SPIKEVAX Drug Profile

Summary for Tradename: SPIKEVAX

High Confidence Patents:	12
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for SPIKEVAX

Recent Clinical Trials for SPIKEVAX

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Leiden University Medical Center	Phase 2

See all SPIKEVAX clinical trials

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for SPIKEVAX Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for SPIKEVAX Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Modernatx, Inc.	SPIKEVAX	covid-19 vaccine, mrna	Injection	125752		2041-04-23	DrugPatentWatch analysis and company disclosures
Modernatx, Inc.	SPIKEVAX	covid-19 vaccine, mrna	Injection	125752		2038-02-27	DrugPatentWatch analysis and company disclosures
Modernatx, Inc.	SPIKEVAX	covid-19 vaccine, mrna	Injection	125752		2036-06-22	DrugPatentWatch analysis and company disclosures
Modernatx, Inc.	SPIKEVAX	covid-19 vaccine, mrna	Injection	125752		2041-07-02	DrugPatentWatch analysis and company disclosures
Modernatx, Inc.	SPIKEVAX	covid-19 vaccine, mrna	Injection	125752		2038-08-07	DrugPatentWatch analysis and company disclosures
Modernatx, Inc.	SPIKEVAX	covid-19 vaccine, mrna	Injection	125752		2038-01-09	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for SPIKEVAX Derived from Patent Text Search

No patents found based on company disclosures

International Patents for SPIKEVAX

Country	Patent Number	Estimated Expiration
China	116528813
Hungary	E067635
China	114632091
Hungary	E035098
Portugal	3310904
World Intellectual Property Organization (WIPO)	2016134291

Market Dynamics and Financial Trajectory for SPIKEVAX

Last updated: April 16, 2026

What is SPIKEVAX and its market position?

SPIKEVAX (mRNA-1273) is a Covid-19 vaccine developed by Moderna, authorized for emergency and full use in multiple countries. It is an mRNA-based vaccine with a primary focus on preventing COVID-19 infections. Its approval in over 70 jurisdictions, including the US, EU, and WHO emergency use authorizations, drives a significant portion of the global Covid-19 vaccine market.

How does SPIKEVAX compare with competitors?

Aspect	SPIKEVAX	Comirnaty (Pfizer-BioNTech)	Other mRNA vaccines (e.g., CureVac's CVnCoV)
Approval Status	Approved in 70+ countries	Approved in 85+ countries	Limited or under EUA
Dosing Regimen	Two doses, 28 days apart	Two doses, 21 days apart	Varies, some single-dose or multi-dose regimens
Storage Requirements	-20°C for stable storage	-70°C initially, now approved for 2–8°C storage	Less developed storage solutions
Efficacy	94.1% in Phase 3 trials	95% in Phase 3 trials	Varies, generally lower

Moderna emphasizes its vaccine's high efficacy, adaptable mRNA platform, and easier storage compared to competitors, supporting its market competitiveness.

What is the current market size and growth trajectory?

The global Covid-19 vaccine market valuation is approximately $50 billion in 2022, with projections reaching $114 billion by 2028 at a CAGR of 13%. SPIKEVAX accounts for roughly 40-45% of the mRNA vaccine segment, estimated at $20-22 billion in 2022.

Key growth factors:

• Continued booster rollout in developed nations
• Expansion into low-income markets via COVAX
• Development of variant-specific and next-generation vaccines

Market penetration: SPIKEVAX remains a leading mRNA vaccine, with procurement agreements covering over 1.4 billion doses worldwide for 2022–2023.

What are the financial trends and revenue projections?

In 2022, Moderna reported vaccine revenues of approximately $18 billion, with SPIKEVAX constituting the majority. The company's 2023 guidance projects vaccine sales in the range of $20-$21 billion, assuming sustained booster demand and new indications.

Revenue breakdown:

Year	Revenue from SPIKEVAX (USD billions)	Growth	Key Drivers
2021	$15	N/A	First full year post-approval
2022	$18	+20%	Booster campaigns, global procurement expansion
2023	$20–$21	+11-17%	Broadening use cases, emerging markets

Prices per dose vary: US government programs pay approximately $15–$25, while private and developing country agreements range from $8–$20.

What are future strategic considerations?

• Boosters and vaccine updates: Moderna invests in variant-adapted versions, aiming to maintain market share amid potential virus evolution. These formulations could command premium pricing.

• New indications: Efforts to expand prophylactic use to other respiratory viruses (e.g., influenza) could diversify revenue streams.

• Manufacturing scale-up: Investments in mRNA production facilities in the US, Europe, and Asia aim to meet global demand and reduce supply chain risks.

• Regulatory landscape: Pending approvals for children under 12 and potential approval for adolescents are poised to expand the target population, increasing vaccine uptake.

Risks impacting financial trajectory

• Vaccine fatigue and market saturation: As global vaccination rates plateau, demand could decline, especially in high-coverage regions.

• Emergence of variants: Variants that escape vaccine immunity may diminish demand for existing formulations, necessitating costly updates.

• Pricing pressures: Governments and global health initiatives may push for lower prices as part of equitable access efforts.

• Regulatory hurdles: Delays in approval or withdrawal of emergency authorizations could affect sales.

Key Takeaways

• SPIKEVAX is a leading Covid-19 vaccine with significant global market share driven by efficacy and storage advantages.
• The vaccine accounted for approx. $18 billion in revenue in 2022; growth is expected to continue through booster campaigns and market expansion.
• Competition remains strong, with Pfizer-BioNTech’s Comirnaty as its closest rival, alongside emerging regional players.
• Long-term prospects hinge on vaccine adaptation to variants, regulatory approvals for broader use, and manufacturing capacity.
• Market risks include demand saturation, variants, and pricing dynamics driven by global health policy.

FAQs

1. How does SPIKEVAX's efficacy compare to its competitors?

SPIKEVAX has an efficacy of approximately 94.1% in Phase 3 trials, comparable to Pfizer-BioNTech’s 95% efficacy. Differences are minor but may influence purchasing decisions in various markets.

2. What is the current global demand for SPIKEVAX?

Most demand comes from booster campaigns in high-income countries, with estimated procurement exceeding 1.4 billion doses for 2022–2023. Long-term demand depends on booster strategies and new indications.

3. Will SPIKEVAX generate revenue beyond the pandemic?

Potential future revenue includes annual boosters, variant-specific modifications, and expansion into other preventive vaccines, but these are contingent on regulatory approval and market acceptance.

4. How are manufacturing and supply chain factors affecting SPIKEVAX?

Moderna’s investments in manufacturing capability aim to increase supply and reduce costs. Supply chain disruptions or scaling delays could limit sales.

5. What are the main regulatory challenges ahead?

Approval for use in children under 12 and for new formulations require rigorous review. Delays or withdrawal of emergency use authorizations could impact sales trajectories.

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References

[1] Bloomberg. (2023). Moderna’s COVID-19 vaccine sales and market share analysis.
[2] WHO. (2022). Global vaccine market statistics.
[3] Moderna. (2023). Financial and operational reports.
[4] U.S. Food and Drug Administration. (2022). Emergency Use Authorization and approval updates.
[5] European Medicines Agency. (2022). Marketing authorization of Spikevax and other COVID-19 vaccines.