China’s Sinopharm Vaccine Approved for Emergency Use By W.H.O.

on May8
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Developing countries racing for coronavirus vaccines now have another dependable option, according to the World Health Organization. And China’s reputation as a rising scientific superpower just got a big boost.

On Friday, the global health agency declared a vaccine made by a Chinese company, Sinopharm, to be a safe and reliable way to fight the virus. The declaration marks a significant step toward clearing up doubts about the vaccine, after little late-phase clinical trial data was disclosed by the Chinese government and the company.

The W.H.O. emergency use approval allows the Sinopharm vaccine to be included in Covax, a global initiative to provide free vaccines to poor countries. The possible inclusion in Covax raises hopes that more people — especially those in developing nations — will get access to shots at a crucial moment.

Rich countries are hoarding doses of vaccines. India, a major vaccine maker, has stopped exports to address its worsening coronavirus crisis. Safety concerns led health authorities in some countries to temporarily pause the use of vaccines made by AstraZeneca and Johnson & Johnson.

“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. Mariângela Simão, W.H.O. assistant director general for access to health products, said in a statement.

Reliable vaccine access could improve even further next week when the W.H.O. considers another Chinese shot, made by a company called Sinovac. But the fanfare may be short-lived. While China has claimed it can make up to five billion doses by the end of this year, Chinese officials say the country is struggling to manufacture enough doses for its own population and are cautioning a pandemic-weary world to keep expectations in check.

“This should be the golden time for China to practice its vaccine diplomacy. The problem is, at the same time, China itself is facing a shortage,” said Yanzhong Huang, a senior fellow for global health at the Council on Foreign Relations. “So in terms of global access to vaccines, I don’t expect the situation to significantly improve in the coming two to three months.”

Sinopharm and Sinovac are producing about 12 million doses a day, just a little over the 10 million doses that China hopes to administer daily to meet the domestic target. The companies would have to produce roughly 500 million additional doses to meet the demands of other countries, according to a calculation of data provided by Bridge Consulting, a Beijing-based consultancy focused on China’s impact on global health.

The vaccine shortage in China underscores the complexity of rolling out a mass vaccination campaign for the world’s most populous nation while also trying to execute an ambitious export program. Companies involved in the vaccine supply chain, such as those making syringes, are working overtime.

“The whole world is short of this vaccine,” said a Sinovac spokesman, Pearson Liu. “The demand is just too great.”

To mitigate the shortfall, Chinese officials said those getting vaccinated in China could delay getting their second shot by as long as eight weeks, or they could combine the same type of vaccine from different companies. They have said the shortage should ease by June.

Andrea Taylor, who analyzes global data on vaccines at the Duke Global Health Institute, called the potential addition of two Chinese vaccines into the Covax program a “game changer.”

“The situation right now is just so desperate for low and lower middle income countries that any doses we can get out are worth mobilizing,” Ms. Taylor said. “Having potentially two options coming from China could really change the landscape of what’s possible over the next few months.”

China’s vaccines have been rolled out to more than 80 countries, but they have faced significant skepticism, in part because the companies have not released Phase 3 clinical trial data for scientists to independently assess the vaccines’ efficacy rates. An advisory group to the W.H.O. published the data this week.

The Sinopharm vaccine developed with the Beijing Institute of Biological Products has an efficacy rate of 78.1 percent, according to the W.H.O. advisory group. The Sinovac vaccine has varying efficacy rates of between 50 percent to 84 percent, depending on the country where Phase 3 trials were conducted. Both vaccines were made using a tried-and-tested technology that involves weakening or killing a virus with chemicals.

The advisory group’s data showed that it had a “high level of confidence” that the Sinopharm vaccine worked in preventing Covid-19 in adults, but a “low level” of confidence for people over 60. The group’s findings were similar for the Sinovac vaccine.

The W.H.O. said that because Sinopharm enrolled few adults above 60 years old in its trials, the health agency could not estimate the vaccine efficacy for this group. But the W.H.O. said it would not restrict the use of the vaccine in that age group because preliminary data suggests “the vaccine is likely to have a protective effect in older persons.”

There is limited data on how well the vaccine will work against the many coronavirus variants cropping up around the world. Chinese vaccines are overall less effective than the inoculations produced by Pfizer-BioNTech and Moderna.

But for China’s leaders, the W.H.O. approval can still be seen as a badge of honor. Xi Jinping, China’s top leader, has pledged to make a Covid-19 vaccine a “global public good.”

After India announced export restrictions on vaccines last month, Indonesia and the Philippines said they would turn to China for help. Last week, China’s foreign minister offered to help South Asian nations get access to vaccines.

Indonesia said it would get additional doses from Sinovac after President Joko Widodo held talks with Mr. Xi. In a speech the same week, President Rodrigo Duterte of the Philippines said he owed “a debt of gratitude” to China for its vaccines.

It remains to be seen whether the W.H.O. approval will change Beijing’s approach to doling out vaccines. China has given only 10 million doses to Covax, though it has independently donated 16.5 million doses and sold 691 million doses to 84 countries, according to Bridge Consulting. Many of the donations were made to developing nations in Africa and Asia.

“They don’t like to subsume their generosity in their products under some U.N. brand,” said J. Stephen Morrison, director of the global health policy center at the Center for Strategic and International Studies. “They are in a historic phase,” he said. “They want the recipients to know that this is China delivering.”

Jason Gutierrez contributed reporting. Elsie Chen contributed reporting and research.

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