China's First Domestic 13-Valent Pneumococcal Conjugate Vaccine Launched in Kunming, with 1 Million Doses Supplied in H1

Pneumococcal disease is one of the most serious public health challenges worldwide. The launch of the first domestically produced 13-valent pneumococcal polysaccharide conjugate vaccine has provided a breakthrough in alleviating the severe shortage of this vaccine in China.

On May 20, 2020, the launch ceremony for the first batch of domestically produced 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13) in Yunnan Province, developed by Walvax Biotechnology, was held in Kunming. Attendees included Pan Xuyang, Director of the Maternal and Child Health Division of the Yunnan Provincial Health Commission; Ding Zhengrong, Chief Expert of the Yunnan Provincial Center for Disease Control and Prevention and Chairman of the Vaccine and Immunization Branch of the Yunnan Preventive Medicine Association; Li Zhen, President of Kunming Maternal and Child Health Hospital; Liu Hong, Director of the Kunming Center for Disease Control and Prevention; and Li Jijun, Chief of the Immunization Planning Section. Also present were Li Yunchun, Chairman of Walvax Biotechnology Co., Ltd.; Huang Zhen, Vice Chairman; and Jiang Runsheng, President. Experts from the Centers for Disease Control and Prevention of Wuhua, Xishan, Panlong, and Guandu Districts in Kunming, as well as from Kunming Children’s Hospital and Kunming Maternal and Child Health Hospital, attended the event to jointly witness the official commencement of vaccination with the first domestically produced PCV13 in Yunnan Province.

Walvax’s 13-valent pneumococcal polysaccharide conjugate vaccine is not only the first of its kind in China, but also the second globally, breaking the monopoly held by imported products.Recently, the Wuhua District Maternal and Child Health Hospital in Kunming administered its first dose on May 15, 2020. In addition, four other districts in Kunming (Panlong District, Xishan District, Guandu District, and Jinning District), as well as Dali, Yuxi, and Wenshan, have successively launched vaccinations with the first batch of domestically produced 13-valent pneumococcal polysaccharide conjugate vaccines in Yunnan Province.

Vaccination is one of the most significant and far-reaching achievements in China’s public health sector.

Through vaccination, China eradicated the smallpox virus in the 1960s and achieved its goal of zero cases of wild poliovirus infection as scheduled in 2000, thereby preventing limb disabilities in thousands of children. Meanwhile, the hepatitis B virus carrier rate among children under five years of age decreased from 9.7% in 1997 to 0.3% in 2014, and the incidence of epidemic cerebrospinal meningitis dropped from 3.04 million cases in the 1960s to 104 cases in 2018. It can be stated that vaccination is the most economical and effective means for the prevention, control, and even elimination of infectious diseases.

However, it is worth noting that the effectiveness of pneumococcal disease prevention and control in China remains insignificant.

Pneumococcal diseases are among the most serious public health concerns worldwide. Streptococcus pneumoniae is the primary pathogen responsible for severe conditions in children, such as pneumonia, meningitis, and bacteremia, and is also a common cause of acute otitis media and sinusitis.

The incidence of pneumococcal disease is extremely high among children under the age of five, with nearly 80% of patients falling into this age group. According to Levels and Trends in Child Mortality: Report 2017, published by the United Nations Inter-agency Group for Child Mortality Estimation (UN IGME), pneumonia is the leading infectious cause of death globally among children under five, accounting for 16% of all deaths in this age group. Pan Xuyang, Director of the Maternal and Child Health Division of the Yunnan Provincial Health Commission, also stated, “Yunnan Province has compiled statistics on the causes of child mortality within the province; unintentional injuries rank first, while pneumococcal diseases rank second.”

Antibiotics are the primary treatment for pneumococcal diseases. However, as antibiotic resistance becomes increasingly prominent, treatment difficulty continues to rise, treatment courses are prolonged, and the economic burden consequently increases. Vaccination has become an effective measure for preventing pneumococcal diseases.

Currently, there are two vaccines available in China for the prevention of Streptococcus pneumoniae infection: the 13-valent pneumococcal polysaccharide conjugate vaccine and the 23-valent pneumococcal polysaccharide vaccine. The differences between the two lie in23-Valent Pneumococcal Polysaccharide Vaccine Belongs to "Polysaccharide Vaccines", it cannot elicit a sufficient immune response in infants and young children under 2 years of age, is only indicated for vaccination in children aged 2 years and older, and fails to induce immunological memory.13-valent pneumococcal polysaccharide conjugate vaccine belongs to “polysaccharide conjugate vaccines”, can be administered as early as 6 weeks of age, and features enhanced immunogenicity with a more robust immune response, capable of inducing immunological memory to provide long-term protection.

In 2017, the 13-valent pneumococcal polysaccharide conjugate vaccine developed by Pfizer was launched in China, but a supply shortage quickly emerged, which has been one of the main factors contributing to the low coverage rate of this vaccine in the country.Ding Zhengrong from the Yunnan Provincial Center for Disease Control and Prevention stated, “It is estimated that the vaccination rate of the 13-valent pneumococcal conjugate vaccine in China is less than 5%.”

Now, with the market launch of WoAnXin, Walvax’s first domestically produced 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13), and the commencement of its initial round of vaccinations, the severe shortage of PCV13 vaccines in China can be effectively alleviated. This will improve vaccine accessibility and coverage, protecting more children from the threat of pneumococcal diseases.

Walvax Biotechnology Co., Ltd. is a modern, high-tech biopharmaceutical enterprise in China that specializes in the integrated research and development, production, and sales of biotechnological drugs, including human vaccines.Its domestically developed 13-valent pneumococcal polysaccharide conjugate vaccine, WoAnXin, is used to prevent infectious diseases caused by 13 serotypes of Streptococcus pneumoniae (including pneumonia, meningitis, sepsis, and bacteremia), covering nearly 90% of the serotypes of invasive strains responsible for pneumococcal diseases in children aged five years and under in China.

From the initiation of the R&D project in 2005 to the successful market launch and administration of WoAnXin in 2020, a period of 15 years elapsed. Walvax conducted years of exploration and intensive research in pneumococcal fermentation culture processes, polysaccharide purification techniques, polysaccharide activation and derivatization, as well as the establishment of quality standards, achieving multiple breakthroughs and successfully developing WoAnXin.

Notably,The vaccination schedule for WoAnXin covers all children aged 6 weeks to under 5 years (before their 6th birthday), offering a broader age range compared to imported counterparts.Significantly extending the vaccination window for children in China, the more flexible and convenient immunization schedule effectively addresses the time constraint imposed by imported counterparts, which require the three-dose primary series to be completed within the first six months of life. This provides greater flexibility in scheduling vaccinations, enabling more Chinese children to be protected against the threat of pneumococcal disease.

In addition, among the 9 specifications of Walvax’s 7 marketed products is the 23-valent pneumococcal polysaccharide vaccine. This vaccine is indicated for individuals aged 2 years and older at increased risk of infection, and is primarily recommended for the elderly, patients with chronic diseases, and those with impaired or compromised immune function.Walvax is currently the only company that possesses two 13-valent pneumococcal polysaccharide conjugate vaccines and one 23-valent pneumococcal polysaccharide vaccine, making it a veritable “Pneumonia Prevention Expert.”

With the market launch of Prevnar 13, the supply of the 13-valent pneumococcal polysaccharide conjugate vaccine in China will be significantly increased. Currently, the vaccine has been included in the procurement lists in Jiangxi, Jilin, Yunnan, Hubei, and Guangdong provinces, with the first doses already administered in Jiangxi, Jilin, and Yunnan provinces.

Huang Zhen, Vice Chairman of Walvax, stated: “Moving forward, Walvax will strictly adhere to the relevant requirements of the Vaccine Administration Law and the Drug Administration Law. Upholding our commitment to greater safety, efficacy, controllability, accessibility, and advancement, we will increase production capacity and accelerate vaccine distribution to alleviate the imbalance between market supply and demand, ensuring that more children in China can receive timely vaccinations.”“In the first half of 2020, the company had the capacity to supply nearly 1 million doses of the 13-valent pneumococcal polysaccharide conjugate vaccine to the market.”

Meanwhile, Walvax will also leverage platforms such as media outlets and academic conferences to vigorously promote knowledge related to vaccination, assist communities in popularizing health science education, and enhance public awareness of disease prevention.Amid epidemic prevention and control, the advantages of internet-based vaccination models have become prominent, with vaccination sites widely adopting time-slot appointment systems to ensure safer and more convenient preventive services.It is understood that parents with vaccination needs can make online appointments in advance to secure time slots, ensuring timely and safe vaccination. Parents in Yunnan Province can obtain information by following the official WeChat accounts of various clinics or download the “Xiao Dou Miao” app to schedule timed vaccinations.

Additionally, as Woanxin initiates its first round of vaccinations, the potential inclusion of the 13-valent pneumococcal polysaccharide conjugate vaccine in the National Immunization Program has also drawn industry attention. In this regard, Huang Zhen believes that,It will take a considerable amount of time for the 13-valent pneumococcal polysaccharide conjugate vaccine to be included in the National Immunization Program.He stated that the issue of insufficient vaccine supply must first be addressed to meet the rigid vaccination demands of tens of millions of age-eligible children in China. In the future, Walvax will continuously optimize production management and increase vaccine production capacity to fully ensure the supply of the 13-valent pneumococcal polysaccharide conjugate vaccine.