Review on Drug Regulatory Science Promoting COVID-19 Vaccine Development in China.

Regulatory science is a discipline that uses comprehensive methods of natural science, social science, and humanities to provide support for administrative decision-making through the development of new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of regulated products. During the pandemics induced by infectious diseases, such as H1N1 flu, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS), regulatory science strongly supported the development of drugs and vaccines to respond to the viruses. In particular, with the support of research on drug regulatory science, vaccines have played a major role in the prevention and control of coronavirus disease 2019 (COVID-19). This review summarizes the overall state of the vaccine industry, research and development (R&D) of COVID-19 vaccines in China, and the general state of regulatory science and supervision for vaccines in China. Further, this review highlights how regulatory science has promoted the R&D of Chinese COVID-19 vaccines, with analyses from the aspects of national-level planning, relevant laws and regulations, technical guidelines, quality control platforms, and post-marketing supervision. Ultimately, this review provides a reference for the formulation of a vaccine development strategy in response to the current pandemic and the field of vaccine development in the post-pandemic era, as well as guidance on how to better respond to emerging and recurring infectious diseases that may occur in the future.

Early smallpox vaccine manufacturing in the United States: Introduction of the "animal vaccine" in 1870, establishment of "vaccine farms", and the beginnings of the vaccine industry.

For the first 80-90 years after Jenner's discovery of vaccination in 1796, the main strategy used to disseminate and maintain the smallpox vaccine was arm-to-arm vaccination, also known as Jennerian or humanized vaccination. A major advance occurred after 1860 with the development of what was known as "animal vaccine", which referred to growing vaccine material from serial propagation in calves before use in humans. The use of "animal vaccine" had several advantages over arm-to-arm vaccination: it would not transmit syphilis or other human diseases, it ensured a supply of vaccine even in the absence of the spontaneous occurrence of cases of cowpox or horsepox, and it allowed the production of large amounts of vaccine. The "animal vaccine" concept was introduced in the United States in 1870 by Henry Austin Martin. Very rapidly a number of "vaccine farms" were established in the U.S. and produced large quantities of "animal vaccine". These "vaccine farms" were mostly established by medical doctors who saw an opportunity to respond to an increasing demand of smallpox vaccine from individuals and from health authorities, and to make a profit. The "vaccine farms" evolved from producing only smallpox "animal vaccine" to manufacturing several other biologics, including diphtheria- and other antitoxins. Two major incidents of tetanus contamination happened in 1901, which led to the promulgation of the Biologics Control Act of 1902. The US Secretary of the Treasury issued licenses to produce and sell biologicals, mainly vaccines and antitoxins. Through several mergers and acquisitions, the initial biologics licensees eventually evolved into some of the current major American industrial vaccine companies. An important aspect that was never clarified was the source of the vaccine stocks used to manufacture the smallpox "animal vaccines". Most likely, different smallpox vaccine stocks were repeatedly introduced from Europe, resulting in polyclonal vaccines that are now recognized as "variants" more appropriately than "strains". Further, clonal analysis of modern "animal vaccines" indicate that they are probably derived from complex recombinational events between different strains of vaccinia and horsepox. Modern sequencing technologies are now been used by us to study old smallpox vaccine specimens in an effort to better understand the origin and evolution of the vaccines that were used to eradicate the smallpox.

The role of the vaccines industry in Mission Grand Convergence.

The vast majority of vaccines used throughout the world are supplied by the private sector. It is essential therefore that the industry is closely engaged in future policy developments at a national and international level and is able to respond to the changing needs and priorities that may be required to ensure the success of Mission Grand Convergence. Uniquely, the major vaccine companies have the expertise and technical capacity to develop, produce and supply vaccines on a global scale. Through partnering with Governments, charities and NGOs, they must play a pivotal role in the Mission and, at the same time as agreeing on objectives that may not be entirely market driven, must be able to sustain their commercial obligations to shareholders. Similarly, small and medium sized companies, with the global investor market and government incentives that underpin and support them, also have a very important role to play; for example in innovation around a given disease and on technology, process and platform development across the whole value chain. The industry at large is therefore an essential player. Indeed Mission Grand Convergence can only succeed with the full and willing participation of the vaccines industry.

Patent analysis-based technology competition situation in vaccine industry of Jilin Province / 中华医学图书情报杂志

Objective To analyze the technology competition situation in vaccine industry of Jilin Province from the visual angle of patents. Methods The Dawei Patents Database-covered patents data of vaccine industry in Jilin Province were analyzed by patent mapping, patent metrical analysis and social network analysis respectively. Re-sults The vaccine industry in Jilin Province was in a growing stage with a good development situation and a solid strength in its research institutions. Conclusion Stress should be laid on city development-driven production, pro-duction-driven city development, and optimizing industry policies for the development of vaccine industry in Jilin Province. Scientific research institutions should strengthen their collaboration in professionals, technologies, funds and markets in order to make breakthroughs in technologies and realize the economic value of patents.

From population to public institutions: what needs to be changed to benefit from the full value of vaccination.

The poor perception of the benefits of vaccines, and their subsequent underuse, can result in substantial economic, societal, and political burden. Adequate support and communication from health authorities and governments is essential to promote the benefits of vaccination and reduce the risk of infectious diseases outbreaks. Cost-containment policies in the vaccine procurement processes could also be a threat to the long-term sustainability of the vaccine industry and manufacturing sites in Europe. Biologicals, such as vaccines, are highly technical and complex products to manufacture and only a few industries are engaged in this activity. Developing incentives to encourage vaccine manufacturers and identifying means of taking into consideration the specificities of vaccines in economic evaluations could allow the full value of vaccination to be appreciated. In conclusion, governments, international agencies, and other stakeholders have an important role to play to help society regain confidence in vaccination and ensure that the benefits of vaccination programmes are fully recognised and valued.