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- 2026-03-17 19:30:53
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- Ildong Idience’s Venadaparib IND approved in China
- by Kim, Jin-Gu Dec 13, 2021 05:56am
- On the 10th, Ildong Holding’s new drug development subsidiary Idience announced that its IND(Investigational New Drug) application for ‘Venadaparib (IDX-1197)’ for gastric cancer patients was approved by China’s National Medical Products Administration. Venadaparib, a PARP (ADP-ribose polymerase) inhibitor, is a new targeted therapy candidate that is being developed to target breast cancer, ovarian cancer, gastric cancer, and PARP inhibitor-resistant cancers. Idience plans to evaluate the safety and efficacy of Venadaparib in combination with irinotecan, an established anticancer drug, on gastric cancer patients in China as soon as all the requirements are met. Idience is in clinical trials with Venadaparib in Korea and the US after receiving approval for its IND application from Korea’s Ministry of Food and Drug Safety and the US Food and Drug Administration. The company had presented results that demonstrate the efficacy of Venadaparib in PARP inhibitor-resistant cancer and BRCA mutation-negative cancer at academic conferences held this year by the American Association for Cancer Research (AACR), American Society of Clinical Oncology (ASCO), and the European Society for Medical Oncology (ESMO). An official from Idience said, “The high incidence of gastric cancer and relatively high number of patients in China make the country advantageous for clinical trials. The IND approval in China will allow us to speed up the development and commercialization of Venadaparib.” He added, “We will also continue research to confirm the effectiveness of Venadaparib and present our development progress, research results, and differentiated strengths of the drug at academic meetings and conferences overseas”
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- GC Pharma, stopped discussing consignment of Janssen vaccine
- by Kim, Jin-Gu Dec 13, 2021 05:56am
- GC Pharma announced on the 9th that it will suspend discussions on Janssen's consignment production of the COVID-19 vaccine. GC Pharma said it has suspended discussions with Johnson & Johnson on consignment production of vaccines as of today (9th). It has been about four months since GC Pharma announced in August that it will produce Janssen's COVID-19 vaccine on consignment. At the time, a local media reported that GC Pharma was discussing consignment production of COVID-19 vaccines with Janssen. At that time, GC Pharma made an official position that "it has not been confirmed." The pharmaceutical bio industry expected that if GC Pharma signs a consignment production contract with Janssen, it will be the third case of domestic production of the global corona vaccine after SK Bioscience-AstraZeneca and Samsung Biologics-Moderna. Janssen's COVID-19 vaccine was approved in Korea in April. One vaccination has a preventive effect. The preventive effect is 66.9%. However, it is known that the preventive effect decreases sharply over time after inoculation.
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- PH3s of Daewoong’s SGLT-2i antidiabetic near completion
- by Kim, Jin-Gu Dec 10, 2021 05:53am
- #1i Clinical trials for the new antidiabetic SGLT-2 inhibitor ‘Enavogliflozin’ in development by Daewoong Pharmaceutical are gaining speed. One of the three Phase III clinical trials is already complete, and the remaining two are also nearing their final stages after completing patient recruitment. With such progress, the industry expects the authorities to grant marketing authorization for Enavogliflozin within the first half of next year, then be released in 2023. ◆Phase III trial on two-drug combo complete… trials on monotherapy and three-drug combo also in final stages According to the industry on the 10th, Daewoong Pharmaceutical had recently completed the Phase III trial for its Enavogliflozin(DWP16001)+metformin combination therapy. Enavogliflozin, a new SGLT-2 inhibitor antidiabetic, is the first SGLTi developed by a domestic pharmaceutical company. Other antidiabetic SGLTi options available include AstraZeneca’s ‘Forxiga,’ Boehringer Ingelheim’s ‘Jardiance,’ Astellas’ ‘Suglat,’ MSD’s ‘Steglatro,’ among others. Last year, Daewoong Pharmaceutical had received approval to initiate a Phase III clinical trial on 190 patients with type 2 diabetes in 24 hospitals in Korea, including Seoul Saint Mary’s hospital, to assess the efficacy of its Enavogliflozin+metformin combination therapy. After registering the last patient in May this year, the company completed observations on the last patient in November and is currently analyzing clinical data. The company had initially expected to complete the trial by December 2023, but due to smooth progress, the end date was pulled forward by a year. Other clinical trials on Enavogliflozin are also in smooth progress. Daewoong Pharmaceutical is currently running 3 trials related to Enavogliflozin. In addition to its two-drug combination trial on Enavogliflozin+metformin, the company is also assessing Enavogliflozin as a monotherapy and a three-drug combination that uses metformin and DDP-4 inhibitor in addition to Enavogliflozin. Among these, the Phase III trial on the Enavogliflozin monotherapy has started in September last year on 140 patients in Korea. Patient recruitment is now complete and observation of the last patient is expected to be completed within this year at the earliest. The patient recruitment for the three-drug combo has also been completed. Daewoong Pharmaceuticals had received approval to initiate a Phase III trial to assess the efficacy of the Enavogliflozin+metformin+DPP-4 inhibitor combination on 256 patients last October. LG Chem’s gemigliptin was selected as the DPP-4 inhibitor for the three-drug combo, and patient recruitment was completed in August this year. With all three Phase III trials coming to an end, prospects on when the drug will be authorized have also been rising. The pharmaceutical industry believes that it is strongly likely that the company will apply for marketing authorization next year and release the drug in 2023. Daewoong Pharmaceutical had originally planned to release its drug in 2023. The pharmaceutical industry believes that there is a strong possibility that the company will apply for product approval in the first half of next year and release it in 2023. Daewoong Pharmaceutical had originally planned to release it in 2023. ◆ Extension studies for data acquisition also in smooth progress… started trials to enter global market For the Enavogliflozin monotherapy and the two-drug combination using metformin, an extension (long-term administration) trial is also underway in addition to the Phase III trial. Trials on long-term administration of drugs are usually conducted after the product is released, but Daewoong Pharmaceutical plans to release the drug after securing relevant data. The company’s move to first secure the long-term clinical data is interpreted as a strategic attempt to compete with existing SGLT-2 inhibitors. The extension trial for the Enavogliflozin monotherapy was approved in August this year. The clinical trial size is 70. The company started the trial in full by starting recruitment in September last year. The extension trial for the two-drug combination therapy using metformin was approved in March this year, and the company had succeeded in recruiting all 100 patients in November. The trial is expected to be completed by the first half of next year. With existing Enavogliflozin trials entering completion, the company has also been initiating new trials. The company had started a Phase I trial targeting Koreans, Westerners, and Latin American patients on December 1st. It is explained that the trial was prepared with global expansion in mind. The company is also actively seeking indication extensions. In August this year, the company had received approval to initiate a Phase I trial for DWP30600. DWP30600 is a combination of Enavogliflozin and an anorectic agent (DWC202010).
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- ₩150 bil export of Celltrion’s Regkirona on track to
- by Kim, Jin-Gu Dec 10, 2021 05:51am
- Export of Celltrion’s COVID-19 antibody treatment ‘Regkirona (regdanvimab)’ is now fully on track. On the 9th, Celltrion Healthcare announced that it had completed shipping 150,000 vials of the initial load of Regkirona for 9 countries in Europe. Celltrion Healthcare has been discussing exporting Regkirona with 70 countries. In addition to the 9 countries that the company is supplying its initial load to, the company has signed supply agreements with a total of 18 countries. The total amount that has been and will be supplied in December alone is expected to reach ₩150 billion. Demand for the supply of Regkirona has been increasing due to the increased product reliability following the European Commission's (EC) marketing approval and the rapid increase in the number of confirmed COVID-19 cases. Celltrion Healthcare plans to supply the maximum amount this year through close cooperation with Celltrion, which is in charge of production. Regkirona received official marketing authorization in Korea and Europe. Also, the drug received conditional approval or emergency use authorization in other countries including Australia, Indonesia, Brazil, and Peru. Celltrion Healthcare said that the company is expanding discussions to sign new agreements with these countries. As a result, the industry experts expect the company to supply more Regkirona next year compared to this year. An official from Celltrion Healthcare said, “With additional approvals continuing around the world following the EC approval, we plan to continue to increase making supply agreements. In addition to Regkirona, the Celltrion group will continue to contribute to overcoming the global COVID-19 pandemic by developing innovative solutions such as CT-P63 to tackle new variants and inhalable forms of treatment.
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- Signifor Lar discontinued in the lacking acromegaly Tx mkt
- by Eo, Yun-Ho Dec 09, 2021 05:59am
- A considerable blow is expected in the already lacking acromegaly treatment market with the discontinuation of one of its very few available options. According to industry sources, the domestic supply of the acromegaly treatment ‘Signifor LAR (pasireotide)’ has been discontinued. The decision was made as Novartis sold the rights to Signifor La to Recordati SpA.,an Italian pharmaceutical company. As a result, the drug that had been developed by Novartis and distributed by Samoh Pharm will now be discontinued in Korea. However, the problem lies in the patients. Signifor LAR is a second-line treatment for acromegaly that was listed for reimbursement in November 2017. At the time, Signifor LAR was the only second-line treatment option available in the market. However, Pfizer’s ‘Somavert (pegvisomant)’ was listed in September, adding one more option as a second-line treatment. The discontinuation in its supply would most greatly affect those who are currently receiving Signifor LAR. As a rare disease treatment, around 10 patients in Korea have been using Signifor LAR, but they may experience insurance cuts if they switch to Somavert due to unclear reimbursement standards. And the patients cannot return to the drugs that they had used for first-line treatment after already failing treatment with the same drugs. Also, there are only two options available in the first-line – Ipsen’s ‘Somatuline Autogel (lanreotide acetate)’ and Novartis’ ‘Sandostatin LAR (octreotide).’ Acromegaly is a rare disease in which the pituitary tumor causes hypersecretion of growth hormones to result in facial deformation and hypertrophy of the hands and feet. The key treatment objective for acromegaly is to reduce the level of growth hormones and insulin-like growth factor-1 (IGF-1) secretion. However, 45% of the patients who were treated with first-generation somatostatin analog (SSA) were unable to achieve biochemical control. Meanwhile, in a Phase III trial that compared Signifor LAR with a maximum dose first-generation SSA, Signifor LAR demonstrated superiority in ▲ Biochemical control (mean GH level under 2.5㎍/L and normal range IGF-1 level) ▲GH and IGF-1 control ▲decrease n tumor size Patients whose acromegaly was not adequately controlled after being treated for over 6 months existing SSA (octreotide 30mg or lanreotide 120mg) participated in the trial and were randomly assigned to Signifor LAR 40mg, 60mg, or first-generation SSA for treatment. Study results showed that the proportion of patients that met the primary endpoint of biochemical control at 24 weeks was 15% for the Signifor LAR 40mg group and 20% for the Signifor LAR 60mg group, which was higher than that of the control group (0%).
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- Hanmi’s poziotinib enters final phase for commercialization
- by Kim, Jin-Gu Dec 08, 2021 06:00am
- ‘Poziotinib,’ a drug licensed out by Hanmi Pharmaceuticals, is entering its last phase for authorization in the US. The variables that remain to approval are the US FDA’s interpretation of the clinical trial results and the on-site investigations on the company’s production and manufacturing facilities. If these progress as planned, Hanmi Pharmaceuticals will be able to achieve its first global commercialization landmark with the new drug technology export earlier next year. On the 6th (local time), the US company Spectrum Pharmaceuticals submitted a new drug application (NDA) for poziotinib. It is indicated for the treatment of locally advanced and metastatic HER2 Exon20 mutant-positive non-small cell lung cancer (NSCLC) in patients who have previous treatment experience. Poziotinib received the fast-track designation in March from the FDA. Drugs that receive the fast-track designation receive various support from the FDA in the stages of its development. Also, when applying for marketing authorization, the drugs are allowed to submit data sequentially under a rolling review as soon as data is available and are allowed to be discussed for priority review, etc. In particular, the priority review would shorten the FDA's marketing authorization review period from 10 months to 6 months. Considering the circumstances, Spectrum expects poziotinib to be approved in the US by the first half of next year. If poziotinib receives FDA approval, it would be a first for Hanmi to succeed in the global commercialization of a new drug that it had exported technology for. The variables that remain to approval now are poziotinib’s clinical trial data and on-site investigation. Spectrum submitted the NDA based on the cohort 2 results of the ‘ZENITH20’ clinical trial. Trial results showed that the objective response rate (ORR) of patients with HER2 Exon20 mutant-positive non-small cell lung cancer (NSCLC) with treatment experience was 27.8%, the median duration of response (mDOR) 5.1 months, and the median progression-free survival (PFS) 5.5 months. However, the drug showed somewhat less encouraging results in a clinical trial that was independently conducted in Europe. Professor Arsela Prelaj of the IRCCS National Cancer Institute Foundation in Italy compared data of 30 patients who were administered poziotinib to 28 that did not. No significant difference was found, with the overall survival (OS) of the poziotinib-treated group being 19.2 months compared to the 18.2 months in the control group. However, when matched by propensity score and calculated by Cox's proportional hazard regression model, the risk of death in patients who took ‘poziotinib’ was reduced by 34% at the most. Although no significant OS improvement was demonstrated in the study, the study still had meaning as it identified the possibility that the drug can reduce the risk of death. The results were announced at the ESMO virtual congress in September. The study was an investigator-led study without sponsorship from Hanmi or Spectrum. The other variable that remains is the on-site investigation. In the case of ‘Rolontis,’ another one of Hanmi’s technology export new drugs that Spectrum applied marketing authorization for, the on-site investigation had deferred what was on the brink of approval. The FDA determined that there were some problems with Hanmi’s factory in Pyeongtaek and sent a complete response letter (CRL) to Spectrum. Although Rolontis was expected to be approved in October last year, the FDA’s CRL has pushed back the schedule by over a year. Hanmi believes such an issue will not arise for poziotinib because the two drugs have different manufacturing facilities. An official from Hanmi said, “Rolontis is manufactured at Hanmi’s Pyeongtaek plant, whereas poziotinib is manufactured in the US. Also, most of the FDA’s requests for supplementation have been now addressed.” Therefore, the industry’s eyes are focused on whether Hanmi will be able to overcome its two previous failures and succeed in its third attempt. The FDA had deferred approval of Hanmi’s two technology export new drugs ‘Oraxol’ and ‘Rolontis’ in March and August this year. The company had licensed out the technology for its metastatic breast cancer drug Oraxol to Athenex but the FDA deferred its approval due to neutropenia concerns.
- Company
- Hanmi's lung cancer drug Poziotinib has been applied for NDA
- by Kim, Jin-Gu Dec 08, 2021 06:00am
- The U.S. FDA marketing approval process for Poziotinib, a new lung cancer drug developed by Hanmi Pharmaceutical, has begun. Hanmi Pharmaceutical's partner Spectrum announced on the 6th (local time) that it has submitted an NDA to the U.S. Food and Drug Administration (FDA). This indication is NSCLC with local progression and metastatic HER2 Exon 20 insertion mutation with treatment experience. This NDA submission is based on the positive cohort 2 results of the ZENITH20 clinical trial that evaluated the safety and efficacy of Poziotinib. Poziotinib was designated as FastTrack by the FDA. As a result of this indication, there are no FDA-approved treatments so far. Spectrum President Joe Turgon said, "HER2 Exon 20 insertion mutation has reached an important stage for achieving the first treatment for lung cancer patients. We thank researchers, patients, and spectrum executives and employees for their passionate efforts to achieve important milestones in areas with high unmet medical demand."
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- The kit for precocious puberty in Korea has been stopped
- by Moon, sung-ho Dec 08, 2021 06:00am
- The increase in the number of precocious puberty patients in Korea is unusual. As the number of patients, which was 80,000 in 2015, exceeded 130,000 in 2020, there are opinions that it should now be recognized as a social problem. In response, some in the medical community and clinical sites predict that the number of precocious puberty patients will increase further as outdoor activities decrease due to the prolonged COVID-19 pandemic. Amid this situation, it has been confirmed that confusion is occurring at front-line medical sites due to the recent suspension of the supply of "diagnostic reagents" that can identify patients with precocious puberty. With the suspension of the supply of diagnostic reagents, which were the only health insurance coverage targets, even the diagnosis of precocious puberty patients, which is rapidly increasing due to prolonged COVID-19, is developing. According to the medical and pharmaceutical industries on the 4th, clinical doctors are suffering from the suspension of supply of injection items that are prescribed precocious puberty as a "diagnostic reagent" since March. The item is Relefact LH-RH supplied by Handok in Korea. As Sanofi, the original developer, decided to suspend the supply of this item in March, stock of reagents for diagnosing precocious puberty has disappeared in Korea. According to the MFDS, the import performance of Relefact LH-RH in 2020 is about 1.132.26 billion won. Considering that it was 650.58 million won in 2015, the performance has increased, but it is lower than expected. The problem is that Relefact LH-RH is the only item as a diagnostic reagent for precocious puberty. Lutrelef of Perring Pharmaceutical Korea, which can be said to be the same ingredient, has already been withdrawn from the domestic market due to the expiration of its validity period. For this reason, medical sites are unable to diagnose precocious puberty patients due to a lack of diagnostic reagents. In the diagnosis of precocious puberty, LH and FSH are measured in the blood for 2 hours at intervals of 15 to 30 minutes after administration of "sexual stimulation hormone secretion hormone." If the maximum concentration of sulfonation hormone is 5 IU/L or higher, it is judged to be activated and diagnosed with precocious puberty. , that is, "sexual stimulation hormone secretion hormone" plays a role in the diagnosis process of precocious puberty, and it is Relefact that diagnoses it. As Relefact has not been imported into Korea, it is difficult to diagnose precocious puberty nationwide, said a professor of pediatrics in a province who asked for anonymity. "As the number of precocious puberty patients has already increased rapidly through the COVID-19 pandemic, I wonder what preparation the health authorities have made." It is prescribed as an "off label" for precocious puberty, which has become difficult to diagnose. If so, how is the medical field responding to the suspension of the supply of diagnostic reagents? As a result of the coverage, it was found that some hospitals and clinics are prescribing other drugs offline as the supply of Relefact has been stopped. In fact, it has been confirmed that some hospitals and clinics apply for approval for excessive use of Ferring's Decapeptyl Depot and use it as a reagent for diagnosing precocious puberty. Decapeptyl is a specialized drug licensed for hormone-dependent prostate cancer, endometriosis and uterine myoma, central puberty early onset in girls under the age of 9 and boys under the age of 10. Another professor who runs a clinic said, "As papers have been presented that they have obtained good results in Thailand, some hospitals in Korea are already receiving health insurance benefits by submitting approval to the HIRA for the use of non-reimbursed drugs beyond the scope of reporting." In fact, the HIRA official also said, "As the supply of Relefact injections has been suspended, off-label use through Decapeptyl is being carried out. Currently, we are considering approving the use of hospitals and clinics that submit overseas papers." It was found that the seriousness of the problem was recognized and countermeasures began to be prepared, focusing on related societies such as the Korean Society of Pediatric Endocrinology. If it is no longer possible to secure Relefact, the use of off-label for Decapeptyl is suggested as an alternative, and some pharmaceutical companies are requesting the re-import of related items. It is only hoped that the suspension of supply will end in a short period of time as a pharmaceutical company that resupplies the drug to Korea.
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- Dire need for a rational pricing system for new drugs
- by Nho, Byung Chul Dec 07, 2021 05:57am
- Improving the drug pricing system through social consensus has been proposed as a prerequisite for the government to achieve the 60 trillion won export and 300,000 job creation in the biohealth industry as one of its 3 new growth engine industries. In addition to the primary purpose of fostering the biopharmaceutical industry to create national wealth, there is no disagreement on the fact that the localization of vaccines and treatments as the nation’s key industry is essential to address the national need and respect and realize the right to life of the citizens in Korea in the COVID-19 pandemic. In particular, the emphasis Yong-Ik Kim, the President of the National Health Insurance Service, made at special lectures, in raising the will for R&D among biopharmaceutical companies through appropriate pricing of new drugs and the joint growth of the nation and its companies, has been interpreted as an exemplary blueprint for the soft landing of Mooncare. Seong-min Park, a lawyer from HnL law firm said, " An irrational pricing system for new drugs may infringe the Korean patients’ access to treatment as well as adversely affect the fostering of a health drug ecosystem with fair competition.” Essentially, 4 rational drug pricing measures were considered eligible for review/introduction through communication with the Ministry of Health and Welfare, as well as the Korea Pharmaceutical and Bio-Pharma Manufacturers Association and other industry pricing managers: ▲ reducing the scope of alternative drugs ▲flexible application of negotiations(diversifying types of pricing negotiations allowed to include refund system, etc) ▲price discount accumulation system ▲pricing premium for new drugs that have conducted Phase III trials on Koreans First, the system to reduce the scope of alternative drugs was proposed to improve the standards for selecting alternative drugs so that new drugs can be compared with each other. According to the industry, one issue in setting prices for new drugs is that the price of originals and generic drugs that have been discounted 53.55% due to patent expiry are all included in the standard used to set new drug prices and are continuing to be discounted due to post-marketing measures. If this intensifies, the price of new drugs could be set at a lower level than alternative generics, reducing the will for companies to research or develop new drugs and also inducing voluntary withdrawal of licenses due to loss of cost. In other words, Korea will not be able to leap forward and become a pharmaceutical powerhouse if the virtuous cycle of ‘R&D-new drug discovery- national wealth creation’ is broken. On this, Park said, “Special measures such as excluding patent-expired products from alternative drugs is necessary. Global competitiveness can be secured only when practical standards are established for the selection of alternative drugs such as those with therapeutic equivalence and the price set at 80-120% of the price in foreign countries.” Under the price discount accumulation system, pricing discounts that are accumulated during a new drug’s patent period after term expiry, effectively preserving the R&D value of a new drug to allow faster recovery of R&D expenses and induce reinvestment. The system does not provide preferential treatment by exempting drug price discounts but defers it, therefore retaining the effect of reducing insurance finances. The irrationality of lowering drug prices of new drugs that are more cost-effective than its alternatives with the price-volume linkage system and the discount applied when a drugs attempts to add indications that are within the scope held by its alternatives, has been constantly raised. For example, compared to other drugs of the same class, Zemiglo had been subject to numerous more price-volume linkage discounts than its number of sales since it was released in 2012. Its price had been discounted a total of 6 times. The pricing premium system for new drugs that have provided Phase III trials on Koreans allows the price of new drugs that conducted Phase III trials on local patients to be set at 95-100% of the market price of substitute drugs rather than at 90% when omitting pricing negotiations. The system does not conflict with international trade as it allows new drugs from multinational pharmaceutical companies that conduct multinational clinical trials to receive benefits while local new drugs that did not conduct Phase III trials of a certain size in Korea to become ineligible for such benefits. The system is already being applied and operated abroad. For example, in Taiwan, a 10% premium is provided for new drugs that conducted clinical trials over a certain size to demonstrate safety and efficacy. In Japan, a new drug that was first-ever to be approved in Japan receives a premium of 10-20% for early introduction (new drugs that explicitly include dosage regimens for pediatric patients area are applied a 5-20% premium, however, the premium is not applied if the clinical trial conducted in Japan do not include pediatric patients). The greatest advantage of the 'pricing premium system for new drugs that have conducted Korean Phase III trials’ is that it provides base data on the safety, efficacy, clinical utility of a drug in Koreans. It is also easy to track and manage, improves R&D ability by the full step of the trial being conducted domestically, provides a performance upgrade for domestic clinical trial institutions, creates jobs, and contributes to new drug development fit to match the condition and diseases of Koreans.
- Company
- Moderna tackles the Omicron variant with booster shots
- by Dec 07, 2021 05:57am
- ” We are developing three vaccine strategies to rapidly respond to the much-concerned Omicron variant. We plan to soon release a booster shot that is most appropriate for the Omicron variant.” Randall N. Hyer, senior vice president of Global Medical Affairs at Moderna, replied so to an inquiry about the company’s plans on responding to the Omicron variant at a press conference that was held at the Somerset Palace in Jongno-gu, Seoul, on the 2nd. According to SVP Hyer, Moderna is preparing three different strategies to respond to the Omicron variant: ▲high dose booster shot; ▲new booster shot to respond to the Omicron and other emerging variants; and ▲an Omicron-tailored booster shot. For the first option, a high-dose booster shot, the company has already completed safety and immunogenicity tests on 306 adults with a 100μg dose that is twice the dose currently in use. As the second option, the company is testing 2 multivalent booster candidates – one that added the Beta variant to the existing vaccine (mRNA-1273.211), and the other that combined the beta and delta variant (mRNA-1273.213). The two candidates include the 4 and 8 variants found in the Omicron variant. As the third option, Moderna is developing the vaccine candidate mRNA-1273.529 that specifically targets the Omicron variant. The development is expected to take 2-3 months. Randall N. Hyer, Senior Vice President of Moderna Inc.i2Hyer said, “We have been developing various booster shots since earlier this year to respond to anticipatable variants. We are reviewing which strategy is most effective among the three. We will be able to identify the effect of the high-dose booster shot within a few weeks.” However, it would take some time for a booster shot that can prevent the Omicron variant to be available for inoculation in the field, as it requires clinical trials and approval by the regulatory authorities. Moderna believes that the benefits of vaccination outweigh the risk even in young adults and children. There were concerns over the risk of myocarditis in young adults with the Moderna vaccine, however, the company says its data demonstrates the fact that its vaccine’s risk is no different than that of Pfizer’s. Some Northern European countries have only allowed the use of Pfizer’s vaccine to children and young adults due to the risk of side effects such as myocarditis and pericarditis among youths and young adults. Korea has also made the same recommendation. Also, the US Food and Drug Administration has deferred extending approval of Moderna’s vaccination to those aged 12-17, saying that the risk of myocarditis in teenagers needs to be reviewed. On this, Hyer said, “The absolute risk of myocarditis after vaccination is very low. Some monitoring results showed that Moderna’s vaccine had a higher risk than Pfizer’s vaccine, but others have also shown that there was no difference at all between the two. The incidence of myocarditis and pericarditis in those 30 years or less who were vaccinated were no different for the two - 0.45(0.45 per 100,000) for Pfizer and 0.49(0.49 per 100,000) for Moderna.” He added, “Please bear in mind that the risk of myocarditis is higher if you are unvaccinated and confirmed with COVID-19 rather than from vaccination with COVID-19 vaccines. Of course, we fully understand the concerns of the health authorities as the results vary by each dataset. Moderna is also conducting its safety investigations to examine the association between myocarditis and mRNA vaccines.” Moderna also stressed the need for smooth communication with the Korean government. That day, Moderna had also announced that it had appointed Ji-young Sohn, former general manager of CSL Behring Korea, as its new general manager for its Korean subsidiary. Hee-Soo Kim, Country Medical Director of Moderna Korea, said, “After the Korean subsidiary was established in May, the general manager and medical director joined the company in November, and various departments have also been established since then.” Kim added, “We are hiring many employees now. Although we had issues communicating with Korean government authorities before, we hope that the establishment of our Korean subsidiary may contribute in various ways, including facilitating the smooth supply of vaccines and R&D partnerships.” As part of such efforts, Moderna has started a fellowship program under which young researchers can learn about the development of mRNA therapeutics, and encouraged active participation of Korean researchers. Hyer said, “We are pleased that 2 Korean professors have joined our Fellowship Promotion Committee. We hope many young researchers in Korea would join us to study mRNA-based therapeutics."
