The last week of April each year is World Immunization Week. In 2018, the WHO designated the theme “Protected Together, #VaccinesWork,” encouraging everyone—from donors to the general public—to redouble their efforts to increase immunization coverage in the interest of the greater good. Vaccination saves countless lives and is widely recognized as one of the most successful and cost-effective public health interventions, playing a vital role in preventing certain infectious diseases, curbing antimicrobial resistance, and strengthening public health and population well-being.

　　Immunization can prevent diseases such as diphtheria, hepatitis B, measles, pertussis, pneumonia, poliomyelitis, rubella, and tetanus, thereby reducing the disability and mortality associated with these conditions. Vaccines against these diseases have been introduced in most countries worldwide, and the majority are included in routine immunization schedules. Infants and young children are the primary target of global immunization programs. According to WHO data, in 2016 approximately 86% of infants and young children globally—about 116.5 million—received three doses of the DTP vaccine. Nevertheless, more than 19 million children worldwide remain unvaccinated or under-vaccinated, facing a significant risk of contracting life‑threatening illnesses.

　　2018 marks the 40th anniversary of China’s implementation of its immunization program. April 25 this year is the 32nd National Immunization Day, with the theme “Immunization: Safeguarding Life.”

　　The 2016 revised Regulations on the Administration of Vaccine Distribution and Immunization clearly stipulate that vaccines in China are divided into two categories: Category I vaccines are those provided free of charge by the government to citizens, which citizens are required to receive in accordance with government regulations. These include vaccines specified in the National Immunization Program, vaccines added by the people’s governments of provinces, autonomous regions, and municipalities directly under the central government when implementing the National Immunization Program, as well as vaccines used in emergency vaccinations or mass preventive vaccinations organized by people’s governments at or above the county level or their health administrative departments. Category II vaccines are other vaccines that are voluntarily administered at the expense of the individual.

　　Category I vaccines

　　Currently, the routine vaccines included in the National Immunization Program mainly comprise BCG vaccine, attenuated live or inactivated poliovirus vaccine, acellular pertussis–diphtheria–tetanus combination vaccine (including diphtheria–tetanus combination vaccine), measles vaccine (including measles–rubella vaccine), measles–mumps–rubella vaccine (including measles–mumps vaccine), attenuated live or inactivated Japanese encephalitis vaccine, Group A meningococcal polysaccharide vaccine, Group A+C meningococcal polysaccharide vaccine, hepatitis B vaccine, and attenuated live or inactivated hepatitis A vaccine. All of these vaccines bear the word “Free” on their packaging, along with a dedicated “Immunization Program” logo.

　　Category II vaccines

　　Vaccines such as the varicella vaccine, pneumococcal vaccine, influenza vaccine, oral live rotavirus vaccine, Haemophilus influenzae type b (Hib) vaccine, and HPV vaccine may be administered on a voluntary, self‑pay basis, depending on individual circumstances.

　　According to the China Institute of Food and Drug Control’s “2017 Annual Report on Batch Release of Biological Products,” in 2017, the Institute and seven provincial drug testing institutions authorized to conduct batch release of biological products—located in Beijing, Shanghai, Guangdong, Sichuan, Hubei, Gansu, and Jilin—issued a total of 4,388 batches of vaccine products meeting regulatory requirements, equivalent to approximately 712 million doses. Among these, 39 domestic enterprises submitted applications for batch release, resulting in the issuance of 4,237 batches of domestically produced vaccines, totaling about 694 million doses; six foreign‑origin enterprises received approval for 151 batches of imported vaccines, amounting to roughly 18 million doses. In 2017, 20 types of Class I vaccines were released, accounting for approximately 561 million doses, or 78.79% of all vaccines released; 34 types of Class II vaccines were also released, totaling about 151 million doses. State-owned enterprises continued to be the primary suppliers of Class I vaccines.

　　In China, Class I vaccines are primarily funded by the national budget and manufactured by the country’s six major vaccine research institutes. Historically, they have been mandated through centralized procurement and free distribution, embodying a strong social welfare orientation and exhibiting distinct characteristics of low profitability and monopolistic control. Only a small number of private and foreign‑invested enterprises supply Class I vaccines such as hepatitis B, hepatitis A, and meningococcal vaccines. In contrast, Class II vaccines typically feature a higher degree of marketization, with correspondingly higher prices and profit margins; they are quintessential innovation‑driven products. Moreover, most of the vaccines supplied in China by foreign companies fall into the Class II category. In recent years, several robust Chinese private firms have also been actively engaged in the research, development, and commercialization of novel Class II vaccines.

　　At present, public awareness of certain vaccine categories remains limited, resulting in low penetration rates for Class II vaccines and low adult vaccination coverage in China. Moreover, the hepatitis B vaccine incident and the Shandong vaccine scandal in recent years have further undermined the country’s vaccine industry. Nevertheless, driven by growing public health consciousness, improvements in domestic R&D and manufacturing capabilities, and supportive government policies, China’s vaccine sector continues to hold substantial growth potential.

　　Newborns and children constitute the primary population for vaccine use in China, and the size of the vaccine market is highly correlated with the growth in the number of newborns and children. Currently, China’s fully liberalized two-child policy will directly boost the rigid demand for vaccine products. In 2016, the country’s annual birth rate exceeded 17 million; in addition to the mandatory routine immunizations covered by Category I vaccines, parents also opt for privately paid Category II vaccines, thereby expanding demand for both categories.

　　From late 2017 to early 2018, the influenza epidemic in China brought flu vaccination into the spotlight. As public awareness of preventive healthcare continues to grow, second‑category vaccines—including influenza vaccine, human papillomavirus (HPV) vaccine, rotavirus vaccine, and EV71 vaccine for hand, foot, and mouth disease—are poised to enter a period of robust market growth.

　　Vaccine products that have received WHO prequalification can be included in the procurement lists of organizations such as UNICEF and Gavi, the Vaccine Alliance, as well as other NGOs. As of January 2018, China had four vaccine products that had obtained WHO prequalification: the live attenuated Japanese encephalitis vaccine from Chengdu Institute of Biological Products, the influenza vaccine from Walvax Biotechnology, the bOPV vaccine from Beijing Institute of Biological Products, and the hepatitis A vaccine from Sinovac Biotech. Obtaining WHO prequalification signifies that the quality of domestically produced vaccines has met the relevant international standards, which will help expand China’s vaccine exports, facilitate market access for these products overseas, and drive the transformation and upgrading of China’s vaccine industry.

　　In recent years, widespread outbreaks of emerging infectious diseases—such as novel influenza viruses, Ebola virus, and Zika virus—have made the demand for next-generation vaccines increasingly urgent. Meanwhile, infectious diseases like poliomyelitis, measles, and tuberculosis are showing signs of resurgence worldwide, including in China, while other pathogens have accumulated numerous genetic mutations, underscoring the pressing need to update and upgrade existing vaccine platforms. Domestic vaccine manufacturers with strong R&D capabilities, if they can accelerate their development processes and seize these opportunities, stand to unlock substantial growth potential.

　　The vaccine industry is characterized by high technological barriers. Under the influence of multiple favorable factors, China’s leading vaccine companies have accelerated their pace of innovation, with several blockbuster vaccine candidates either in development or already on the market.

　　HPV vaccine

　　At present, China has approved two HPV vaccines: the bivalent human papillomavirus adsorbed vaccine, manufactured by GSK and approved in 2016 under the brand name Cervarix; and the quadrivalent human papillomavirus vaccine (produced in Saccharomyces cerevisiae), developed by MSD and approved in 2017 under the brand name Gardasil. Although both currently approved HPV vaccines are imported products, numerous domestic pharmaceutical companies have already entered this field. Watson Bio’s bivalent HPV vaccine is now in the final stage of Phase III clinical trials and is poised to become the first domestically produced product of its kind to reach the market. Meanwhile, its wholly owned subsidiary, Shanghai Zerun Biotechnology, received approval for a Phase I clinical trial of its nine-valent HPV vaccine in early 2018. In addition, Xiamen Wantai and Bowei Biotech have also obtained clinical trial approvals for their respective nine-valent HPV vaccines, while MSD’s nine-valent HPV vaccine submitted its marketing application on April 20. Notably, during his inspection of drug supply and pricing in Shanghai on April 11, Premier Li Keqiang specifically instructed relevant authorities to expedite the approval process, ensure adequate supply, and enable those who wish to do so to gain timely access to the latest HPV and other cancer‑preventing vaccines.

　　Pneumonia vaccine

　　In China, only two pneumococcal vaccines have been approved for market: the 23-valent pneumococcal polysaccharide vaccine and the 13-valent pneumococcal conjugate vaccine. The 23-valent polysaccharide vaccine is indicated for children aged 2 years and older, as well as for adults in high-risk groups, while the 13-valent conjugate vaccine is recommended for children under 2 years of age.

　　The approved manufacturers of the 23-valent pneumococcal polysaccharide vaccine include SANOFI PASTEUR, MSD, the Chengdu Institute of Biological Products, and Watson Bio. Watson Bio’s product is the world’s first 23-valent pneumococcal polysaccharide vaccine without preservatives. Among domestic companies currently developing this vaccine, Kangtai Biological and Sinovac Biotech are in the final pre‑marketing approval stage, while Changsheng Bio and others remain in the clinical trial phase.

　　Pfizer’s Prevnar 13 is the only 13-valent pneumococcal conjugate vaccine approved for marketing in China. It is also the sole vaccine product to have earned “blockbuster” status worldwide and is an exclusive Pfizer offering. Currently, four domestic companies—Kangtai Minhai, Watson Bio, Sinovac Biotech, and the Lanzhou Institute of Biological Products—are the main competitors in the development of a 13-valent pneumococcal conjugate vaccine. Among them, Watson Bio has completed its clinical trials and entered the regulatory submission stage, while the other companies remain in the clinical trial phase.

　　Combined vaccine

　　Combination vaccines can prevent a broader range of diseases while reducing the number of injections, thereby alleviating the discomfort experienced by infants and their parents, simplifying vaccine administration, and lowering vaccination costs. They also enable a reduction in the amounts of preservatives and adjuvants typically required in vaccine production, thus minimizing adverse reactions. As such, combination vaccines represent the future trend and direction for upgrading and replacing conventional vaccine products. In China, most marketed combination vaccines are based on the DPT trivalent formulation. The product with the greatest number of combined antigens is Sanofi Pasteur’s adsorbed acellular DPT–inactivated poliovirus–Haemophilus influenzae type b (conjugate) combination vaccine, which is also the only pentavalent vaccine currently available in the country. Other representative domestically produced combination vaccines include Minhai Biologics’ acellular DPT–Haemophilus influenzae type b combination vaccine, the Wuhan Institute of Biological Products’ adsorbed pertussis–diphtheria–tetanus–hepatitis B combination vaccine, and Zhifei Biological’s AC‑group meningococcal (conjugate)–Haemophilus influenzae type b (conjugate) combination vaccine. At present, numerous domestic companies are focusing on the research and development of multivalent vaccines, aiming to narrow the gap with imported multivalent vaccine products in the near future.

　　Seasonal influenza vaccine

　　With the exception of a few vaccines targeting specific influenza subtypes, all seasonal influenza vaccines currently used in China are the WHO‑recommended trivalent formulations for the Northern Hemisphere; however, their uptake remains low. Abroad, quadrivalent influenza vaccines—offering broader coverage, enhanced protection, and greater WHO endorsement—are already available, yet they have not yet been introduced in China. The influenza outbreak in late 2017 and early 2018 significantly raised public awareness of influenza vaccination. Coupled with the recent prevalence of the B/Yamagata (BY) lineage and the trend toward vaccine product upgrades, domestic manufacturers have shifted their focus to the research and regulatory submission of quadrivalent influenza vaccines. Among them, Changsheng Bio and Wuhan Institute of Biological Products have advanced most rapidly; both companies’ quadrivalent influenza vaccines currently under review have completed all required technical assessments, including pharmacology, toxicology, clinical trials, and pharmaceutical evaluations, and are expected to receive approval for market launch shortly.

　　In addition to the aforementioned vaccines, the Sabin strain inactivated poliovirus vaccine (Vero cell–derived), the enterovirus 71 vaccine (commonly known as the hand, foot, and mouth disease vaccine), rotavirus vaccines, shingles vaccines, and norovirus vaccines are all key vaccine candidates currently warranting close attention.

　　In recent years, China has approved the market launch of several blockbuster vaccine products, and the competitive landscape in the domestic vaccine market is expected to become increasingly intense. An increasing number of companies have shifted their strategic focus to upgrading and replacing traditional vaccines and developing next‑generation vaccines, while simultaneously striving to enhance both the quality and speed of vaccine R&D in order to secure a leading position in the market. With the continuous strengthening of China’s vaccine R&D and manufacturing capabilities, coupled with ongoing reforms of the drug review and approval system and other favorable factors, we can expect more vaccines—more effective and safer—to receive regulatory approval, thereby better underscoring the critical role and value of vaccines in improving public health in China.