What we know about China’s Covid-19 vaccines —

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Early into the pandemic, drug makers around the world began a race to deliver a safe and effective coronavirus vaccine. On March 16, the first dose of US biotech firm Moderna’s vaccine candidate was administered in the US. On the same day, just hours earlier, the first dose of a Chinese Covid-19 vaccine was given to volunteers in Wuhan.

This week, the UK became the first western country to authorize the widespread use of a vaccine developed by Pfizer and German firm BioNTech, after the firms shared final-stage trial data with its medicines regulator. The first jabs could be given to frontline medical workers as soon as next Monday (Dec. 7).

In the intervening months, several of the companies furthest ahead in the effort to provide a vaccine have released preliminary data from late-stage trials of their vaccines’ efficacy and safety (none of the data is peer-reviewed yet).  Meanwhile, Chinese vaccine makers haven’t released any data from this final stage of clinical trials, even though some of these vaccines are already being used on hundreds of thousands of people even outside of clinical trials. Overseas at least two countries have approved emergency use of at least one of China’s vaccines.

But we may see some data and more widespread use of Chinese vaccines soon. On Friday (Dec. 4), Wang Junzhi, the deputy head of China’s task force on vaccine development, said at a briefing that China has 600 million doses ready to administer this year, and promised a “major announcement in the coming one to two weeks.” Wang’s remark came days after Sun Chunlan, China’s vice premier, gave instructions for Chinese drug makers to be prepared to mass-produce the shots during her visit to a major vaccine maker in Beijing.

The rollout of China’s vaccines, like those out of the US and Europe, will have a major impact not only on the global efforts to stop the pandemic, but also on the international diplomatic landscape as Beijing promises developing countries priority access to its doses.

Here’s where things stand on China’s vaccines, including what we know about their safety and efficacy, and how widely they have been administered so far.

How many Chinese vaccines are in development?

Of the roughly dozen vaccines in development out of China, four Covid-19 vaccine candidates from three Chinese companies are at an advanced point in their phase 3, or the final stage, of clinical trials.

Two of the vaccines are being developed by the state-run China National Pharmaceutical Group, or Sinopharm, both via its subsidiary China National Biotec Group (CNBG). For one of the vaccines, known by the initials BBIBP-CorV, a Beijing unit of the subsidiary is working with China’s Center for Disease Control, while the other vaccine is being developed by a Wuhan unit.

Sinopharm’s vaccines were the first among the Chinese vaccines to begin widespread human trials, starting in mid-July in the United Arab Emirates. Later that month, Nasdaq-listed Sinovac, which is developing a vaccine called CoronaVac, also began its late-stage trial in São Paulo, Brazil.

By September, another major player, CanSino Biologics announced that its vaccine, co-developed with a Chinese military research unit, had entered phase 3 trials, with the aim of inoculating 40,000 volunteers. That development effort is led by Chinese infectious disease expert Chen Wei, a military scientist highly regarded in China for her work on an Ebola vaccine.

The technology used by the Chinese shots is different from those deployed by Moderna and Pfizer, which use messenger RNA (mRNA), a genetic material that gives cells the instructions for mounting defenses against a virus that isn’t there. This approach is novel—it hasn’t been used in existing vaccines.

Sinopharm and Sinovac, meanwhile, are developing inactivated Covid vaccines—an approach used often in developing other vaccines—which deploys a dead version of the coronavirus to generate immunity. CanSino’s vaccine, like the AstraZeneca candidate, uses a weakened version of the common cold virus to deliver genetic material to spark antibodies to Covid-19.

Like the other vaccines, these are delivered in two doses given over 14-28 days.

Reuters/Tingshu Wang

A CNBG booth at a trade fair in Bejing in September displays a Sinopharm Covid-19 vaccine.

What do we know about their safety and efficacy?

To be frank, not a whole lot. Yet that hasn’t stopped some of the vaccines from being quite widely used in the country already. In China, over a million people have received injections of Sinopharm’s Covid-19 vaccines, according to Liu Jingzhen (link in Chinese), the chairman of the company, under an emergency use program.

The final stage of clinical trials for the vaccines has largely happened outside of the country, with Chinese officials citing the control of the outbreak within China as hampering the ability to carry out these tests there as well as the desire to improve international acceptance as the reasons for this.

Some 60,000 volunteers from 10 countries have been inoculated with the Sinopharm vaccines as part of clinical trials, according to Liu (link in Chinese). CoronaVac, the vaccine from Sinovac, has been widely tested in Brazil, Indonesia, and Turkey, and scientists affiliated with the effort published some findings from earlier trial stages in the scientific journal the Lancet.

While none of the Chinese companies have revealed preliminary efficacy and safety results from their final trials, Brazilian medical officials say they could release such data for Sinovac’s vaccine as early as this week.

Sinopharm and Sinovac didn’t reply to requests for comment.

Which is the closest to regulatory approval?

Both Sinopharm and Sinovac seem to be running neck-and-neck.

Sinopharm subsidiary CNBG submitted an application to China’s Food and Drug Administration for regulatory approval this month, according to Chinese media reports last week. It’s unclear which of its two vaccine candidates the application was for, or if it applied for both.

Meanwhile, Brazilian regulators have said they expect to see the vaccine that has been tested there—Sinovac’s CoronaVac—get regulatory approval in China this month.

The “major announcement” teased by Wang, the deputy head of China’s task force on vaccine development, on Dec. 4, could refer to upcoming regulatory approval for one or more vaccines.

When is a mass rollout in China expected?

Perhaps as soon as the end of this year, based on Wang’s comments.

The pharmaceutical companies developing the vaccines have already geared up for large-scale production.

Sinovac, for example, has a 20,000 square meter plant (215,000 sq ft) that will eventually be able to produce 300 million doses a year, according to its chairman. Sinopharm, meanwhile, has facilities in Wuhan and Beijing that can produce 2.2 million doses a year. Both developers have said they expect the product to be commercially available by the end of the year.

While there isn’t an official price tag on the vaccines yet, one Chinese city offered Sinovac’s CoronaVac to essential workers at about $60 earlier this year (200 yuan, or $30, for each of two shots). In August, Sinopharm said that two shots of its vaccines—the required injection amount—wouldn’t cost more than $145.

Which other countries will use these vaccines?

China-developed vaccines currently make up a very small portion of global pre-orders of more than 7 billion confirmed purchases for Covid-19 vaccines—most of which have been for the candidates from Pfizer, Moderna, and AstraZeneca. And demand for the Chinese vaccines has mostly come from low or middle-income countries with a few exceptions.

At least two countries in the Middle East have authorized the Sinopharm vaccine for emergency use for healthcare workers and other priority individuals. The United Arab Emirates was the first to do so, in September, while the kingdom of Bahrain granted approval in November. In Bahrain 7,700 people had participated in the clinical trials there, and as of this month the vaccine is available to frontline healthworkers, according to a government spokesperson.

Members of their ruling families, such as Dubai’s ruler and Bahrain’s crown prince, have been among the prominent early volunteers for the vaccine, making the region an early success in China’s vaccine diplomacy efforts.

Going by pre-orders tracked by a Duke University initiative, Chile has signed up for 60 million doses of Sinovac’s CoronaVac, its biggest order of any of the vaccines. Indonesia has placed 50 million orders for it and Brazil has ordered a similar number, while Turkey has placed orders for 20 million doses (which could go up to 50 million). Indonesia has also ordered 60 million doses of one of the vaccines developed by Sinopharm.

Past vaccine scandals in China could make other potential users hesitant until more data are available about the country’s Covid-19 vaccines.

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