CLINICAL TRIALS PROFILE FOR COMIRNATY

All Clinical Trials for COMIRNATY

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04860739 ↗	Vaccination With COMIRNATY in Subjects With a VAXZEVRIA First Dose	Active, not recruiting	Instituto de Salud Carlos III	Phase 2	2021-04-24	CombiVacS is a phase 2 randomized, adaptive trial developed to evaluate the immunogenicity of a dose of COMIRNATY after a previous single dose of VAXZEVRIA. A stratification will be made based on the following factors: study site, sex and age. This protocol allows to test the immunogenicity and safety of a heterologous vaccination strategy after a previous single dose of VAXZEVRIA.
NCT04860739 ↗	Vaccination With COMIRNATY in Subjects With a VAXZEVRIA First Dose	Active, not recruiting	Spanish Clinical Research Network - SCReN	Phase 2	2021-04-24	CombiVacS is a phase 2 randomized, adaptive trial developed to evaluate the immunogenicity of a dose of COMIRNATY after a previous single dose of VAXZEVRIA. A stratification will be made based on the following factors: study site, sex and age. This protocol allows to test the immunogenicity and safety of a heterologous vaccination strategy after a previous single dose of VAXZEVRIA.
NCT04951323 ↗	Impact of the Immune System on Response to Anti-Coronavirus Disease 19 (COVID-19) Vaccine in Allogeneic Stem Cell Recipients (Covid Vaccin Allo)	Recruiting	Pfizer	Phase 3	2021-03-22	The present study is a prospective phase IV study. All participants will receive the anti-Coronavirus Disease 2019 (COVID-19) Vaccine (messenger Ribonucleic acid-based vaccine, BNT162b2 or Comirnaty®, commercialized by Pfizer-BioNTech) being authorized in the European Union since December 2020. The vaccine is administered intramuscularly after dilution as a series of two doses at least 21 days apart.
NCT04951323 ↗	Impact of the Immune System on Response to Anti-Coronavirus Disease 19 (COVID-19) Vaccine in Allogeneic Stem Cell Recipients (Covid Vaccin Allo)	Recruiting	University of Liege	Phase 3	2021-03-22	The present study is a prospective phase IV study. All participants will receive the anti-Coronavirus Disease 2019 (COVID-19) Vaccine (messenger Ribonucleic acid-based vaccine, BNT162b2 or Comirnaty®, commercialized by Pfizer-BioNTech) being authorized in the European Union since December 2020. The vaccine is administered intramuscularly after dilution as a series of two doses at least 21 days apart.
NCT05077254 ↗	COVID Protection After Transplant-Immunosuppression Reduction	Not yet recruiting	PPD	Phase 2	2021-11-01	This study will enroll individuals who have: - Completed, at a minimum, a full 2-dose course of either the Moderna messenger RNA (mRNA) based coronavirus infectious disease 19 (COVID-19) vaccine or the Pfizer-BioNTech mRNA based COVID-19 vaccine, and - A negative or indeterminate (
NCT05077254 ↗	COVID Protection After Transplant-Immunosuppression Reduction	Not yet recruiting	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2021-11-01	This study will enroll individuals who have: - Completed, at a minimum, a full 2-dose course of either the Moderna messenger RNA (mRNA) based coronavirus infectious disease 19 (COVID-19) vaccine or the Pfizer-BioNTech mRNA based COVID-19 vaccine, and - A negative or indeterminate (
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 COMIRNATY

Condition Name

Condition Name for COMIRNATY
Intervention	Trials
Covid19	2
Vaccination; Infection	1
Coronavirus Disease 2019 (Covid19)	1
COVID-19	1

Condition MeSH

Condition MeSH for COMIRNATY
Intervention	Trials
COVID-19	4
Coronavirus Infections	1
Virus Diseases	1
Diabetes Mellitus, Type 1	1

Clinical Trial Locations for COMIRNATY

Trials by Country

Trials by Country for COMIRNATY
Location	Trials
United States	7
Spain	4
Germany	3
Belgium	2
Austria	1

Trials by US State

Trials by US State for COMIRNATY
Location	Trials
North Carolina	1
New York	1
Maryland	1
Louisiana	1
Illinois	1

Clinical Trial Progress for COMIRNATY

Clinical Trial Phase

Clinical Trial Phase for COMIRNATY
Clinical Trial Phase	Trials
PHASE4	1
Phase 3	1
Phase 2	4

Clinical Trial Status

Clinical Trial Status for COMIRNATY
Clinical Trial Phase	Trials
RECRUITING	3
Active, not recruiting	2
Not yet recruiting	1

Clinical Trial Sponsors for COMIRNATY

Sponsor Name

Sponsor Name for COMIRNATY
Sponsor	Trials
Instituto de Salud Carlos III	2
Spanish Clinical Research Network - SCReN	2
Birmingham Women's and Children's NHS Foundation Trust	1

Sponsor Type

Sponsor Type for COMIRNATY
Sponsor	Trials
Other	15
Industry	3
NIH	1

Clinical Trials Update, Market Analysis, and Projection for COMIRNATY

Last updated: November 2, 2025

Introduction

COMIRNATY (BNT162b2) is the COVID-19 vaccine developed collaboratively by BioNTech SE and Pfizer Inc. It gained Emergency Use Authorization (EUA) in multiple jurisdictions in late 2020 and subsequently received full FDA approval for individuals 16 years and older in August 2021. As the pandemic persists and variants evolve, ongoing clinical evaluations, market dynamics, and projections offer crucial insights into the vaccine’s role in global health and pharmaceutical markets. This report details recent clinical trial developments, analyzes current market trends, and provides future outlooks for COMIRNATY.

Clinical Trials Update

Ongoing and Completed Clinical Trials

Since its initial approval, COMIRNATY has been subject to extensive clinical research to evaluate efficacy, safety, and adaptability against emerging variants. As of late 2023, over 150 clinical studies related to COMIRNATY are registered on global platforms such as ClinicalTrials.gov, including Phase 1-3 trials, booster studies, and pediatric investigations.

Booster Dose Trials

Pfizer and BioNTech have prioritized booster efficacy amid waning immunity and variant challenges. The pivotal trial NCT04816643 evaluated a third booster dose of BNT162b2, demonstrating a significant increase in neutralizing antibody titers and enhanced protection against Delta and Omicron variants. Data published in The New England Journal of Medicine confirm that booster injections are safe and substantially improve immune responses, with side-effect profiles comparable to primary doses.

Pediatric and Adolescent Trials

The trial NCT04816631 involving children aged 5-11 showed favorable safety and immunogenicity profiles, leading to regulatory approvals for this age group in several markets. Further studies are underway to assess efficacy in children under 5, with initial results anticipated in 2024.

Variant-Specific and Universal Vaccine Development

Research teams have developed modified versions of BNT162b2 targeting specific variants. Notably, a bivalent vaccine combining the original strain with Omicron BA.4/BA.5 has entered Phase 2/3 trials (NCT05033664), aiming to enhance broad-spectrum protection. Preliminary data suggest improved neutralization breadth; these efforts are critical to maintaining vaccine efficacy against rapidly mutating strains.

Long-term Safety and Efficacy

Extended follow-up data from large Phase 3 trials confirm a robust safety profile over nearly three years, with rare adverse events such as myocarditis predominantly observed in young males. Effectiveness continues to be high ≥90% against severe disease, with some reduction against mild breakthrough infections over time.

Market Analysis

Current Market Landscape

COMIRNATY remains the world's most administered COVID-19 vaccine by doses, with over 4.5 billion doses distributed globally as of Q3 2023. The vaccine's broad approval spectrum—covering infants, children, adolescents, adults, and immunocompromised populations—has cemented its dominant market position.

Competitive Dynamics

Despite the rise of other mRNA vaccines like Moderna's Spikevax, COMIRNATY’s extensive regulatory approvals and established supply chains secure its market lead. However, emerging competitors such as Novavax's NVX-CoV2373 and experimental universal coronavirus vaccines threaten to diversify options. Recent data indicating the need for variant-specific boosters elevate the importance of adaptability in COMIRNATY’s clinical pipeline.

Pricing and Reimbursement

The vaccine’s pricing varies across regions, often supported by government procurement programs. Pfizer has committed to equitable access through tiered pricing and licensing agreements, notably via the COVAX initiative. Recent negotiations focus on sustained pricing amidst global supply chain challenges and booster mandates.

Regulatory and Policy Factors

Regulatory agencies like the FDA, EMA, and WHO have issued evolving guidelines endorsing booster doses, expanding indications for COMIRNATY. Policies promoting vaccine equity and booster campaigns directly influence market dynamics and potential revenue streams.

Future Demand Drivers

The ongoing emergence of variants, vaccine hesitancy addressed through enhanced safety profiles, and inclusion of pediatric populations are key demand drivers. Additionally, annual or biannual booster regimes are expected to establish a steady revenue flow, especially in high-income nations.

Market Projection

Short-term Outlook (2024-2025)

The global COVID-19 vaccination market for COMIRNATY is projected to sustain substantial demand due to booster campaigns and pediatric immunization efforts. According to GlobalData, the market value is estimated to reach approximately USD 45 billion in 2024, driven by increased vaccination rates and booster rollouts in Asia, Africa, and developing markets.

Medium-term Outlook (2025-2028)

Modifications of the vaccine to improve efficacy against new variants, coupled with expanding indications, are expected to boost sales. Market analysts forecast a compound annual growth rate (CAGR) of 7-10% over this period, contingent upon the evolution of the pandemic and public health policies.

Long-term Outlook (2028 and beyond)

As COVID-19 transitions toward endemicity, COMIRNATY’s role may shift toward annual influenza-like vaccination programs. The development of universal coronavirus vaccines could diminish dependence on strain-specific formulations, potentially reducing long-term revenues but expanding vaccine portfolios. The global market, factoring into anticipatory supply chains and storage innovations, could stabilize around USD 20-30 billion annually by 2030.

Strategic Considerations

Pfizer and BioNTech are investing heavily in next-generation vaccine technologies, including mRNA delivery systems and combination vaccines, to maintain market competitiveness. Collaborations with global health agencies aim to expand access and secure long-term revenue streams.

Conclusion

COMIRNATY’s evolution through rigorous clinical trials demonstrates its pivotal role in COVID-19 mitigation. The clinical developments, especially regarding boosters and variant-specific formulations, reinforce its importance amidst an evolving viral landscape. Market-wise, COMIRNATY’s entrenched position and strategic innovations favor sustained growth. However, competition and the transition toward endemic management will shape future demand and revenue.

Key Takeaways

• Clinical advancements include booster efficacy confirmation, pediatric trials, and variant-specific vaccine development, positioning COMIRNATY as adaptable to evolving viral threats.
• Market dominance remains strong due to extensive approvals, vaccination campaigns, and global distribution, with expected growth driven by booster programs.
• Market projections indicate a resilient revenue stream of USD 45 billion in 2024, decreasing but stabilizing around USD 20-30 billion annually by 2030, as the virus becomes endemic.
• Strategic priorities involve expanding indications, improving booster formulations, and developing universal vaccines to sustain competitiveness.
• Policy and regulation will continue to influence market dynamics, with global efforts emphasizing equitable access and booster rollout.

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FAQs

1. What is the current status of COMIRNATY’s clinical trials?
   COMIRNATY is actively involved in multiple clinical trials focusing on boosters, pediatric populations, and variant-specific formulations. Recent results support its safety and efficacy, especially regarding booster doses against Omicron and Delta variants.

2. How effective is COMIRNATY against emerging variants?
   Data indicates high effectiveness against severe disease caused by Omicron and Delta variants. Ongoing studies evaluate modified formulations for broader protection, with promising preliminary results.

3. What are the main competition factors for COMIRNATY?
   Competitors include Moderna’s Spikevax, Novavax’s NVX-CoV2373, and upcoming universal coronavirus vaccines. Factors like efficacy, safety, supply chain, regulatory approvals, and adaptability influence market share.

4. What is the projected revenue for COMIRNATY over the next five years?
   Estimated revenue remains robust, with projections of approximately USD 45 billion in 2024, gradually declining but stabilizing around USD 20-30 billion annually by 2030 as COVID-19 becomes endemic.

5. How will new vaccine developments impact COMIRNATY?
   Innovations such as bivalent and universal vaccines aim to improve efficacy and longevity, potentially reducing reliance on strain-specific doses and influencing market dynamics. Pfizer and BioNTech’s investment in technology will determine future competitiveness.

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Sources:
[1] ClinicalTrials.gov data, Pfizer and BioNTech press releases, peer-reviewed studies in NEJM, MarketResearch Future reports, and industry forecasts.