Indonesia, one of the first nations to bet its Covid-19 vaccination campaign on Sinovac Biotech Ltd., was set to announce a mind-boggling development, which would help justify a plan that has been shrouded in controversy for months. In Beijing, however, the company’s general manager was unaware.
A A study of some 128,000 health workers in Jakarta released Wednesday found that Sinovac’s vaccine – known as CoronaVac – was much more protective than clinical trials had indicated. A day earlier, this had not been mentioned by CEO Yin Weidong in a broad interview with reporters at Bloomberg, and representatives later confirmed that the company did not know the announcement was coming.
It’s a disconnect that echoes the events of Christmas Eve 2020, when the Chinese developer who will be the key to immunizing much of the developing world had little explanation for why Brazil and Turkey have released wildly divergent data on its firing hours apart. In January, the Sinovac vaccine had seen four different efficacy rates – ranging from as high as 91% to as low as 50% – raising concern among scientists and putting a question mark on its ability to protect against the virus that still cripples the globe .
Sinovac has already shipped some 380 million doses, more than AstraZeneca Plc and just behind Pfizer Inc. globally. But unlike these companies – and even Sputnik firing in Russia – he still has not published data in an academic journal, the gold standard used by experts to evaluate a vaccine.
Places that use Sinovac fire
|South and Central Asia||Sub-saharan
|Middle East and North Africa||Central and Eastern Europe||Latin America and the Caribbean|
For the emerging biotechnology industry in China, the pandemic was meant to be an unprecedented opportunity to present the progress they have made over the past decade – and in many ways, dozens of countries are depending on the gunfire from Sinovac and its Sinopharm counterpart to get out of Covid-19. Yet, while pharmaceuticals developed in China have never had such reach, the rollout has exposed their limitations and the difficulties Chinese companies face when trying to compete on the global stage, where higher standards. responsibility and information sharing are required only at home.
Sitting Tuesday in his office at the sprawling Sinovac plant in the southern suburbs of Beijing, CEO Yin was unimpressed by the criticism of communication around his vaccine, and unfazed that it may have affected public perceptions. from his view.
“I respect all the doubts around CoronaVac, which is a testament to the attention we are receiving, but the most important thing is to seek approval to use the vaccine in a country – it is not up to public opinion but to ‘strict scrutiny from the authorities,’ Yin said in the interview. “What do you think is more important than that?”
The divergent efficacy rates were simply a function of the different strains of the virus that were present in countries where Sinovac’s phase III trials were underway, Yin said, adding that Sinovac relied on those countries and their partners on the ground to disseminate and interpret the results.
But the puzzling numbers – and other negative publicity around the shot the company didn’t do to deflect – had an impact, fueling criticism in Brazil of the vaccine by President Jair Bolsonaro and undermining confidence in Hong Kong, where the coup of Pfizer and BioNTech SE is rather favored. Despite its list of global orders, CoronaVac has yet to be approved by the World Health Organization, which has requested more detailed information, as have regulators in Singapore. Hong Kong approved the shot, but only after waiving the requirement for publication and peer review in a journal.
Once the exclusive competence of scientists, the pandemic has seen technical details such as the effectiveness of vaccines dissected by everyone from investors to ordinary citizens. Western pharmaceutical companies quickly realized the power of this information and the need for constant communication, with most using a unified protocol to aggregate the data themselves into single reports rather than allowing local partners to relay them. information.
Given the intense attention, public perception of the safety and strength of vaccines has not only influenced whether people will take them, but also the actions of governments. AstraZeneca vaccine was suspended in a number of European Union countries in March due to anxiety over blood clots, although the block’s drug regulator said its benefits outweighed the risk of effects very rare secondary.
In contrast, Chinese vaccine developers have communicated much less. Like Sinovac, state-run Sinopharm, whose vaccine is administered from the Maldives to Hungary, has yet to publish its clinical trial data in a peer-reviewed journal, although a study has appeared in a national study. The company does not generally respond to requests from foreign media.
Used to operating in China, where public opinion is censored, Chinese vaccine makers have struggled to show their “growth in front of the world, in a very tight time, in a period of heightened surveillance,” said Helen Chen , Greater Chinese Managing Partner of LEK Consulting, which has advised global pharmaceutical companies on their strategy in the country.
AstraZeneca has also been criticized for testing snafus and side effects, but has acted to neutralize it, Chen said.
“AstraZeneca has been criticized for providing poor data, but you see them trying to explain it.” she said. For the Chinese developers, “we just haven’t seen this level of polish and communication about it, which makes everyone think they need to be hiding something. “
Yin has built Sinovac from the ground up for the past 20 years, but so far the company has made most of its $ 510 million in annual revenue in China and hasn’t had to deal with the genre. scrutiny observed in the West. Sinovac is more concerned with the safety and deployment of vaccines to as many people as possible, as this is critical in determining whether countries can emerge from the pandemic, Yin said.
The best way to judge the Sinovac vaccine is to publish its data in peer-reviewed articles, which “prove that these studies and clinical trials were done in the right way and showed strong efficacy results,” said David Heymann, epidemiologist at the London School of Hygiene and Tropical Medicine.
So far, Sinovac has only provided an unpublished draft of a study by researchers at the company and its Brazilian testing partner that has been submitted for publication to The Lancet. This lack of peer-reviewed scientific data has allowed speculation about Sinovac – and in turn, Chinese vaccines more generally, for which it is considered a flagship – to flourish. A WHO expert group that reviewed existing data from Sinovac at the end of April said it had a high level of confidence in the effectiveness of CoronaVac, but there was no was not enough information to assess the potential for serious side effects in people aged 60 or older and those with the medical conditions.
The irony is that while the divergent efficacy rates have contributed to the suspicion surrounding the Sinovac firing, the evidence emerging in the real world is increasingly positive.
Officials in Chile – which has vaccinated 41.5% of its population, mostly older people – CoronaVac credit for lowering Covid death and hospitalization rates. While cases have increased again there, which Yin says is due to the fact that young people have not been vaccinated as widely, actual data from Chile shows that CoronaVac prevented 80% of deaths in children. people vaccinated and protected 67% of the development of symptomatic Covid.
Indonesian data that Sinovac was not aware of were even more positive than Chile’s results, concluding that the vaccine protected 98% of health workers studied against death and 96% against hospitalization as early as seven days after being trapped. Additionally, the gunshot protected 94% of workers from symptomatic infection, well above deviation rates seen in clinical trials of Sinovac.
The fact that Chinese vaccines are now being administered outside the country and around the world is a significant achievement, which would have been “virtually unthinkable” before the pandemic, said Brad Loncar, managing director of Loncar Investments, which owns shares. in the Chinese vaccine. manufacturer CanSino Biologics Inc. and Shanghai Fosun Pharmaceutical Group Co, license holder for Pfizer-BioNTech vaccine in the Greater China Area.
“Without a doubt, the transparency that Chinese companies and regulators have shown is far from the highest level and needs to be improved,” he said. “This is what it takes to gain the greatest public confidence in medicine, and this is why the United States has achieved this gold standard.
“If China is to be a world leader in medicine at this level in the future, at some point it will have to get there from a transparency and regulatory standpoint.”
– With the help of Emma O’Brien, Dong Lyu and Claire Che