BEIJING – China authorized its first homegrown COVID-19 vaccine for general use Thursday, adding another shot that could see wide use in poorer countries as the virus surges back around the globe.
The Sinopharm vaccine had already been given to groups such as health care professionals and essential workers under emergency-use guidelines as part of China's program to inoculate 50 million people before the Lunar New Year holiday in February. But the go-ahead should allow it to be supplied more broadly at home and moves Beijing closer to being able to ship it abroad. It comes one day after British regulators authorized AstraZeneca's inexpensive and easy-to-handle vaccine.
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Both shots have been closely watched by developing countries, many of which have been unable to secure the Pfizer and Moderna doses being snapped up by rich nations. Pakistan's science minister said Thursday that his government will buy 1.2 million doses of a Sinopharm shot, two days after its death toll topped 10,000.
The greenlight came a day after the state-owned company announced that preliminary data from last-stage trials had shown it to be 79.3% effective. That announcement did not detail the size of the control group, how many people were vaccinated and at what point the efficacy rate was reached after injection, and experts have cautioned that trial data needs to be shared.
Officials have said the vaccine standards were developed in “close cooperation” with the World Health Organization. Securing WHO's so-called pre-qualification could go some way toward assuring the rest of the world about the quality of Chinese vaccines, which already face a reputation problem back home. It would also open the path for the shots to be distributed in the global vaccine consortium, COVAX, and potentially in countries that don’t have their own regulatory agencies.
China is eager to ship its vaccines globally, driven by a desire to repair the damage to its image caused by the pandemic that started a year ago in the central city of Wuhan.
Technically, China granted conditional approval for the vaccine, meaning that research is still ongoing, and the company will be required to submit follow-up data as well as reports of any adverse effects after the vaccine is sold on the market, Chen Shifei, the deputy commissioner of the National Medical Products Administration, told a news conference. Final proof of its effectiveness will depend on publication of more data.
Sinopharm, which has another shot under development, is one of at least five Chinese developers that are in a global race to create vaccines for the disease that has killed more than 1.8 million people. While the Pfizer and Moderna shots have been greeted with much fanfare in the West, those shots must be stored at ultra-cold or freezer temperatures, complicating distribution.
The Sinopharm vaccine, like the AstraZeneca one, could be easier for countries around the world to handle since they can be stored at normal fridge temperatures.
Both shots, as well as Russia’s Sputnik, are expected to be supply much of the developing world. That means the cost will also be important. AstraZeneca is expected to cost about $2.50 a dose, while Russia has said its doses will be priced at $10 for the global market. Pfizer’s vaccine costs about $20, while Moderna’s is $15 to $25, based on agreements with the U.S. government.
Chinese officials declined to name a particular price and gave conflicting statements about it. One official said it would be affordable for the Chinese public, but another jumped in to clarify that it will be free. President Xi Jinping had previously vowed to donate a Chinese-made vaccine as a public good to the world.
The Sinopharm shot is already under mass production, though officials did not answer questions about current capacity. It has already been approved in the United Arab Emirates and Bahrain, and is slated for use next in Morocco.
Other countries have also been buying doses of another Chinese vaccine candidate, made by Sinovac Biotech. Turkey received shipments this week of 3 million doses, and Indonesia and Brazil have also purchased it.
Belarus and Argentina both launched mass vaccinations Wednesday using Russia's vaccine, and Guinea has begun giving it to government officials.
In addition to the emergency vaccinations already underway in China, the country plans to start vaccinating high-risk population, such as seniors as well as people with existing chronic illnesses. Officials did not say what percentage of the population they will vaccinate in China.
“This is very exciting that there is another vaccine and one that can be distributed in locations that don’t have the cold chain,” said Ashley St. John, an immunologist at the Duke-NUS Medical School in Singapore. “But at the same time we have to temper the excitement. We have to understand the long term efficacy, effect on transmission and effect on severe disease.”
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Wu reported from Taipei, Taiwan.
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The name of China’s drug regulator has been corrected to the National Medical Products Administration, not the Medical Production Administration.