Vaccines

  • When will the vaccines for 56 million individuals that are reserved to be purchased be introduced?
    ◌ They will be introduced starting in February, step by step.
    - While AstraZeneca's vaccine is expected to be introduced starting in the 1st quarter, Janssen's & Moderna's vaccines starting in the 2nd quarter, and Pfizer's vaccine starting in the 3rd quarter, we are making efforts to move up the days of introduction through continuous consultation with the pharmaceutical companies.
    - 1.5 million doses of AstraZeneca's vaccine will first be supplied after the vaccine is approved by the Ministry of Food and Drug Safety and its shipment is approved by the national government in February.
    - AstraZeneca's and Pfizer's vaccines will be supplied through the COVAX Facility. The detailed types of vaccine, quantity, and the period of administration will be determined and announced around the end of January.

    ◌ The government is discussing with pharmaceutical companies the detailed administration schedule for each vaccine. Please understand that these details are confidential under the confidentiality obligation of the contract.
    - While AstraZeneca's vaccine is expected to be introduced starting in the 1st quarter, Janssen's & Moderna's vaccines starting in the 2nd quarter, and Pfizer's vaccine starting in the 3rd quarter, we are making efforts to move up the days of introduction through continuous consultation with the pharmaceutical companies.
    - 1.5 million doses of AstraZeneca's vaccine will first be supplied after the vaccine is approved by the Ministry of Food and Drug Safety and its shipment is approved by the national government in February.
    - AstraZeneca's and Pfizer's vaccines will be supplied through the COVAX Facility. The detailed types of vaccine, quantity, and the period of administration will be determined and announced around the end of January.
  • What are the criteria related to the procurement of vaccines from overseas?
    ◌ We comprehensively considered factors related to purchasing including ▴ the stage of development, ▴ safety and effectiveness, ▴ platform, and ▴ the period of supply and selected vaccines through professional screenings by Vaccine Introduction TF and Vaccine Introduction Advisory Committee made up of experts in the private sector.

    ◌ In addition, we procured vaccines from various companies and of various types in order to be prepared for the failure of development of the vaccines and disperse the risk of side effects of the vaccinations.
  • Have enough COVID-19 vaccines been procured? Please tell me about the supply schedule.
    ◌ Vaccines for 56 million people is enough for 108% of the total population of our nation. The quantity is enough for achieving the goal of vaccination and securing general collective immunity.
    - However, we are still examining the additional quantity in preparation for the liquidity of the manufacturing and production of the vaccines, uncertainty of the durability of immunity, and adverse reactions to each vaccine.
    - We are pursuing to purchase Novavax's vaccine for 20 million people. We will announce information as transparently and quickly as possible as we decide on the contract for an additional quantity of vaccines.
  • Will vaccines other than those for which the contract is signed be introduced as well?
    ◌ We are examining additional quantities in preparation for the liquidity of the manufacturing and production of the vaccines, uncertainty of the durability of immunity, and adverse reactions to each vaccine.

    ◌ Currently, we are in discussions with SK Bioscience, which is pursuing the technology license contract with Novavax, for the purchase of Novavax's vaccine for 20 million people.
    - As for Novavax's vaccine, the consignment production was pursued based on the LOI between the Ministry of Health and Welfare, SK Bioscience, and Novavax in August 2020.
    - Novavax's vaccine is a synthetic antigen* vaccine that has been applied to a number of vaccines such as those for influenza and hepatitis B. It can secure a variety of platforms, is easy to store and distribute (2-8℃), and has a long expiration date (1 to 3 years), which allows it to be used for vaccinations next year.
    * A vaccine that induces an immune response by synthesizing an antigenic protein with immune boosters before being administered to the human body
    - We will announce information as transparently and quickly as possible as we decide on the contract for an additional quantity of vaccines.
  • (Pfizer & Moderna) They are the type of vaccines that are applied for the first time, and their harmfulness to the human body has not been verified. It is okay to introduce these vaccines?
    ◌ According to the results of their phase 3 clinical test, Pfizer's vaccine has a 95% prevention effect (announced on Nov. 18) and Moderna's vaccine 94.1% (announced on Nov. 30).
    - They are platforms that have not been used for vaccines, but it seems there have not been any serious side effects.

    ◌ However, we will keep monitoring for adverse reactions after vaccinations.
    - We will also continue to monitor the trends of vaccination in the U.S. and Canada, where they already started the administration of Pfizer's and Moderna's vaccination.
  • How do you permit the vaccines that will be shipped in the beginning of February? Is there a special approval process?
    ◌ The vaccines that will be introduced early through the COVAX Facility before the approval of individual vaccines can be introduced into our nation through a special import process, referring to the status of the WHO's approval for emergency use.
    - In the process of special approval, advisory meetings will be held by the Ministry of Food and Drug Safety together with the Korea Disease Control and Prevention Agency to listen to advice on the safety and effectiveness of the vaccines.
  • Is there any possibility that the vaccine that we secured will be discarded in the future?
    ◌ As of now, there are uncertainties, such as whether the development of the vaccine is successful or the scope of approval, we should first secure the vaccines considering the aspect of protecting the health of the public by securing the vaccines rather than considering the possibility of discard.
    - Other countries are also making efforts to secure a sufficient amount of vaccines, and our government has also pursued the purchase of sufficient quantities so that the necessary vaccinations can be administered promptly.

    ◌ We will strive to minimize the discard of vaccines through various efforts, including the establishment of an efficient distribution and storage system, encouragement and promotion to improve vaccination rates, and prompt vaccination following the schedule.
  • Is the introduction of vaccines and vaccination delayed compared to other countries due to safety reviews and avoidance of decision-making by the ministries?
    ◌ The purpose of vaccination is to form collective immunity. How it “ends” is more important than how it “starts.”

    ◌ The government has consistently pursued a “two-track” strategy* ① to support domestic vaccines to the end and ② to quickly introduce successful overseas vaccines.
    * COVID-19 Treatment and Vaccine Development Support Measures (June 3, 2020, Government Support Group)

    ◌ The government has operated the “Vaccine TF” made up of relevant ministries (Ministry of Health and Welfare, Ministry of Foreign Affairs, Ministry of Food and Drug Safety, Korea Disease Control and Prevention Agency) and private experts since June 2020 and has been discussing the purchase of vaccines with global pharmaceutical companies and set the plan for securing vaccines after the Cabinet meetings (Sep. 15, Dec. 18, Dec. 29, 2020).
    - The government has already signed a contract for a sufficient number of vaccines (for 56 million people), and vaccination is scheduled to begin in February with close monitoring of the vaccination situation in each country.

    ◌ Those who are recommended to be vaccinated first will be vaccinated first, and all people will be administered with the vaccine before the influenza period epidemic (November).
    -If vaccinations are carried out well sticking to the vaccination plan, the formation of collective immunity will not be late compared to that of other countries.
  • How is the effectiveness of each vaccine?
    ◌ It does not seem appropriate to directly compare the effectiveness of each vaccine as they were developed in a short period and have not been in use for a long period of time.
    -For reference, the clinical efficacy criterion for a COVID-19 vaccine recommended by WHO is over 50% and that of all three vaccines – Pfizer's, Moderna's, and AstraZeneca's vaccines – exceeds the level.
    *Flu vaccine effect: 60%; shingles vaccine effect (over 60 years old): 51%
  • How is the vaccine distribution and transportation system prepared?
    ◌ As COVID-19 vaccines of different manufacturers require different storage and distribution conditions and the vaccination locations are different for each vaccine, a thorough distribution and storage system will be established for strict management until vaccination after the vaccines arrive in Korea.

    ◌ On January 21, SK Bioscience was selected as the agency to carry out the “Establishment and Operation Project for the COVID-19 Vaccine Distribution Management System,”
    - and the project implementation agency will operate a system* that can monitor temperature maintenance and delivery routes in real time during vaccine transportation by establishing a customized cold chain management system for each vaccine.
    * M2cloud Co., Ltd. participates as a partner to build an IoT-based integrated control center for real-time temperature management and a vaccine location tracking system

    ◌ Through this, the government has plans to create a system to manage the input/output of each vaccine, inventory, and status of vaccine administration by region and by vaccination agency.

    ◌ We are also preparing to install a “cryogenic freezer*,” an essential item for maintaining the cold chain of Pfizer's vaccine, so that each vaccination center can store vaccines safely.

    ◌ In addition, the Ministry of National Defense will form a “COVID-19 Vaccine Transportation Support Headquarters” to support the safe transportation and storage of vaccines from the airport to warehouses and vaccination centers (including community health centers, medical institutions, and vaccination centers).

    ◌ In order to establish cold chain management standards, the government will cooperate with the Ministry of Food and Drug Safety to prepare “COVID-19 Vaccine Storage and Transportation Guidelines” and prepare alternatives for problems that may arise during transport by conducting preliminary training for transportation.
  • How is the cold chain managed during transportation of the COVID-19 vaccine?
    ◌ The government has plans to operate a cold chain management system* that can monitor whether the cold chain is maintained during the transportation process. To this end, a GPS system will be installed on the vaccine transport vehicles so that the driving route can be checked in real time, and a temperature monitoring device will be installed inside the vaccine packaging container.
    * M2cloud Co., Ltd. participates as a partner to build an IoT-based integrated control center for real-time temperature management and a vaccine location tracking system

    ◌ In addition, we will make every effort to manage vaccine distribution through preliminary on-site inspections on vaccine storage and vaccine distribution simulation training.
  • Are there any countermeasures in case of an accident such as a power failure during the storage process?
    ◌ We will do our best to install an uninterruptible power supply (UPAS) that the enables stable use of electricity even when the electricity supply is interrupted in preparation for power failure while storing vaccines in warehouses and vaccination centers.

    ◌ Additionally, an accident response manual will be prepared to provide thorough training for operation personnel.
  • Are there any countermeasures in case of failure of refrigerators at medical institutions or community health centers?
    ◌ In case of an accident, such as the malfunction of a refrigerator, which is the equipment used for vaccine storage, or power failure, we will use an alternative storage device (dry ice, ice bag, icebox, etc. that were kept in a freezer) to store vaccines until the refrigerator is repaired. If the repair process is prolonged, we will transfer the vaccines to an alternative storage device that has been prepared.
  • Are there any countermeasures in case of an accident during the transportation process?
    ◌ Our real-time cold chain management system will immediately recognize if an accident occurs and report it to the Korea Disease Control and Prevention Agency (COVID-19 Vaccination Response Team). A response manual will be established to provide thorough training for operation personnel as well.

    ◌ The Ministry of National Defense will form a “COVID-19 Vaccine Transportation Support Headquarters” to support the safe transportation and storage of vaccines from the airport to warehouses and vaccination centers (including community health centers, medical institutions, and vaccination centers).
  • In Norway, there were successive cases in which people died after receiving Pfizer's vaccination. What is the opinion of the quarantine authorities on the safety of vaccines? What are the vaccine safety-related measures and communication plans?
    ◌ The government will swiftly analyze adverse reaction trends from overseas in cooperation with relevant ministries and actively monitor adverse reactions using text notification services and mobile apps.

    ◌ We will organize a joint public-private Adverse Reaction Rapid Response Team for each city and province, and establish a hotline with the Korea Disease Control and Prevention Agency and local governments to conduct rapid epidemiological investigations in case of serious adverse reactions such as death.

    ◌ In addition, we will quickly disclose the results of the epidemiological investigation on adverse reactions after vaccination.
  • Is Pfizer's vaccine more dangerous for older people? (considering the death of older people in Norway)
    ◌ In Norway, it has been announced that the death of older people with preexisting diseases after being administered with Pfizer's vaccine has no direct association with the vaccine, and there is no evidence that Pfizer's vaccine is dangerous to elderly people.
  • Is the COVID-19 vaccination safe? Are there any adverse reactions?
    ◌ All vaccines may have adverse reactions after administration due to their biological characteristics, and adverse reactions may vary according to the constitution of the individual.

    ◌ However, COVID-19 vaccination is strongly recommended as the adverse reaction rate of the COVID-19 vaccination reported so far is low and the effectiveness of vaccination is greater than that of no vaccination.
  • For how long should I observe myself for adverse reactions after receiving COVID-19 vaccination?
    ◌ After vaccination, it is recommended to stay at the institution where you were inoculated for 15 to 30 minutes to fully observe oneself for any adverse reactions that may appear immediately. After you go home, it is best to see a doctor if you observe any unusual physical symptoms.
  • How will adverse reactions be managed, if any, after vaccination?
    ◌ Due to their biological characteristics, all vaccines are known to have localized reactions around the inoculation area and can induce severe allergic reactions such as anaphylaxis.

    ◌ We will conduct active monitoring of adverse reactions as well as create a general reporting system by strengthening the monitoring system for adverse reactions after vaccination.

    ◌ In preparation for the occurrence of a serious adverse reaction, we will establish a rapid response system for adverse reactions and promptly disclose the results through thorough investigations.

    ◌ In addition, in cooperation with relevant ministries, we will investigate and evaluate the causality between the vaccine and adverse reactions, quick respond to
  • What should I do if an adverse reaction occurs after receiving COVID-19 vaccination?
    ◌ If you suspect you are having an adverse reaction, the recipient of the vaccination or their guardian can check for the adverse reaction and receive information on how to respond through the vaccination assistant website (https://nip.kdca.go.kr).

    ◌ However, if you experience symptoms such as high fever or severe allergic reactions (difficulty breathing, swelling of the lips and mouth, hives, etc.), you should immediately visit an inoculation center or a nearby medical institution for treatment.
  • Can I receive compensation if I experience an adverse reaction after receiving COVID-19 vaccination?
    ◌ The “National Compensation System for Vaccination Damage” is in operation for inevitable adverse reactions after vaccination provided by the nation.
    - A person who intends to receive compensation for damages for a case reported as an adverse reaction must attach a certificate of damage to the compensation request form and submit it to a local community health center.
    - Based on the opinions of the Special Vaccination Damage Compensation Committee, the decision on compensation will be made and told to the applicant through the community health center.

    National Compensation System for Vaccination Damage
    < National Compensation System for Vaccination Damage >
    *(Legal Basis) Article 71 of the 「Infectious Disease Control and Prevention Act」
    * Articles 29 to 31 of the Enforcement Decree of the 「Infectious Disease Control and Prevention Act」
    * Article 47 of the Enforcement Decree of the 「Infectious Disease Control and Prevention Act」
    *(Types of Compensation) Medical expenses and nursing expenses, temporary disability compensation, temporary death compensation, funeral expenses
    *(Criteria for Application for Compensation) Those who were administered a temporary vaccination by the Governor of the Special Self-Governing Province or the head of a si, gun, and gu
    *(Period of Validity for Application for Compensation) Within 5 years from the date of the adverse reaction after vaccination
    *(Minimum Amount of Compensated Damage) Copay of KRW 300,000 or more
    *(Number of Applications for Compensation) The time of appeal is limited to one time, and there is no limit for additional compensation.

    * This is the “National Compensation System for Vaccination Victims” currently in operation in accordance with the law.
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