By Xiaoyaowan

The two specifications (0.25ml and 0.5ml) of quadrivalent influenza vaccine (split virion) developed by Jiangsu Walvax under Yunan Walvax Biotechnology have been approved by CFDA recently to enter clinical trial. It is reported that this quadrivalent influenza vaccine (split virion) in development includes the hemagglutinin antigen for two influenza A virus strains and two influenza B virus strains, and is mainly used for prevention of seasonal influenza. With this, another member is added to the queue of the Chinese-produced quadrivalent influenza vaccines (split virion) in clinical development.

The quadrivalent influenza vaccines in development are better than the current trivalent products on the market

The seasonal influenza is an acute respiratory infection caused by influenza viruses, spreads worldwide, and can infect people in any age group. According to statistics, annual epidemics are estimated to result in about 3 to 5 million cases of severe illness, and about 250,000 to 500,000 deaths worldwide. During epidemics of seasonal influenza, around 90% of deaths occur in the frail elderly. Currently, vaccination is the most effective method for infection prevention.

The trivalent influenza vaccines (split virion) have good antigenicity, and small side effects, being the influenza vaccine variety uniformly promoted for use in China by the Ministry of Health of China (now, the National Health and Family Planning Commission of China). Quadrivalent influenza vaccines (split virion), compared to the existing trivalent influenza vaccines (split virion), increase the prevention capacity for another lineage of influenza B virus, which will prevent seasonal influenza more effectively, and improve vaccine’s protection for the populations, especially of great significance to infants, school-age children, the elderly, weak, and chronic disease patients.

A glimpse of the pattern of influenza vaccines in China

From the perspective of release of vaccines in China, the number of influenza vaccines released in China in the past 7 years has been among the top 10 of vaccines released in China, showing the situation of consumption of such preventive biological product, wherein, all the seasonal influenza vaccines currently marketed in China are trivalent influenza vaccine, and no quadrivalent influenza vaccines have been approved for marketing.

Among the queue of Chinese-produced quadrivalent influenza vaccines in development, the vaccines in development of Changchun Changsheng Bio-technology (CXSS1700015) and Hualan Bio (CXSS1700014) have been applied for production, and both are in the "Under review and approval" status according to the pharmaceutical product registration progress results of CFDA, wherein, Changchun Changsheng Bio-technology seems to be ahead in the approval time node and it is estimated that the quadrivalent influenza vaccine (split virion) of the company will hopefully receive the production approval at the beginning of next year, to become a new profit growth point of the company in the future.

Besides the above two vaccine manufacturers that have applied for production, the application status of quadrivalent influenza vaccines of some Chinese vaccine manufacturers is as shown in the following table:

A quick look of the quadrivalent influenza vaccine products approved by FDA for marketing

The quadrivalent influenza vaccines approved by FDA for marketing currently include GSK’s Fluarix Quadrivalent/FluLaval Quadrivalent, Sanofi’s Fluzone Quadrivalent, AstraZeneca’s FluMist Quadrivalent, and Protein Sciences Company’s Flublok. See the following table for the details:

About the author: Xiaoyaowan, a pharmaceutical industry practitioner, "word porter" in the era of we-media, focusing on the climate changes in the pharmaceutical circle.