Observers puzzled by delays in China's approval of BioNTech-Pfizer vaccine

The potent COVID-19 vaccine developed by Pfizer Inc. and BioNTech SE is widely used in the U.S. and Europe, but China has yet to approve the shot, leaving questions about Beijing’s plans for an inoculation that’s heavily coveted in the rest of the world.

Regulators on China’s mainland haven’t signed off on the vaccine nearly nine months after it received its first regulatory clearance in the U.K.

Shanghai Fosun Pharmaceutical Group Co. — which has an agreement with BioNTech to sell it in mainland China, Hong Kong, Macau and Taiwan — has seen its shares fall about 23% below an all-time high set in early August.

The Chinese drugmaker was among the first globally to spot the potential of the mRNA vaccine, which was originally developed by BioNTech.

In a July meeting with investors, Fosun Pharma’s Chief Executive Officer Wu Yifang said the shot had cleared China’s expert reviews and was undergoing final administrative vetting, local business news outlet Caixin reported.

Yet more than a month has passed, and the much anticipated approval hasn’t been announced. It’s also nearly two months behind an end-of-June timeline suggested in articles by the Wall Street Journal and China’s Global Times.

China doesn’t urgently need a new shot because it’s quelled all outbreaks so far. Some analysts say the apparent delay could be due to the government’s reluctance to greenlight a foreign vaccine, with Beijing concerned that approval of the BioNTech shot could be interpreted as an acknowledgment that local shots are less effective than Western ones.

Tensions have run high between China and the West over issues from the virus’s origins to trade in recent months.

Chinese health authorities now worry that if the BioNTech vaccine is approved, a lack of confidence in homegrown shots will make it harder to reach its goals on inoculation rates, the Wall Street Journal reported, citing an 80% vaccination goal it said was set by President Xi Jinping.

Delaying approval also leaves more time for local drugmakers to work on their own mRNA shots, the newspaper said.

On Aug. 25, the chairman of the Chinese drugmaker’s parent, Fosun International Ltd., said the regulatory review was proceeding normally, but didn’t provide a timeline.

Distributed by BioNTech and Pfizer Inc. in the rest of the world, the shot uses cutting-edge mRNA technology and is among the most effective vaccines against COVID-19. China’s decision would impact Fosun Pharma and BioNTech’s earnings, and could also play a role in determining how the world’s most populous nation eventually loosens its pandemic restrictions.

“This whole thing about BioNTech not reaching the hospital is a huge mystery,” said Joerg Wuttke, the Beijing-based president of the European Union Chamber of Commerce in China.

As far back as last year, Fosun Pharma was asking such groups if their members would be interested in getting the vaccine, but the timing on when it will actually be available in China is now unclear and appears to keep shifting, he said.

BioNTech has agreed to supply at least 100 million doses to mainland China this year. Fosun and BioNTech have agreements on dividing profits on the shot in the greater China region, where Pfizer doesn’t have the rights to sell it. Fosun Pharma and China’s National Medical Products Administration didn’t respond to requests for comment. BioNTech declined to comment.

“We hope the vaccine can arrive in mainland China’s market as soon as possible,” Fosun International’s Chairman Guo Guangchang said on an Aug. 25 earnings conference call, adding that the company had received support from all levels of the country. “I haven’t seen any deliberate stalling of the process.”

Meanwhile, vaccines initially intended for the mainland could end up elsewhere. The Taiwan Centers for Disease Control said on Aug. 25 that the island could receive the BioNTech shot earlier than scheduled as a batch licensed by Fosun Pharma and previously meant to be sold in other places would be ready by the end of August.

If permitted on the mainland, the BioNTech shot would be the only foreign inoculation to join seven locally made ones in China, which studies have found to be less effective than mRNA shots.

Approving the BioNTech vaccine would introduce competition against Chinese vaccines and could even be seen as denting confidence in Chinese inoculations, said Huang Yanzhong, director of the Center for Global Health Studies at New Jersey’s Seton Hall University. “There is no reason to not approve the vaccine if they are judging by its safety and efficacy,” he said.

Wuttke said there’s speculation that China might want to withhold approval for a foreign vaccine until Chinese shots are accredited in the European Union. “So if China makes the approval of BioNTech contingent of the approval of Sinovac and Sinopharm in Europe, then I think we’re in for a long march,” Wuttke said.

Earlier this year, Gao Fu, director-general of the Chinese Center for Disease Control and Prevention, discussed changing things like dosage or mixing vaccines to enhance the protection offered by Chinese shots. The remarks were interpreted as an admission of the lower efficacy of Chinese vaccines, but in a later interview with state media, Gao said he was misunderstood.

China in recent weeks has also weathered its worst domestic outbreak since the virus emerged in Wuhan in late 2019. It did so by largely relying on techniques like mass testing and quarantines.

“Maybe the reason you haven’t seen them worked out in China means that the situation on the ground there isn’t currently viewed as an emergency,” Brad Loncar, chief executive officer of Loncar Investments said of the BioNTech shot.

About 55% of China’s population is fully vaccinated, still far from the more than 80% some experts see as crucial. The more infectious delta variant is making it harder for nations to achieve herd immunity.

The efficacy of inactivated vaccines from China’s Sinovac Biotech Ltd. and Sinopharm and the one-shot viral vector vaccine from CanSino Biologics Inc. have been below 80% in clinical trials. Some Chinese vaccine makers also have experimental mRNA vaccines in Phase III testing.

Against the delta variant, BioNTech’s mRNA vaccine was found to be 88% effective in preventing symptomatic disease, according to a U.K. study. A separate study on vaccinated COVID-19 patients and their close contacts in an earlier outbreak in the southern Chinese province of Guangdong found that the two inactivated vaccines from Sinopharm and Sinovac have a combined effectiveness of 70% against pneumonia caused by COVID-19 and 100% against severe disease.

In recent months, people familiar with the matter have said that Beijing was considering using the BioNTech shot as a booster in China. Still, the global debate around the use of boosters has been getting more complicated.

The World Health Organization has, in recent weeks, urged wealthier nations to hold off on boosters for now to ensure more equitable distribution of vaccines globally. On Friday, China said those at higher risk of getting COVID-19 could seek a booster shot six months after they are fully vaccinated, though officials didn’t specify which vaccines would be used as booster shots.

If the BioNTech vaccine has been under administrative review as Fosun’s Wu suggested, that means the drug regulator would usually make a decision within 20 days. If they did approve the shot, the certificate of approval would be given in 10 days, according to China’s drug registration rules. That could still leave the door open for an approval soon.

“I’ve seen people saying there’s 90% chance the vaccine will be approved on the mainland in August,” Seton Hall’s Huang said. “But there’s also no indication it will ever be approved.”