BEIJING (AP) – China has approved its first self-produced vaccine COVID-19 for general use, health regulators said on Thursday, marking the addition of another vaccine in the global fight against a virus that grows back in many places as winter begins.
The state-owned Sinopharm two-dose vaccine is the first to be approved for general use in China. The approval comes shortly after the country launched a program to vaccinate 50 million people before the Lunar New Year holidays in February. It also comes a day after British regulators authorized it AstraZeneca’s cheap and easy-to-use vaccine.
Consecutive approvals could result in poorer countries, many of which have been unable to ensure that doses of Pfizer and Moderna are fixed by rich countries, a step closer to getting vaccines sooner. Pakistan’s science minister said on Thursday that his government would buy 1.2 million doses of a Sinopharm vaccine, two days after the death toll exceeded 10,000.
Technically, China granted conditional approval for the vaccine, which means the investigation is still ongoing, and the company will have to submit follow-up data as well as reports of adverse effects after the market sale. of the vaccine, Chen Shifei, deputy commissioner of the National Administration of Medical Products, said at a news conference.
The vaccine was developed by the Beijing Institute of Organic Products, a subsidiary of the state-owned Sinopharm conglomerate. The company announced Wednesday that preliminary data from last-stage trials had shown it to be 79.3% effective.
It is an inactivated vaccine, which means the virus was cultured in a laboratory and then killed. The germ is injected into the body to generate an immune response.
The final test of its effectiveness will depend on the publication of more data. Experts said important data was missing from Wednesday’s announcement, such as the size of the control group, the number of people vaccinated and at what time the 79.3% effectiveness rate was reached after the injection.
Sinopharm is one of at least five Chinese developers who are in a global race to create vaccines for the disease that has killed more than 1.8 million people.
In addition to the emergency vaccinations already underway, China plans to start vaccinating high-risk populations, such as the elderly and people with existing chronic diseases. Officials did not say what percentage of the population will be vaccinated in China.
“This is different in all countries, but the general thinking is that it should reach 60% to protect the entire population,” said Zeng Yixin, deputy minister of the National Health Commission.
Zeng said that in case of emergency, 4.5 million doses have already been administered, including 3 million in the last two weeks.
Practically, conditional approval means that the drug or product in question can be restricted to certain age groups, according to Tao Lina, a former immunologist at the Shanghai Disease Control Center.
Officials refused to name a specific price and gave contradictory statements in this regard. “It will certainly be at the limit of what people can afford,” said Zheng Zhongwei, another National Health Commission official.
A minute later, NHC official Zeng intervened to say the vaccines “will definitely be free for the public.”
The vaccine is already in mass production, although officials did not answer questions about current production capacity.
China’s vaccine, like Russia’s Sputnik shot, could be easier to handle for countries around the world than Pfizer or Moderna shots, which have stricter cold chain requirements. The Sinopharm vaccine can be stored at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit), or at a normal cooling temperature.
Belarus and Argentina launched massive vaccines Wednesday with the Russian vaccine. The Sinopharm vaccine has already been approved in the United Arab Emirates and Bahrain and is planned for use in Morocco.
Other countries have also been buying doses from another Chinese vaccine candidate, made by Sinovac Biotech. This week Turkey received shipments of 3 million doses. Indonesia and Brazil have bought Sinovac vaccines.
China is eager to distribute its vaccines worldwide, motivated by the desire to repair the damage caused to its image by the pandemic that began a year ago in the central city of Wuhan.
President Xi Jinping has vowed to give the vaccine as a public good to the world and China has joined COVAX, a global plan for equal distribution and access.
“We look forward to Chinese vaccines being soon included in COVAX’s vaccine bank and we will soon obtain WHO prequalification,” said Shen Bo, a Foreign Ministry official.
Vaccine standards were developed in “close cooperation” with the WHO, officials said.
Compliance with the WHO qualification could help ensure the quality and effectiveness of Chinese vaccines, which already have a reputation problem, to the rest of the world. return home. It would also pave the way for the distribution of Chinese vaccines to COVAX and potentially to countries that do not have their own regulatory agencies.
“It’s very exciting to have another vaccine that can be distributed in places that don’t have the cold chain,” Ashley St. said. John, immunologist at Duke-NUS Medical School in Singapore. “But at the same time we have to temper the enthusiasm. We need to understand the long-term effectiveness, the effect on transmission and the effect on serious diseases. ”
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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.