The supply of diphtheria, tetanus and disruption vaccines for the National Immunization Program continues.
Recently, a reporter from The Paper (www.thepaper.cn) learned that at present, Shandong, Jiangsu, Guangdong, Guangxi, Hainan, Guizhou, Chongqing and other provinces and cities have tight or out of stock supply of diphtheria, tetanus and disruption vaccines to varying degrees.
As a diphtheria, tetanus and disruption vaccine for the National Immunization Program vaccine (i.e., a free vaccine for Class I), why are there extreme situations such as out of stock? Why are only three companies still producing this vaccine? When will the shortage be alleviated?
Changchun Changsheng stopped production, and the supply of diphtheria, tetanus and rupture vaccines was tight
According to data from the website of the China Food and Drug Inspection Institute (hereinafter referred to as the "China Inspection Institute"), in the first half of 2019, the vaccine sector was issued in the entire first half of 2019, a 17% decrease from 2018; among which 76 million were sold in Class II seedlings, a 20% decrease from 2018, and 153 million were sold in Class I seedlings, a 16% decrease from 2018.
More than the staff of the Provincial Center for Disease Control and Prevention confirmed to the Paper reporter that the out-of-stock of diphtheria, tetanus and disruption vaccines is related to the suspension of production of Changchun Changsheng Biotechnology Co., Ltd. (hereinafter referred to as "Changchun Changsheng").
" (Deptaneous and Tetanodispersive vaccine) supply has been tight for more than a year, and it has started since Changchun Changsheng was investigated in July last year." A staff member of the Shandong Provincial Center for Disease Control and Prevention said, "Not only Shandong Province, this shortage is nationwide."
"Deptaneous and Tetanodispersive vaccine is now the most in short supply." A staff member of the Hainan Provincial Center for Disease Control and Prevention told the Paper reporter on the phone that the diphtheria and Tetanodispersive vaccine in Hainan Province has been out of stock because "the manufacturer does not provide us with the goods."
In July last year, Changchun Changsheng was exposed to "falsifying rabies vaccine production records", and it was later revealed that the company was fined more than 3.44 million yuan by the Jilin Provincial Food and Drug Administration for the "unqualified titer value of diphtheria, tetanus and disruption vaccine" incident in 2017.
On July 19, 2018, Changsheng Bio announced that its diphtheria, tetanus and rupture vaccine production workshop has been suspended. However, the Paper inquired and found that the CPR brokerage and issuance records of the CPR found that the latest brokerage and issuance records of Changchun Changsheng were still in the second half of 2017. This means that Changchun Changsheng's diphtheria, tetanus and rupture vaccine production line was actually stopped before the rabies vaccine incident was exposed.
Changchun Changsheng's financial report shows that in 2015, the company's batch issuance of cell-free diphtheria and tetanus combined vaccine was approximately 5.625 million units, equivalent to 16.88 million doses. Changchun Changsheng has not announced the number of diphtheria, tetanus and disruption vaccines issued after 2015.
data shows that the approval volume of the combined adsorption of cell-free diphtheria and tetanus vaccine in my country was 61.6402 million doses. This means that Changchun Changsheng's batch issuance accounted for 27.37% of the total national volume.
Other Class I vaccines are also out of stock
In addition to diphtheria, tetanus and permeation vaccines, other national immunization program vaccines in some provinces (i.e. Class I free vaccines) are also out of stock.
Guangxi Center for Disease Control and Prevention stated that the first type of free vaccines that Guangxi currently lacks include five types: leprosy vaccine, meimphosy vaccine, diphtheria and tetanus vaccine, hepatitis A vaccine and J encephalitis vaccine. Among them, the supply rate of leprosy vaccines with the largest gap is less than 20%.
In addition, a reporter from The Paper learned from the Centers for Disease Control and Prevention of Shandong Province, Qinghai Province, and Guizhou Province that measles and leprosy vaccines are second only to diphtheria, tetanus and dysfunction.
"There are mainly two companies in China to produce leprosy vaccines. Some time ago, one of them stopped production due to adjustment of production lines, resulting in a shortage of leprosy vaccines." The staff of the above-mentioned Shandong Center for Disease Control and Prevention said, "After the leprosy vaccine is out of stock, we received a notice that the leprosy vaccine can be used as a substitute, which has led to a surge in demand for leprosy vaccines in many places. According to the previous supply plan, leprosy does not have such a large demand, so it is out of stock."
But there are also areas that are only temporarily out of stock. Staff of the Shanghai Center for Disease Control and Prevention said that the leprosy vaccines were out of stock for not long and have returned to normal.
Only 3 companies are still producing diphtheria, tetanus and disruption vaccines
Pengpai News reporter learned that there are currently 3 companies in China that are still producing diphtheria, tetanus and disruption vaccines, namely Wuhan Institute of Biological Products (hereinafter referred to as "Wuhan Institute"), Chengdu Institute of Biological Products (hereinafter referred to as "Chengdu Institute") and Watson Bio-.
The " Chinese Center for Disease Control and Prevention National Immunization Program Vaccine Procurement Project - Announcement on the Winning Bidding of Cell-Free Diphtheria-Tembourg for Adsorbent Diphtheria-Tembourg for Adsorbent Diphtheria-Tembourg for Adsorbent Diphtheria-Tembourg for Adsorbent Diphtheria-Tembourg for Adsorbent Diphtheria-Tembourg for Adsorbent Diphtheria-Tembourg for Adsorbent Diphtheria-Tembourg for Adsorbent Diphtheria-Tembourg for Adsorbent Diphtheria-Tembourg for Adsorbent Diphtheria-Tembourg for Adsorbent Diphtheria-Tembourg for Adsorbent Diphtheria-Te The winning companies are Wuhan Institute, Chengdu Institute and Watson Bio, with winning bids of 25 million, 10 million and 8.32356 million respectively.
Staff from the Shandong Provincial Center for Disease Control and Prevention told reporters that after Changchun Changsheng stopped production, for a period of time, only Wuhan Institute and Watson Biotechnology were supplying diphtheria, tetanus and disruption vaccines, and Chengdu Institute only started production and supply not long ago. The staff member also said that the Chengdu Institute has just started production and its production capacity is still very limited.
Dipexane and Tetanodispersive vaccine profit is meager, and one ex-factory price is less than 4 yuan
Why are there only 3 companies producing diphtheria and Tetanodispersive vaccines?
The Paper reporter checked the website of the State Drug Administration and found that there were 7 enterprises with approval documents for diphtheria, tetanus and dysfunction vaccines. Except for Changchun Changsheng, which has been discontinued, three enterprises did not actually produce them after obtaining the approval documents.
As for the reason why companies get approval documents but do not produce them, vaccine expert and popular science writer Tao Lina told the reporter of The Paper that diphtheria, tetanus and disruption vaccines have certain technical difficulties compared with other vaccines. In addition, the first type of vaccine purchased by the state has lower national pricing and meager profits, and the company's production motivation is insufficient.
The Paper reporter found that in 2009, the National Development and Reform Commission issued the "Notice on the Formulation of Ex-factory Prices of 14 National Immunization Program Vaccines, including Recombinant Hepatitis B Vaccine".
The "Notice" shows that the ex-factory price of adsorbent cell-free diphtheria and tetanus combined vaccine is 3.4 yuan/0.5ml; the ex-factory price of adsorbentia and tetanus combined vaccine is 0.28 yuan/0.5ml; the ex-factory price of adsorbentia and tetanus combined vaccine is 0.32 yuan/0.5ml.
data shows that after 2011, my country will no longer issue whole-cell diphtheria and tetanus vaccines. From 2010 to 2015, the number of manufacturers of cell-free diphtheria and tetanus vaccines decreased from 6 to 2, namely Changchun Changsheng and Wuhan Institute.
An industry expert pointed out to the reporter of The Paper that after 2010, the dividend period for the expansion of the first-class vaccine varieties brought about by the expansion of the national immunization program has passed, and the number of first-class vaccines in the market has generally shown a downward trend.
Tao Lina believes that for a long time, the domestic diphtheria, tetanus and tetanus vaccine has always had potential risks on the supply side, but it has not been taken seriously. Changchun Changsheng's suspension of production completely exposed this problem. "From a national perspective, diphtheria, tetanus and tetanus vaccine has been in the state of full load production of for a long time. In the top-level design, redundant production capacity is not taken into account. Once a company has problems, supply will be cut off." When and how to alleviate the shortage of
?
The Paper reporter learned that diphtheria, tetanus and disruption vaccines in each province and city are uniformly tendered and purchased by provincial-level centers of disease control, and the quantity is planned by each province based on the number of immunized population. The Provincial Center for Disease Control and Prevention signed a procurement contract with the winning manufacturer once a year. The validity period of diphtheria and tetanus vaccine is 24 months, so companies do not supply it in one go, but ship to provinces according to quarterly periods. Few provinces and cities will take the initiative to stock up.
In the interview, many provincial centers of disease control told the Paper reporter that they do not know when the free diphtheria, tetanus and disruption vaccine will be restored. If you are eager to get the diphtheria and tetanus vaccine, you can use the self-funded quadruple vaccine or penta vaccine as a substitute.
"There is no better way except waiting." Tao Lina said that at present, all manufacturers are producing at full capacity, and it is impossible to expand production capacity in the short term. In addition, the production capacity of enterprises must be registered with the drug supervision department. If the enterprise changes the size, it needs to re-approve and other reviews.
Tao Lina also pointed out that the method of introducing imported vaccines is also difficult at this stage. This year, whooping cough has begun to become popular again in many countries and regions, and the supply of diphtheria, tetanus and disruption vaccines worldwide is not abundant.
The Paper reporter called Wuhan Institute and Chengdu Institute to consult on the production of diphtheria, tetanus and disruption vaccines, but did not receive a positive response from the company.
According to statistics from Guoyuan Securities, in the first half of 2019, 23.114 million diphtheria, tetanus and disruption vaccines were issued, a year-on-year decrease of 19.68%; 9.40 million tetanus and disruption vaccines were issued, a year-on-year decrease of 1.04%. From the perspective of major manufacturers, Watson Biotech had 3.869 million units, a year-on-year increase of 144.56%; Wuhan Institute had 15.3923 million units, a year-on-year decrease of 43.40%; Chengdu Institute had 3.8527 million units.
Tao Lina pointed out that the decline in the issuance of diphtheria, tetanus and disruption vaccines is also related to the Changchun Changsheng vaccine scandal to a certain extent. The China Procuratorate has increased the proportion of random inspections of domestic vaccines since last year, and the requirements for production quality are also stricter. Therefore, the slowdown in the release of vaccines has also affected the supply to a certain extent.
