China Approved Its First COVID-19 Vaccine Based on Interim Result

On Thursday, December 31, 2020, China approved its first COVID-19 vaccine developed by a Chinese state-backed pharmaceutical company, Sinopharm, founded by China National Pharmaceutical Group (CNPG). As per the claim of the vaccine producer, Beijing Biological Products Institute, a subsidiary of CNPG, the vaccine was found 79.34% effective against the COVID-19 based on the interim analysis. However, the clinical result of the vaccine efficacy rate is comparatively lower as compared to other peer competitors including vaccine candidates from AstraZeneca and Pfizer. Meanwhile, many healthcare professionals have expressed their doubtful concerns regarding the key method used by Chinese companies in the preparation of the vaccines.

China’s First Vaccine Approval to Sinopharm

The news of Chinese approval of the vaccine by Sinopharm has appeared the next day after the United Kingdom (UK) became the world’s first country to approve a COVID-19 vaccine on Wednesday. The state-owned pharmaceutical company was reported to be working on two vaccine candidates, which are among the country’s five final testing vaccines since the COVID-19 pandemic had erupted in the Wuhan Province, China around a year ago. However, it is yet uncertain which one between the two vaccines of the company has been approved by the Chinese regulatory authority. Most of the clinical trials of the vaccines are conducted outside China since the country witnessed a low rate of the COVID-19 infection rate domestically.

Sinopharm’s vaccines are the forerunner in the country since the beginning of the pandemic and the vaccines had been earlier approved for emergency use purposes. As per media reports, more than 1 million Chinese people have already used the vaccines by the end of November 2020 as a part of immunization of the frontline health workers including nurses, medical staff, and high-risk people. The company claimed that the vaccination had positive results except a few individuals have reported having some mild symptoms. Considering the positive developments around the vaccine, the Chinese regulatory authority approved it for public use on Thursday.

Unlike other global competitors, the Chinese companies, however, mostly develop their vaccines relying on a traditional method that encourages the use of an inactive virus in boosting the immune system. Several health experts have shared their concerns about the method used by Chinese drug manufacturing companies. Head of the Peter Doherty Institute’s vaccine and immunization research group, Professor Terry Nolan explained that the use of an inactive virus method was expected “to have adverse effects.” Moreover, the lack of detailed information about the efficacy rate of the vaccine and clinical test results are some of the key concerns raised by global experts regarding the latest news of the Chinese vaccine.

Clinical Tests and Supply Volume of the Vaccine

Before Thursday’s approval, a large volume of Sinopharm vaccines have been supplied to several countries and several late-stage clinical tests have been conducted across countries including the United Arab Emirates (UAE), Argentina, Peru, and Morocco. Outside China, the UAE became the first country that approved a Sinopharm vaccine for emergency use and the clinical trial of the vaccine in the country showed an 86% efficacy rate. Around 100,000 volunteers in the country had taken the doses, as a senior UAE health official stated. On the contrary, the Government of Peru suspended the vaccine clinical test on Saturday due to some “serious adverse event.”

Meanwhile, the Chinese company has agreed to supply a bulk of vaccines to these countries namely Indonesia, Egypt, and Brazil that cover the different regional zones. Recently, Pakistan made an announcement to buy a 1.2 million dose from the Chinese pharmaceutical company. Although the exact data are not available, many media reports projected that the company could have supplied more than 100 million doses in several countries this year and, as per the Chinese healthcare authorities, around 600 million vaccines would be ready by the end of 2020. According to media sources, over 4.5 million doses had been administrated from July to mid-December considering the combining strength of vaccines produced by Sinopharm and Sinovac Biotech for emergency use.

At present, China has five final vaccine candidates, developed by Sinopharm, Sinovac, CanSino Biologics, and the Chinese Academy of Sciences, which are underway of their last clinical trials that have the potential to challenge Western competitors. Some of the prominent global players such as Pfizer/BioNTech and Moderna have shown that both of their vaccines succeeded 95% efficacy rate and AstraZeneca working with the collaboration of the Oxford University has shown the result of efficacy to 90%. Several health experts pointed out that the Chinese vaccines especially Sinopharm vaccines were trailing after Western competitors and lacked transparency as these companies had not published any major test results of their vaccine candidates.

Need Extensive Data Support

Several countries, facing limited access to Western vaccines, are considering especially China and Russia as their alternative sources for vaccine supply. A professor at the University of Hong Kong, Dong-yan Jin stated, “China’s approval could boost the credibility of the vaccine,” but insisted, “If the vaccine wants to take a share in the global market, especially in developed countries, more data is necessary. If the vaccine could win approval in the United States or European Union, where the regulatory bars are higher than in China and in the UAE, more people would trust it.”

Following the announcement of the vaccine approval, an official with National Health Commission told Reuters, “We call on people … to take an active part in vaccination to protect themselves, family members and others, which is also contributing to global epidemic control.” Similarly, a local newspaper reported that China aimed at wide vaccination for about 50 million before the Lunar New Year holiday in February next year.

The approval of the AstraZeneca vaccine by the UK regulatory authority on Wednesday was a vital step considering the eruption of the second wave of the COVID-19 infection in the country and emerging risks over the winter. Although China could easily contain the spread of the new COVID-19 wave in the country, some experts explained that China approved the vaccine considering the similar view of potential risks over the winter.