Why are domestic vaccines so good?—The Story Behind Told by the World’s Largest Hepatitis B Vaccine Manufacturer

2021-11-25 Source:Finet

Open the “small green book” recording infant vaccination history, in the column of “hepatitis B vaccine”—the first vaccine given to a baby, you will find the manufacturer to be AIM Hissen, which has the full confidence of Ms. Li, a first-time mother. She has done her homework beforehand, finding that over 80% of neonates in China are inoculated with hepatitis B vaccine by AIM Hissen, which represents the best quality recognized by the industry.


Since the “black swan” incident of Changsheng Biotechnology in 2018, which cast a shadow on domestic vaccines, the industry has resumed growth in 2019. In 2020, the lot release of a total of 650 million vaccines has been granted, up 14% year-on-year, which shows a good growing trend of the industry overall. Today, the reputation of vaccines “made in China” has spread all over the world. Domestic vaccines such as COVID-19 vaccine, hepatitis B vaccine, rabies vaccine and hand-foot-and-mouth disease vaccine have been vastly appreciated by the international society


How did vaccines “made in China” rise so quickly? Why are domestic vaccines so good?


The answers are pursuit of excellent quality in R&D, conscientious and meticulous quality control, and craftsmanship spirit of striving for perfect, which are given by AIM Hissen, a wholly-owned subsidiary of AIM Vaccine Co., Ltd., long-time leader of the recombinant hepatitis B vaccine market, and the world’s largest hepatitis B vaccine manufacturer.


(1) Enhancing the protective efficacy of domestic vaccine with industry-recognized optimal technology


Compared to vaccines made with advanced technologies of the world, are the vaccines independently developed and made in China really good?


The answer given by Gao Fu, academician of the Chinese Academy of Sciences and Director of the Chinese Center for Disease Control and Prevention, is positive. Gao once appealed to the public that Chinese vaccines are one of the best vaccines in the world; don’t evade problems when they present themselves or lose confidence in our own vaccines.


Of this, the R&D process of AIM Hissen’s recombinant hepatitis B vaccine (hansenula polymorpha) is the best epitome.


In the 1990s, when the situation of hepatitis B prevention and control was grim in China due to technology blockage imposed by foreign countries, AIM Hissen volunteered to participate in the R&D of hematogenous hepatitis B vaccine, and completed the task in only two years.


Since the early 21st Century, China has been striving with all its strength to get rid of the title of “big hepatitis B nation.” With years of technological innovation, AIM Hissen took the initiative to undertake the national “863 program”—the R&D of recombinant hepatitis B vaccine (hansenula polymorpha). As a world-leading gene engineering expression platform with a high technical threshold, at that time hansenula polymorpha was still unexplored territory in the industrialization of vaccines for human use in China.


After fighting for over 1800 days and nights (almost 5 years), in 2004, the first recombinant hepatitis B vaccine (hansenula polymorpha) independently researched, developed and made in China passed the testing of NIFDC and obtained approval for market sales. Clinical trials showed that it achieved a blocking rate of 97.36% of hepatitis B transmission from HBsAg-positive and HBeAG-positive mother to infant, an average antibody positive rate of 99%, and a high immune response level of an average antibody titer of over 1000mIU/ml, with an immune effect better than imported product of the same dosage and even domestic product of several times of its dosage.


In 2013, Han Xun Rui An (name of hepatitis B vaccine)—the 20μg/0.5ml hepatitis B vaccine for adults independently researched and developed by AIM Hissen—successfully filled in the gap of 20μg hepatitis B vaccine of small volume. Compared to existing 20μg/1.0ml products in the world, it has reduced both product volume and impurity content by half yet stills has higher safety.


Facts have proven the actual strength of the domestic hepatitis B vaccine “made by AIM Hissen.”


According to the data of China Insights Consultancy, AIM Hissen is not the only domestic supplier of hepatitis B vaccine using hansenula polymorpha for antigen presentation. Its technology is characterized by high productivity, high purity of antigen presentation and low cost. Based on the lot release data of 2020, AIM Hissen occupies 59.4% of the domestic market share.


(2) Eliminating the crisis of trust in domestic vaccine quality with 100% pass rate


After e the “black swan” incident of Changsheng Biotechnology, domestic vaccine enterprises have been faced with enhanced administrative and legal supervision, covering various links including R&D, production, circulation, sales and after-sales safety, which has fundamentally eliminated the crisis of trust in domestic vaccine quality.


According to the supervision requirements, vaccine manufacturers should establish perfect quality control and product safety traceability system, implement risk reporting system, and guarantee the quality of vaccine products, while regulatory authorities reinforce on-site inspection of manufacturers.


Besides, the Chinese Pharmacopoeia has more vaccine assay items than the European Pharmacopoeia, and the majority of vaccines have to pass higher testing standards than the EU stadnards. The Chinese supervision laws and regulations and standards for vaccines are as much rigorous as their European and American counterparts.


In an ecology of high regulatory pressure and fierce industry competition, vaccine manufacturers have come to realize that product quality is the lifeblood for development. For instance, strictly following national regulatory and industry standards, AIM Hissen’s recombinant hepatitis B vaccine has always maintained a pass rate of 100% in the lot release quality audit by the NIFDC since its approval.


Furthermore, AIM Hissen has continued to improve its quality standard to become a well-deserved industry benchmark.


In 2010, as an important reference standard for domestic recombinant hepatitis B vaccine (hansenula polymorpha), the quality standard for AIM Hissen’s Han Xun Rui An is included in the Chinese Pharmacopoeia (2010 edition) almost word for word. With continuous innovation of product technology, Han Xun Rui An has promoted the improvement of multiple national stadnards for domestic hepatitis B vaccine including low mercury, mercury-free and impurity reduction in succession.


(3) Establishing a new image of domestic vaccine with craftsmanship spirit


Domestic vaccine is a pillar of the nation.


Establishing a pillar of the nation with craftsmanship spirit and establishing a new image of domestic vaccine have become the consensus of increasingly more vaccine manufacturers. Take AIM Hissen as an example, it always keeps in mind the mission of “producing good vaccines for the health of the people,” and remains devoted to the R&D and production of vaccines with craftsmanship spirit.


According to the Production Manager of AIM Hissen, one of its process characteristics is the polishing purification step, which is aimed at further purifying cell culture fluid to derive stock solution with high-purity HBsAg. Different from the conventional adjuvant process, the patented “in situ absorption process” of AIM Hissen directly produces aluminium hydroxide adjuvant while diluting and mixing HBsAg, and the adjuvant absorbs antigens in the process of formation. Characterize by a high antigen absorption rate, this in situ absorption process prolongs the reaction time of human antigens and enhances the stimulation of immune response.