CLINICAL TRIALS PROFILE FOR SPIKEVAX

All Clinical Trials for SPIKEVAX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05315362 ↗	Establishing Immunogenicity and Safety of Needle-free Intradermal Delivery of mRNA COVID-19 Vaccine	Recruiting	Leiden University Medical Center	Phase 2	2022-05-01	COVID-19 vaccines are limited in supply, especially in low- and middle-income countries, leading to substantial morbidity and mortality. Despite the COVID-19 Vaccines Global Access (COVAX) Facility initiated by the WHO to provide vaccine access for low-income countries, probably 80% of the vaccine needs of participating countries will not be met soon. In addition, there is an increasing demand for revaccination of the population globally, because of waning immunity which will further limit vaccine supplies. Exploring dose-sparing techniques, could therefore provide the solution to immunise more people with the same vaccine stockpile. The intramuscular injection (IM) is the standard inoculation route of vaccines. However, the skin (dermis) is much richer in antigen presenting dendritic cells than muscle. As a consequence, a fractional vaccine dose introduced directly into the dermis (intradermal administration, ID) might be as effective as the intramuscular administration of the full standard dose to achieve a protective immune response. This principle has recently been demonstrated for the ID dermal delivery of one-fifth fractional dose mRNA-1273 (Spikevax, Moderna) vaccine. However, needle-based immunisation has several limitations. Fear of needles makes immunisation a stressful event. In addition, needle stick injuries, as well as unsafe injection practices carry serious health risks. Therefore, the development of needle-free delivery has been identified as an important goal in global health care. The WHO reported that microneedle vaccine delivery is top priority and requires additional research to explore the benefits in more detail. A big advantage of intradermal delivery via a solid needle patch is not only the absence of needles and pain since no nerves are at the proximity where the needles are presented, but also the local delivery close to immune cells as with the above mentioned intradermal injection enables a much lower dose as compared to IM dosing. And since with the patch a larger skin surface is involved as compared to intradermal injection, even lower doses are possibly still immunogenic. In this study, we will investigate the immunogenicity and safety in healthy volunteers of the needle-free intradermal delivery of a single fractional dose of 20µg mRNA-1273 LNP vaccine (Spikevax, Moderna) more than 3 months after primary vaccination with Comirnaty (Pfizer) vaccine and/or after having contracted COVID-19.

Clinical Trial Conditions for SPIKEVAX

Condition Name

Condition Name for SPIKEVAX
Intervention	Trials
COVID-19	1
Vaccination; Infection	1

Condition MeSH

Condition MeSH for SPIKEVAX
Intervention	Trials
COVID-19	1

Clinical Trial Locations for SPIKEVAX

Trials by Country

Trials by Country for SPIKEVAX
Location	Trials
Netherlands	1

Clinical Trial Progress for SPIKEVAX

Clinical Trial Phase

Clinical Trial Phase for SPIKEVAX
Clinical Trial Phase	Trials
Phase 2	1

Clinical Trial Status

Clinical Trial Status for SPIKEVAX
Clinical Trial Phase	Trials
Recruiting	1

Clinical Trial Sponsors for SPIKEVAX

Sponsor Name

Sponsor Name for SPIKEVAX
Sponsor	Trials
Leiden University Medical Center	1

Sponsor Type

Sponsor Type for SPIKEVAX
Sponsor	Trials
Other	1

Last updated: February 15, 2026

mmary
SPIKEVAX (mRNA-1273, Moderna’s COVID-19 vaccine) remains an active focus in ongoing clinical research, with several trials exploring booster efficacy, age-specific dosing, and new indications. Market adoption has stabilized globally, but growth prospects depend on evolving COVID-19 variants, regulatory decisions, and booster policies. The vaccine's revenue projections are influenced by pandemic waves, vaccination rates, and geopolitical factors.

---

What Are the Latest Clinical Trials for SPIKEVAX?

Current Trials
As of mid-2023, Moderna is conducting multiple clinical trials related to SPIKEVAX, including:

• Booster efficacy studies: Evaluating the durability and breadth of immune responses against emerging variants, including XBB and BQ.1 lineages.
• Pediatric and adolescent populations: Phase 2/3 trials assessing safety, immunogenicity, and dosing in children ages 6 months to 17 years.
• Heterologous boosting: Trials combining SPIKEVAX with other COVID-19 vaccines to examine immune responses.
• New indications: Exploring use in immunocompromised patients and possibly for respiratory syncytial virus (RSV) in upcoming studies.

Key Trials Noted:

1. NCT05669453 (ongoing) — Booster efficacy against Omicron subvariants in adults.
2. NCT04995709 — Pediatric safety and dosing, anticipated completion 2024.
3. NCT05590674 — Heterologous booster combination, expected results 2023.

Regulatory Status

• The U.S. FDA has authorized SPIKEVAX for emergency use in individuals 6 months and older.
• The European Medicines Agency (EMA) approved the vaccine for children 6 months to 4 years.
• Ongoing requests are submitted for market extension to include booster doses and new variants.

---

Market Overview and Current Position

Market Adoption
SPIKEVAX became one of the leading COVID-19 vaccines globally, with over 800 million doses distributed by Q2 2023. Key markets include the U.S., EU, and emerging markets with delayed vaccination campaigns.

• The U.S. CDC reports over 30% of the eligible population has received a booster dose (as of June 2023).
• Global vaccination efforts face challenges due to vaccine hesitancy, logistical issues, and supply.

Competition
Main competitors include Pfizer-BioNTech's BNT162b2, AstraZeneca's Vaxzevria, and newer entrants like Novavax’s NVX-CoV2373.

• SPIKEVAX has been favored in the U.S. due to high efficacy and supply agreements.
• Pfizer’s vaccine maintains a slight edge in global market share but SPIKEVAX holds a foothold due to its distribution agreements and public health partnerships.

---

Market Projection and Revenue Outlook

Near-term Forecast (2023-2025)
Market revenue peaked at approximately $20 billion globally in 2022. Post-pandemic projections indicate:

• Decline in sales: Expected to decline to approximately $8-12 billion annually by 2025 as booster campaigns plateau and newer variants demand updated formulations.
• Steady demand in specific populations: Immunocompromised groups and pediatric populations sustain consistent sales.

Factors Influencing Future Market Growth:

• Variant evolution: Emergence of immune-evasive variants like XBB could trigger updated booster requirements, prolonging vaccine sales.
• Regulatory approvals: Extended approvals for new indications and age groups can expand market share.
• Global vaccination strategies: Ongoing efforts in low- and middle-income countries (LMICs) could sustain demand.

Long-term Projections (2026 and beyond)

• Moderna anticipates that SPIKEVAX could transition into annual or biannual booster role, similar to influenza.
• Alternative delivery methods (e.g., nasal vaccines) could reshape strategic positioning.
• Potential uses against other coronaviruses or respiratory pathogens may diversify revenue streams.

Competitive Landscape and Patent Dynamics

• Patent protections granted until 2030 provide exclusivity, though biosimilar development may begin earlier.
• Strategic licensing in LMICs will impact market penetration and profit margins.

---

Key Takeaways

• Clinical pipeline emphasizes booster durability, pediatric applications, and heterologous vaccination strategies.
• Market adoption remains high, but growth is constrained by vaccination fatigue and variant evolution.
• Revenue projections indicate a decline but sustained demand in specific demographics and booster renewal cycles.
• Regulatory progress supports broader and longer-term use, contingent on variant response and public health policies.
• Strategic positioning involves differentiating from competitors via updated formulations and expanding indications.

---

FAQs

1. When will SPIKEVAX likely be replaced by next-generation vaccines?
   Typically, updates are based on variant evolution; Moderna is testing bivalent and multivalent formulations, with potential approvals expected in 2024.

2. What is the efficacy of SPIKEVAX against current variants?
   Real-world studies show approximately 60-70% effectiveness against symptomatic infection from Omicron subvariants post-primary series, higher against severe disease.

3. Are there any safety concerns with SPIKEVAX?
   Reactogenicity remains within expected limits. Rare adverse events include myocarditis and pericarditis, especially in young males. Monitoring continues as additional data emerges.

4. Will SPIKEVAX be used for future pandemics or other coronaviruses?
   Moderna develops pan-coronavirus vaccines; SPIKEVAX could serve as a platform or reference for future vaccine development.

5. How will commercial strategies evolve for SPIKEVAX?
   Emphasis on booster campaigns, pediatric approvals, and licensing in emerging markets will be central. Collaboration with health agencies and adaptation to new variants will guide market strategy.

---

References

1. Moderna. ClinicalTrials.gov. (2023). https://clinicaltrials.gov/
2. Centers for Disease Control and Prevention. COVID-19 vaccine data. (2023). https://covid.cdc.gov/covid-data-tracker
3. European Medicines Agency. Review reports on SPIKEVAX. (2023). https://www.ema.europa.eu
4. Moderna Investor Presentation. Q2 2023. https://investors.modernatx.com
5. World Health Organization. COVID-19 Vaccine Market Data. (2023). https://unicef.org/supply/covid-19-vaccine-market-data