Where is the unqualified vaccine for DTP in the three places?

Can the unqualified DTP vaccine in the three places regain confidence or can we only choose Wuhan Bio?

Shandong CDC plans to replant the unqualified batch of DTP vaccine of Changsheng Bio (002680, SZ), and the replanted vaccine comes from "Wuhan Bio".

In neighboring Hebei, the local provincial CDC is also arranging to replant a batch of unqualified vaccines last year, but the manufacturer is not a fairy, but a "Wuhan creature".

Last year, the unqualified vaccine of "Wuhan Bio" also flowed to Chongqing. Talking about this matter, a person from the US Food and Drug Administration in Chongqing who asked not to be named said: "Maybe you can only choose" to replant Wuhan biological vaccine.

At present, the DTP vaccine market is divided into three parts. However, Yongsheng stopped production, and watson biological just moved in, with limited production capacity. At this time, for replanters, it is necessary to know more about "Wuhan Bio"-Wuhan Institute of Biological Products Co., Ltd. At the beginning, it has to be explained that after the rectification of Wuhan Bio-Company, the Chinese Procuratorate has tested the titer of 30 batches of DTP vaccine produced continuously. Relevant local food and drug regulatory authorities are also collecting information and will announce it to the public.

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It accounts for 80% of the DTP vaccine market.

Recently, the provincial centers for disease control and prevention have successively issued a notice to replant children who fail to get DTP vaccine. It is noteworthy that it is reported that Shandong CDC will replant unqualified batches of DTP vaccine from Changchun Changsheng, and the replanted vaccine is provided by Wuhan Bio.

However, according to the information released by official website, the titer index of DTP vaccine produced by former US Food and Drug Administration, 20 1 165438, was also found to be unqualified. 400,520 unqualified batches of vaccines were sold to Chongqing CDC 190520 and Hebei CDC 2 10000.

The Implementation Plan of Replanting DTP Vaccine in Hebei Province (Trial) issued by Hebei CDC on July 23rd showed that * * * 14394 1 person used unqualified vaccine, which may affect the immune protection effect (but has no impact on human safety). The DTP vaccine for replanting will be uniformly deployed by the provincial CDC, but it is not clear whether it will be used. This matter is not clear in the public information of Chongqing CDC.

At this time, it becomes a problem to choose which company to replant the vaccine.

According to a survey conducted by the reporter of the National Business Daily, the domestic DTP vaccine market leaves little choice for the CDC. At present, DTP vaccine market is divided into three parts: Wuhan Bio, Changchun Changsheng and Yuxi Watson (holding subsidiary of watson biological).

Screenshot of watson biological Announcement

According to the financial reports released by watson biological over the years, the market share of DTP vaccine produced by Wuhan Biotech ranks first for many years in a row. In 20 16 and 20 17 years, the batches of DTP vaccine produced by Wuhan Bio were 611.53 million and 45,696,700 respectively, accounting for 8 1% and 83.09% respectively. The market share of Changchun Changsheng is 19% and 16.37% respectively. Yuxi Watson's DTP vaccine was only launched in 20 17 years, and the batch released in 20 17 years was 294,800, accounting for only 0.54% of the market.

A person from the US Food and Drug Administration in Chongqing who did not want to be named said: "Now Changsheng Bio has completely stopped production, which means that only Wuhan Bio and Yuxi Watson can provide such vaccines in the market, and Yuxi Watson only started listing approval last year, and its production capacity is limited in the short term. It may only be possible to choose the vaccine of Wuhan Bio for replanting. "

So, can Wuhan Biology restore the confidence of replanters? Let's start with a better understanding of this company.

The next 30 batches of products are all compliant.

According to public information, Wuhan Bio is located in Jiangxia District of Wuhan City, and its vaccine products include adsorbed acellular DTP combined vaccine, freeze-dried rabies vaccine for human use, live attenuated Japanese encephalitis vaccine, live attenuated measles vaccine and live attenuated measles vaccine-mumps combined vaccine; It is the main research institution of national medical microbiology, immunology, cell engineering and genetic engineering, a large-scale high-tech enterprise integrating the production, learning, research and marketing of biological products, and also the guidance center of immunization planning in Central and South China.

According to the industrial and commercial archives, Wuhan Bio is controlled by China Bio 100%, and as far as vaccines for human use are concerned, China Bio is the largest vaccine manufacturer in China.

On the evening of July 25th, the State Administration of Pharmaceutical Products issued the "Questions and Answers of the State Administration of Pharmaceutical Products: Vaccine Supervision" in official website, revealing that it is a serious illegal act for Changsheng to fabricate production records and product inspection records and change process parameters and equipment without authorization when producing freeze-dried rabies vaccine for human use. At the same time, two batches of unqualified DTP vaccines, Changsheng Bio and Wuhan Bio, were further explained.

After receiving the report from the Central Inspection Institute, the former China Food and Drug Administration took the following measures: ordering enterprises to find out the flow direction; Stop using unqualified products immediately; Ordering vaccine production enterprises to report the factory inspection results of 2 batches of unqualified vaccines, re-examining the retained samples, and carefully finding out the reasons for unqualified titer; Send an investigation team to investigate the two enterprises and conduct on-site production system compliance inspection; All samples of DTP vaccines produced by the two companies within the validity period were taken for inspection.

All vaccines involved have been sealed and recalled by enterprises; Changsheng Biological Company has not resumed the production of DTP vaccine since last year. After the rectification of Wuhan Bio-company, the Chinese Procuratorate tested the titer of 30 batches of DTP vaccine continuously produced by Wuhan Bio-company, and the results all met the requirements. Combined with on-site inspection, resume production.

US Food and Drug Administration in Hubei: The information being collected will be released to the public.

However, the reasons for the unqualified titer of DTP vaccine in Wuhan biological unqualified batch have not been disclosed.

On the afternoon of 25th and the morning of 26th, I called the Propaganda Department of US Food and Drug Administration in Hubei Province to inquire about the reasons why DTP vaccine failed. The other party replied that the US Food and Drug Administration in Wuhan was responsible for "understanding the reasons". "Today, the leader also asked us to collect information, which will be announced to the public at that time, probably in these two days." The staff member said.

As of press time, the official website of the US Food and Drug Administration in Hubei has not released relevant information.

Then, I called the US Food and Drug Administration in Wuhan. After understanding the demands of the interview, the other party said that all the interviews of the bureau in the near future need to be conducted through the Propaganda Department of Hubei Provincial Party Committee. It is suggested that the reporter contact the Propaganda Department of the Provincial Party Committee before making arrangements. However, the reporter repeatedly called the office of the Propaganda Department of Hubei Provincial Party Committee, but no one answered.

On the morning of 26th, Hubei Daily WeChat WeChat official account published the article "Hubei US Food and Drug Administration: Strengthening the Supervision of Vaccine Enterprises in an All-round Way", and also disclosed that the titer determination of 30 batches of DTP vaccines continuously produced by Wuhan Institute of Biology met the requirements.

It is also found that Tiantan Bio (600 16 1, SH), a bio-listed company in China, is a great channel to learn about Wuhan Bio. According to Tiantan Bio-disclosure, the annual revenues of Wuhan Bio-20 15 and 20 16 were 792 million yuan, 7110 million yuan respectively, and the net profit returned to the mother was 25.86 million yuan and 43.84 million yuan respectively. 20 16 in the case of a slight decline in revenue, the net profit increased by about 70%.

Screenshot of Tiantan Biological Announcement

Source:? Beautiful scenery. Com (Shanghai)