January 24, 2021

Chinese and Russian Vaccines in High Demand Despite Having No WHO Approvals

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Russian officials say 1.5m people worldwide have already received its Sputnik V Covid-19 vaccine © Natalia Kolesnikova/AFP via Getty Images

As the international scramble for Covid-19 vaccines intensifies Chinese and Russian manufacturers have found a growing list of foreign buyers despite lingering concerns over incomplete trial data and the rigour of domestic approval processes.

Russia’s Gamaleya Research Institute of Epidemiology and Microbiology has agreed to sell its Sputnik V vaccine to countries including Algeria, Argentina, Saudi Arabia and Brazil, while the two leading Chinese manufacturers have signed deals with more than a dozen countries including Bahrain, United Arab Emirates, Egypt, Philippines, Indonesia and Hungary.

For Moscow and Beijing, both keen to see their pharmaceutical sectors compete internationally, the sales represent a significant political and commercial coup. China in particular has made bold promises that its vaccines will deliver a diplomatic win by playing a leading role in the global immunisation drive.

“Covid has the potential to significantly change how the world will see China’s vaccines,” said Jennifer Huang Bouey, an expert on China’s health policy at RAND, a California-based think-tank. “We could for the first time see a critical vaccine from China on the global stage.”

Men in Beijing wait to receive a Covid-19 vaccine developed by state-owned Sinopharm, one of several Chinese groups with a coronavirus shot approved or under development © Roman Pilipey/EPA-EFE/Shutterstock

Yet for all the grand ambitions and the queue of willing buyers, neither the Gamaleya Institute nor the leading Chinese manufacturers, Sinopharm and Sinovac Biotech, have published full sets of trial data, leaving most scientists unable to make rigorous comparisons to their western rivals.

“I am very confident with the data we have on the mRNA vaccines,” said Fiona Smaill, a pathologist at McMaster University in Ontario, Canada, referring to the jabs developed by US company Moderna and the German-American partnership of BioNTech and Pfizer. “Because we don’t see that same data for the Chinese vaccines, it is much more challenging for us to have that same confidence.”

The leading Chinese and Russian vaccines all published promising results from early stage clinical trials in peer-reviewed international journals such as The Lancet. In each case, phase 3 safety and efficacy trials were then set up in ways that appeared to meet international standards in terms of scale and process, experts said.

But complete interim results from those trials — the data underpinning conclusions about efficacy — were not released before the vaccines received regulatory approvals either in China or Russia, or in other countries that have registered the vaccines for use.

“Approvals without publishing full phase 3 data is becoming something of a trend,” said Professor Raina MacIntyre, an infectious diseases specialist at the University of New South Wales in Sydney. “Bottom line is, when you are talking about rolling out a vaccine to the public you want to see that data published.”

Russia has supplied doses of Sputnik V to Argentina © Marcos Brindicci/Getty Images

In Russia, President Vladimir Putin made Sputnik V the world’s first registered vaccine in August — its name a nod to the Soviet satellite that launched the space race — when it had only completed phase 2 trials on 76 participants. 

Phase 3 trials of Sputnik V began in September on 30,000 volunteers. Though they will not conclude until later this year, the state-run Gamaleya Institute said in November that interim data from the trials showed the vaccine’s efficacy was 92 per cent — on a par with its western counterparts. The shot uses a harmless adenovirus to deliver the immunising protein into the body, similar to the technology in the Oxford/AstraZeneca jab. The Gamaleya Institute says it has been working on adenoviral vaccines since the 1980s and points to its recent success with an Ebola shot in 2015.

In China, the authorities have allowed the limited use of several vaccines since the summer and gave conditional approval to a vaccine developed by state-owned Sinopharm in December after the company said it was 79 per cent effective in an interim analysis of phase 3 results. Earlier that month, Bahrain and the UAE, which also trialled the vaccine, had said it was 86 per cent effective. None of the announcements included key information normally considered by regulators such as the number of infections among trial participants. Sinopharm did not respond to a request for comment.

Approvals without publishing full phase 3 data is becoming something of a trendFiona Smaill, McMaster University

Conflicting efficacy data has also been released for the Chinese vaccine developed by Sinovac Biotech. The shot was found to be 91.3 per cent effective in trials in Turkey and 65 per cent effective in trials in Indonesia. In Brazil, trial organisers announced it was 78 per cent effective, then revised that rate to 50.4 per cent when “very mild” cases were included.

Sinovac told the Financial Times the findings were “objective” and a “reasonable” outcome from carrying out independent trials in multiple locations. But the confused releases have raised fears of a knock to public trust in places such as Hong Kong, which is likely to delay its rollout of the jab until seeing more data.

China’s vaccine industry has long been dogged by quality and corruption scandals and none of the companies producing Covid-19 shots have been big exporters in the past.

In 2017, during a public outcry over faulty vaccines, the Wuhan Institute of Biological Products — a branch of the Sinopharm subsidiary developing one of its Covid-19 jabs — was found to have produced 400,520 doses of substandard inoculations against diphtheria, pertussis and tetanus, known as DPT vaccines.

Efforts have since been made to clean up the sector and, domestically, public confidence has improved. One recent study found almost 90 per cent of respondents in China were likely or somewhat likely to take a Covid-19 vaccine, the highest among the 19 countries surveyed.

But China’s vaccine industry is used to supplying government-backed immunisation programmes at home, and has struggled to understand how to develop trust outside China, said Jin Dong-Yan, a virologist at the University of Hong Kong.

“State-owned vaccine makers have basically never needed to work on branding or to describe their review process, because they can rely on the government to gain public trust,” said Mr Jin. “The model of ‘if the nation says it’s OK, then it’s OK’ is clearly insufficient if they want to gain a large share of international markets.”

The Financial Times

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