Merck's Hepatitis A Vaccine Exits China: A Retrospective on Its Legacy and Product Details

May 27, 2024 21:11 CST Updated 21:11

MSD

Pharmaceutical R&D and Manufacturer

MSD's Hepatitis A Vaccine Exits the Chinese Market.

March 27,MSD(China)Based on the adjustment of global business strategies, prudent evaluation of existing R&D and production resources, and full consideration that locally produced products can meet market demands,Decided to stop supplying Vicate to the Chinese market effective immediately®。

Currently, there are four specifications of the Vaqta vaccine® approved in the Chinese market, with registration validity all extending until July 15, 2025. This means that after this date, the vaccine will no longer be able to be imported into China.

Tracing back to the source, delisting might have shown "signs" earlier.

Previously, before the official announcement of delisting, there were reports thatMSD's imported inactivated hepatitis A vaccine is experiencing shortages and stockouts in multiple cities across China.Many recipients of the first dose of MSD's inactivated hepatitis A vaccine have expressed on social media platforms that they were informed of a stock-out when trying to get the second dose after completing the first dose of MSD's inactivated hepatitis A vaccine.

It is not difficult to find,The supply shortage of Vicalt is related to the issuance volume in China.According to the data issued by the National Institutes for Food and Drug Control (NIFDC) throughout 2023,In 2023, MSD was issued only twice., and all were approved in the first half of the year. In the second half of the year, its inactivated hepatitis A vaccine failed to gain approval.

Figure 1: National Institutes for Food and Drug Control, China

Relevant data shows that MSD received approval for 311,400 doses of inactivated hepatitis A vaccine in 2023, which, despite a significant increase compared to the same period in 2022, still marks the year with the lowest number of approvals in recent years.

Figure 2: Zhifei Biological 2023 Semi-Annual Report

Compared with similar types of domestically produced drugs in China, MSD's approved volume is significantly lower. WithTaking Beijing Sinovac Biotech as an example, it received 16 issuances in January 2023.`, much higher than MSD's total for the entire year.`

Figure 3: National Institutes for Food and Drug Control (NIFDC)

According to the 2023 biological product lot release disclosed by the National Institutes for Food and Drug Control, besides MSD, companies including Beijing Sinovac Biological Products Co., Ltd., Amblue Kanghuai Biopharmaceuticals (Jiangsu) Co., Ltd., Changchun Institute of Biological Products Co., Ltd., Zhejiang Pukang Biotechnology Co., Ltd., and the Institute of Medical Biology, Chinese Academy of Medical Sciences,TotalFive Chinese companiesObtained batch release for different batches of hepatitis A vaccines, andThe number of batches released for approval in China is greater than the number of batches from MSD.

Specifically, in 2023, Sinovac Biotech, Changchun Biologic Products Institute, and AmoyVac accounted for 27%, 23%, and 15% respectively. Additionally, Sinovac Biotech had the highest number of approvals at 28 times, followed by Changchun Biologic Products Institute with 24 approvals. Among these companies, AmoyVac and Beijing Sinovac produce inactivated hepatitis A vaccines, while the other companies manufacture live vaccines.

The mass availability of domestically produced vaccines has brought significant competition to MSD, which cannot be ignored. However, we should also recognize the substantial role MSD has played in the history of vaccine development in China.

The More Than 30-Year Bond Connected by Small Medicine Bottles

Speaking of MSD, its connection with China began with the hepatitis B vaccine.。

Hepatitis B is one of the key infectious diseases targeted for prevention and control in China, as well as a major global public health issue. From 1970 to 1992, there was a large-scale outbreak of hepatitis B virus (HBV) in China. Within just 20 years, the number of HBV carriers surged to 120 million, accounting for one-third of the total number of carriers worldwide at that time, making China the "hepatitis B giant" with the heaviest burden of hepatitis B globally.

According to data from the Chinese Center for Disease Control and Prevention, in 1992, a survey of 67,124 people aged 1-59 years across 145 disease surveillance points in 30 provinces of China showed a hepatitis B virus positivity rate of 9.75%. The positivity rate among children was similar to that of adults, making hepatitis B a significant threat to public health in China and profoundly impacting the development of the national economy.

Figure 4: The First Batch of Recombinant Hepatitis B Vaccines Produced in China with the Support of MSD

At that time, MSD had just developed the most advanced recombinant gene hepatitis B vaccine in the world., the root of the connection surfaced. At that time, a delegation from China's health department visited MSD and expressed the desire to introduce hepatitis B vaccine technology to China.

After multiple rounds of negotiations,In 1989, MSD transferred the recombinant hepatitis B vaccine production technology to China., this technology was the most advanced genetic engineering recombinant technology globally at that time.。

It is worth mentioning that, according to the agreement at that time,MSD transferred the complete production process, technology, and equipment design for recombinant hepatitis B vaccine to China at a very low price., while also helping to guide and train relevant Chinese personnel. This assistance aimed not only to address China's urgent needs at the time but also to provide practical help for China’s subsequent development, enabling the country to later produce hepatitis B vaccines with equivalent efficacy and quality on its own. After providing this entire set of content, MSD almost made no profit.

In the final contract reached, MSD waived any patent fees and profits related to the hepatitis B vaccine., Not only that, but MSD also donated equipment to China and sent engineers and technicians to provide on-site guidance in China.

In his memoir, Roy Vagelos, then CEO and Chairman of the Board of Merck & Co., Inc., wrote:"Time is so urgent. I want to protect children from this fatal disease and help those who are at risk of the disease and cannot afford it."

Figure 5: Roy and Diana Vagelos

Former Deputy Director of the Chinese Center for Disease Control and Prevention, Liang Xiaofeng, also remarked, "MSD's noble act has protected millions of Chinese children from hepatitis B virus infection, saving enormous costs for the country and society."

From this beginning, MSD has formed an indissoluble bond with the people of China and the health of the Chinese people.

Thereafter, MSD established MSD (China) to assist China in building two factories in Beijing and Shenzhen, each with an annual production capacity of 20 million doses of genetically recombinant hepatitis B vaccine.In 1993, China successfully produced the first batch of genetically engineered hepatitis B vaccines, and newborns began to be vaccinated.。

It was precisely due to MSD's generous assistance that the development of vaccines in China also began to gradually take off. In December 2001, China’s Ministry of Health and Ministry of Finance jointly issued the "Notice on Including Hepatitis B Vaccine in the Children's Immunization Program."Since 2002, the hepatitis B vaccine has been officially incorporated into the national children's immunization program in China.The "Regulation on the Circulation of Vaccines and Prevention and Control of Immunization," implemented on June 1, 2005, stipulates that all vaccines within the national immunization program are to be provided free of charge.

At this point, China has fully implemented free vaccination for newborns against hepatitis B.On October 29, 2020, the State Council Information Office announced that China had shed the label of being a "Hepatitis B major country."The basis is: The infection rate of hepatitis B virus (HBV) in children under 5 years old has dropped to less than 1%.This has been praised by the World Health Organization as a model for developing countries.

Since the vaccination of hepatitis B vaccine among children in China, the incidence rate of viral hepatitis has decreased from 8%-15% in 1982 to less than 1% in 2015. Over the decades, China's fight against hepatitis has been remarkably effective, largely due to the relentless efforts of Chinese researchers.MSDMSDThe generous move over the years has not only advanced China's disease prevention efforts but also served as a conveyor belt accelerating the development of vaccines in China.

Although imports are good, independent research and development never ceases.

For many years, imported vaccines have been highly sought after in China, but at the same time, Chinese researchers have been working tirelessly to develop domestically produced vaccines. As China’s first independently developed inactivated hepatitis A vaccine, Beijing Sinovac Biotech's hepatitis A vaccine Healive has not only become the most widely used hepatitis A vaccine in China since its market launch in 2002, but also the largest exported inactivated hepatitis A vaccine.

Figure 6: Beijing Sinovac's Inactivated Hepatitis A Vaccine "Healive"

From 2009 to the present, domestically produced hepatitis vaccines in China have gradually achieved domestic substitution. Overall, China's hepatitis vaccine industry has entered a mature phase. With the persistence and research efforts of domestic biopharmaceutical companies such as Sinovac Biotech, Changchun Biologics, and AmoyVac Biotech, although Merck Sharp & Dohme AG (MSD) has withdrawn from the market, domestically produced vaccine formulations will still provide many recipients with alternative options.

References:

National Institutes for Food and Drug Control (NIFDC)

Report on China's Hepatitis A Vaccine Industry: Gross Profit Margin Generally Above 80%

Imported Hepatitis A Vaccines Leave the Scene, Domestically Produced Vaccines Are Actually Great

U.S. Pharmaceutical Giant MSD and China's Hepatitis B Vaccine

This multinational pharmaceutical company has been dedicated to Chinese patients for over three decades (Trend News Client)

A Brief History of Hepatitis B Transmission in China: Unveiling the Historical Reasons Behind the Increase of Hepatitis B Virus Carriers from 0 to 120 Million in China (Liver Disease Treatment Consulting Center)

2023 China Hepatitis Vaccine Industry Overview Report (Head Leopard Research Institute)

Vaccine-preventable disease control in the People’s Republic of China:1949–2016

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