Merck's imported inactivated hepatitis A vaccine is experiencing widespread shortages in many parts of China.
Interface News reporters have observed in the past three months that there is a shortage and shortage of inactivated hepatitis A vaccines in cities such as Beijing, Shanghai, Guangzhou, Xi'an, and Chengdu.
Many recipients who have received their first dose of the inactivated Merck Hepatitis A vaccine recently stated on social media that they were informed by the local community health service center that they had run out of stock after receiving their second dose of the inactivated Merck Hepatitis A vaccine.
The official WeChat official account of the Community Health Service Center in Lingyuan Street, Jinjiang City also released the article [Notice of Vaccine Shortage] Imported Hepatitis A Vaccine Shortage on January 27, saying that "due to force majeure, the imported Hepatitis A vaccine is temporarily out of stock in our center's vaccination clinic, and the specific arrival time will be notified later".
Interface News reporters randomly called multiple community health service centers in cities such as Beijing, Shanghai, Guangzhou, Xi'an, and Chengdu, and the vast majority of them replied that they did not have access to the Merck East Hepatitis A inactivated vaccine.
However, some community health service centers in some cities still have a small inventory of Merck Hepatitis A inactivated vaccines. For example, the WeChat official account of Pazhou Health Service Station, Pazhou Street, Haizhu District, Guangzhou announced that as of February 19, it still had a small amount of imported inactivated vaccine.
On February 26th, Interface News asked Merck China about the widespread shortage of inactivated hepatitis A vaccines in many parts of China, but as of the time of publication, no response has been received.
On February 27th, Interface News asked the Chinese agent of Merck's inactivated hepatitis A vaccine, Zhifei Biotechnology, about this matter. The staff of the other party's secretary office replied that the distribution and promotion contract for the inactivated hepatitis A vaccine with Merck is still being fulfilled. Merck will report the shortage of inactivated hepatitis A vaccines to the company's marketing department.
The hepatitis A vaccine is prepared using a strain of hepatitis A virus, which can stimulate the body to develop immunity against the virus and is used to prevent hepatitis A.
According to production process classification, there are two types of hepatitis A attenuated live vaccines and hepatitis A inactivated vaccines. The inactivated hepatitis A vaccine and attenuated hepatitis A vaccine are both based on human diploid cells. Overall, the inactivated hepatitis A vaccine has fewer safety issues, is more biologically stable, and is easy to store.
The attenuated live hepatitis A vaccine is suitable for susceptible individuals over the age of 1 and a half. Children and adults should receive the same dose and receive one dose. The inactivated hepatitis A vaccine is suitable for susceptible individuals over 1 year old, and is available in both adult and pediatric formulations. Inoculate twice, with an interval of ≥ 6 months between the two doses.
There has been a widespread shortage of inactivated hepatitis A vaccines in many parts of China, mainly due to a decrease in the number of batches issued in China, resulting in insufficient inventory. In addition, Interface News compared the annual reports of Zhifei Biotechnology and found that 2023 was the year with the lowest number of approved and issued versions of the Merck Hepatitis A inactivated vaccine in the past five years, with only 311400 doses.
According to Interface News, the batch issuance of biological products by the China Food and Drug Control Research Institute for the whole year of 2023 found that Merck's inactivated hepatitis A vaccine only received two batches of batch issuance in the first half of 2023, including one batch of inactivated hepatitis A vaccine in February and one batch of inactivated hepatitis A vaccine in June.
However, in the second half of 2023, Merck's inactivated hepatitis A vaccine did not receive any new approvals. In addition to the issuance data disclosed by the China Food and Drug Control Institute, this conclusion has also been verified by some local disease control centers in China. For example, the CDC in Hongshan District, Wuhan City, Hubei Province, published an article on its WeChat official account on January 30, 2024, in which the CDC said that since 2023, the quantity of imported hepatitis A vaccine supplied to China has decreased, especially after July, the supply has almost stopped.
According to Interface News statistics, as of February 27th, a total of 6 domestic enterprises have been approved for listing with hepatitis A vaccines, including 5 local enterprises and 1 foreign-funded enterprise. Five local enterprises are Beijing Kexing, Institute of Medical Biology, Chinese Academy of Medical Sciences, Emmy Vaccine, Zhejiang Pukang Biotechnology, and Changchun Biotechnology. The only foreign company is Merck&Matheson.
According to the statistics of the batch issuance of biological products by the China Food and Drug Control Research Institute in 2023, Sinovac Biotech, Changchun Biotech, and Aimei Vaccine accounted for 27%, 23%, 15%, 18%, and 15% respectively. Among them, Kexing Biotechnology has been approved the most times, with 28 times, followed by Changchun Biotechnology with 24 times.