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The cessation of free colostrum flu vaccination was identified because a private consignment company that delivered the nationally purchased vaccine to a medical institution exposed part of the vaccine at room temperature while transferring it from one car to another. The company responsible for the procurement and supply of vaccines is Shinsung Pharm, a small and medium-sized pharmaceutical wholesale company that entered this business for the first time this year. Shinsung Pharm’s inexperienced distribution management and complex distribution structure that goes through various stages and companies to final supply appear to be the cause of this incident.
On the 22nd, the head of the Korea Centers for Disease Control and Prevention (KCDC) held a briefing at the Osong Centers for Disease Control and Prevention in North Chungcheong Province. “We are judging that we were exposed (to room temperature) in the process of going from a (refrigerated) vehicle to a vehicle,” he said. Vaccines are distributed refrigerated at 2 ~ 8 ℃, but this was not observed. The Agency for Disease Control and Prevention believes that Shinsung Pharm worked in an environment higher than the proper temperature, such as opening the car door while transferring the vaccine for supply to local medical institutions to a transport truck.
Disease Agency Report
In the afternoon of the previous day, the Agency for Disease Control and Prevention stopped supplying vaccines to Shinsung Pharmaceuticals immediately after being informed of such reports, photographs and videos that support the content of the report, and suspended the entire vaccination schedule free. The quantity that Shinsung Pharm decided to purchase and supply is 12.59 million doses (one serving), of which around 5 million doses, which are scheduled to be used for free vaccines ages 13 to 18, were delivered on yesterday. However, the suspension of the entire free vaccination schedule is a measure to avoid mixing some 5 million doses already supplied by Shinsung Pharmaceutical and some 7 million doses to be supplied in the future.
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The ‘Guidelines for the management of the transport and storage of vaccines’ published in July by the Agency for Disease Control and Prevention and the Ministry of Food and Drug Safety (KFDA) said: “The most important thing in the cold chain of vaccines (refrigerated distribution) is the distribution of vaccines produced and imported by manufacturers and importers. “It’s maintaining the right temperature until inoculation is achieved.” However, it is noted that this type of accident could be attributed to Shinsung Pharm’s immaturity. A vaccine industry official said: “I saw the flu vaccine supply process every year, but this did not happen.” “This year, the vaccine procurement tender was reconsidered four times as a tug of war between the government and pharmaceutical companies, and as a result, a company that is the first to supply and supply large-scale quantities. “It seems like four months have passed since I took over.”
Acquired by private companies and transported by multiple companies
Complex vaccine distribution and transportation processes are also identified as problems. Although free vaccination is a business for which the state is responsible, private supply companies purchase large quantities and contractors entrust transportation to various delivery companies. Kim Woo-joo, a professor at Korea University Guro Hospital (department of infectious medicine), said: “There are many wholesalers entering the intermediate distribution process, and some wholesalers are distributing with insufficient investment or understanding in the supply chains. cold, so this problem has arisen. ” Related ministries, such as the Ministry of Health and Welfare, the Ministry of Food and Pharmaceutical Safety, and local governments, are planning to investigate problems in the vaccine distribution process.
The flu vaccine is not a live vaccine, but a killed vaccine (a vaccine that killed the virus and inactivated it), so experts believe that if it is exposed to room temperature for a short time, it will not lead to abnormalities. quality. The question is how long has it been exposed? Won-seok Choi, professor at the Ansan Hospital of Korea University (department of infectious medicine), said: “If the time of exposure to room temperature is prolonged, the efficacy of the vaccine decreases and, in severe cases, there may be adverse reactions after vaccination. In the worst case, it can be ruled out. Commissioner Eun-kyung Jeong said, “We will investigate and check the period of exposure to room temperature, etc.,” he said. “It is difficult to predict (elimination) because you need to do a distribution process investigation and quality test first.”
Discard in the worst case
The disease administration and the Ministry of Food and Pharmaceutical Safety are scheduled to resume vaccinations sequentially after quality testing for 5 million doses for up to two weeks. Commissioner Eun-kyung Jung said, “We are considering resuming vaccination for the amount that medical institutions have secured (not the national purchase).” “If the test is done to a certain point (2 weeks), it is judged (whether to resume vaccination). It would. There are some quantities that the manufacturer has not supplied yet, so we will supply those quantities first and the rest after distribution. and quality inspections. “
However, if the results of the quality tests are found to be “ruled out”, this year’s free vaccination will inevitably be interrupted. Quarantine authorities repeatedly explained that it would take five to six months to produce a new vaccine and that it was “physically impossible” to accept the opposition party’s request for “free national vaccination.” Currently, the number of free government-insured vaccines is only 1.8% (for 342,000 people) of the 19 million people who are eligible for free vaccination.
Meanwhile, Shinsung Pharm officials <한겨레>In a conversation with the company, “we are aware that a competitor has made a negative report that employees of the consignment shipping company did not comply with some delivery regulations in the process of transferring the vaccine from a refrigerated vehicle. big to a delivery vehicle. ” We know that this is not the case, and we plan to report the improvement plan to the KFDA by the 23rd. ”
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