On March 31, the Chinese government assisted Sri Lanka’s Sinopharm vaccine arrived at Colombo International Airport, and Sri Lankan President Gotabaya Rajapaksa led a number of ministers to the airport to greet it. However, two days later, the expert committee of Sri Lanka’s drug regulatory department issued a statement not approving the vaccination on the grounds that there was insufficient data to prove the safety and efficacy of the Sinopharm vaccine.
This is certainly a major setback to China’s push for vaccine diplomacy.
So far, the World Health Organization has not approved the authorization for emergency use of Chinese vaccines, and on March 7, Gao Fu, director of the Chinese CDC, gave a corresponding explanation on the matter in an interview with the media. According to Gao, we do not have enough phase III clinical data yet, and the WHO evaluation process may be cautious, “which is understandable.
Why hasn’t China come up with enough phase III clinical data? We know that vaccine development and production in China started very early. Last September, there were eight vaccines in Phase III clinical trials worldwide, including four in China. Only until today, WHO has only approved a few vaccines in collaboration with several US, UK and German companies, including: Pfizer, Modena, AstraZeneca and Johnson & Johnson; and none of the Chinese vaccines have been approved by WHO.
Last September 16, China Economic Weekly published an article titled “Phase III clinical trials of the new domestic crown vaccine, why should they be done overseas? According to Chinese experts, because phase III clinical trials require a much larger sample size than phase I and II, and because the domestic epidemic was effectively controlled and sufficient samples could not be provided, phase III clinical trials needed to advance across the border for a larger scale evaluation of vaccine effectiveness and safety.
As early as August 11, the Phase III clinical study of Kexing’s vaccine was launched in Brazil with a planned vaccination population of between 9,000 and 13,000 people. Weidong Yin, Kexing’s chairman and CEO, said, “Brazil has a serious epidemic, a large population and a much larger market in the future.” Countries and regions like Indonesia, Turkey and Bangladesh, Yin Weidong said, “could be available in November or December if things go well.” However, eight months have passed, and the phase III data for the Kexing vaccine has not yet been taken out.
During that time, WHO urged several times. On January 22, WHO Assistant Director-General Mariangela Simao On March 12, WHO spokesperson Margaret Harris said that the review of the Chinese New Crown vaccine was in its final stages and that an emergency authorization for use could be granted soon.
But all we hear is the sound of the stairs, and no one comes down. To this day, Phase III trial data for Chinese vaccines have not been released, and none of the Chinese vaccines have had their Phase III trial data reviewed by international peers.
China has been exporting vaccines to the outside world since August last year, and more than 25 countries have officially started Chinese vaccination, and the global supply of Chinese vaccines has exceeded 100 million doses. The sample size needed for Phase III clinical trials should have been sufficient and more than adequate long ago, so why has the Phase III trial data not been released?
The only reasonable explanation is that the Phase III trial data for Chinese vaccines are low and not very impressive. In mid-January this year, Brazil released data showing that the overall effectiveness of the Kexin vaccine was 50.4%. This is only a little higher than the 50% efficiency threshold set by the WHO and national regulatory agencies. It is said that the efficiency rate of another Chinese vaccine, Sinopharm, is much lower than that of the Kexing vaccine, and it cannot even pass the 50% threshold. Comparing with European and American vaccines, the overall efficiency rate of both Pfizer vaccine and Modena is around 95%, while the overall efficiency rate of AstraZeneca and Johnson & Johnson is around 70%. There is a clear gap between the two.
It is reasonable to speculate that the reason for the delay in releasing Phase III trial data for Chinese vaccines is because of the low efficiency of the relevant data.
Why hasn’t the Chinese vaccine released Phase III trial data? Let’s take a look at the countries that have used the Chinese vaccine.
Brazil was the first country to use the Chinese vaccine and the epidemic in Brazil has intensified rather than abated. Calculations based on official data released by Brazil show that in the week ending March 18, the average number of new confirmed cases and new deaths in Brazil on a single day reached the highest values since the outbreak. The city of São Paulo, where the outbreak is most severe, designated the 10-day period from March 26 to April 4 as a non-working day, hoping to achieve enhanced social isolation and contain the spread of the virus.
The vaccine used in Brazil is the UK’s AstraZeneca vaccine in addition to China’s Kexing vaccine, so while the situation in Brazil may not be very telling, the situation in Chile, which primarily uses China’s Kexing vaccine, is very telling. Chile is also one of the few countries with the highest vaccination rates. The recent rebound in Chile has been severe, with a record number of new confirmed cases in a single day and a high rate of admissions to ICUs, with 95% of ICU beds now full. The Chilean government has implemented the largest city closure since the outbreak began on March 27, affecting more than 80% of the country’s population.
In contrast, several other countries with the highest vaccination rates, Israel, the United States, and the United Kingdom, have seen a significant downward curve in the epidemic. Israel uses Pfizer vaccine, the US uses Pfizer and Modena, and the UK uses AstraZeneca. It is not necessary to say much about Israel and the United States, but here it is particularly important to mention the United Kingdom because the vaccination rate in the United Kingdom is very close to Chile. On April 6, Prime Minister Johnson announced that the United Kingdom will ease more public health restrictions starting next week and that the domestic economy is expected to fully reopen by summer.
In addition, both the president and prime minister of Pakistan were reportedly infected after receiving the China Kexin vaccine.
Granted, there are many factors that contribute to the ebb and flow of epidemics in various countries; however, the above facts certainly add to the doubts about the safety and especially the effectiveness of the Chinese vaccine.
Not long ago, Zhong Nanshan, an academician of the Chinese Academy of Sciences, said in a media interview that although China is second only to the United States in terms of absolute number of vaccinations, China is very low in terms of percentages: China is currently at 4 percentage points. Zhong Nanshan said that China’s epidemic is well controlled in order to seize the time to vaccinate, so don’t wait until foreign countries are relying on vaccine herd immunity, China is in danger.
Although the Chinese government has repeatedly encouraged people to get vaccinated, many are reluctant to do so. An article published by Xinhua News Agency points out that for various reasons, there are currently some people who are not very active in vaccination. The article asks that grassroots cadres should play a demonstration role and take the lead in vaccination. Over the past few days, there have been phenomena across China linking vaccination rates to cadres’ political achievements, linking vaccination to higher education and employment, and even rewarding eggs.
Why are many people reluctant to get vaccinated? The explanation from the Chinese official media is that many people believe that the epidemic is well controlled in China, so there is no need to risk vaccination. This is certainly true, but on the other hand, that is also because many people are not comfortable with domestic vaccines.
A follow up post appeared on NetEase: “Before there were the ten tainted vaccines, after there was the Changchun Changsheng fake vaccine case, you tell me to play vaccines without phase III clinical data, I am not timid, I am too good at remembering.”
The lack of phase III clinical data is the main reason why the public is not comfortable with Chinese vaccines. The other is that leaders do not take the lead, and many netizens question how leaders do not take the lead in administering such a good vaccine. The Xinhua News Agency article calls for grassroots cadres to take the lead, but what about the central cadres? In other countries, the top leaders take the lead to fight. It is not that CCP leaders do not know the demonstration effect of top leaders taking the lead in vaccination, for example, they asked Hong Kong’s Chief Executive Carrie Lam to take the lead in vaccination. But Xi Jinping himself is not taking the lead. By association, the Chinese government ordered 100 million doses of Pfizer vaccine as early as last year, and the shipment started arriving in January this year. It’s reasonable to assume that the party-state elites have been doing it for a long time, but with foreign vaccines instead of Chinese ones. But how can you get the Chinese people to believe in Chinese vaccines when the Chinese leaders themselves don’t believe in Chinese vaccines?
Remember that Edelman, an American public relations firm, released a “Global Trust Survey” the year before last. Of the 27 countries and regions surveyed, China topped the list in terms of trust in government. However, in the case of this vaccination, the Chinese people’s trust in the government is far from high.
Wu Zunyou, chief scientist of the CDC, said that when there was no vaccine, China became the winner in the first round of the global encounter with the new pneumonia using a containment strategy; after the vaccine came out, countries in Europe and the United States and other countries were able to achieve herd immunity faster through a two-wheel drive of “natural infection + vaccination”; China, due to its large population base, achieved herd immunity through the vaccine. China has no special advantage in the global competition for herd immunity, and we hope that China can raise the vaccination rate as soon as possible. Humanity’s victory over the new crown ultimately relies on vaccines.
On April 2, QQ.com published an article, “Zhong Nanshan Zhang Wenhong’s urgent voice: Can the new crown vaccine be administered in the end? An article to tell you all the truth! The article said, “Why do many people still hold a wait-and-see attitude towards vaccines and dare not take this step? Most of the reasons are, firstly, to struggle whether it is necessary to fight, and secondly, to question whether they can fight”. The article quotes academician Zhong Nanshan and Dr. Zhang Wenhong, trying their best to explain how necessary, safe and effective vaccination in China is. But they both avoid the key question of why the phase III trial data of the Chinese vaccine has not been released yet. Why has no Phase III trial data for a Chinese vaccine been reviewed by international peers to date?
Without an answer to this question, there is no way to dispel people’s concerns.
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