Clinical Trials
57
4 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
1992
Active, not recruiting
4
7.0%
Completed
48
84.2%
Recruiting
3
5.3%
Terminated
1
1.8%
Withdrawn
1
1.8%
No approval data available
- The European Commission has extended Imvanex (MVA-BN) marketing authorization to children aged 2 to less than 12 years, making it the only non-replicating mpox vaccine approved for all individuals aged 2 and older in the EU. - The approval is supported by a Phase II study (NCT06549530) demonstrating non-inferior immune responses in children compared to adults, with similar safety profiles between both populations. - Children have been disproportionately affected during recent mpox outbreaks, particularly in Africa, and this label extension addresses a critical regulatory gap for a vulnerable population. - MVA-BN's non-replicating profile makes it suitable for immunocompromised individuals, distinguishing it from replication-competent vaccines like ACAM2000 that carry contraindications in this population.
- The global vaccine sales market is projected to reach US$141.40 billion by 2036, driven by next-generation platforms including mRNA and viral vector technologies. - U.S. tariff policies and cross-border supply chain vulnerabilities are reshaping competitive strategy, with manufacturers localizing production and diversifying suppliers to manage cost pressures. - Competition is increasingly defined by platform capabilities, regulatory credentials, manufacturing scale, and access to government and multilateral procurement contracts. - The report profiles 21 leading vaccine companies including GSK, Pfizer, Sanofi, Moderna, Merck, BioNTech, AstraZeneca, and Serum Institute of India, with forecasts across 26 national markets.
- Multiple pharmaceutical companies including Bavarian Nordic, BioNTech, and Moderna are advancing innovative monkeypox vaccines and treatments through clinical trials and regulatory approvals. - Bavarian Nordic's JYNNEOS vaccine provided broad coverage during the 2022-2023 outbreak, while the company seeks regulatory extension for adolescent use of IMVANEX. - mRNA-based vaccine candidates from Moderna (mRNA-1769) and BioNTech (BNT166a) are progressing through clinical trials to enhance immune responses against monkeypox. - Recent developments include TC BioPharm initiating preclinical studies for TCB 008 and preliminary results from NIH trials on SIGA's tecovirimat treatment.
- The US House of Representatives unanimously passed the Mikaela Naylon Give Kids a Chance Act, reauthorizing the FDA's rare pediatric disease priority review voucher program that expired in December 2024. - The legislation combines regulatory frameworks to accelerate therapy access for children with rare diseases and certain cancers, with priority review vouchers currently valued at approximately $150 million. - Industry organizations and patient advocacy groups strongly support the bill, emphasizing its critical role in incentivizing pharmaceutical companies to develop treatments for rare pediatric conditions. - The bill now advances to the Senate for consideration before potentially reaching President Trump for final approval.
- Nordic Capital and Permira have reduced the minimum acceptance threshold for their Bavarian Nordic takeover to two-thirds of shares, marking the second time they've lowered this requirement. - The private equity consortium raised their offer price to 250 kroner per share after facing significant investor resistance to their initial 233-krone bid announced in July. - The bidders extended the offer deadline to October 14 to secure final regulatory approvals while maintaining pressure to complete the acquisition of the Danish vaccine maker. - The ongoing shareholder clash highlights the challenges facing the private equity firms in their attempt to acquire the biotechnology company despite regulatory clearance efforts.
- VIMKUNYA, a non-live virus-like particle vaccine for chikungunya prevention, has shown no serious adverse events in early real-world use since its February 2025 U.S. approval. - Only three non-serious adverse events have been reported to VAERS as of September 2025, including vasovagal syncope and mild skin reactions in two patients. - The vaccine is now available in the United States, European Union, and United Kingdom, with Germany and France being the first European countries to launch the product. - Early post-marketing safety data remains consistent with findings from two pivotal clinical trials, strengthening confidence in the vaccine's role for chikungunya prevention.
- Bavarian Nordic's MVA-BN mpox/smallpox vaccine demonstrated non-inferior immune response in children aged 2-11 years compared to adults, with pediatric patients showing 2.5 times higher neutralizing antibody titers. - The clinical study enrolled 460 individuals across Democratic Republic of Congo and Uganda, with 451 evaluable for the primary endpoint, showing comparable safety profiles between pediatric and adult populations. - Results will support a label extension filing with the European Medicines Agency in 2026 to expand approval from the current 12 years and older to include children aged 2 years and older. - The findings could significantly strengthen public health response capabilities against ongoing mpox outbreaks in Africa, where children remain highly vulnerable to severe illness.
- Vaccine maker Bavarian Nordic has agreed in principle to a roughly $3 billion take-private offer from private equity firms Nordic Capital and Permira, with completion expected in the fourth quarter. - The deal offers 233 Danish kroner per share, representing a 21% premium to the company's closing price before takeover talks were confirmed. - Bavarian Nordic has developed vaccines for mpox, smallpox, and chikungunya virus, with its Vimkunya vaccine recently launched in the U.S. and approved by the CDC. - The company's revenue is growing due to rising demand for traveler vaccines and continued government contract business, including recent U.S. government orders for smallpox vaccine supply.
- Bavarian Nordic has launched two groundbreaking clinical trials to evaluate the safety and immunogenicity of MVA-BN mpox vaccine in 344 infants aged 4-24 months and 359 pregnant or breastfeeding women. - Both studies are being conducted in the Democratic Republic of Congo, the epicenter of the ongoing mpox outbreak, where these vulnerable populations remain at high risk. - The trials are part of the PregInPoxVac research project and could support regulatory approval to expand MVA-BN vaccine access to the most vulnerable populations. - Results from a concurrent pediatric trial in children aged 2-11 years are expected in Q3 2025, potentially supporting broader age group approvals.
- Valneva SE announced an exclusive three-year agreement with CSL Seqirus for marketing and distribution of three proprietary vaccines in Germany, Europe's largest travel vaccine market. - The partnership will commercialize IXCHIQ chikungunya vaccine from July 2025, followed by IXIARO Japanese encephalitis and DUKORAL cholera vaccines from January 2026. - Valneva reported €48.6 million in Q1 2025 product sales and projects growth to €170-180 million for the full year, driving positive cash flows for its commercial business. - The agreement replaces Valneva's previous distribution partnership with Bavarian Nordic and includes minimum annual purchasing quantities with standard performance-based termination clauses.
