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COVID vaccines

WHO approves Sinopharm vaccine for emergency use

Health body's first greenlight for Chinese-made shot raises hopes for emerging-market access

A health worker holds a dose of Sinopharm's coronavirus vaccine, in Lima, Peru, on Feb. 9.   © Reuters

SHANGHAI -- One of China's COVID-19 vaccines gained crucial recognition Friday, nearly one year after its debut, as the World Health Organization approved the shot for emergency use.

The SARS-CoV-2 vaccine by China National Biotec Group (CNBG) -- a unit of state-owned Sinopharm -- joined five Western peers on the WHO's emergency list.

The approval raises hope for boosting supplies in lower-income economies through the COVID-19 Vaccines Global Access (COVAX) initiative.

Saying the world needed to "pull out all the stops" to increase vaccine availability, WHO head Tedros Adhanom Ghebreyesus told a news conference the Sinopharm decision "gives countries confidence to expedite their own regulatory approval and to import and administer a vaccine."

An expert group in the WHO evaluated the quality, safety and efficacy of the Sinopharm vaccine, criteria for the COVAX supply.

"The addition of this vaccine has the potential to rapidly accelerate COVID-19 vaccine access for countries seeking to protect health workers and populations at risk," Dr Mariangela Simao, WHO assistant director general for access to health products, said in a statement. "We urge the manufacturer to participate in the COVAX Facility and contribute to the goal of more equitable vaccine distribution."

Shares of Hong Kong-listed Sinopharm have risen 28% this year, closing Friday at 24.20 Hong Kong dollars.

"[The WHO approval] would send a strong signal that these candidates are safe and effective," Imogen Page-Jarrett, China analyst for The Economist Intelligent Unit, told Nikkei Asia ahead of the decision.

Sinovac Biotech's CoronaVac, another Chinese-made coronavirus vaccine up for evaluation by the WHO, was not granted emergency use approval Friday.

More than 270 million doses of CoronaVac have been administered as of April 22, with 60% of them used by 37 countries and institutions, Sinovac data posted on the WHO website shows. The vaccine has an efficacy rate ranging from 50.65% to 83.5% based on Phase 3 clinical trials in Brazil, Turkey and Indonesia.

CNBG's candidate was first approved for emergency use in China last June, and 65 million doses have been administered in 45 countries since. The company reported an efficacy rate of 78.89%, more than the WHO's requirement of 50%.

This wide use "reflects the fact that many governments are desperate for vaccine supplies, especially as many other vaccine producing countries such as the U.S., [European Union] and India have prioritized their domestic vaccination program over exports," Page-Jarrett said.

The vaccines from Chinese companies could ease the supply bottleneck faced by COVAX and speed the delivery of inoculations to low-income countries, she said.

More than 53 million vaccine doses have been shipped to 121 COVAX participants as of Wednesday. The WHO-led initiative aims to provide 2 billion doses this year to 190 economies that signed up for the facility.

India was anticipated to supply over 80% of COVAX doses, but New Delhi has pressured the Serum Institute -- the country's main vaccine producer -- to cease exports since April, Page-Jarrett said. The South Asian country seeks to redirect supplies toward the domestic population as the outbreak there worsens.

WHO approval was granted previously to the Pfizer-BioNTech vaccine as well as those developed by AstraZeneca, Johnson & Johnson-Janssen, Moderna and the Serum Institute.

SARS-CoV-2 and CoronaVac are among the five Chinese candidates approved for emergency use in China. A lack of information about the products has made them less welcome in developed countries compared with emerging economies. No Phase 3 clinical trial data has been published in a peer-reviewed journal, the British Medical Journal said in a report last month.

"Combined with the history of vaccine scandals in China, this has fueled distrust in Chinese vaccines," Page-Jarrett said.

In a rare acknowledgment, a top Chinese official said last month the country's vaccines provide low protection and proposed mixing them to raise their efficacy.

"We will solve the issue that current vaccines don't have very high protection rates," Gao Fu, director of the Chinese Center for Disease Control and Prevention, said in a presentation on the country's COVID-19 vaccines and immunization strategies at a conference last month. "It's now under consideration whether we should use different vaccines from different technical lines for the immunization process."

Gao later clarified through Global Times, a media outlet affiliated with the Chinese Communist Party, saying he did not specifically cite Chinese vaccines.

"The protection rates of all vaccines in the world are sometimes high, and sometimes low," Gao was quoted as saying. "How to improve their efficacy is a question that needs to be considered by scientists around the world. In this regard, I suggest that we can consider adjusting the vaccination process, such as the number of doses and intervals and adopting sequential vaccination with different types of vaccines."

China has yet to approve the use of any Western vaccines, though authorities reportedly are evaluating Pfizer-BioNTech's product, the distribution of which has been awarded to Shanghai Fosun Pharmaceutical. Pfizer-BioNTech's messenger RNA vaccine boasts an efficacy rate of 95%, but it and other Western inoculations continue to receive negative publicity in Chinese media.

Global Times quoted local health experts in a report Wednesday that cast doubt on Pfizer-BioNTech's protection against COVID-19's new mutant strain in India after the recent death of a foreigner in the country. The victim, an infectious-disease specialist from the U.S., was inoculated with two Pfizer shots before his arrival in India.

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