China has all it needs to vaccinate millions, except proof its vaccines work

By Sui-Lee Wee

Hospitals all over China have almost everything necessary for a mass vaccination drive: Millions of doses. Refrigerators to store them. Health care workers trained to administer them.

Everything, that is, except much proof that any of their vaccines work.

Unlike their Western competitors, most Chinese companies have not disclosed data from late-stage clinical trials that would show whether their vaccines are effective; just one, the state-owned Sinopharm, has released findings, which it did on Wednesday. Regulators in China have not officially approved any of them.

That has not deterred local governments across the country, which have begun an ambitious vaccination campaign. The goal is to inoculate 50 million people — roughly the population of Colombia — by the middle of February, before the Lunar New Year holiday, when hundreds of millions of people are expected to travel.

China, where the virus first emerged a year ago, is going to great — and scientifically unorthodox — lengths to prevent a resurgence of the outbreak. While Beijing has not officially announced the vaccine target, the government has signaled the rollout will be managed in much the same way as the outbreak, through a top-down approach that can mobilize thousands of workers to produce, ship and administer the shots. Local officials were told that the drive was a “political mission.”

The campaign will focus on what China calls “key priority groups,” including doctors, hotel employees, border inspection personnel, food storage and transportation workers, as well as travelers. Irene Zhang, a 24-year-old student, got a vaccine on Dec. 22 in the city of Hangzhou before going to Britain next month for graduate school.

“Because my situation is pretty urgent and all the students around me going abroad have taken it, I feel it’s relatively reliable,” Zhang said.

Even before this current campaign, more than 1 million people had lined up to get vaccinated, bewildering scientists who have warned that taking unproven vaccines poses potential health risks. Their efforts now, which are wider in scope, are being rolled out in a similarly ad hoc fashion.

In southern Guangdong province, 180,000 people — mostly workers involved in food storage and transportation, quarantine facilities and border inspection — had been inoculated as of Dec. 22. In the eastern province of Zhejiang, 281,800 people had been vaccinated. In Wuhan, where the outbreak was first detected, the government said it had designated 48 vaccination clinics for its emergency program, which started Thursday.

China, which is testing five vaccines in Phase 3 trials, has not provided any information from this last stage to show the efficacy of these vaccines. By contrast, the United States and Britain started inoculations after reviewing and approving such trial data.

Instead, Chinese officials have issued broad statements with few details, assuring the public that the vaccines are safe and effective. Three of the vaccines have been approved only for emergency use. Last month, Liu Jingzhen, the chairman of Sinopharm, a state-owned vaccine-maker that has two vaccines in late-stage trials, said that none of the roughly 1 million people vaccinated so far had any adverse reactions and that “only a few had mild symptoms.”

On Wednesday, Sinopharm said that one of its vaccine candidates, made by its Beijing Institute of Biological Products arm, had proved to be 79% effective in interim Phase 3 trials. Sinopharm said it had applied for Chinese regulatory approval for the vaccine to be used en masse.

The data and approval are expected to come within weeks. While there have been promising signs, they have come with caveats.

The United Arab Emiratessaid this month that the vaccine made by Sinopharm was effective, although it offered few details on how the conclusions were reached. Bahrain announced much the same, without indicating which of the two Sinopharm vaccines it was referring to.

Turkey said a vaccine made by Sinovac, a private Beijing-based vaccine-maker, has an efficacy rate of 91.25%, a finding that was based on preliminary results from a small clinical trial. Officials in Brazil said the Sinovac vaccine had an efficacy rate over 50% but put off releasing detailed data.

The scale and speed of the vaccination drive are the outgrowth of a centralized public health infrastructure in an authoritarian system. During the crisis, China showed how it can mobilize thousands of workers to reach millions of people; it tested 11 million people in Wuhan in 10 days.

Chinese vaccine-makers have worked to ramp up their production, both for the country’s own needs and global exports. The Chinese government has promised to produce 610 million doses by the end of the year and expects to make more than 1 billion doses next year.

“When they say 50 million, they probably will do it,” said Jennifer Huang Bouey, a senior policy researcher at the RAND Corp. and a public health researcher. “The question is how much it would cost and what is the effect.”

China has some advantages in its rollout. Unlike the Pfizer vaccine, those made by Sinopharm and Sinovac are based on traditional methods that use inactivated or weakened forms of the virus, making them easier to store and distribute.

But the pitfalls are plenty, as the U.S. experience has shown. In the United States, just over 2 million people have received a COVID-19 vaccine, far short of the 20 million goal the government had set for this month. Hospitals had to prepare the frozen shots and find employees to staff the clinics.

As China has geared up, local officials have been surveying the number of people in the “key priority groups.” They had to “ensure there were no omissions,” according to a government document from Xinchang County in Zhejiang province.

Just two months ago, it appeared that demand could outstrip supply. The eastern city of Yiwu had offered 500 doses, which were used within hours.

The government has stressed that the vaccination drive is voluntary, and people will have to pay for the inoculations. Yanzhong Huang, a senior fellow for global health at the Council on Foreign Relations and an expert on health care in China, noted that the two-dose regimen could cost about $70, putting it out of reach for the rural poor.

China could also have problems trying to persuade people to take the vaccine. Scientists warn that the lack of transparency could set off fears about taking a new vaccine, especially in an industry that has a history of quality scandals.

Tao Lina, a vaccine expert and a former immunologist at the Shanghai Center for Disease Control and Prevention, said he knew of several health care workers who had declined the shots. “In the minds of doctors, they feel that any drug that has not passed Phase 3 trials is unreliable,” Tao said.

Tao, who got a Sinopharm vaccine on Monday, said he felt confident that the vaccines were safe and effective, echoing officials’ comments that there have been no reports of serious, adverse reactions. But he added that the companies could do better in their messaging.

“If you say that it’s safe, then you should show all kinds of evidence to show that it’s safe,” he said.