China’s Xinguan Vaccine Trial Data Worrisome, Vaccine Diplomacy Difficult to Shake U.S. Position

In Phase I and Phase II trials, the vaccine produced lower levels of antibodies in human blood vessels than in recovered neoconvicts, according to data published Tuesday in the British medical journal The Lancet.

In addition, some of the 743 participants had adverse reactions, which was as high as 38% in some trial groups. In contrast, the vaccines from U.S. pharmaceutical companies Moderna and Pfizer produced levels of antibodies that were comparable to, or even higher than, those produced by people recovering from the new coronavirus. The report does not provide specific data on the effectiveness of the Koxing vaccine, which was about 95% effective for both Moderna and Pfizer.

Oxford University scholar Lyman Fu told VOA that although the Chinese researchers emphasized the safety and effectiveness of the vaccine in their report, the data were not satisfactory. The Chinese company Kexing’s vaccine has just released data from a phase II trial and it doesn’t look good, producing lower levels of antibodies in humans than Moderna’s and Pfizer’s vaccines, and it’s more toxic, which means people are more likely to experience side effects such as pain, nausea and other severe reactions,” he said. From these early data, if you had a choice, you would prefer these two Western vaccines that can be approved by regulatory agencies in developed countries.”

Dr. Paul Offit, co-inventor of the rotavirus vaccine and director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, questioned China’s delay in giving specific data on effectiveness and safety, saying, “Pfizer and Moderna have provided data, there’s no reason why China can’t give data, they’re way ahead of us. When I was asked earlier which would be the first commercial vaccine, I said it would be an inactivated vaccine from China. But we haven’t seen any data from the phase 3 trial yet.”

Three of the four vaccines are traditional inactivated vaccines, including the aforementioned Kexing vaccine, while the Moderna and Pfizer vaccines are both “messenger RNA” or mRNA vaccines. Traditional vaccines produce the active ingredients of a virus in vitro and then refine them into a vaccine for injection into the body. mRNA vaccines use a new technology that injects nucleic acid substances into the body, allowing the vaccine ingredients to be produced in the body and then continuously stimulate the body’s immune system to develop resistance.

Compared to inactivated vaccines, mRNA vaccines do not require a new coronavirus in the production process, so they are less expensive and can be produced quickly and in large quantities; in terms of effectiveness, mRNA vaccines can also cope with virus mutations to some extent, and the immunity period is longer after injection.

However, inactivated vaccines have their own advantages, such as low temperature requirements for storage and transportation, with a shelf life of 1-3 years at 2-8 degrees Celsius. In terms of risks, inactivated vaccines have been around for decades and are technically mature. mRNA vaccines are the first of their kind in human history and may have some unknown risks.

Dr. Stephen Morrison, director of the Center for Global Health Policy at the Center for Strategic and International Studies, told VOA that there are legitimate concerns about China’s choice of traditional inactivated vaccines. China’s inactivated vaccine is a dead virus injected into the body, which is the most standard and traditional type of vaccine, and there’s a lot of research and history to prove its effectiveness,” he said. So China would say that maybe our vaccine is the oldest of the vaccines, but we know and believe in it and have confidence in it and can anticipate the possible risks and problems,” he said. China’s choice is a reasonable and safe one.”

Morrison noted that the problem with the Chinese vaccine is not so much the type, but the lack of data transparency and the Chinese government’s shortcutting approach. China currently has two inactivated neoconazole vaccines that have been rolled out for mass vaccination, and China National Pharmaceutical Group said in September that two vaccines it developed have been administered to hundreds of thousands of people in the country.

It’s important to note that neither vaccine has yet completed clinical phase III trials and has yet to prove its effectiveness and safety in trials. No other country has ever administered an untested vaccine on such a large scale outside of routine drug testing procedures.

Sinopharm chairman Liu Jingzhen said in early November that none of the hundreds of thousands of people who have received the group’s two vaccines have had any serious adverse reactions, and that 56,000 people who have left China since the vaccines were administered have not been infected.

However, between 2004 and 2018, China has had nearly 10 vaccine scandals, including the famous Changchun Changsheng case, which resulted in hundreds of thousands of children receiving faulty vaccines and showed the chaos in China’s pharmaceutical industry. Among the pharmaceutical companies involved in the Phase III trial, Wuhan Bioproducts Research Institute, as well as the aforementioned Kexing, have also been involved in vaccine scandals.

In 2016, Kexing’s general manager, Yin Weidong, was exposed for bribing vaccine regulatory officials in order to get his vaccine product approved.

Morrison noted that the international community is still reeling from these vaccine scandals, and that Chinese vaccine maker Concino has previously sought emergency approval to use its experimental vaccines in several countries without completing Phase III trials. China now has several potentially successful vaccines and has already begun vaccinating the general population,” he said. They claim to have proven efficacy and safety of these vaccines, but they have not yet completed Phase III trials to meet the standards and requirements to be approved by WHO, and it is difficult to get many countries to accept their vaccines. China is under a lot of pressure in this regard. They are scrambling to come up with a legitimate and credible vaccine, specifically trial data. But China is taking shortcuts and changing regulations, and many countries see this as a problem.”

At the same time, China is engaging in “vaccine diplomacy,” not only conducting vaccine trials in nearly 20 countries, but also pledging to prioritize vaccines to countries of strategic value, including the Philippines, Indonesia, and Brazil, China’s most important political and economic partner in Latin America, as well as those with strategic claims in the South China Sea. The Mexican Foreign Ministry said in June that China plans to provide $1 billion in loans to give countries in Latin America and the Caribbean access to China’s New Crown vaccine.

We’re going to see a lot of low-income countries using Chinese vaccines, so China is ahead of us in terms of diplomacy, prestige, epidemic recovery, and competition for influence, but the race is not over yet,” Morrison said. We don’t know if China’s vaccines are safe and effective, and if they’re not safe and effective and they’re already vaccinating large numbers of their own citizens and people in other countries, that could become a big problem and have an impact on China’s reputation, and I hope that doesn’t happen.”

China formally joined the WHO-led New Coronary Pneumonia Vaccine Implementation Program in October, which aims to provide 2 billion doses of vaccine worldwide by 2021, primarily to help developing countries. At the same time, relations between the United States and WHO remain tepid, and the U.S. has not yet said it will join the program.

However, the U.S. spends more on international public health than any other country each year and still has considerable international influence over the long term, Fritzman told VOA. That’s why many countries see the United States as a role model and a leader in the international order, and even as a moral model for advanced, wealthy democracies, and it would be a huge mistake for the United States to concede to China in this area,” he said. But the race is far from over; China has temporarily increased its soft power through various investments, but the U.S. still has a lot to win.”

A 2019 report by the Kaiser Family Foundation, a U.S. healthcare nonprofit, notes that the U.S. is the largest donor to global health, with funding steadily increasing over the past 15 years to $11 billion in fiscal year 2019.

From 2018 to 2019, the U.S. gave 20% of its total budget to WHO, far more than any other country. From 2001 to 2019, the U.S. donated to the most important international medical and health aid agency – The Global Fund to Fight AIDS, TB and Malaria (GFATM) – with a total of $11 billion. The total amounted to $15 billion, or 30% of the total donations to the institution.