China’s First Formal Conditional Vaccine Approval to Sinopharm But Lacks Transparency and Leaves Open Questions

China’s First Formal Conditional Vaccine Approval to Sinopharm But Lack Transparency Leaves Open Questions

China’s National Medical Products Administration announced that the first formal conditional approval for a COVID-19 vaccine was granted to Beijing Biological Products Institute, a subsidiary of state-owned Sinopharm. The biotech organization had just recently announced that the vaccine’s efficacy rate was 79.3% when the Chinese regulatory agency made the announcement. Unfortunately the Sinopharm claims are under question by experts that have declared the necessary data hasn’t been made available for independent verification. Of course, the vaccine from this group, and others in China, have been in use for months given the emergency access programs in place in that country. In total, 4.5 million doses originating from one of five companies have been administered since July 2020 to essential workers and those individuals deemed high-risk, including just 3 million since mid-December.  Beijing has a target of 40 million vaccinations by mid-February. Moreover, China’s vaccine company’s, again some either directly owned by or influenced by the state, has been inking many deals around the world in a bid to distribute the vaccine at purported low costs. And the Sinopharm product was granted emergency access by the United Arab Emirates in early December after it was recorded at 86% effective in actually stopping moderate to severe COVID-19 in a study conducted in September.

Other Activity

In mid December, the National Health Regulatory Authority (NHRA) announced it’s formal approval of the registration of Sinopharm’s COVID-19 vaccine after the submission by Mideast partner G42 Healthcare: they have exclusive distribution in both the Middle East and North Africa. The Kingdom of Bahrain participated in Phase 3 clinical trials as part of the 4 Humanity campaign, involving 7,700 volunteers.

By September, the company’s other Phase 3 clinical trials were in Morocco, Argentina and Jordan.  Sinopharm also has another vaccine product in development.

China & Russia Supplying Much of the Developing World

Of interest, the Chinese and Russians will probably supply most vaccine product to the developing word as the developed world has been hardest hit in the pandemic—America is the epicenter for instance and the Western governments have spent billions of dollars to support vaccine developers in a bid to not only accelerate clinical development, production, and distribution but also to secure sufficient vaccine supply.

The Western mRNA-based vaccines must be stored at ultra-low temperatures making practical distribution in poor, tropical or arid and hot countries not practical. The costs and infrastructure necessities are too great. The AstraZeneca (Oxford) vaccine recently approved by the UK is an exception. Hence Sinopharm and other Chinese vaccine makers such as Sinovac and CanSino Biologics as well as Russia’s “Sputnik” may well supply much of the developing world. TrialSite has chronicled evidence of this case via various press releases, interviews, and some official chatter.

Who is Sinopharm?

Sinopharm Group Co. Ltd, a Chinese pharmaceutical company known as China National Pharmaceutical Group Corporation. A large healthcare group directly under the State (Chinese government) via its Assets Supervision and Administration Commission (SASAC) of the State Council, with 128,000 employees and a full capability from discovery and R&D to manufacturing, distribution and commercialization.  Sinopharm owns over 1,100 subsidiaries and 6 listed companies which are SinoPharm Group Co. Ltd (Sinopharm Holding), China National Medicines Corporation Ltd., China National Accord Medicines Corporation, Ltd., Beijing Tiantan Biological Products Co., Ltd., Shanghai Shyndec Pharmaceutical Co., Ltd., and China Traditional Chinese Medicine Holdings Co., Ltd.

According to Sinopharm’s website, they are ranked 169th in Fortune Global 500 with revenue by 2018 totaling over 400 billion yuan ($61.2 billion USD).

Infrastructure Spanning China

Sinopharm has developed an advanced marketing and distribution network within the country for drugs, medical devices and appliances with 5 logistical hubs and over 40 provincial-level centers and over 240 municipal-level logistical sites. Moreover, they tout a “smart medical service system” facilitating faster and higher quality delivery of product and services to over 230,000 corporate clients.

Research and Development

The company has invested in an applied pharmaceutical research institute and an engineering and design institute, purported to be among the best in China. They also own and operate two Chinese Academy of Engineering centers, 11 national R&D institutes, 44 provincial-level technology centers and what they claim are 5,000 scientists.

6th Leading Vaccine Producer Worldwide

Sinopharm claims to be the 6th largest vaccine developer in the world.  With an ability to produce all vaccines in China’s National Vaccination Program, the state-owned organization supplies 80% of the vaccines used in the Expanded Program on Immunization to China.

Doing Business

Sinopharm sponsors or supports 30 notable events represented by CMEF (China International Medical Equipment Fair—a trade show), which serves the ecosystem of the company. The number of conferences and tradeshows represented a nexus of exchange, collaboration and engagement for new business.

Additionally, the company has developed a new type of value-added drug store chain with over 5,100 locations under the brands of Guoda, Jinxiang, Dadesheng and Tianyitang. These branded drug store chains provide direct access to consumers.

The company is part of a Chinese healthcare network consisting of regional healthcare groups in select provinces including Henan, Hubei, Liaoning and Heilongjiang. What is the benefit of this network? Purportedly to offer easier access to healthcare services for the people in dozens of their medical institutions with over 10,000 hospital beds.

International Activity

The global pandemic led both China and Russia to active vaccine diplomacy initiatives in a bid to expand business development activities. Sinopharm is active around the world founding 26 joint ventures with world-renowned pharmaceutical companies and trading with over 120 countries and regions, including 60 “Belt and Road countries.”

It’s vaccine enterprise is listed in the procurement catalog by the United Nations. The company maintains production sites in Vietnam and Malaysia; it is also in association with China-supported hospitals and clinics developed by Sinopharm subsidiaries in Myanmar and Cambodia.  

As chronicled, the pandemic has led to a number of vaccine deals in Asia, Middle East and North Africa and South America.