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The first company to begin human clinical trials of its coronavirus vaccine candidate in the United States — Moderna (MRNA) — has once again come up with encouraging study data relating to mRNA-1273. National Institutes of Health -appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273 has informed Moderna that with a vaccine efficacy of 94.5%, the trial has met the pre-mentioned statistical parameter in the study protocol for efficacy. Notably, the aforesaid study, which is known as the COVE study, is being conducted in association with the National Institute of Allergy and Infectious Diseases (NIAID). It enrolled more than 30,000 participants in the United States.

Notably, the primary endpoint of the Phase 3 COVE study covers the analysis of COVID-19 cases that were confirmed and adjudicated beginning two weeks after the second dose of vaccine. In fact, this first interim analysis was based on 95 COVID-19 cases, out of which 90 cases were observed in the placebo group versus 5 cases observed in the mRNA-1273 group and delivered a point estimate of vaccine efficacy of 94.5% (p <0.0001), according to the company.

Moderna aims to submit for an Emergency Use Authorization (EUA) with the FDA in the coming weeks based on the above-mentioned interim safety and efficacy data. The company expects to receive the EUA informed by the final safety and efficacy data (with a median duration of at least 2 months). Moderna will also submit applications for approvals to global regulatory agencies.

In order to be prepared for the distribution of mRNA-1273, post-receipt of EUA and similar global authorizations, Moderna is working with the U.S. Centers for Disease Control and Prevention (CDC), Operation Warp Speed, and McKesson (MCK), a COVID-19 vaccine distributor that has been contracted by the U.S. government, along with global stakeholders.

Moderna anticipates to have around 20 million doses of mRNA-1273 to ship in the United States by the end of this year. It is also on track to produce 500 million to 1 billion doses worldwide in 2021. The American Medical Association also recently issued a Current Procedural Terminology code to report vaccination with mRNA-1273 (code: 91301).

Notably, Moderna has informed about further progress toward the distribution, storage, and handling of the vaccine using the existing infrastructure entirely. Going by the latest updates provided by the company, the vaccine candidate is now expected to stay stable at standard refrigerator temperatures of 2° to 8°C (36° to 46°F) for 30 days, up from the prior estimate of seven days. Moreover, shipping and long-term storage conditions can be maintained at standard freezer temperatures of -20°C (-4°F) for six months.

Other Vaccine Developers Progressing Well

On Nov 9, Pfizer (PFE) and BioNTech announced the efficacy of their mRNA-based coronavirus vaccine candidate, BNT162b2. According to them, the vaccine was more than 90% successful in preventing COVID-19 in participants without prior evidence of SARS-CoV-2 infection. The results are based on the first interim efficacy analysis conducted on Nov 8, by an external, independent Data Monitoring Committee from the Phase 3 clinical study, per the company.

Going on, Pfizer and BioNTech will keep gathering safety data and currently project that a median of two months of safety data following the second (and final) dose of the vaccine candidate matching the FDA guidance for potential EUA should be available by the third week of November.

Meanwhile, other front runners in vaccine development, AstraZeneca (AZN) working in collaboration with Oxford University, and Johnson & Johnson (JNJ), have resumed their late-stage coronavirus vaccine trials in the United States.

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, which was up 9.5% after the announcement of encouraging vaccine data:

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. Focused on advancements with targeted exposure to the forefront of R&D, vaccines, therapies, and testing technologies. It holds 63 stocks in its basket, with Moderna occupying the top spot at 8.7% share. The fund has amassed $55 million in its asset base and charges 68 basis points (bps) in annual fees.

Principal Healthcare Innovators Index ETF (BTEC Quick Quote BTEC - Free Report)

This fund invests in companies that are leading the charge toward innovative solutions, rather than spending money on marketing and distribution by tracking the Nasdaq Healthcare Innovators Index. It holds 262 stocks in its basket, with Moderna taking the top spot at 3.9%. BTEC charges 42 bps in annual fees and has AUM of $121.4 million.

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 24 securities in its basket, with 7.5% exposure to Moderna. Its AUM is $471.8 million and it has an expense ratio of 0.35%.

iShares Genomics Immunology and Healthcare ETF (IDNA Quick Quote IDNA - Free Report)

The fund seeks investment results, before fees and expenses, which match the NYSE FactSet Global Genomics and Immuno Biopharma Index. It holds about 46 securities in its basket with Moderna, occupying a weight of 5.6%. It has AUM of $175.4 million and an expense ratio of 0.47%.

Other broader biotech ETFs that hold companies developing tests, vaccines, and therapies for coronavirus include:

iShares Nasdaq Biotechnology ETF (IBB Quick Quote IBB - Free Report)

This fund seeks to provide exposure to U.S. biotechnology and pharmaceutical stocks and tracks the Nasdaq Biotechnology Index. It has an AUM of $9.66 billion with an expense ratio of 0.46%.

SPDR S&P Biotech ETF (XBI Quick Quote XBI - Free Report)

The fund seeks daily investment results, before fees and expenses, which match the S&P Biotechnology Select Industry Index. It has AUM of $6.49 billion and an expense ratio of 0.35%.