MRNA Quick Quote MRNA - Free Report) , the first company to initiate human clinical trials of its coronavirus vaccine candidate in the United States is once again in the spotlight with an impressive update on its COVID-19 vaccine (mRNA-1273). The company recently informed that it submitted applications seeking U.S. authorization of its mRNA-1273 in adolescents (from 12 to less than 18 years). The company also filed for receiving a conditional marketing approval or regulatory authorization in Europe and Canada for the use of mRNA-1273 in adolescents.
Encouraging data from the phase II/III study TeenCOVE that assessed mRNA-1273 in adolescents in the United States prompted Moderna to file applications. The company also announced of late that the Phase 2/3 study of its COVID-19 vaccine (mRNA-1273) in adolescents met its primary immunogenicity endpoint. Markedly, there was no record of coronavirus cases among the participants who were administered both the mRNA-1273 doses.
According to the company, a 93% vaccine efficacy was recorded in seronegative participants beginning 14 days after the first dose, applying the secondary Centers for Disease Control and Prevention case definition of COVID-19, which tested for milder disease.
Moving on, Moderna recently started filing a biologics license application (BLA) with the FDA looking for approval/licensure of mRNA-1273 in adults. The company will keep submitting supportive data from the ongoing clinical trial and other studies and aims to request the FDA for a priority review of the regulatory application. It is worth noting here that a potential nod to the BLA for mRNA-1273 will enable Moderna to keep commercializing the COVID-19 vaccine even during the periods of lower infection rate and the recession of the emergency situation.
Furthermore, Moderna and Aldevron, LLC, recently informed about their expanded partnership in support of Moderna’s COVID-19 vaccine and additional programs in the vaccine developer’s clinical development pipeline. Also, in a positive update, the company informed about securing the Conditional Marketing Authorization for its mRNA vaccine from the Ministry of Food and Drug Safety of South Korea (MFDS).
In this regard, the company further informed about two Memoranda of Understanding (MoU) with the government of South Korea. The first MoU is with the Korea National Institute of Health, an agency of the Korea Centers for Disease Control and Prevention Agency, for a new collaboration on mRNA vaccine research in South Korea. Another MoU is with the Ministry of Trade, Industry and Energy of the Republic of Korea, and the Ministry of Health and Welfare of the Republic of Korea to study the local manufacturing opportunities for mRNA vaccines in South Korea.
Moderna ETFs to Gain
The competition to come up with a vaccine is opening up near-term opportunities, making the biotech sector a prospective space for investments. Therefore, we discuss a few ETFs that provide exposure to Moderna
: ETFMG Treatments Testing and Advancements ETF ( GERM Quick Quote GERM - Free Report)
This fund is designed to give direct exposure to biotech companies, directly engaged in the testing and treatment of infectious diseases. It holds 78 stocks in its basket, with Moderna occupying the second spot at 8.39% share. The fund has amassed $56.7 million in its asset base and charges 68 basis points (bps) in annual fees (read:
5 Sector ETFs That Crushed the Market in April). VanEck Vectors Biotech ETF ( BBH Quick Quote BBH - Free Report)
The underlying MVIS US Listed Biotech 25 Index tracks the overall performance of companies involved in the development and production, marketing and sales of drugs based on genetic analysis and diagnostic equipment. It holds about 25 securities in its basket, with 7.20% exposure to Moderna. Its AUM is $545.7 million and it has an expense ratio of 0.35% (read:
Biotech ETFs to Suffer as US Backs IP Waiver for COVID-19 Vaccines). iShares Nasdaq Biotechnology ETF ( IBB Quick Quote IBB - Free Report)
This fund seeks to track the investment results of an index composed of biotechnology and pharmaceutical equities listed on the NASDAQ. It holds about 277 securities in its basket, with 6.90% exposure to Moderna. IBB has an AUM of $10.87 billion with an expense ratio of 0.46% (read:
How Will Biotech ETFs React to These Q1 Earnings Releases?). iShares Genomics Immunology and Healthcare ETF ( IDNA Quick Quote IDNA - Free Report)
The fund seeks to track the investment results of an index composed of developed and emerging market companies that could benefit from the long-term growth and innovation in genomics, immunology, and bioengineering. It holds about 49 securities in its basket, with 5.29% exposure to Moderna. IDNA has an AUM of $297.4 million with an expense ratio of 0.47%
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