The Vaccine Industry Should Pay Attention To The Localization Of Key Production Equipment

"The impact of the new pneumonia epidemic on the world has made it impossible for us to use traditional methods to make vaccines, and the world can't afford to wait." On September 26, the Chief Strategic Officer of Yunnan Watson Biotechnology Co., Ltd. told Zuo Yun at the "2020 China's big health industry summit - value reconstruction of big health industry under the public health crisis" sponsored by the 21st century economic report.

According to Zuo Yun, the research and development cycle of vaccines generally takes 10-15 years, including the confirmation of antigens, the production of small-scale antigens, the pre clinical animal tests, the evaluation of efficacy, and the summary of data, the clinical application to the State Food and drug administration, and the phase I, II and III clinical trials will be carried out after the approval. Complete the third phase clinical verification of the effectiveness of the vaccine, and then apply for marketing.

After the national development and production of vaccines, it will take about 8 years for the vaccine to be manufactured and approved by the country. Take the research and development of Watson biological vaccine as an example. At present, there are seven varieties on the market. The longest research and development cycle is the 13 valent pneumonia combined vaccine, which took 14.5 years. The average research and development cycle of the seven varieties is 9.13 years. The long period of vaccine research and development has not only scientific problems, but also long clinical time and strict national supervision.

However, the outbreak of new coronal pneumonia suddenly broke out. It is obviously impossible to use the traditional vaccine preparation method to solve the problem in 8-10 years.

To left cloud. Information map

All departments of the National Drug Administration and the national drug administration have accelerated the development of the new drug supervision and development policy.

First, the original step of series connection is changed to parallel connection, and multiple things can be done at the same time. However, the key point is that the evaluation standard is not lowered, or the original standard is maintained. The speed can be accelerated through parallel connection. Second, enterprises have also increased investment at any cost. After the drug approval department opened a green special approval channel, it took only 24 hours for Watson's new crown vaccine to apply for clinical application and obtain clinical approval documents. Previously, it took a year to a year and a half to be approved.

In addition, Xiang Zuoyun said that China is one of the countries with the most complete technical routes for the new coronavirus vaccine in the world, and we have five technical routes to go. Most of the European and American countries do not use inactivated vaccines. Most of them are RNA technology and adenovirus vector vaccines.

Talking about the challenges and opportunities brought about by the outbreak of new coronavirus pneumonia to the vaccine industry, he said that for the challenge, the demand for new coronavirus vaccine in the future will be very large. If 7.6 billion people in the world need to be vaccinated, 15 billion doses are needed for one person and two doses, and the production capacity is far more than the existing production capacity of vaccines. In addition, the cold chain system will also be under pressure. Vaccines with several existing technical routes need to be transported at minus 70 ℃ and minus 20 ℃. Large scale cold chain vaccine transportation is a challenge.

Under the favorable development opportunities of vaccines in China, Xiang Zuoyun also suggested that the innovation of vaccine industry should focus on some R & D parts. For example, genomics and proteomics, structural biology and reverse genetics vaccine design platform, mRNA vaccine with protein as protective antigen, research and development platform of recombinant virus vector vaccine, advanced vaccine quality analysis and detection technology, etc.

"At present, we should focus on high-end equipment industry, among which the most important part is to solve the key problem of imported equipment." He said to Zuo Yun.

?