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

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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

Spikevax: Clinical Trials, Market Analysis, and Projections

Clinical Trials and Efficacy

Adult Population

Spikevax, the COVID-19 vaccine developed by Moderna, has undergone extensive clinical trials to establish its efficacy and safety. A large clinical trial involving around 30,000 participants showed that the vaccine, given as a two-dose regimen, was highly effective in preventing COVID-19 in people aged 18 to 94 years. The trial demonstrated a 94.1% reduction in symptomatic COVID-19 cases among vaccinated individuals compared to those who received placebo injections[1].

Pediatric Population

The vaccine has also been tested in children aged 12 to 17 years. A study involving over 3,000 children showed that Spikevax produced a comparable immune response in this age group to that seen in young adults. None of the 2,163 children who received the vaccine developed COVID-19, while four out of 1,073 children who received a placebo did[1].

Adapted Vaccines

Adapted versions of Spikevax, targeting various variants such as Omicron XBB.1.5 and JN.1, have been developed and authorized. These vaccines are expected to maintain protection against the virus by containing mRNA that more closely matches circulating variants. The safety and immunogenicity of these adapted vaccines are comparable to the original Spikevax vaccine[1][3].

Safety Profile

Common Side Effects

Most side effects associated with Spikevax are mild to moderate and resolve within a few days. These include common vaccine-related side effects such as pain at the injection site, fatigue, and headache[1].

Rare but Serious Side Effects

Rare but serious side effects include myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart), which may occur in up to 1 in 10,000 people. There have also been reports of allergic reactions, including a very small number of cases of severe allergic reactions (anaphylaxis) and erythema multiforme (a skin condition)[1].

Market Analysis

Competitive Landscape

Moderna's Spikevax operates in a competitive market dominated by other major vaccine manufacturers such as Pfizer-BioNTech and Novavax. Moderna faces significant competition, particularly in the RSV vaccine market where it competes with GSK and Pfizer. Despite this, Moderna has made strides in establishing its presence, especially with the approval of its RSV vaccine and the development of a flu-COVID combination vaccine[5].

Market Share and Sales

The sales of Spikevax have seen a decline as the COVID-19 crisis has eased, prompting Moderna to diversify its product portfolio to drive growth. However, the company remains a key player in the COVID-19 vaccine market, with its updated vaccines targeting current variants receiving approvals in multiple regions[5].

Strategic Priorities

Moderna is focusing on expanding its respiratory vaccine portfolio, which includes next-generation COVID-19 vaccines, a flu-COVID combination vaccine, and an RSV vaccine. The company expects to submit several vaccines for approval in 2024, including a next-generation COVID-19 vaccine and a flu-COVID combination vaccine[2].

Projections and Future Developments

Next-Generation Vaccines

Moderna is advancing its next-generation COVID-19 vaccine, mRNA-1283, which has shown non-inferior relative vaccine efficacy compared to Spikevax in Phase 3 trials. This vaccine is designed to have enhanced stability in refrigerated conditions and will be packaged in pre-filled syringes, making it more convenient for distribution and administration[2].

Combination Vaccines

The company is also developing a flu-COVID combination vaccine, which has demonstrated superior immune responses against both the coronavirus and three influenza strains. This combination vaccine is expected to be a significant addition to Moderna's respiratory vaccine portfolio and could help the company gain a competitive edge in the market[2][5].

Regulatory Approvals

Moderna has received recommendations for the authorization of its adapted Spikevax vaccines targeting various variants, including the JN.1 and Omicron XBB.1.5 subvariants. These approvals are crucial for maintaining public health efforts to combat COVID-19 and will continue to support the vaccine's market presence[1][3].

Financial Projections

Moderna anticipates significant research and development expenses in 2025, estimated to be between $4.2 billion and $4.5 billion. Despite the competitive pressures, the company is optimistic about its growth prospects, driven by its diverse pipeline and the expected approvals of its new vaccines[2].

Key Takeaways

• High Efficacy: Spikevax has demonstrated high efficacy in preventing COVID-19 in both adult and pediatric populations.
• Adapted Vaccines: The vaccine has been adapted to target various variants, ensuring continued protection against the evolving virus.
• Safety Profile: While generally safe, the vaccine can cause rare but serious side effects such as myocarditis and pericarditis.
• Competitive Market: Moderna faces competition from other vaccine manufacturers but is expanding its portfolio to drive growth.
• Future Developments: Next-generation vaccines and combination vaccines are in the pipeline, with several expected approvals in 2024.

FAQs

What is the efficacy of Spikevax in preventing COVID-19?

Spikevax has shown a 94.1% reduction in symptomatic COVID-19 cases in clinical trials involving adults and a similar efficacy in children aged 12 to 17 years[1].

What are the common side effects of Spikevax?

Common side effects include pain at the injection site, fatigue, and headache, which are generally mild to moderate and resolve within a few days[1].

Are there any rare but serious side effects associated with Spikevax?

Yes, rare but serious side effects include myocarditis, pericarditis, and severe allergic reactions such as anaphylaxis[1].

How does Moderna's Spikevax compete in the market?

Moderna competes with Pfizer-BioNTech and Novavax in the COVID-19 vaccine market and with GSK and Pfizer in the RSV vaccine market. Despite competition, Moderna is expanding its portfolio with new vaccines and combination vaccines[5].

What are the future developments for Spikevax?

Moderna is developing next-generation COVID-19 vaccines and a flu-COVID combination vaccine, with several expected approvals in 2024. These developments aim to enhance the company's respiratory vaccine portfolio[2].

How does the safety of adapted Spikevax vaccines compare to the original vaccine?

The safety of adapted Spikevax vaccines is comparable to that of the original vaccine, with similar side effect profiles and no significant additional risks identified[1][3].

Sources

1. European Medicines Agency: Spikevax (previously COVID-19 Vaccine Moderna)[1].
2. Moderna: Moderna R&D Day Highlights Progress and Strategic Priorities[2].
3. Health Canada: Regulatory Decision Summary for Spikevax XBB.1.5[3].
4. Yale Medicine: Comparing the COVID-19 Vaccines: How Are They Different?[4].
5. BioSpace: Moderna Lays Foundations for Growth, but Can It Turn Strategy Into Execution[5].