Moderna Faces FDA Setback on Influenza Vaccine Application
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 4 days ago
0mins
Should l Buy MRNA?
Source: Benzinga
- Regulatory Setback: Moderna's investigational influenza vaccine, mRNA-1010, faced a refusal-to-file letter from the FDA, citing the choice of a standard-dose seasonal influenza vaccine as a comparator, despite no identified safety or efficacy concerns, which may hinder the company's goal of advancing innovative medicines.
- Meeting Request: Moderna has requested a Type A meeting with CBER to understand the basis for the refusal and stated that this incident will not impact its 2026 financial guidance, indicating the company's confidence in its future prospects.
- Inconsistent Feedback: CBER previously indicated that using a licensed standard-dose influenza vaccine as a comparator was acceptable, yet the refusal letter failed to provide specific safety or efficacy concerns, reflecting inconsistencies in regulatory communications that could affect Moderna's credibility.
- International Review Progress: Despite setbacks in the U.S., mRNA-1010 has been accepted for review in the EU, Canada, and Australia, with potential approvals expected by late 2026 or early 2027, highlighting its international market potential and Moderna's strategic global positioning.
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Analyst Views on MRNA
Wall Street analysts forecast MRNA stock price to fall
20 Analyst Rating
1 Buy
16 Hold
3 Sell
Hold
Current: 40.110
Low
17.00
Averages
32.47
High
63.00
Current: 40.110
Low
17.00
Averages
32.47
High
63.00
About MRNA
Moderna, Inc. is a biotechnology company. The Company is advancing a new class of medicines made of messenger ribonucleic acid (mRNA). It is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that have a therapeutic or preventive benefit with the potential to address a spectrum of diseases. The Company’s diverse development pipeline consists of 44 therapeutic and vaccine programs, 11 of which are in late-stage development. Its commercial products include Spikevax (its COVID vaccine) and mRESVIA (its respiratory syncytial virus (RSV) vaccine). Additionally, it has achieved four positive Phase III data readouts for its COVID vaccine (mRNA-1283), its RSV vaccine for high-risk adults aged 18 to 59 (mRNA-1345), its seasonal flu+COVID vaccine (mRNA-1083), and its seasonal flu vaccine (mRNA-1010).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Vaccine Policy Changes: Under Secretary of Health and Human Services Robert F. Kennedy Jr., the CDC recommended earlier this year a significant reduction in the number of diseases covered by the childhood immunization schedule from 17 to 11, raising widespread concerns about the implications for public health.
- Committee Restructuring: Kennedy's abrupt dismissal of all 17 members of the CDC’s Advisory Committee on Immunization Practices in June, followed by the appointment of critics of mRNA vaccines, is viewed as a major interference in vaccine policy that could affect medical practices.
- Public Health Risks: Attorney James Oh stated that this policy change poses a “clear and present danger” to public health and could undermine the functions and missions of healthcare organizations, with Judge Murphy acknowledging the need for a timely decision in this case.
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