First participant dosed in trial targeting potential regulatory approval in 2025

  • First participant dosed in Phase 3 study of Moderna Flu-Covid combination vaccine mRNA-1083
  • Trial expected to enroll about 8,000 people aged 50 and over
  • mRNA-1083 is Moderna’s first respiratory combination vaccine candidate to enter Phase 3 trial
  • Moderna targets potential initial regulatory approval in 2025
  • Moderna reported a $1.38 billion loss in Q2 with revenue falling to $344 million
  • Reaffirmed 2023 Covid-19 vaccine sales guidance of $6 billion to $8 billion

Factuality Level: 8
Justification: The article provides factual information about Moderna’s Phase 3 study of mRNA-1083, its combination vaccine candidate against influenza and Covid-19. It also mentions the favorable Phase 1/2 data for mRNA-1083 and the company’s financial information. The article does not contain any irrelevant or misleading information, sensationalism, redundancy, or opinion masquerading as fact. However, it lacks some important details such as the specific goals and timeline of the Phase 3 study.

Noise Level: 4
Justification: The article provides information about Moderna’s Phase 3 study of its combination vaccine candidate against influenza and Covid-19. It also mentions the company’s financial performance. However, the article lacks in-depth analysis, evidence, and actionable insights. It mainly focuses on reporting basic facts and updates without providing much context or critical analysis.

Financial Relevance: Yes
Financial Markets Impacted: Moderna

Presence of Extreme Event: No
Nature of Extreme Event: No
Impact Rating of the Extreme Event: No
Justification: The article pertains to financial topics as it discusses Moderna’s Phase 3 study of its combination vaccine candidate against influenza and Covid-19. It also mentions Moderna’s financial performance and sales guidance for its Covid-19 vaccine.

Public Companies: Moderna (MRNA)
Private Companies:
Key People:


Moderna has announced the dosing of the first participant in the Phase 3 study of its combination vaccine candidate, mRNA-1083, which targets both influenza and Covid-19. The trial aims to enroll approximately 8,000 individuals aged 50 and over. This marks an important milestone for Moderna as mRNA-1083 becomes the company’s first respiratory combination vaccine candidate to enter Phase 3. Moderna is optimistic about the potential initial regulatory approval of the vaccine in 2025. In the second quarter, Moderna reported a loss of $1.38 billion, with a decline in revenue to $344 million. However, the company remains confident in its 2023 Covid-19 vaccine sales guidance of $6 billion to $8 billion. Moderna is scheduled to release its third-quarter results on November 2.