As the global epidemic continues to rage and India’s New Coronavirus is out of control, the World Health Organization recently released an Evidence Assessment of China’s Sinopharm and Kexing’s New Coronavirus vaccine, confirming its high protective efficacy in adults aged 18 to 59 years, but also revealing doubts about the vaccine’s efficacy and safety in people over 60 years old and those with comorbidities. Several public health experts emphasized the lack of publicly available clinical data in China, the need to track vaccination responses in the elderly, and the need to investigate and deepen the dynamics of the epidemic in countries where the vaccine is imported into China.
Globally, more than 154 million confirmed new cases and more than 3.2 million deaths have been reported to date. China has provided vaccine aid to several countries, but there are concerns about the transparency and safety of its data.
For Sinopharm BBIBP-CorV and Sinovac, the WHO Strategic Expert Group on Immunization (SAGE) report states that there is “highly plausible” evidence of protective efficacy, “moderately plausible” evidence of protective efficacy, and “moderately plausible” evidence of protective efficacy in people aged 18 to 59 years. There is “moderately credible” evidence for safety.
However, for those aged 60 years and older, the evidence for the protective efficacy of GMP and Kexin vaccines was “low confidence” and “moderate confidence”, respectively, and the evidence for safety was “very low confidence” and “low confidence”, respectively. For people with comorbidities, the evidence for both the protective efficacy and safety of Sinopharm vaccine was “very low confidence”, while that for Kexing was “moderate confidence” and “low confidence”. The relevant data from Kexing are “moderate confidence” and “low confidence”.
In general, the efficacy of the GMP vaccine in Phase III trials was 78.1% for those aged 18-59 years, and 78.7% for hospitalization prevention. However, this data is not estimable in people over 60 years old, and the report shows a clear lack of clinical trial data. Meanwhile, the efficacy of Kexin was 67% for protection and 85% for prevention of hospitalization, but was only validated with high reliability in the 18-59 year old population.
Safety of Chinese vaccines for high-risk groups such as the elderly is a mystery
“The WHO assessment report is not an assessment of the safety and efficacy of the vaccine itself, but an assessment of the reliability and credibility of the available data. This does not necessarily mean that the panel believes that the vaccine is not safe or effective for people over 60 years of age, but that the available data do not support such a conclusion.” Huang Yanzhong, a senior fellow on global health issues at the Council on Foreign Relations, a U.S. think tank, told the station.
“Phase III trials have to be done abroad, and for some reason, only a small percentage of the elderly (participate in the trials). Theoretically, it should go to countries with high incidence such as the United States, India and Brazil, but the relationship between China and India is not good. Kexing before to Brazil to do (experiments), but the President of Brazil is not very friendly, can only do in the state of São Paulo, the process is also affected by political factors.”
It is reported that the first two trials of the WHO-reported Chinese drug vaccine were small-scale studies in China, and the third trial was a large-scale study in the United Arab Emirates, Egypt and Jordan, among other places. In total, the study evaluated more than 20,000 people, with only about 400 over 60 years of age.
The lack of data on vaccines for the elderly is very strange, as noted by Yokogawa, a current political commentator who used to work for the Medical Research Center, “It’s easier to find data on cases around the world when the elderly are sicker, especially in nursing homes, than adults, and it’s very suspicious if WHO has no evidence. I don’t know what WHO means by engaging in evidence assessment now, desperate to find out the chances of using the Chinese vaccine. mRNA vaccine adenovirus vaccine are more effective than it.”
However, China recently announced its intention to mass promote vaccination for the over-60 age group. Liu Peicheng, director of brand and public relations at Kexing, said in March that feedback from the phase I and II clinical elderly groups in China and from large-scale use outside the country showed that the incidence of adverse reactions to vaccination in the elderly group was relatively low, and that the situation was relatively similar to that of the adult group. “So far, no abnormalities related to the vaccine have been monitored.”
In this regard, Huang Yanzhong stressed that open and honest research is essential before giving mass vaccinations to the elderly, “The elderly must be the key protection group. The focus of vaccination in the U.S. is on the elderly, and more than two-thirds of them have seen a dramatic drop in lethality and hospitalization rates after vaccination. The safety of the inactivated vaccine itself may not be a major problem, but it is still important to do follow-up surveys of older people who have received the vaccine.”
WHO may approve emergency use permit for Chinese vaccine
The WHO-led New Coronavirus Vaccine Implementation Program (COVAX), which was expected to deliver two billion doses of the vaccine worldwide this year, has only shipped about 50 million doses. According to Nature, Pfizer’s deliveries to the program have been limited, and Johnson & Johnson vaccine has not yet been shipped. India, which was supposed to deliver a billion doses of Covishield vaccine to the program, is now on its own.
China has taken the opportunity to engage in vaccine diplomacy, with Sinopharm vaccine approved in 45 countries and 65 million doses administered, and Covishield vaccine approved in 32 countries and 260 million doses delivered worldwide. In countries such as Chile, Turkey and Brazil, 80% to 90% of the population has been vaccinated with the Chinese vaccine. However, Brazil and Peru have both called off the Chinese vaccine for a time due to cases of serious adverse reactions; Hungary, Chile and other countries still have high mortality rates of the new crown. There is an urgent need for the international community to understand the clinical data of the Chinese vaccine, such as its effectiveness in special groups such as the elderly, infirm and young, the types of reactions after vaccination, the duration of protective effectiveness and the effectiveness of response to variant viruses, etc.
“Exactly what vaccination rate is achieved to achieve herd immunity? Countries that use the Chinese vaccine on a large scale, this is the time to track their cases.” Huang Yanzhong said countries that receive the Chinese vaccine should be targeted for priority research.
WHO is evaluating whether to approve the emergency authorizations for the two Chinese vaccines and is expected to announce the results this week. If approved, the New Crown Pneumonia Vaccine Implementation Plan may open the door to Chinese vaccines. Five New Crown vaccines have previously been approved by WHO: the New Crown vaccine jointly developed by Pfizer Inc. of the United States and BioNTech of Germany, two versions of the New Crown vaccine jointly developed by AstraZeneca Pharmaceuticals of the United Kingdom and Oxford University, the New Crown vaccine by Johnson & Johnson of the United States and the New Crown vaccine by Modena.
Gao Fu, director of the Chinese CDC, has made a rare admission that the protection rate of domestic vaccines is not high. For a vaccine that the Chinese themselves are afraid to administer, Yokogawa believes that WHO and foreign countries should be wary of “anxiety” and that this evaluation report is not enough to give it a green light.
“Who is selecting the samples for WHO’s foreign experiments? The WHO has not published the details of the clinical trials. Unlike the United States Pfizer, Modena vaccine at any time to publish, track the effect on the variant of the virus. It is not that there is no data in China, because medical ethics are very loose and many experiments are done on the mainland. China itself is not even sure about the data, because once it is taken out, it may not be promoted.”
Europe is also speeding up its review of Chinese vaccines. The European Medicines Agency (EMA) said Tuesday it has begun a rolling approval of the Kexing vaccine, a first step toward the vaccine’s possible approval for vaccination in 27 EU member states, but there is no specific timetable.
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