The gap between Chinese vaccines has obviously not passed the WHO pre-certification

Health News

March 1 this year was the year when China's national vaccine regulatory system passed the World Health Organization assessment for one full year. However, a year has passed. As the world's largest vaccine producer, only two vaccine manufacturers in China have submitted pre-certification applications to WHO, and so far no one has passed.

At the same time, the transnational vaccine giants represented by GlaxoSmithKline and Sanofi Pasteur have already held the WHO pre-certification “international permit” and seized more than 80% of the global vaccine market.

For domestic companies, why is it so difficult to obtain this "International Passport"? What is the magic of this "International Pass"?

The gap appears at multiple levels

China has an annual vaccine output of 1 billion people. It is the world's largest vaccine producer and the country with the largest number of vaccine manufacturers in the world. There are currently 85 vaccine manufacturers in the world, and there are only 36 in China, accounting for more than 40%. However, to this day, there is no vaccine manufacturer in the country that has passed the WHO pre-certification. That is to say, domestic vaccines can only be exported from households to households by means of donation or national registration.

On March 1 last year, the National Vaccine Surveillance System passed the WHO assessment. From that day onwards, domestic vaccine manufacturers were eligible to apply for the “International Pass” and, after passing the WHO pre-certification, entered the UN vaccine procurement program. Broad share of the international market. On October 28 last year, Hualan Biological Vaccine Co., Ltd. submitted a pre-certification application for seasonal influenza vaccine to WHO; on January 18 this year, Chengdu Biotechnology Co., Ltd. formally submitted the encephalitis B subtraction. Poison vaccine application. Although it is still unknown whether pre-certification can be approved, the preparatory and tedious preparatory work for the two companies has already sent such an excuse that the road to vaccine internationalization is very difficult.

“In the past, Chengdu had a total of about 1,000 staff trainings per year. Since it started to apply for pre-certification, the amount of training each year has grown from 50,000 people in recent years, and the single-year workload has increased by nearly 50 times.” China Biotechnology Wu Yonglin, vice president of the company’s stock company, said that over the past five years, the China Development Institute has invested a total of 800 million yuan in preparations for workshop renovation and personnel training.

Another big feeling for the two companies applying for the pre-certification process is that if a product wants to pass pre-certification, it must be done in strict accordance with the WHO guidelines at the beginning of product development. "At present, there is a certain gap between the management and pre-certification requirements of many domestic enterprises, so the pre-certification preparation time will generally exceed the enterprise's pre-judgment time by more than 1 time."

Among the pre-certification standards, Chinese companies are most worried about clinical data. According to WHO's requirements, vaccine manufacturers must not only provide their own clinical data, but also provide clinical data of the vaccine product in different geographical areas and among different populations, and even the same vaccine for premature infants, malnourished children, immunocompromised children. Children with other diseases have different roles. A few days ago, Hualan Vaccine Co., Ltd. received a reply from WHO, requesting further improvement of the clinical research report in the application materials.

In Wu Yonglin's view, the change in employee behavior and thinking patterns is also a problem. For example, if the workshop light bulb is broken, the employee’s usual thinking is to change it directly. According to the WHO's request, the quality department should first be asked to assess whether changing the light bulb has an impact on the product quality; if not, please change the bulb for the engineering department; Please assess the quality department and confirm that there is no problem before you can continue production.

“The process of pre-certification is cumbersome and involves a large amount of work involving various aspects such as enterprise software and hardware. However, this process can also significantly increase the market competitiveness of enterprises.” Wu Yonglin said that although there are only two companies applying in China, the Certainly more. The Zhongsheng Group has already set up a plan to require six subordinates, each of which will have at least one product to submit a pre-certification application. The polio vaccine product is likely to be the second project submitted by Zhongsheng for pre-certification applications.

Domestic vaccine manufacturers' research and development capabilities are "weak"

"Currently, the annual production capacity of Hualan Biological Influenza Vaccine can reach 100 million doses, while the domestic market uses less than 40 million doses." Lin Xiaojun, general manager of Hualan Biological Vaccine Co., Ltd. said that the products are pre-certified and not only internationally The market has gained a share, and it will be able to take the initiative in the highly competitive domestic market.

It is reported that most of the high-end market for vaccines in China is controlled by foreign pharmaceutical companies. "Only Sanofi-Pasteur, GlaxoSmithKline and Novartis accounted for 45% of the market for valuable vaccines," said a pharmacist familiar with the domestic vaccine industry in Shenyang.

"At present, the domestic vaccines are mainly based on imitation and integration, and most of them are imitation products. Some newer vaccine products are still in the laboratory stage," said Yu Mingde, president of the China Pharmaceutical Enterprise Management Association. China has a large number of vaccine companies. The degree of industry concentration is relatively low, and there is still a gap between innovation and R&D capabilities from the international level. The total investment in research and development of the 36 domestic vaccine companies cannot compete with any of the "Five Giants" of transnational vaccines: Sanofi Pasteur, GlaxoSmithKline, Merck, Novartis and Pfizer.

Compared with the “weak” research and development capabilities, the market potential of vaccines in China is incalculable. In recent years, the vaccine market in China has maintained a high growth rate of about 15%.

Advantageous policies such as the Vaccine Supply System Construction Plan and the 12th Five-Year Plan for the Development of Medical Science and Technology have been issued one after another. While stimulating the enthusiasm of the domestic vaccine industry, overseas vaccine manufacturers have also accelerated the pace of entry into China. The United States, a famous medical industry venture capital firm, Weisheng Biotechnology, recently stated that it will expand investment in vaccine production, pharmaceuticals, medical devices and APIs in China in the next few years.

Yu Mingde said that in the next few years, domestic vaccine manufacturers must organically integrate and increase the research and development of therapeutic vaccines and combination vaccines, and gradually grasp the innovation and key technologies of vaccine production. Applying for and passing the WHO pre-certification can make them stronger.