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Entry 2020.09.22 10:58 | Revision 2020.09.22 11:05
Authorities “The quantity of influenza vaccine that has been discontinued is 5 million doses … refrigerated cars, problems in the distribution process”
Vaccine targeting 13-18 year olds blamed for ‘room temperature exposure’ … “No problem for the 118,000 children who have already been vaccinated”
Influenza (flu) vaccines were partially exposed to room temperature during the distribution process and free vaccines, which were scheduled for day 22, were completely discontinued.
In a regular briefing on the 22nd, the head of the Korea Centers for Disease Control and Prevention (KCDC) said: “Based on current knowledge, the vaccine supplier is believed to be partially exposed to the room temperature in the process of redistribution of the vaccine by region in a refrigeration vehicle. I decided to stop. “
The government plans to provide free national vaccines to 19 million people this year and decided to receive 12.59 million doses through a procurement contract. Of these, this time around 5 million doses are delivered, and the number has not yet been inoculated. The procurement company in question turned out to be Shinsung Pharmaceutical. The following is a question and answer session based on an emergency report from the Korea Centers for Disease Control and Prevention and the Ministry of Food and Drug Safety.
“Vaccines are a biological material and must be kept refrigerated from production to inoculation. During transfer from one refrigerated vehicle to another, exposure to room temperature occurred.”
ㅡ What vaccine is the problem?
“The vaccine that has been raised at this time was delivered through a separate delivery system from the childhood dual vaccination vaccine, which began vaccination on September 8. It was raised that there was a problem with maintaining the refrigeration temperature during distribution with the quantity purchased by the government. It is a product that has been developed, but it is not a manufacturing or production problem. “
ㅡ Will the planned vaccination schedule be completely interrupted?
“The amount of vaccination that was administered previously is not related to the vaccine exposed to room temperature. To date, 118,000 people have been vaccinated and no cases of adverse reactions have been reported. The vaccine is being administered with the amount guaranteed by institutions private doctors, not with the government amount. ” Children’s vaccines will resume as soon as supply status is confirmed. The Agency plans to further investigate the exact time of exposure to room temperature, check if there is a problem with the effect of the influenza vaccine from exposure to room temperature and decide to use or discard it. “
ㅡ When to resume flu vaccination?
“It takes a long time to check the quality and about 2 weeks. If the inspection or review is done to some extent earlier, I will pass judgment even earlier.”
ㅡ What will happen if the vaccine is exposed to room temperature?
“In flu vaccine distribution, the appropriate standard for ‘low temperature’ is 2 to 8 degrees. If it is exposed to room temperature for a longer time, the area that may be most affected is the decrease in protein content, which indicates efficacy. This means that the effect can be reduced. Additionally, security issues can arise, so I’d like to report all of them. “
ㅡ What is the vaccine supply process like?
“In the case of free supply of national purchases, a wholesaler signs a contract and the company receives the supply contract from each pharmaceutical company and distributes and supplies the product to front-line medical institutions. Some parts for delivery are consortia or other parts of the country. It is proceeding in some way, the amount paid is processed by the medical institution contracting individually with the delivery company.
ㅡ Can you ask about the negligence of vaccine distributors?
“Among the compliance requirements of pharmaceutical wholesalers under the Pharmaceutical Affairs Act, pharmaceutical wholesalers are responsible for maintaining and transporting pharmaceuticals at the approved temperature. The violation is subject to suspension of business and Penalties. According to Article 47 of the Pharmaceutical Affairs Act, If they violate quality control for distribution, it is said that they will be penalized with a prison term of no more than one year or a fine of no more than 10 million won. By investigating the degree of violation, the final sentence can be decided.
ㅡ If the entire quantity of vaccine is discarded, is the inoculation quantity available?
“It is difficult to predict and talk about it because it has to be judged on the basis of the distribution process investigation and quality test. However, it is not a problem of a major manufacturing defect, but rather a refrigeration maintenance problem. and refrigeration temperature in the supply chain where the products must be supplied to medical institutions in a refrigerated state. Since there are suspected cases that have not been maintained, it is reported, so we will proceed with the investigation taking into account the safety and We will examine the content of the investigation to make a judgment ”.
ㅡ Can you get a paid vaccination?
“Paid vaccination is in progress without stopping. The amount of paid vaccination is purchased independently from wholesalers by individual private medical institutions, so this is irrelevant.”
ㅡ Where was the vaccine exposed at room temperature?
“You can investigate and disclose. The report was received through a channel other than the company that delivered the vaccine, and there are areas in the report that may affect the efficacy of the vaccine. I thought it was good.”
ㅡ How is the flu vaccine for those over 62 years of age?
“As planned, it will start in mid-October.”
