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All-Hands-on-Deck : Whole-of-Government Approach to Securing Vaccines for 79 Million in 2021

  • Date : 2021-04-28
  • Hit : 292

All-Hands-on-Deck : Whole-of-Government Approach to Securing Vaccines for 79 Million in 2021
- Aside from the planned 79 million, additional vaccine purchases under review as part of response to variants and other transmission variables.
- In response to vaccine raw material export restrictions by the US, Korea utilized its administrative capacity and diplomatic skills to successfully resolve uncertainties surrounding access to these vaccine components, thereby enabling supply of 20 million doses by third quarter.
- Korea remains steadfastly committed to supporting the development of its own treatment/vaccines, with full force of the government behind clinical trials and other R&D effort.
- Continued community transmission could imply accumulated latent transmission factors which could lead to a fourth wave larger than the third.
- Joint Inter-Governmental Infection Prevention/Control Inspection Force formed to perform focused inspections of nine facility types vulnerable to disease transmission including private educational institutes, places of worship, and entertainment facilities.

□ President Moon Jae-in convened a Special Meeting on COVID-19 Response and Disease Control in Yeomingwan-Building 1 (Yeomingwan : offices of the Presidential Secretariat) at Cheong Wa Dae, from 16:00 today (April 12th (Mon)).

○ The Ministry of Economy and Finance, the Ministry of the Interior and Safety, the Ministry of Health and Welfare, the Office for Government Policy Coordination, the Ministry of Food and Drug Safety, and Korea Disease Control and Prevention Agency attended the meeting which reviewed response strategies and updates including COVID-19 infection prevention/control strategies, plans to enhance the ability to deploy infection prevention/control measures, vaccine rollout strategies, supporting the development of Korean vaccines, and the authorization of vaccines, treatment, and at-home testing kits.

1. COVID-19 Response and Infection Prevention/Control Strategies

□ Korea Disease Control and Prevention Agency (KDCA) (Commissioner Jeong Eun-kyoung) delivered the COVID-19 Response and Infection Prevention/Control Strategies report at the Special Meeting on COVID-19 Response and Disease Control.

○ The third wave of infections followed a curve that picked up in November of last year and peaked during the fourth week of December, 2020, with the national figure for average daily new cases hitting 1,016.4 at its most severe. Thereafter the numbers gradually decreased and plateaued around the 400 range from mid-January, before trending up again lately. This trend can be explained as one in which the transmissions that had persisted in Greater Seoul throughout this whole period had lately been occurring also in Non-Greater Seoul, thus creating a nation-wide trend of growing infections.

* (Greater Seoul Cases out of Nation-wide Numbers) Week 3 of March : 28% → Week 4 of March : 32% → Week 1 of April : 35.2%

○ As things stand currently, there exist a number of risk factors that cause concern. First, there is the possibility of an exponential spread of the virus in the local community when a patient from a cluster outbreak which had occurred via a medium of infection such as a publicly used facility that had reopened after the February 15th easing of social distancing rules, goes on to transmit the disease at the home, workplace, school, and other facilities.

- Second, there is also a likelihood that communities have accumulated mild symptom and asymptomatic cases while the third wave of infections was moving through its protracted trajectory, allowing disease transmission to happen before tests can be performed, thereby turning these hidden cases into sources of infection.

- Furthermore, the COVID-19 variants spreading across the globe are entering Korea, and cluster outbreak incidents are also continuing to increase.

○ On the other hand, after the proactive decision to conduct preemptive testing at high-risk facilities in addition to the inoculations, cluster outbreaks and the proportion of critical/severe cases and fatal cases at convalescent hospitals/facilities have dropped significantly (remaining at about 1% in March), allowing 80% of beds dedicated to critical cases to remain available for potential patients.

* Proportion of cases attributed to cluster outbreaks at convalescent hospitals/facilities : (January, 2021 – Week 9) 5.7% → (Week 14) 1.0%

- The Korean-made COVID-19 antibody treatment has entered the pandemic response system with its approval for groups most likely to report severe/critical cases such as the 60-or-older group.

□ Given the current environment surrounding infection prevention/control efforts, when handling the concomitant risk factors, the government’s focus will be : ① Special management of infection prevention/control programs dedicated to high-risk groups, ② Enhancing the efficiency of testing efforts, ③ Early testing of those showing symptoms, ④ Stopping the spread of variants, ⑤ Rapid and safe rollout of the vaccination program, and ⑥ Active engagement regarding the use of antibody treatments.

① (Special management of infection prevention/control programs dedicated to high-risk groups) Preemptive testing will continue for staff at public baths, child-care facilities, and entertainment facilities. This will be expanded to include regular preemptive testing centering around regions reporting mass disease transmission incidents.

- In addition, monitoring efforts will be implemented at facilities vulnerable to the virus such as high-risk workplaces and schools where regular sample inspections will be performed. Further, where local situation allows, preemptive testing will also be expanded by the local governments.

② (Enhancing the efficiency of testing efforts) Leveraging the increased testing capacity that allows for as many as 500,000 tests per day, testing is now available at screening centers in community health centers irrespective of* social distancing levels, address of residence, symptoms, and epidemiological connection.

* (Previously) Screening centers at community health centers only allowed testing in the case of contact with patients, and when showing certain symptoms.

- Furthermore, individuals showing symptoms who are tested in response to doctor/pharmacist recommendations, he/she can be tested free of charge* without consultation – should the person so choose – with a health worker. Coverage by the National Health Insurance is expected to be expanded** for selective testing for hospitalized patients.

* Fees waived at screening centers in general hospitals/hospitals (screening centers in tertiary hospitals not included)
** (Out-of-pocket cost burden borne by patient) ▴Pooling tests : 10,000 won (50%) → 4,000 won (20%), ▴Individual test 40,000 won (50%) → 16,000 won (20%)

- There are also plans to support the development of kits that enable at-home tests (joint public-private initiative led by the Ministry of Food and Drug Safety) by creating an option to use nasal cavity swabs instead of the nasopharyngeal swabs which are mainly collected by trained personnel.

③ (Proactive measures to encourage testing of those showing symptoms) Authorities will also prepare simplified forms for ordering tests, writing prescriptions, and providing guidance, which is hoped to make these actions easier for doctors/pharmacists to take.

- Authorities will cooperate with key stakeholders such as local governments, and the medical/pharmaceutical associations of relevant jurisdictions to create an enabling atmosphere for voluntary testing, while also issuing administrative orders for regions reporting significant mass disease transmission incidents.

④ (Stopping the spread of variants) Stricter rules will be applied when determining exemptions from mandatory isolation requirements for international travelers entering Korea. Stronger monitoring measures will be put in place such as a PCR testing requirement after five to seven days in the country for everyone.

- There will be additional steps to shore up isolation measures, such as placing all arrivals from South African variant hotspots, South Africa and Tanzania, in temporary residential facilities for 14 days.

⑤ (Rapid and safe rollout of the vaccination program) The 2021 Second Quarter COVID-19 Vaccination Program will be administered smoothly so as to stay on target for herd immunity by November.

- Acccess to Pfizer-BioNTech vaccines will be enhanced by operating one or more vaccination centers at every city/county/district level* by the end of April. Plans will be implemented beginning on April 19th to inoculate groups prioritized for early vaccination** through officially designated clinics (1,686 sites) at each city/county/district level.

* 71 centers (April 8th) → 267 centers (end of April)
** Vaccination starts (from April 19th) for 880,000 essential care-givers including visiting care-givers for senior citizens and care-givers for people with disability

- Improve the efficiency of the vaccine program at every point possible, such as using low dead space (LDS) syringes (additional purchase of 7.07 million LDS syringes in April) that minimize vaccine wastage. Better management of vaccine supplies can also enhance efficiency as the resulting inventory data can better inform decisions in redistributing vaccines according to inoculation rates. These efforts are expected to raise the overall speed of vaccinations.

- Based on scientific evidence, the AstraZeneca COVID-19 vaccine will be recommended to individuals 30 years or older. The vaccines excluded from the initial vaccination plans are to be rapidly utilized for inoculation of seniors, while also strengthening monitoring of adverse reactions such as those related to blood clots.

⑥ (Active engagement regarding the use of antibody treatments.) New COVID-19 cases requiring antibody treatments will be admitted to hospitals dedicated to infection disease where this medication is available for administration.

- Further, the decision to expand the use of antibody treatments (high-risk cases*) will reflect European Medicines Agency (EMA) recommendations and expert consultations. Applications for the use of antibody drugs for COVID-19 treatment will be rapidly authorized (Ministry of Food and Drug Safety).

* (Currently) Advanced age, cardiovascular and respiratory diseases, diabetes, hypertension → (Additionally) Kidney disease, cancer, immune compromise, obesity, etc.

2. Strategies to Enhance Compliance to Infection Prevention/Control Measures

□ The Ministry of the Interior and Safety (Minister Jeon Hae-cheol) delivered the Strategies to Enhance Compliance to Infection Prevention/Control Measures report during the Special Meeting on COVID-19 Response and Disease Control.

○ With the social distancing rules in effect for a prolonged period, vigilance has admittedly flagged. The number of violations of the infection prevention/control codes are on the rise, and the Ministry is planning to respond with stronger inspections at high-risk facilities and strict yet fair application of rules in addressing violations of infection prevention/control measures.

□ The Joint Inter-Governmental Infection Prevention/Control Inspection Force will bring together central and local government authorities to focus their inspection efforts on high-risk facilities, while responding to violations according to a zero-tolerance policy.

○ The Ministry of the Interior and Safety will be in charge of the Inspection Force, with relevant departments, police force, and local governments participating. In addition, private sector representatives (associations/organizations) of each high-risk facility type will be also participating during the on-site inspections.

- Focused inspections will be performed beginning on April 15th (Thu) for the nine major facility types* of private educational institutes, places of worship, athletic facilities, child-care facilities, public baths, construction sites, door-to-door sales, entertainment facilities, and restaurants/coffee shops, where cluster outbreaks are frequently occurring.

* Private educational institutes (Ministry of Education), places of worship/athletic facilities (Ministry of Culture, Sports and Tourism), child-care facilities/public baths (Ministry of Health and Welfare), construction sites (Ministry of Employment and Labor, Ministry of Land, Infrastructure and Transport), door-to-door sales (Fair Trade Commission), entertainment facilities (Ministry of Food and Drug Safety), restaurants/coffee shops (Ministry of Food and Drug Safety)

- Risk levels for the 17 cities/provinces will be assessed to prioritize the most urgent regions for on-site inspections of high-risk facilities by both the central and local governments, which will minimize blind spots overlooked by infection prevention/control policies.

* Examples : Entertainment facilities (Seoul), public baths (Gyeongsangnam-do), indoor athletic facilities (Gyeonggi), child-care facilities (Incheon)

- During its on-site inspections, the Joint Inter-Governmental Infection Prevention/Control Inspection Force will maintain its zero-tolerance policy in addressing violations such as non-compliance to infection prevention/control codes. Penalties – such as bans on gatherings and fines – will be based on the strict yet fair application of the Infection Disease Control and Prevention Act

○ Such joint inspections will be performed continuously until the infection prevention/control situation becomes stable, while the activites and inspection results of the Joint Inter-Governmental Infection Prevention/Control Inspection Force will be transparently disclosed according to a predetermined schedule.

□ As the Officer in Charge for the infection prevention/control activities of the inspection, Ministers will take part in field inspections.

○ The Minister will become the Officer in Charge for the infection prevention/control of facilities within the Ministry’s purview, and the Managing Officer will be those at the Director General level. All such officers will be part of the inspection efforts at the aforementioned facilities.

- The Minister will form a consultative organ with associations/organizations representing each facility type and hold regular meeting sessions during which authorities will request the voluntary participation in infection prevention/control measures by the facilities, while also visiting the sites with the members of the consultative organ to immediately resolve issues regarding shortfalls in infection prevention/control response.

* Examples : Ministry of Justice (corrective facilities), Ministry of the Interior and Safety (citizen complaint centers), Minister of Culture, Sports and Tourism (arts and culture facilities such as art galleries), Ministry of Environment (national parks), Ministry of Employment and Labor (job training facilities), Ministry of Land, Infrastructure and Transport (logistics distribution centers), Ministry of SMEs and Startups (traditional markets)

- Furthermore, plans are being prepared to rapidly address deficient laws and systems that hobble infection prevention/control efforts by collecting recommendations and grievances from the field at the local government levels.

○ This Minister Accountability Program will remain in place along with the Joint Inter-Governmental Infection Prevention/Control Inspection Force initiative until the infection prevention/control situation stabilizes.

□ Model cases of local government programs and private sector participation in infection prevention/control will be recognized with administrative and financial support, while also cultivating voluntary accountability so that government efforts and citizen participation can align as a successful voluntary infection prevention/control strategy.

○ Discussions are planned with the Central Disaster Management Headquarters (Ministry of Health and Welfare) and local governments to review methods to support a participatory program of accountable infection prevention/control. This could potentially include partial easing of restrictions for certain publicly used facilities by local governments when facilities actively engaged in inspections by the central/local governments do not see cluster outbreaks for a predefined period of time (EG. more than 1-2 months).

○ Special grants will be allocated to local governments successfully implementing decentralized infection prevention/control programs for voluntary participation, reflecting the unique needs of each region.

- The decision to provide incentives and prioritized support to local governments will be based on a comprehensive review of local government activities such as participation in the central government’s special infection prevention/control response strategy*, and the development and implementation of infection prevention/control programs like cluster outbreak prevention and response measures tailored to the region.

* Field inspection (regular/need-based) participation of agency heads, track record of prosecution/fines/bans of gatherings and the quality of the determination process

- Additionally, financial support will be provided whenever needed in consideration of needs and timing, by taking into account infection prevention/control tasks and costs arising from testing, treatment, and vaccinations. These steps will be taken so that infection prevention/control measures on the frontlines can be implemented effectively and easily.

○ Further, central government evaluations of local governments will be simplified so that local authorities will be able to reduce administrative workload and focus on infection prevention/control.

3. COVID-19 Vaccine Programs and Supporting the Development of Korean-made Vaccines

□ The Ministry of Health and Welfare (Minister Kwon Deok-cheol) presented the nation’s COVID-19 vaccine programs and strategies to support the development of Korean-made vaccines at the Special Meeting on COVID-19 Response and Disease Control.

○ The nation has signed agreements for a total of 152 million doses of COVID-19 vaccines to be delivered in 2021. This is enough to inoculate 79 million people, and as of April 12th (Mon), 3.373 million doses have been dispensed for vaccination.

- 18.088 million doses have been secured for the first half of 2021. This covers the first shots of the 12 million people scheduled for vaccination in the first half of this year, in addition to the second shots for those who are required to get the scheduled second dose during this period.

□ The government will be placing all its available capacity to securing vaccines (additional shots on top of the planned 12 million people dosage) so as to further widen access to COVID-19 vaccinations.

○ First, the government will actively engage in discussions with suppliers so that the nation can receive confirmed vaccine delivery dates that supply the shots in the first half of 2021.

- When additional vaccine productions are identified in the first half of this year, all available avenues for dialogue will be activated to secure their delivery as early as possible.

- Further, authorities are taking into account the possibility that more vaccines might be needed as more age groups enter the vaccination program, and when variables such as the duration of antibodies, and variant outbreaks figure into the overall picture. The government will remain prepared for these scenarios while continuing active negotiations with suppliers.

○ Second, to guarantee the safety of vaccines, the government will simplify administrative processes so that the doses already allocated to the inoculation plans can be utilized as quickly as possible.

○ Third, diplomatic efforts to secure vaccines will be ramped up, while the government will pursue active engagement with key parties when issues arise regarding the supply of raw materials for the production of Korean-made vaccines.

○ Fourth, the Pan-Government Vaccine Rollout TF* formed on April 1st will carefully monitor vaccine administration, and rapidly resolve issues that might arise during the process.

* The tasks involved in the rollout of vaccines will be mainly handled by the Ministry of Health and Welfare, with other branches such as Ministry of Foreign Affairs, Ministry of Trade, Industry and Energy, Ministry of Food and Drug Safety, Korea Disease Control and Prevention Agency, Ministry of SMEs and Startups, and Korea Customs Service participating in tasks including international cooperation, raw materials supply, rapid authorization (use, delivery)

□ Recently, as a result of a successful joint effort between relevant government departments and private corporations for the rollout out of COVID-19 vaccines in Korea, the nation has seen production start on Novavax vaccines for the country.

○ In early February, the United States extended the Health Resources Priorities and Allocation System* (HRPAS), a form of export restriction, and the overwhelming global demand for raw materials combined to create delays in components supply for the domestic production of Novavax vaccines.

* HRPAS (Health Resources Priorities and Allocation System) : An administrative order that determines the priority of healthcare resources and their allocations, which has been currently set to prioritize the United States (extended until December, 2021).

- The government responded with an active engagement strategy that began by bringing together Director General level representatives of relevant departments to form a Novavax Vaccine Raw Material Consultation Team* which met once a week with key stakeholders including relevant government branches, SK Bioscience, and suppliers of raw materials.

* Members include : Ministry of Health and Welfare, Korea Disease Control and Prevention Agency, Ministry of Foreign Affairs, Ministry of Trade, Industry and Energy, Ministry of SMEs and Startups, Ministry of Food and Drug Safety, SK Bioscience

- As a result, supply bottlenecks were successfully resolved for a total of 17 items by securing components, identifying replacements, and converting in-stock materials. This translates into removal of obstacles for most of the vaccine components under question.

○ As such, should relevant administrative procedures proceed without incident, the final vaccine can be shipped out as early as June of this year, and by the third quarter the nation is expected to have secured stable domestic production capacity for COVID-19 vaccines.

* SK Bioscience predicts up to 20 million doses by the third quarter of 2021, if the following conditions are met : ① Item permission for Novavax vaccines acquired by the first half of the year, ② Additional raw materials acquired, ③ Higher yield achieved

□ Along with efforts to secure a stable path towards the safe rollout of COVID-19 vaccines, the government is also shoring up support for the successful development of Korean-made vaccines.

○ Currently five companies* have entered the clinical trial phase for their vaccines with phase 3 expected to start by the second half of 2021.

* SK Bioscience, Eubiologics, Cellid, Genexine, GeneOne Life Science

- The government will administer a budget of 687 billion won* to support the costs of clinical trials and minimize the number of obstacles on the way to vaccine development. Further support can also be considered should the need arise.

* (Vaccines) 49 billion won (2020) → 68.7 billion won (2021)

○ There will also be government support in defining and utilizing immunological correlate of protection* (ICP) biological indicators to address the difficulties in finding participants in large-scale clinical trials.

* Type and amount of immunological response (antibody titer, duration, etc.) that correlate with vaccine-induced protection which can be utilized as a surrogate index in evaluating a new vaccine’s potency when comparing it against a vaccine with proven efficacy.

- The government is strengthening international cooperation efforts to establish ICP, while also creating an COVID-19 Vaccine ICP TF* (since April, 2021) to power a whole-of-government approach.

* Experts from the private sector and relevant departments such as Ministry of Health and Welfare, Ministry of Science and ICT, Korea Disease Control and Prevention Agency, Ministry of Food and Drug Safety, Ministry of Foreign Affairs

- Further, since clinical trials with ICP will require rapid analysis of large volumes of clinical specimen, the government is continuing to drive strategies to secure facilities, equipment, and human resources which include efforts such as expanding the biosafety level 3 (BL3) capacity* of the National Infectious Disease Research Institute.

* Six new BL3 facilities to be completed by May at the National Infectious Disease Research Institute

○ Furthermore, to resolve the difficulties in finding participants in the clinical trials, the Korea National Enterprise for Clinical Data is providing additional support in ramping up effort to find participants.

- The number of consortia supporting clinical trials has been increased from three to five. The Public Platform for National Clinical Trial Participation, which began operation on April 8th (Thu), provides additional support such as matching up participant volunteers with vaccine developers. The government is also developing a Support System for International Clinical Trials*.

* The Centralized Online Repository of International Clinical Trial Support (since November, 2020) is used to provide information and consulting about overseas clinical trials, and build a 1:1 support system for international clinical trials using the interdepartmental cooperation framework currently in place to support such strategies.

○ Active measures will be pursued to secure technology to rapidly develop mRNA vaccines in response to emerging infectious diseases.

- The government will form an mRNA Expert Panel from both the public and private sectors, while reinforcing plans to support the acquisition of foundational technology through interdepartmental cooperation.

* Department roles (suggested) : Ministry of Science and ICT (patent circumvention foundational technology such as mrna transmission technology), Ministry of Health and Welfare (support clinical trials/non-clinical lab studies), Korea Disease Control and Prevention Agency (identify candidate vaccine molecules, efficacy testing, technology hybridization), Ministry of Trade, Industry and Energy (develop industrial base for raw materials, production technology, etc.), Ministry of Food and Drug Safety (develop evaluation technology for safety and efficacy (quality))

- These initiatives will be accompanied by a continued effort for R&D cooperation and technology acquisition through various channels, such as, MOU negotiations between the National Infectious Disease Research Institute and the National Institute of Allergy and Infectious Disease of the United States, in addition to the creation of a consultative body in healthcare between Korea and Germany.

□ Minister Kwon Deok-cheol explained that “the Ministry has been holding non-stop meetings since last week with relevant industries to build a stable program for vaccine rollout,”

○ “Admittedly, the global competition for vaccines is fierce, but the Novavax raw materials incident and its successful resolution prove that we can hope to overcome any challenge arising during vaccine rollout when there is cross-departmental collaboration and response. We will be committing all our efforts to securing an obstacle-free path towards herd immunity by November of this year.”

○ Minister Kwon added : “In the long run, the nation needs to have in place its own capacity to respond to emerging infectious diseases. We will continue to support the effort to develop Korean-made vaccines until the goal is achieved.”

4. Government support during the authorization and rollout of vaccines, treatment drugs, and at-home test kits

□ The Ministry of Food and Drug Safety (Minister KIM Ganglip) presented its plans to deliver government support during the authorization and rollout of vaccines, treatment drugs, and at-home tests, at the Special Meeting on COVID-19 Response and Disease Control.

□ All available capacity at the Ministry will be committed to the phase 3 clinical trials of Korean-made vaccines, while preparing to rollout vaccines from international firms.

○ As ICP enables clinical trials withaa smaller number of participants and lower costs, the Ministry is working with relevant departments for the early establishment of ICP by defining a guideline for vaccine development using ICP, securing source data for ICP development by performing immunogenicity analysis of vaccine recipients, and building global consensus by working closely with the WHO.

* (Conventional Phase 3) 30,000 participants, 0.4-1.2 trillion won ↔ (Phase 3 Using ICP) 4,000 – 6,000 participants, 80 - 120 billion won

○ Further, the government will provide technical support in production and quality management areas such as production technology used in specific vaccine platforms and testing for venture companies without experience in producing vaccines at scale.

○ For the Novavax vaccine that is being planned for rollout, once data needed for approval is provided, authorities will rapidly authorize its use by way of preliminary examination.

□ The Ministry will support the expanding of the scope of use for Korean-made antibody drugs, while also working for early deployment of treatments developed overseas.

○ The COVID-19 treatment drug, Regkirona (international generic name : regdanvimab), which had received conditional approval (phase 3 clinical trial results pending) on February 5th, 2021, was authorized for limited use for cardiovascular and respiratory illnesses in elderly patients. When phase 3 begins, participants representing additional conditions will be included to expand the scope of use, while timely treatment of critical patients will be enabled by reducing administrative processes when the drug is authorized for use in critical cases.
* (Current scope) Advanced age, cardiovascular disease, respiratory disease, diabetes, hypertension → (Expanded scope) Kidney disease, cancer, immune compromise, obesity, etc.

○ The Ministry will also be reviewing data from early phase clinical trials and engage in consultation programs to enable rapid deployment in Korea of drugs being developed overseas.

□ The changing conditions surrounding infection prevention/control programs are creating a setting where the probability of needing at-home tests is growing. Therefore, the authorities are supporting the rapid adoption of such at-home test kits.

○ Working with relevant departments, the Ministry will take supportive action to raise the probability of successfully developing an at-home test kit. At-home testing guidelines, review and consultations from a designated medical officer before submission is filed, and assistance in acquiring clinical specimen through collaborations with residential treatment centers and clinical facilities are some of the actions that can potentially reduce to two months, the typical eight-month period it used to take to bring such products to the market.

○ Until such a product is developed, authorities will examine products which have been approved for expert use, that have records (data and information) of private use in other countries for special instances like emergencies. Where deemed appropriate, some of these kits may receive conditional approval with follow-up submission of domestic clinical data, so as enable rapid public response to the changing demands on COVID-19 testing strategies.

□ The Ministry will work to guarantee the safety of the vaccines, treatment drugs, and at-home test kits by enforcing a strict approval review procedure, while also endeavoring to bring infection prevention/control products into use at the appropriate time.

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