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Home >Science >Health >China delays approval of BioNTech Covid-19 shot to preserve confidence in Chines

China’s government is slow-rolling approval of its first foreign Covid-19 vaccine out of concern it could undermine confidence in Chinese vaccines, delivering further evidence of the tenacity of vaccine nationalism in the face of a resurgent pandemic.

Chinese health authorities worry that public doubts about Chinese vaccines stemming from approval of Germany’s BioNTech SE’s vaccine could disrupt the country’s plans to use the homegrown shots to reach an ambitious vaccination goal before the end of the year, according to people familiar with the deliberations.

China was expected to approve the BioNTech vaccine, which is based on state-of-the-art mRNA technology, by July. While Chinese vaccines, made with traditional methods, have proven effective at preventing hospitalizations, Chinese public-health experts had pushed for the introduction of Western vaccines that have proven more effective in clinical studies.

Uncertainty about how much more protection the BioNTech vaccine offers against new variants is also driving the hesitation, the people said.

Clinical trials conducted earlier in the pandemic show BioNTech’s vaccine is around 95% effective against symptomatic disease, compared with 51% for Sinovac BioTech Ltd. and 79% for Sinopharm. The Delta variant cuts BioNTech’s efficacy down to 64%, according to data from Israel, while there is little data about how well the Chinese vaccines protect against the new variant.

In addition, the delay buys more time for Chinese drugmakers to introduce their own mRNA vaccines, according to the people and drug industry executives in China.

A BioNTech spokeswoman said approval is “purely up to the regulatory authorities" and declined to comment further. China’s National Health Commission and National Medical Products Administration didn’t immediately respond to requests for comment.

The politicization of vaccines has resulted in uneven distribution of doses around the world, which threatens to prolong the pandemic as new clusters and variants take hold in sparsely vaccinated populations, public-health experts have warned. In China, a refusal to recognize foreign shots has meant sacrificing access to the world’s most advanced vaccines.

The U.S. Food and Drug Administration this week granted full approval to an identical vaccine produced by BioNTech and Pfizer Inc. Chinese shots made by state-owned Sinopharm and Sinovac, a private Chinese drugmaker, have received World Health Organization approval for emergency use but aren’t yet approved for use by the European drug regulator nor are they under consideration in the U.S.

China’s reluctance to approve the BioNTech vaccine is tied to its strategy for controlling Covid-19. Chinese leader Xi Jinping has ordered officials to fully vaccinate 1.1 billion people, or roughly 80% of the population, by the end of October, according to a speech by a municipal official published on a government website run by central China’s Anhui province. The speech was later removed from the website, but people familiar with the vaccination plans confirmed the 80% number to The Wall Street Journal.

On Friday, China’s National Health Commission said the country has fully vaccinated 889 million people, more than 63% of the population, up from 55% two weeks earlier.

Once China reaches Mr. Xi’s vaccination goal, the government wants to look into booster shots, the people said, adding that public-health officials are leery of derailing the vaccination momentum before then and are no longer sure approving BioNTech is worth the risk.

Chinese public-health officials have previously suggested using mRNA vaccines as boosters to supplement the Chinese vaccines. But they are now encouraged by studies showing a third shot of the China-made vaccines will enhance protection without the potential danger of unknown side effects from the new technology, one health official said.

A preliminary study posted to the preprint server MedRxiv in July showed that antibody levels rose up to fivefold if a third dose of Sinovac’s CoronaVac shot was administered six months after the second dose. Preprint studies haven’t been peer-reviewed.

Meanwhile, China’s Academy of Military Medical Sciences is working with two private Chinese drugmakers to develop an mRNA vaccine that would compete directly with the BioNTech vaccine.

The military, Suzhou Abogen Biosciences Co. and Shenzhen-listed Yunnan Walvax Biotechnology Co. are running late-stage clinical trials for its shot in China and Mexico, and according to the health official, have been lobbying Chinese authorities to expedite an approval.

BioNTech struck up a partnership with Shanghai Fosun Pharmaceutical Group Co. in early 2020 and the two formed a $200 million joint venture to eventually produce the vaccine in Shanghai. The German company hoped that working with an influential Chinese conglomerate would help get its vaccine approved and distributed widely in China, according to people briefed by the company.

Fosun sales people at one point were telling hospitals they could start shipping batches by August, one of the people said.

In response to a request for comment, Fosun Pharma referred to remarks made by Fosun CEO Guo Guangchang in an earnings call this week.

Mr. Guo said the firm was still collaborating with officials and “pressing ahead" with an approval, while continuing to invest in local production and sales.

BioNTech shots earmarked for the Chinese mainland are now headed for Taiwan, which had initially resisted use of the vaccine because Fosun said it had distribution rights on the island, which Beijing claims as its own. Taiwanese health officials said they expect the first batch to get shipped out this month, ahead of schedule.

The first batch could arrive in Taiwan as early as next week, according to a person familiar with the matter.

Mr. Xi has doubled down on China’s Zero Covid strategy for now, issuing an order in August to maintain the tight borders and strict internal controls that have kept the number of confirmed infections there under 100,000, according to people familiar with the discussions.

Some Chinese public-health officials argue, however, that the country will eventually have to learn to live with the virus.

“We should change our mind-set. The goal is not to eliminate the virus but to eliminate people getting sick," Zeng Guang, the chief scientist at China’s Centre for Disease Control and Prevention, said in an internal presentation in early August according to leaked transcripts that he later confirmed to Chinese media as authentic.

Mr. Zeng suggested China could eventually treat Covid-19 vaccines like flu shots and said Chinese vaccines offered several options.

“The state should allow a hundred flowers to bloom and evaluate the dynamic," he said of the country’s future strategy for booster shots.

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