The vaccine incident of Changsheng Bio-technology has continued to simmer recently. Vaccine fabrication is something absolutely intolerable.

However, there have been frequently vaccine accidents in recent years:

In 2013, the Ministry of Public Security of China uncovered an extraordinary serious case of production and sales of fake and inferior human rabies vaccine; in December of the same year, many infants died after injection with hepatitis B vaccine and DPT vaccine

In 2014, a baby girl died after receiving hepatitis B vaccine in Guangzhou

In 2016, Shandong illegal vaccine case affected many provinces in China

In November 2017, Changchun Changsheng sold unqualified DPT vaccine

On July 15, 2018, production of Changchun Changsheng’s rabies vaccine violated provisions of GMP

I.     Both President Xi and Premier Li Keqiang made important directives regarding Changchun Changsheng vaccine incident

Vaccines are a serious matter. Both President Xi and Premier Li Keqiang have instructed relevant departments to investigate thoroughly, and improve the vaccine management system with a firm determination mustered.

Premier Li Keqiang required a clear explanation to the Chinese people. I don’t want to comment on Changchun Changsheng incident here, but will give a rough review of the vaccines marketed in China at present.

According to the statistical data of Evaluate Pharma, the global vaccine market approached USD 30 billion in 2017, wherein, GSK, MSD, Sanofi and Pfizer are the "Four Heavenly Kings" on the vaccine market, with accumulated market share of 90.1%.

The release system is implemented for vaccine sales in China. The release work is jointly advanced by the National Institutes for Food and Drug Control of China and 7 provincial pharmaceutical product inspection institutions authorized to undertake biological product release.

The situation is roughly as follows: 1. Overall, Chinese-produced vaccines account for the main part of the marketed vaccines (as shown in the following figure), reaching above 90%;

Fig. Release Amount of Chinese-produced Vaccines and Imported Vaccines from 2012 to 2017

2. There are 20 varieties of Class 1 vaccines released for marketing in 2017. State-owned enterprises are still the main supplier of Class 1 vaccines, and private enterprises mainly supply Class 2 vaccines.

II. A review of the marketed vaccines: 63 varieties of vaccines from 45 enterprises

The rough situation of the Chinese vaccine market is introduced here by sorting out the vaccines marketed in China and according to the 2017 Annual Report of Release of Biological Products issued by the National Institutes for Food and Drug Control of China.

1.    Statistics of the marketed vaccines: 63 varieties, flu vaccines with the largest proportion

According to the public data organized, there is a total of 63 varieties of vaccines approved for marketing in China, wherein, the flu vaccines account for 13%, followed by 11% of meningococcal vaccines, 11% of rabies vaccines, and 10% of hepatitis vaccines.

2.    Statistics of the 45 vaccine manufacturers: China National Biotec Group Company Limited has the largest number of varieties

From the perspective of enterprises, ranked by the number of varieties without considering the release amount, China National Biotec Group Company has 98 varieties marketed, the National Vaccine & Serum Institute has 11, Changsheng Bio-technology has 10, and Sanofi has 10.

3.    Release data in 2017: Poliomyelitis (Live) Vaccine Type I Type III (Human Diploid Cell), Oral had the largest release amount.

According to 2017 Annual Report of Release of Biological Products, Poliomyelitis (Live) Vaccine Type I Type III (Human Diploid Cell), Oral had the largest release amount, supplied for a total of 162,083,400 people. Overall, Chinese-produced vaccines account for the main part of the marketed vaccines, reaching above 90%; however, certain varieties still cannot be produced in China and all depend on import, such as Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine (adsorbed) and Haemophilus influence type b conjugate vaccine, Pneumococcal 13-Valent Polysaccharide Conjugate Vaccine, Human Papillomavirus (Types 16 and 18) Vaccine, Bivalent, and Recombinant Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine.

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