As the international rush for Covid-19 vaccines intensifies, Chinese and Russian manufacturers have found a growing list of foreign buyers despite lingering concerns over incomplete test data and the stringency of domestic approval processes.
The Russian Institute for Epidemiology and Microbiology Gamaleya has agreed to sell its Sputnik V vaccine to countries such as Algeria, Argentina, Saudi Arabia and Brazil, while the two main Chinese manufacturers have signed agreements with over a dozen countries including Bahrain, the 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 major political and commercial coup. China, in particular, has made bold promises that its vaccines will bring diplomatic victory by playing a leading role in the global vaccination campaign.
“Covid has the potential to dramatically change the way the world views Chinese vaccines,” said Jennifer Huang Bouey, Chinese health policy expert at RAND, a California-based think tank. “We might for the first time see a critical vaccine from China on the world stage.”
Yet despite all the big ambitions and the queue of willing buyers, neither the Gamaleya Institute nor the major Chinese manufacturers, Sinopharm and Sinovac Biotech, have released full sets of test data, leaving most of the scientists unable to make rigorous comparisons with their Western rivals.
“I am very confident with the data we have on mRNA vaccines,” said Fiona Smaill, pathologist at McMaster University in Ontario, Canada, referring to the jabs developed by the American company Moderna and the German partnership. American company from BioNTech and Pfizer. “Because we don’t see the same data for Chinese vaccines, it’s much more difficult for us to have the same confidence.”
Major Chinese and Russian vaccines have all published promising early-stage clinical trial results in international peer-reviewed journals such as The Lancet. In each case, Phase 3 safety and efficacy trials were then set up to meet international standards in terms of scale and process, experts said.
But the full interim results of those trials – the data underlying the efficacy conclusions – were not released until the vaccines received regulatory approvals in China or Russia, or elsewhere. countries that have registered the vaccines for use.
“Approvals without publishing full Phase 3 data is becoming a trend,” said Prof Raina MacIntyre, infectious disease specialist at the University of New South Wales in Sydney. “At the end of the day, when you talk about releasing a vaccine to the public, you want that data released.”
In Russia, President Vladimir Putin made Sputnik V the world’s first recorded vaccine in August – its name is a nod to the Soviet satellite that launched the space race – when he hadn’t finished only phase 2 trials involving 76 participants.
Sputnik V phase 3 trials began in September on 30,000 volunteers. Although they won’t end until later this year, the state-run Gamaleya Institute said in November that preliminary data from the trials showed the vaccine’s effectiveness to be 92% – on par with its western counterparts. The shot uses a harmless adenovirus to deliver the immune protein into the body, similar to the Oxford / AstraZeneca jab technology. The Gamaleya Institute says it has been working on adenoviral vaccines since the 1980s and highlights its recent success with an Ebola vaccine in 2015.
In China, authorities have cleared 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 effective in 79% in an interim analysis of the Phase 3 results. Earlier that month, Bahrain and the United Arab Emirates, which also tested the vaccine, said it was 86% effective. None of the announcements contained key information normally considered by regulators, such as the number of infections among trial participants. Sinopharm did not respond to a request for comment.
Conflicting efficacy data have also been published for the Chinese vaccine developed by Sinovac Biotech. The shot was found to be 91.3% effective in the trials in Turkey and 65% in the trials in Indonesia. In Brazil, the organizers of the trial announced that it was 78% effective, then amended this rate to 50.4% when “very mild” cases have been included.
Sinovac told the Financial Times the findings were “objective” and “reasonable” from conducting independent testing in multiple locations. But the muddled statements raised fears of a blow to public confidence in places like Hong Kong, which is likely to delay its deployment of the jab until seeing more data.
China’s vaccine industry has long been plagued by quality and corruption scandals, and none of the companies producing Covid-19 injections have been large 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 vaccines – was found to have produced 400,520 doses of inoculations of inferior quality against diphtheria, pertussis and tetanus, known as DTP vaccines.
Efforts have since been made to clean up the sector and, nationally, public confidence has improved. A recent study found that nearly 90% of those polled in China were likely or somewhat likely to take a Covid-19 vaccine, the highest among the 19 countries studied.
But the Chinese vaccine industry is used to providing government-backed immunization programs in its country and struggles to understand how to build trust outside of China, said Jin Dong-Yan, a virologist at the university. from Hong Kong.
“State-owned vaccine makers have hardly ever needed to work on branding or describe their review process because they can count on the government to gain the trust of the public,” he said. Mr. Jin said. “The model of ‘if the nation says it’s OK, then it’s OK’ is clearly insufficient if they are to gain a significant share of international markets.”