Moderna’s forthcoming vaccine for cytomegalovirus (CMV) leverages relatively new RNA technology to neutralize the virus and prevent a potential infection in cases of exposure. Although clinical trials for the vaccine were delayed amid the pandemic, Moderna as well as industry experts appear optimistic about its potential, potential among women of childbearing age.
- Moderna’s anticipated vaccine for CMV is a messenger RNA (mRNA) vaccine, which is a relatively new but not untested form of technology.
- Notably, RNA (mRNA) vaccines will be used for the first time in a mass immunization program to combat COVID-19.
- At a high level, the company’s RNA vaccine triggers a human’s immune system to produce antibodies for CMV, and thereby helps neutralize the virus and prevent a potential infection in the event a person is exposed in the future.
- In particular, Moderna’s vaccine “combines six mRNAs (five encoding for the pentamer complex and one encoding for gB) together into one vial” to combat the virus, per the company’s website.
- As of the company’s latest March 2020 press release, Moderna reported several points of progress related to its CMV clinical trials, including:
- Successful completion of its Phase 1 seven-month interim safety trial.
- Targeting the third quarter of 2020 to report results from the first interim analysis of its Phase 2 dose-confirmation trial.
- Expected to start the Phase 3 dose selection trial in 2021, while completing associated manufacturing and planning in 2020.
- However, as of the end of March 2020, Moderna stated that its CMV trials had been interrupted indefinitely due to the pandemic.
- Notably, commentary by Moderna CEO Stéphane Bancel this past November 30, 2020 confirmed that its CMV vaccine remained in Phase 2 clinical trials, but also indicated that Phase 3 testing might still start in 2021.
- Meanwhile, an extensive review of Moderna’s owned media (e.g., press releases), industry trades (e.g., Genetic Engineering & Biotechnology News) and other credible sources (e.g., SEC archives) indicates that the company has no partners that are specific to its CMV vaccine development.
- However, Moderna continues to rely on financial backers (e.g., EDBI, BB Biotech, Julius Baer, Sequoia Capital China) as well as its clinical trial partners to support CMV trials alongside other treatments in development at the company.
- Moderna is currently positioning its CMV vaccine as an intervention for women / pregnancy, per executive statements, company press releases, social media posts and its corporate website.
- As evidence of this positioning, the company and its leaders consistently reiterate several key phrases across interviews and other forms of public marketing:
- In parallel, Moderna routinely emphasizes that “there is no approved vaccine to prevent CMV,” with Mr. Bancel adding that the vaccine is therefore a “potential blockbuster” opportunity that has the potential to achieve “$2 to $5 billion of annual peak sales.”
- The statements about the financial opportunity represented by Moderna’s CMV vaccine are further supported by the company’s increasing indications that its CMV vaccine is “providing strong efficacy.”
- Meanwhile, industry commentary from both pharmaceutical (e.g., The Medicine Maker, Biopharma Dive) and business (e.g., Barron’s, StreetInsider) experts appears to echo Moderna’s statements that the CMV vaccine is an opportunity for women / pregnancy and has a positive outlook for clinical efficacy.
- Notably, CMV affects a preponderance of the human population and has implications far beyond women, pregnancy and newborns.
- However, in a manner consistent with Moderna itself, industry experts consistently discuss Moderna’s vaccine as a solution to address a virus that is “transmitted from infected mothers to babies” and “can cause birth defects.”
- In parallel, the medical and investor communities appear to agree that the outlook for Moderna’s vaccine is “promising” and that it’s clinical trial results are “more confident than ever,” citing the fact that trials for the RNA vaccine are showing”good toleration and no severe adverse events.”