This biweekly Vaccines video recap summarizes key developments across regulatory actions, clinical advancements, and new partnerships. The focus is on the most notable updates that have the potential to shape the future of global immunization efforts.
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- Week 5–12 February 2026
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Top Stories Covered in This Video
Chapters
0:00 Introduction
0:08 Delonix Bioworks Receives IND Clearance for MenB Vaccine DX-104 in China and Australia
0:45 Sanofi Completes Acquisition of Dynavax, Enhancing Vaccine Portfolio
1:17 Moderna Advances Global Vaccine Strategy with mRNA Vaccine Initiatives in the EU and Mexico
1:49 Aptar Pharma’s Nasal Delivery Solutions Integral to CastleVax’s Phase II COVID-19 Vaccine Trials
2:24 GSK’s AREXVY Shows Real-World Effectiveness in Reducing RSV-Related Risks in Older Adults
3:05 Moderna Faces Legal Setback in Patent Dispute with Arbutus Biopharma
3:34 Moderna’s mRNA-1010 Flu Vaccine Faces FDA Refusal-to-File
4:06 European Commission Grants Marketing Authorization for Moderna’s mNEXSPIKE COVID-19 Vaccine
4:38 How to reach us
Transcript
Welcome to the latest edition of Vaccines Research Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.
First, Delonix Bioworks has received IND clearance for its engineered MenB vaccine, DX-104, in both China and Australia. This marks an important step forward for Delonix in the development of next-gen bacterial vaccines. DX-104 aims to address the global burden of invasive meningococcal disease caused by MenB, a major public health challenge. The clearance in these two countries is a significant advancement for the vaccine and strengthens Delonix’s pipeline in the global vaccine landscape.
Sanofi has completed the acquisition of Dynavax Technologies. This deal enhances Sanofi’s portfolio with the hepatitis B vaccine HEPLISAV-B and a shingles vaccine candidate. The acquisition will strengthen Sanofi’s position in the adult immunization market and significantly expand its vaccine pipeline. This acquisition positions Sanofi for further expansion into emerging markets, broadening their reach and impact in global healthcare.
Moderna continues to advance its global vaccine strategy, making regulatory progress in the European Union for its COVID-19 vaccine, mNEXSPIKE. The company is also ramping up its vaccine manufacturing initiatives in Mexico, which will help reduce reliance on international supply chains. Moderna’s global expansion is a strategic move to increase its footprint in the global vaccine market and strengthen its position as a leader in the mRNA vaccine space.
Aptar Pharma’s nasal delivery technologies have become integral to CastleVax’s Phase II clinical trials for CVAX-01, an intranasal COVID-19 vaccine. This collaboration highlights the growing interest in non-injection vaccine delivery systems, offering potentially improved immune responses and greater patient acceptance. Aptar’s innovations could help drive the next generation of needle-free vaccine technologies, which could be key in enhancing global vaccine accessibility.
GSK’s RSV vaccine, AREXVY, has shown significant effectiveness in real-world studies, especially in reducing RSV-related hospitalizations and cardiovascular risks in older adults. This vaccine is demonstrating its potential to protect older populations from severe RSV, reducing complications such as heart attack, stroke, and severe flare-ups of chronic respiratory conditions like COPD and asthma. These findings suggest that AREXVY could become a critical tool in addressing RSV-related health risks among vulnerable populations.
In the ongoing patent dispute between Moderna and Arbutus Biopharma, a federal judge recently dismissed two key defenses presented by Moderna over the lipid nanoparticle technology used in mRNA vaccines. This legal setback may complicate Moderna’s defense in the case, with potentially significant financial and operational consequences for the company, depending on the outcome of the ongoing litigation.
Moderna has also faced a setback in its efforts to bring its seasonal influenza vaccine, mRNA-1010, to market. The FDA issued a refusal-to-file letter for the vaccine, citing concerns over the clinical trial comparators used in its development. This decision will delay the approval of the vaccine and could affect Moderna’s overall vaccine portfolio and timelines, as the company works to address the FDA’s concerns.
On a more positive note, Moderna received marketing authorization from the European Commission for its COVID-19 vaccine, mNEXSPIKE, across the EU. This approval marks a significant achievement for Moderna, further solidifying its position as a leading player in the European vaccine market. mNEXSPIKE is now the third approved COVID-19 vaccine for Moderna in the EU, following the earlier approvals of Spikevax and mRESVIA.
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Why it matters
- Next-Gen Vaccines: The continuous innovations in vaccine delivery systems, such as intranasal vaccines and advanced mRNA technologies, are shifting how we think about both vaccine administration and effectiveness. These developments could significantly enhance global public health, especially in terms of accessibility and immunization rates.
- Global Vaccine Supply Chains: As seen in Moderna’s and Delonix Bioworks’ strategies, strengthening local production capacities for vaccines can help countries become more self-reliant, particularly in times of global health crises.
- Strategic Acquisitions: The Sanofi-Dynavax acquisition highlights the growing importance of strategic mergers and acquisitions in the vaccine industry, particularly in the context of expanding into new therapeutic areas like hepatitis and shingles.
- Patent Disputes: Moderna’s ongoing patent case with Arbutus Biopharma could have significant implications for the company’s financial future, especially in relation to its core mRNA vaccine technology.
🗓️ Explore weekly details and sources
- Week 5–12 February 2026
- Week 13– 19 February 2026
📚 See the full Vaccines archive on our research hub page.
FAQ
What are the new developments in Delonix Bioworks’ MenB vaccine DX-104?
The IND clearance for DX-104 in China and Australia marks a milestone in the company’s efforts to bring next-gen vaccines for meningococcal diseases to market.
How will the Sanofi-Dynavax acquisition impact the vaccine market?
The acquisition strengthens Sanofi’s presence in the adult immunization market, potentially increasing competition and access to vaccines like HEPLISAV-B and a shingles vaccine candidate.
What is Aptar Pharma’s role in advancing COVID-19 vaccines?
Aptar Pharma is providing intranasal delivery technology to CastleVax for use in their COVID-19 vaccine trials, signaling a shift toward more patient-friendly, non-injection vaccine options.
What impact could GSK’s AREXVY have on RSV prevention?
The new data on AREXVY shows that it not only prevents RSV-related hospitalizations but also reduces the risks of heart attack, stroke, and respiratory flare-ups in older adults, making it a significant tool for public health.
What happened with Moderna’s patent dispute with Arbutus Biopharma?
A federal judge dismissed two key defenses from Moderna, potentially complicating the company’s ongoing patent dispute with Arbutus over lipid nanoparticle technology used in its mRNA vaccines.
What does the FDA refusal mean for Moderna’s flu vaccine?
The refusal-to-file from the FDA delays the approval process for Moderna’s mRNA-1010 seasonal flu vaccine, citing issues with the study’s comparator vaccine.
What does EU approval for mNEXSPIKE mean for Moderna?
The EU’s approval of mNEXSPIKE further solidifies Moderna’s position as a leading player in the COVID-19 vaccine market across Europe.
Entities / Keywords
Delonix Bioworks, MenB, DX-104, Sanofi, Dynavax, mRNA, Moderna, Aptar Pharma, Nasal Vaccines, GSK, AREXVY, RSV, Vaccine Technology, mRNA-1273, COVID-19, Flu, Mexico, EU, US
References
https://finance.yahoo.com/news/delonix-bioworks-announces-ind-clearance-120000799.html
https://mexicobusiness.news/health/news/moderna-advances-local-mrna-vaccine-production-mexico
https://feeds.issuerdirect.com/news-release.html?newsid=8201845178897387&symbol=MRNA
https://feeds.issuerdirect.com/news-release.html?newsid=7346090610333866&symbol=MRNA
