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- 2026-04-12 02:53:19
- Policy
- Drug e-labeling and abolition of PMS reexaminations...
- by Lee, Hye-Kyung Jul 22, 2022 05:53am
- The Ministry of Food and Drug Safety announced that it will refrain from making a unilateral announcement of regulations, and Suk-Yeol Yoon’s government announced that it would reform regulations by listening to the opinions of the industry. As part of such efforts, the MFDS had conducted 7 internal discussions since Yoon’s inauguration to set tasks for regulatory innovation and conducted a national public debate at the Korea Chamber of Commerce and Industry from 10:00 a.m. today (21st). (From the left) Seok Yeon Kang, Director-General of the Pharmaceutical Safety Bureau; Sang Bong Kim, Director-General of the Biopharmaceuticals and Herbal Medicine Bureau; Nam Hee Lee, Director-General of the Medical Device Safety Bureu; Hun Woo Hong, Deputy Director General for Narcotics Safety Planning Through the public debate, the MFDS was able to prepare key tasks to review for regulatory innovation, including ▲the introduction of a classification system for temporary items such as digital healthcare devices, ▲support for rapid development of biopharmaceuticals developed using innovative technology (microbiome, exosome, etc.) ▲expanding designation of innovative medical devices ▲promote allowance of the manufacture and import of cannabis containing pharmaceuticals ▲preparing a classification and safety management system that aligns with the characteristics of combination products ▲exemption from receiving MFDS approval for clinical trial protocols for medical devices with a low understanding ▲allowing the performance of clinical trials on diagnostic software at sites other than clinical trial institutions, etc. Also, the MFDS plans to review 20 tasks including: ▲expanding subjects for prior review to rapidly commercialize medical devices, ▲phased introduction of e-labels for pharmaceuticals ▲ private-led conversion of natural/organic cosmetic certification system ▲allowing holding concurrent positions as a manufacturing manager for low-strength vitamin preparations (quasi-drugs) ▲Expanding the use of overseas investigational drugs for therapeutic purposes ▲Improving post-marketing surveillance systems for biopharmaceuticals ▲transferring the sample collection procedure required for national lot release approval to the private sector ▲Introduction of a differential management system when changing labels of a drug ▲Improving indications for quality testing of biologics ▲Simplifying application for performance testing of in-vitro diagnostic devices ▲Abolishing reporting obligations on use of cosmetic ingredients ▲Abolishing reexamination of of post-marketing safety management system and , integrating it into the risk management plan ▲ abolishing the transfer approval system to return medical narcotics. More specifically, in the case of changing the labels of a drug, the company had to change the insert paper in its printed form within the grace period (1-3 months), however, through the phased introduction of the e-label, the ministry plans to provide safety information in real-time with the e-label when labeling changes occur. Also, to allow for the use of real-world data (RWD) in the post-marketing pharmacovigilance of vaccines for infectious pandemic diseases, the MFDS will improve the post-marketing pharmacovigilance system for biopharmaceuticals, as in the US and Europe. Also, among the post-marketing safety management system that has been dualized into the reexamination and risk management plan system, the MFDS will work to abolish the reexamination system and integrate it into the risk management plan system. In the case of the abolition of the transfer approval system, as people had complained of the work delay on site due to the transfer approval procedures of the medical institution, pharmacy, etc. after the transferee receives approval from the competent licensing authority and returns the pharmaceutical to the original owner. Therefore, the system will be improved so that narcotics and psychotropic drugs may be returned to the original owner without approval from the competent licensing authority. At the event, Yoo Kyung Oh, Minister of Food and Drug Safety, said “the subject of regulations is important for the industry to emerge into the global market while ensuring safety. Regulatory innovation should not be a unilateral process where the government decides to lift certain regulatory items and announces it.” Yoo Kyung Oh, Minister of Food and Drug Safety announced that the ministry will l refrain from making a unilateral announcement of regulations at the ‘Public Debate on Regulatory Innovation for the Medical-Pharmaceutical Industry” Minister Oh added, “The MFDS is a regulatory institution that protects public safety. I have contemplated much on wetting the right regulatory target for the past 50 days since my appointment. Regulations play an important role in protecting safety but they may act as a barrier to the industry, so we held 7 internal discussion sessions on regulatory innovation.” Minister Oh said, “The regulatory barriers in the pharmaceutical sector are high and we still have a long way to go. The MFDS wishes to support the pharmaceutical industry’s prompt entry into the global market. Yoon’s administration also aims to innovate the administrative process for food and drugs to meet the international standards, therefore we will humbly listen to the voices of the people rather than unilaterally act on it.” On the 21st, the MFDS held a Public Debate on Regulatory Innovation for the Medical-Pharmaceutical Industry” at the at the Korea Chamber of Commerce and Industry. The MFDS plans to publicly announce its tasks for regulatory innovation that can be felt by the public and industry, including the regulatory innovation review tasks that were disclosed this time. Also, the MFDS announced it will continue to maintain a regulatory innovation system to aid public convenience and industry development, by operating public-private consultative bodies in each field and operating a regulatory innovation promotion team under the MFDS.
- Policy
- Billions of won in losses if applied retroactively
- by Lee, Tak-Sun Jul 22, 2022 05:53am
- The pharmaceutical industry is complaining about the retroactive application of detailed operation guidelines revised in April at this year's PVA. Although it has already officially proposed excluding retroactive application to the NHIS twice, the NHIS' position is firm. Analysts say that such an issue will be a hurdle to settle the negotiations at a time when the NHIS entered negotiations with the aim of adjusting drug prices in September. In particular, there are pharmaceutical companies that are expected to suffer billions of won in losses from retroactive use, which is expected to take legal action in the worst case scenario. According to the industry on the 20th, the industry officially proposed excluding the retroactive application of detailed operation guidelines in May and June, but the NHIS does not accept it and is negotiating. In the detailed operation guidelines revised in April, the key is to limit PVA exclusion to cases where the main component code is less than 90% of the arithmetic average. Previously, cases where the arithmetic mean was less than that were excluded. As a result, although the arithmetic average price is less than 90%, there are items that have been newly negotiated. For example, in the case of Choline alfoscerate which was mentioned in the revision of the guidelines, Gliatamin soft cap, the No. 1 item in sales, is subject to negotiation in accordance with the revised guidelines. The price of the Gliatamin soft cap is 504 won, and the arithmetic average of the main component code is less than 512 won, but the arithmetic average exceeds the 90% (460 won) standard and is included in the target. As of last year's UBIST, Gliatamin's outpatient prescription amount was 110.1 billion won. PVA is supposed to adjust the upper limit from less than 10%, and if the upper limit of Gliatamine falls by only 5%, the company will lose more than 5 billion won. As such losses are formidable, the pharmaceutical industry as a whole is raising its opinion that the revised guidelines should not be applied retroactively in the negotiations. Usually, compared to the previous year's and the previous year's claims, it is an item subject to negotiation if it increases by more than 60% from the previous year's claims, or if it increases by more than 10% and more than 5 billion won. The industry points out that it is impossible to proceed with negotiations based on the previous year's claims as the guidelines have been revised this year. However, the NHIS explained that there is no issue of equity as it has continuously mentioned the guidelines, strengthened the scope of exclusion from negotiations, and applied relaxed standards. The NHIS plans to negotiate with the aim of adjusting the upper limit in September. An official from the NHIS said, "The opinion has been submitted twice, but we plan to proceed with the negotiations as planned." An official from the pharmaceutical industry said, "We mentioned the revised guidelines since last year, but the pharmaceutical industry continued to maintain its opposition until the revision." "If it is applied as a small amount, we plan to watch the results of the negotiations and respond as the damage is great," he said. It is known that both sides are currently reviewing legal principles. If negotiations break down, renegotiation is possible, but if differences are not narrowed in renegotiation, the drug will be excluded from the benefit. In this case, it is highly likely that the pharmaceutical company will solve the problem through lawsuits.
- Company
- Takeda's anti-cancer drug Exkivity has been approved
- by Jul 22, 2022 05:53am
- A second targeted anticancer drug targeting EGFR Exxon 20 insertion mutation has emerged. Takeda Pharmaceutical Korea announced on the 20th that it has received approval from the Ministry of Food and Drug Safety for the EGFR Exxon 20 insertion mutant non-small cell lung cancer treatment Exkivity (Mobocertinib). Exkivity is a TKI that inhibits the growth of cancer cells by targeting the EGFR Exxon20 insertion mutation gene. With this permit, Exkivity can be used to treat locally advanced or NSCLC adult patients with EGFR Exxon 20 insertion mutations that have previously been treated with platinum-based chemotherapy. EGFR exon20 insertion mutations are rare, accounting for about 10% of EGFR mutations in non-small cell lung cancer and about 2% in all non-small cell lung cancer. EGFR Exxon20 insertion mutation Non-small cell lung cancer has a survival period twice as short as that of Exxon19 deficiency and Exon21 (L858R) replacement mutation, which accounts for most of the EGFR mutation. In addition, the prognosis for existing first and second-generation EGFR TKI target treatments and immunotherapy was poor and the response rate was low, so most patients used platinum-based chemotherapy for treatment, so the demand for unmet Exxon20 insertion mutation target treatments was high. Exkivity is an irreversible binding to EGFR Exxon20 insertion mutations that inhibit cancer cell growth and proliferation with a mechanism that blocks binding to ATP, the energy source of cancer cells. Earlier in February, Janssen's Rybrevant, which targets EGFR Exxon 20 insertion mutations, was approved. Unlike the injection Rybrevant, Exkivity is an oral drug Exkivity is the first oral treatment for EGFR Exxon 20 insertion mutant non-small cell lung cancer, which can be taken once a day regardless of meals. The company explained that this not only improves the convenience of taking medicine compared to injections, but also makes it easy to control the dose for adverse reactions, which can help patients improve their quality of life while maintaining their daily lives. The approval was based on a phase 1/2 clinical study conducted on 114 patients with EGFR Exxon20 insertion mutant non-small cell lung cancer who previously received platinum-based chemotherapy. As a result of the clinical trial, the ORR evaluated by IRC was 28% and the mDOR was 17.5 months in the patient group who took 160 mg of Exkivity. In particular, the median reaction time after administration of Exkivity was 1.9 months, and it was confirmed that the drug effect quickly appeared from the beginning of treatment. The mPFS was 7.3 months and the MOS was 24.0 months. The safety profile was also shown to be good. The most common adverse reactions were diarrhea, rash, and fatigue, and can be managed by controlling the dosage. Ahn Myung-joo, a professor of hematologic oncology at Samsung Medical Center, said, "We are very pleased to hear the news of the domestic approval of Exkivity, as the target treatment options have been limited in EGFR Exxon 20 insertion mutant non-small cell lung cancer. The EGFR Exxon 20 insertion mutation had a poor prognosis even with existing treatment options, but Exkivity improved major indicators such as ORR and mPFS median through clinical studies."
- Policy
- Negotiations for Pfizer Lorviqua have not been completed
- by Lee, Tak-Sun Jul 22, 2022 05:52am
- Pfizer It was found that Lorviqua' a third-generation non-small cell lung cancer treatment that inhibits ALK (anaplastic lymphoma kinase), failed just before being listed. The HIRA announced the establishment of a standard next month, but the NHIS negotiations were not completed, leading to the deletion again. According to the industry on the 19th, Lorviqua passed the HIRA Pharmaceutical Benefit Evaluation Committee in April and has since been negotiating drug prices with the NHIS. As the committee judged that there is an appropriate benefit for the treatment of adult patients with ALK-positive progressive non-small cell lung cancer, the industry believes that it would not be unreasonable to pass if the pharmaceutical company and the NHIS derive an appropriate drug price. As a result, some predicted that the benefit would be registered as early as the 1st of next month. However, the negotiations have not yet been completed, so it is expected that it will not be registered until September at the earliest. This fact is known as the announcement of the establishment of an anticancer drug benefit standard by the HIRA. Initially, the HIRA conducted an opinion inquiry on the revision of the announcement according to drugs prescribed and administered to cancer patients on the 18th, signaling the establishment of a new benefit for Lorviqua in August, but it was immediately deleted. This was because drug price negotiations with the NHIS have not yet been completed. Lorviqua is a third-generation drug that can be used if ALK-positive non-small cell carcinoma patients use first-generation Xalkori, second-generation Zykadia, and Alecensa, but it is not effective. In other words, it is a new alternative for patients who have used second-generation drugs but become resistant. Patients are also expected to be registered quickly. However, it will be possible only after one more month.
- Company
- Imbruvica makes 4th attempt to extend reimbursement
- by Eo, Yun-Ho Jul 21, 2022 06:04am
- Already for the fourth time, Janssen is attempting to expand reimbursement for ‘Imbruvica’ as a first-line treatment. According to industry sources, reimbursement of Imbruvica (ibrutinib) as a first-line treatment for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Leukemia (SLL) will once again be deliberated by the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee. Imbruvica’s reimbursement for its first-line indication, which had been deliberated by the CDDC three times from October last year to June this year, had been turned down all three times. The drug was able to receive reimbursement extensions to the second line after being listed through the PE exemption pathway but is having trouble extending its indication further into the first line. However, with voices rising on the need to extend Imbruvica’s reimbursement and HIRA's judgment that there is no problem in Imbrvica's clinical efficacy, there is a possibility that the company will finally see positive results if it proposes an appropriate fiscal sharing plan this time. In fact, the industry’s expectations are rising the agenda is expected to be deliberated at the next CDDC meeting after being turned down at the meeting that immediately preceded it. Imbruvica is a first-in-class oral Bruton's Tyrosine Kinase (BTK) inhibitor that is taken once daily. With its oral formulation, the drug has the strength of being able to be administered in the outpatient setting. Since it was approved in April 2018, the drug is being used as ▲ a second-line treatment for adult patients with recurrent or refractory CLL, ▲monotherapy for the treatment of adult patients aged 65 years or older with previously untreated CLL, ▲ combination therapy with obinutuzumab for the treatment of adult CLL patients over the age of 65 or those who have comorbidities or at high-risk under the age of 65 with previously untreated CLL.
- Policy
- “Pharma companies cannot conduct online product briefings"
- by Kim, Jung-Ju Jul 21, 2022 06:04am
- “Online product briefing sessions by pharmaceutical companies are clearly illegal, but we cannot directly warn the pharmaceutical industry by pressing charges or requesting investigations at the moment." With the prohibition temporarily lifted on the pharmaceutical and medical device companies’ support of online academic conferences, the government made it clear that the online product briefing sessions should be straightened out in a relatively mild manner, such as by status surveys or advance notices. Director Tae Gil Ha and Deputy Director Jung Hyun Yeo of the Division of Pharmaceutical Policy at MOHW responded so during the QA session on the present state of affairs that was held with the MOHW correspondent council. The following is a QA on the present state of affairs discussed at the session. (From the left) Deputy Director Jung Hyun Yeo, Director Tae Gil Ha of the Division of Pharmaceutical Policy at MOHW ▶The government has temporarily extended the allowance of advertisements and sponsorships on online and ‘hybrid (on+offline)’ academic conferences due to the COVID-19 situation. Do you have any plans to institutionalize this in the future? “The regulation on online academic conferences, if amended, falls under the Fair Competition Code of the Korea Fair Trade Commission. Therefore, to systemize this, changes should be made to the Fair Competition Code. We discussed this while meeting with the FTC to temporarily extend the allowance of online academic conferences. The FTC’s position is that the current form of online academic conferences is not fit for temporary extensions and would need to be institutionalized in the future. Lifting the temporary period limitation can be done by revising the Fair Competition Code. Of course, this discussion would be made next year (after the temporary extension ends), but the direction that they will take is to institutionalize online academic conferences through code revision. ▶The training education by individual medical institutions that were allowed for the past one year is now impermissible. Why has this changed? “This is an exception made from the previously allowed acts against the Fair Competition Code. It is MOHW’s role to compromise the opinions between the industry and the medical community. As the online training was exceptionally allowed due to the nation’s social distancing measures, the MOHW worked to coordinate and combine the opinions and derive a compromised option. The “no expense support for long-term care institution-level academic conferences” was not decided by MOHW. The decision reflects the opinion of member companies of industry associations such as the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, the Korea Medical Devices Industry Association, and the Korea Research-based Pharma Industry Association. They say that online events are less effective in terms of advertisement than face-to-face events. There are grounds for allowing events at the long-term care institution level regardless of size. This means that the member companies regarded this burdensome with little advertisement effect. Some may ask whether we disallowed it against evidence, but in the relationship aspect, its allowance would have tilted the scale to one side. This was why we decided to reflect industry opinions.” ▶What plans do you have in place for regulating “digital marketing," the online product briefing sessions? “Under the current law, holding an online product briefing session in itself is allowed, but the company may not provide economic benefits to medical professionals attending the event. Some in the pharmaceutical industry believe this should be deregulated somewhat. However, others in the industry have pointed out that if this is allowed, it may become means to provide detour rebates online. We have listened to the industry’s opinion on this recently, but the discussion is still ongoing as a consensus has not been made yet. In conclusion, it is illegal to hold an online product briefing session and provide economic benefits to attending medical personnel under the current law. We are currently discussing the need to improve the system." ▶Then as the discussions are still ongoing, don’t you think you should inform the companies that are currently providing such benefits of the possibility of punishment to clarify the signal? “We need to first understand the current situation rather than press charges or requesting investigations. We need to see which companies are providing benefits. It means that we should meet with the companies and listen to their story rather than press charges right away.” ▶The pharmaceutical industry would want the government to clarify and organize the situation in advance before cracking down on the industry as it had done in the past for offline rebates. "We will not be requesting prosecutions immediately. It is realistically impossible for MOHW to find all companies and file charges. We should first provide guidance or advance notice.”
- Company
- Tabrecta is scheduled to be introduced in August
- by Eo, Yun-Ho Jul 20, 2022 05:50am
- MET anticancer drugs will enter the first stage of registration of insurance benefits. According to related industries, Tabrecta will be introduced to the HIRA Cancer Disease Review Committee on August 10. Tabrecta was approved in Korea in November last year as a non-small cell Lung Cancer (NSCLC) treatment that confirmed MET Exxon 14 deficiency as the first MET inhibitor. MET mutations are a rare type that accounts for about 3% to 4% of metastatic non-small cell lung cancer, and as there have been no treatments, interest in these new drugs is increasing. Effectiveness was confirmed through GEOMETRY mono-1 study in 97 patients with METex14. As a result of the study, the overall response rate was 68% in patients who had never been treated and 41% in patients who had previously been treated. Among the patients who took Tabrecta, DoR of the previously untreated patient was 12.6 months, and DoR of the treated patient was 9.7 months. Tabrecta is also stepping up research for future combination therapy. In particular, it is expected to solve the problem of EGFR TKI resistance in lung cancer. In fact, Tabrecta is conducting clinical trials in combination with AstraZeneca's third-generation EGFR TKI Tagrisso. Patients with EGFR mutated non-small cell lung cancer with T790M negative and MET gene amplification during treatment with 1st and 2nd generations EGFR TKI or Tagrisso were targeted The combination therapy of Tabrecta and Tagrisso is compared with platinum-based chemotherapy. Han Ji-yeon, a professor of hematologic oncology at the National Cancer Center, said, "It is very important that MET gene number has been identified as prognostic factors. It is very meaningful that drugs such as Tabrecta, which proved a clear effect only on the MET Exxon 14 defect mutation, were approved." Janssen Korea is also in the process of registering the MET inhibitor Rybrevant, but failed to pass the committee last month.
- Policy
- Companies receive mixed reimb results in urothelial cancer
- by Lee, Tak-Sun Jul 20, 2022 05:49am
- The changes made in the reimbursement standards for urothelial carcinoma brought joy or sadness to affected companies. A new reimbursement standard for urothelial carcinoma has been created for MSD’s ‘Keytruda inj (pembrolizumab),’ while the reimbursement standard for Roche’s ‘Tecentriq inj (atezolizumab)' has been removed from the list because it was unable to satisfy the conditional marketing approval requirements set by the Ministry of Food and Drug Safety. The Health Insurance Review and Assessment Service conducted an opinion inquiry on the “notice on the revision of the pharmaceuticals prescribed and administered to cancer patients” that contains the content above by the 18th. Under the revised notice, Keytruda monotherapy (second-line or higher, palliative therapy) will be newly added to the list as of August 1st, but the Tecentiq monotherapy (second-line or higher, palliative therapy) category will be deleted as of September 1st. In the case of Keytruda, results of the long-term follow-up on the open-label, randomized Phase III trial, KEYNOTE-045, that had been conducted on 542 urothelial carcinoma patients that failed platinum-based treatment showed that the Keytruda-administered group demonstrated clinical efficacy over the control group that received chemotherapy (docetaxel, paclitaxel, etc) with an ORR of 21.1% vs. 11.0%, and a median overall survival of 10.1 months vs. 7.3 months, which led to the new establishment of the reimbursement standards. Patients with locally advanced or metastatic urothelial carcinoma that failed treatment using platinum-based chemotherapy will be eligible to receive reimbursement for Keytruda. Patients who have relapsed during or within 12 months of receiving adjuvant and neoadjuvant platinum-based chemotherapy will also be eligible for reimbursement. However, the standard only applies to those who have not revived treatment with immune checkpoint inhibitors like PD-1 class treatments. However, Tecentriq, which has been reimbursed for the same indication, has been removed from the reimbursement standards. The removal was made upon the pharmaceutical company’s request, as the company was unable to satisfy the conditional marketing approval requirements set by the Ministry of Food and Drug Safety. In other words, the company was unable to demonstrate the efficacy of its drug for the indication. Roche had already voluntarily withdrawn the urothelial carcinoma indication abroad. In March last year, Roche announced it will be voluntarily withdrawing the indication for Tecentriq as a second-line treatment for urothelial carcinoma that received conditional marketing approval from the US FDA. While approving Tecentriq’s urothelial carcinoma indication, the US FDA had set the condition that Roche should demonstrate the efficacy of Tecentriq in urothelial carcinoma with the confirmatory clinical trial, IMvigor 211. However, no value result that can demonstrate the clinical efficacy of the drug was derived from the clinical trial, and Roche voluntarily withdrew the approved indication. As the company failed to satisfy the conditional marketing approval requirements in Korea as well, the reimbursement authorities had first waited until a reimbursement category is established in urothelial carcinoma for another immune checkpoint inhibitor, Keytruda, to support patient treatment. And upon Keytrua’s reimbursement, Tecentriq’s reimbursement has been removed. The urothelial carcinoma indication in itself may also likely be removed in Korea as well. However, patients who are receiving Tecentriq therapy will be able to administer the drug under the previous standards until treatment completion. Meanwhile, the revision also contained the establishment of a new category, combined use(first-line, palliative therapy) of Xtandi soft capsule 40mg (enzalutamide) and androgen deprivation therapy (ADT) to treat metastatic hormone-sensitive prostate cancer.
- Company
- Moderna to soon release bivalent COVID-19 vaccine
- by Jul 20, 2022 05:49am
- Moderna is determined to promptly commercialize its new bivalent COVID-19 vaccine “mRNA-1273.214 (214)” in Korea. On the morning of the 19th, Moderna held a “Moderna’s mRNA technology and strategy in the endemic era” press conference at JW Mariott Hotel. At the conference, the company stated that it can “supply the 214 globally by the end of August, and plans to submit data for its approval in a few days.” (From the left) Hee Soo Kim, Medical Director at Moderna Korea; Paul Burton, Chief Medical Officer at Moderna Global ; Ji-Young Sohn, General Manager of Moderna Korea; Francesca Ceddia, Senior Vice President of Respiratory Vaccines at Moderna Global The 214 that was developed by Moderna combines a vaccine that targets the original strain and the Omicron variant BA.1. The vaccine achieved superior neutralizing geometric mean titer ratio (GMR) over the current vaccine against the original virus as well as Omicron subvariants BA.4/5. Specifically, GMR of the 214 was 1.24 against the original virus, and 1.78 against BA.1. The GMR against BA 4/5 was relatively lower at 1.68. Even so, Moderna explained that this demonstrates a superior protective effect compared to the current vaccine. Francesca Ceddia, Senior Vice President of Respiratory Vaccines at Moderna Global, said, “ A GMR of 1 or higher means it has a superior effect over its comparator. In this sense, the 214 has demonstrated a superior effect against BA.4/5. We plan to submit data for its approval to the Ministry of Food and Drug Safety, and will work closely with the regulatory authorities to supply our vaccine by end of August.” However, one obstacle that remains to its use is the FDA’s position. The US FDA had recently requested vaccine manufacturers Moderna and Pfizer to add omicron BA.4/5 spike protein component to the current vaccine composition in the development of their vaccine combos. In consideration of the additional time required for clinical trials, the FDA also emphasized that it will accept animal testing data for approval. Moderna’s position is that its bivalent vaccine, the 214, also shows superior effect against Omicron compared to the current vaccine and should be first administered. The company referred to how other countries and the World Health Organization requested the company to add a BA.1 component to the company’s bivalent vaccine. SVP Ceddia explained, “Moderna is working to take into account the different requests made by each country. The important matter is that our bivalent vaccine is an effective solution. If supplied, the 214 will also provide protection against the BA.4/5 subvariants." Ji-Young Sohn, General Manager of Moderna Korea, said, “The MFDS is also known to be positively reviewing 214. I believe it is important to receive vaccination with a certain vaccine at a certain period according to virus variants. Therefore, rather than waiting several more months for the release of a vaccine against BA.4/5, it would be more beneficial to use a readily available vaccine and protect public health.”
- Policy
- The age group for SKYCovione was expanded
- by Lee, Jeong-Hwan Jul 20, 2022 05:49am
- SK Bioscience has expanded the conditions for clinical trials for cross-administration of booster shots (additional inoculations) of the nation's first COVID-19 vaccine SKYCovione (GBP510) to those aged 50 or older. This is due to the recent diversification of mutations and the re-proliferation of COVID-19. As a result, the company is expected to provide a clinical basis for being used as a booster shot for the elderly who have previously been vaccinated with mRNA vaccines. According to the pharmaceutical industry on the 18th, all adults aged 19 and older can participate in SK Bioscience's heterogeneous booster shot (additional vaccination with other vaccines), which was originally conducted for adults aged 19 to 50. This clinical trial is a test to confirm the safety and immunogenicity of adults who have completed basic vaccinations with other COVID-19 vaccines previously approved in Korea when SKYCovione is additionally inoculated. Nine domestic institutions, including Korea University Guro Hospital, are participating as clinical researchers led by the Korea Centers for Disease Control and Prevention. SK Bioscience was approved by the Ministry of Food and Drug Safety in December last year and has been recruiting participants for those aged 19 to 50. However, as the need for vaccination increased due to mutations this year, the conditions of clinical subjects were expanded and changed to the elderly. Through this clinical expansion, the government plans to provide a basis for significantly expanding the scope of vaccinations in the future by checking the effect of additional vaccinations by crossing SKYCovione in elderly people who have previously been vaccinated with other COVID-19 vaccines such as Pfizer and Moderna. With the recent spread of COVID-19 around the world, quarantine authorities are recommending the fourth round of COVID-19 vaccination for the elderly aged 50 or older. The use of mRNA vaccines such as Pfizer and Moderna is recommended first for the fourth vaccination, and if people do not want the mRNA vaccine, they may receive Novavax vaccine. SKYCovione is also recombinant protein vaccine technology. In addition to clinical trials for additional inoculations of different species, SK Bioscience is also conducting clinical trials for additional inoculations of the same kind that complete basic inoculations and additional inoculations with SKYCovione.
