Depth: There are still issues regarding Chinese vaccine export agreements

Chinese experimental coronavirus vaccines are on the move. Global procurement data shows that three Chinese companies have concluded contracts for the delivery of hundreds of millions of bottles to the world in bilateral agreements with countries such as Indonesia and Brazil.

The elastic mRNA vaccines Pfizer-BioNTech and Moderna are more adaptable and have given enviable results, but the main challenge is to keep them cool enough to prevent the breakdown of their sensitive strands of genetic material.

Chinese vaccine giants have generally applied a more conservative and long-lasting approach to killing the entire coronavirus and giving it to humans to help the immune system respond to the fight against the actual infection.

These vaccines are easier to transport and potentially produce abroad, without cutting-edge technology. But while they may be more attractive to many countries, there seem to be some concerns about the transparency of vaccine manufacturers and the lack of detailed testing data.

Lack of data

The full results of the final phase trials of the Pfizer, Modern, and adenovirus vector vaccines produced by AstraZeneca and Oxford University have been published in peer-reviewed journals for worldwide surveillance.

But Chinese vaccine companies have published only the results of early and middle-level tests, which are not designed to examine whether they actually prevent people from getting the disease. Officials and company bosses have revealed some top results, but no Chinese vaccine has yet been approved for domestic use beyond the controversial and wider emergency program.

Researchers from the Global Health Innovation Center at Duke University in North Carolina followed the commitments of the COVID-19 vaccine, which were taken over by the world’s leading vaccine companies. Their figures show that, in addition to the state’s commitment to the UN-backed COVAX vaccine initiative, three of the four Chinese vaccine companies in the final phase of testing have delivered nearly 380 million doses to Latin America, Southeast Asia and the Middle East. .

That’s just a fraction of the 11.6 billion different doses already pledged around the world, most concentrated in the US, EU, India and the UK – despite their very different populations – as high-income countries protect their bets. . Meanwhile, one model predicts that it could take until September 2023 to make sufficient doses for the entire world.

Researchers from Duke warned that since China, like Russia, controls mostly state chains for vaccine development and production, they are “significantly less transparent than some other countries regarding advance purchases for domestic use as well as exports.”

This means that the assumed obligations of Chinese companies towards foreign countries could be higher than those publicly known, they said.

Overseas trials were closely monitored

Early-stage trials generally check if the vaccine is safe and elicits an immune response and if it can be worked on healthy people anywhere. But the real shot test is whether it prevents people who are exposed to the virus from really catching it.

This can be determined in two main ways: by using ethically questionable “challenging trials,” where scientists intentionally expose inoculated people to the virus; or by vaccinating in the region where the virus is spreading and then recording the number of cases.

It is not known if China is implementing the challenges planned in the UK, but they appear to have been delayed due to ethical approval. Victims of the country’s success in fighting the virus, Chinese vaccine companies have been forced to look for places with uncontrolled spread to test their injections – an effort full of controversy.

The leading race is Sinovac Biotech, a private life science company that has six more vaccines on the market, according to their website. The nephew caught attention in September when CEO Yin Weidong told the media that 90% of his employees were injected with an experimental CoronaVac injection, made from inactivated whole virus and delivered along with an immune booster, as part of an emergency program.

Public figures show that Sinovac has pledged to deliver at least 289 million doses of CovonaWac outside China – mostly to countries that have agreed to test the vaccine. Just over 125 million doses have been earmarked for Indonesia, where President Joko Widodo has pledged to provide free shots to the country’s 270 million residents. Sixty million is planned for Chile, 50 million for Turkey and 46 million for Brazil. All four countries are hosting Phase 3 trials of CoronaWac.

Last month, Sinovac published combined data from phase 1 and phase 2 in the medical journal The Lancet showing that CoronaVac is safe for taking healthy people and elicits an immune response. But it has not yet released data showing whether it prevents the inoculated from catching COVID-19.

The picture was blurred when on December 8, the company’s state partner in Indonesia, Bio Farma, said that the transitional data show that CoronaVac is 97% efficient, which is the best of Pfizer’s 95%. But he quickly withdrew his comment and said the effectiveness could not yet be determined, Bloomberg reported. The son-in-law told Bloomberg the same day that efficiency data were not yet available.

Some have suggested that Bio Farma jumped from a firearm and may have confused the effectiveness – a measure of the vaccine’s effectiveness in stopping people infected with the disease – with the previously announced CoronaVac seroconversion rate of 97%, showing how many subjects produce the virus – fighting antibodies after inoculation.

The effectiveness of Sinovac’s vaccine was expected to be revealed on Wednesday by the Sao Paulo-based Butantan Institute, which has partnered with a Chinese trial company. But suspicions arose when Sinovac told the institute he would keep the details up to next month pending for review in China, Bloomberg reported. The institute only found that the vaccine had crossed the 50% efficacy threshold, which would allow Brazilian health regulator Anvisi to approve it.

Dimas Covas, head of the institute, said the final results of the trial of 13,000 volunteers were denied as part of a contractual agreement with Sinovac and to ensure “consistency of data” among other ongoing surveys of the company.

A spokesman for Sinovac told Bloomberg earlier that the company could disclose efficiency data only after it was reviewed by Chinese regulators.

Butantan is investigating sales of the vaccine – which can be kept at home refrigerator temperature – to other countries in the region, including Argentina, Uruguay, Peru, Ecuador and Honduras.

Anvisa suspended the trial in Brazil last month after a “serious adverse event”, putting it inconsistent with the Butantan Institute. At the time, Covas said it was “impossible” that what happened was related to the vaccine, prompting speculation that Sinovac was embroiled in a political dispute between the two leading candidates for the country’s next presidential election, Bloomberg reported.

Chinese vaccines have faced other setbacks elsewhere. News last week that Cambodia would acquire a million doses from the COVAX initiative – which was set up to subsidize coronavirus vaccines for nearly 100 low-income countries – was considered by some to appeal to Chinese vaccine manufacturers.

In August, Chinese Prime Minister Li Keqiang told Mekong countries, including Cambodia, that they would be given priority when the Chinese vaccine is ready. This was reiterated by Foreign Minister Wang Yi during a visit to Cambodia in October.

However, Cambodian Prime Minister Hun Sen said last week that his country would not accept vaccines that were not certified by the global health authority. “Cambodia is not garbage … and it is not a place to test for vaccines,” he said. Although the comment could exclude Cambodia from trials similar to those that took place in Indonesia and Brazil, the state could eventually get Chinese vaccines if certified by COVAX. China joined the $ 18 billion scheme in October.

State giant Sinopharm, which has two inactivated vaccines near the market – one produced by a Beijing branch and one from its Wuhan unit – has a relatively modest 70 million doses overseas, based on public information. But the footage has high-profile supported people: Sheikh Mohammed bin Rashid Al Maktoum, the ruler of Dubai, received one from the Sinopharm Beijing Institute of Biological Products on November 3, according to a post on his public Twitter account. Other high-ranking officials there also received the shooting, local state media report.

Vaccine data glimpsed advanced trials on 31,000 people concluded in the United Arab Emirates, which state media in the country reported protecting 86% of vaccinated people and not having serious security concerns. Details were not released.

Following the announcement, Abu Dhabi officials said they would start working with local authorities to “continue all activities within two weeks”, including economic, tourism and cultural operations.

The Sinopharma shootings received urgent approval in the UAE in September, and Bahrain in November. In October, Sinopharm Group chief Liu Jingzhen told a news conference that her shots had been subjected to Phase 3 in 10 countries, including Jordan, Peru, Argentina and Egypt.

Meanwhile, CanSino Biologics, which uses the second generation of adenoviral vector vectors to deliver its payload-boosting immune system, has pledged to deliver 20 million shots to Indonesia to date, according to Duke.

CanSino, which uses the same approach as the AstraZeneca / Oxford University vaccine, hit the headlines in March when its vaccine candidate was the first in the world to enter human trials.

New strains

This week, all eyes were on a new strain of the virus that has emerged in the UK and how it could affect vaccination effectiveness.

Experts say the new strain, dubbed B.1.1.7 by British scientists, appears to be more portable than previously known strains, but could actually be less harmful. Its existence is unlikely to thwart current efforts on the vaccine, three immunologists told Caixin.

“He should still be completely sensitive [to current vaccines]”said Marc Pellegrini, head of infectious diseases and immune defense at the Australian Walter and Eliza Hall Institute for Medical Research. But that raises the specter of a more significant future mutation in the virus that could make current vaccines ineffective.

If that happens, the mRNA of the vaccine “could adapt very quickly and very easily” to fight new strains, Pellegrini said. Inactivated vaccines would be harder to repurpose, he said. “From a position of adaptability, mRNA is superior,” he said. “Of course there are warnings about the logistics of transporting it in very cold temperatures.”

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