbreaks -- like Indonesia and Peru -- which have deals for China’s vaccines.
The vaccines could also help China win geopolitical influence and restore an image tarnished by criticism of its initial response to the virus and role as the original epicenter. President Xi Jinping has vowed to share any successful vaccine overseas, and China has joined Covax, a World Health Organization-backed program aimed at ensuring an equitable supply of working vaccines for both wealthy and poor countries.
China’s Race for Covid-19 Vaccine Raises Safety Questions
Chinese vaccines will be priced fairly and reasonably as a public good to the world, and the country is considering various ways of distributing shots to developing nations, including donations, said Shen Bo, an official at the Ministry of Foreign Affairs.
Beijing mobilized its regulators, research institutes and companies to come up with vaccines soon after the novel pathogen first emerged from the central Chinese city of Wuhan in late 2019. That gave the vaccine candidates a head-start, and they were among the world’s first to start testing on humans.
Black Market
But the western peers were faster in providing data on pivotal Phase III trials. The near elimination of the pathogen in China caused delays for the domestic developers, who had to scramble to find testing sites overseas where the pathogen was still spreading rapidly.
Despite the delays, more than a million Chinese received shots under the emergency-use program -- the definition of which was expanded to include frontline medical workers, state-owned employees and students who needed to travel abroad. Even government officials and corporate executives have had access to the shots, raising fears that a black market was developing.
China now has 14 vaccines in clinical trials, five of them in last-stage Phase III, Xu Nanping, deputy head of Ministry of Science and Technology, said at Thursday’s briefing.
— With assistance by John Liu, Claire Che, Kenneth Wong, and Timothy Annett
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