Unicef | MedPath

FDA Approves Bavarian Nordic's Freeze-Dried JYNNEOS Vaccine for Smallpox and Mpox Prevention

2 months ago

• The U.S. FDA has approved Bavarian Nordic's freeze-dried formulation of JYNNEOS for prevention of smallpox and mpox in adults 18 years and older, offering improved storage stability and transportation advantages. • Clinical data demonstrated comparable immune responses and safety profiles between the new freeze-dried formulation and the previously approved liquid-frozen version, which has been in use since 2019. • Manufacturing of the freeze-dried JYNNEOS under a BARDA contract began in 2024, with first deliveries expected later in 2025, strengthening U.S. public health preparedness against potential outbreaks.

Ocean Biomedical Secures $3.5M NIH Grant to Advance Novel Malaria Vaccine Development

4 months ago

• Ocean Biomedical's research team, led by Dr. Jonathan Kurtis, has received $3.5 million in NIH funding to advance their innovative malaria vaccine research targeting the GARP protein. • The company is developing three vaccine candidates currently in non-human primate trials, supported by a $4.6 million foundation grant, with potential human trials starting in Q4 2025. • New FDA guidance on lipid-encapsulated vaccines may accelerate the development pathway for Ocean Biomedical's malaria vaccine, which targets a disease that claims over 500,000 children's lives annually in sub-Saharan Africa.

Merck's Gardasil Approved in China for HPV Prevention in Males

4 months ago

• China's NMPA has approved Gardasil for use in males aged 9-26, marking the first HPV vaccine approved for males in China. • Gardasil is now indicated for the prevention of anal cancers, genital warts, and precancerous lesions caused by HPV types 6, 11, 16, and 18 in Chinese males. • This approval expands the reach of Gardasil, which has already protected over 50 million females in China from HPV-related diseases. • Merck has committed to ensuring sufficient global supply of HPV vaccines, including low- and middle-income countries, through partnerships and increased manufacturing capacity.

FDA Approves Bavarian Nordic's Vimkunya, First Chikungunya Vaccine for Adolescents

5 months ago

• The FDA has approved Vimkunya, a chikungunya vaccine developed by Bavarian Nordic, for individuals aged 12 and older. • Vimkunya is the first virus-like particle (VLP) single-dose chikungunya vaccine approved in the U.S., offering a new preventative option. • Clinical trials showed Vimkunya induced neutralizing antibodies in up to 97.8% of vaccinated individuals within 21 days. • Commercial availability of Vimkunya in the U.S. is expected in the first half of 2025, with launches in key European markets anticipated.

Lenacapavir: Twice-Yearly Injection Shows High Efficacy in HIV Prevention

6 months ago

• Lenacapavir, administered as a twice-yearly injection, demonstrates a 96% reduction in HIV infection risk compared to background incidence. • Clinical trials reveal lenacapavir's superior efficacy over daily oral PrEP medications like Truvada, particularly addressing adherence challenges. • The FDA is reviewing lenacapavir for potential approval in 2025, offering a promising long-acting option for HIV prevention. • Global health experts emphasize the importance of equitable access and affordability to ensure widespread adoption of lenacapavir.

Sanofi's Q3 Sales Surge 15.7% Driven by Vaccines and Dupixent; 2024 EPS Guidance Raised

7 months ago

• Sanofi reported a robust 15.7% sales growth in Q3, fueled by strong vaccine sales and the continued success of Dupixent, with sales up 23.8% to €3,476 million. • Pharma launches, including ALTUVIIIO, Nexviazyme, and Rezurock, saw a significant 67.1% increase, contributing €727 million to the overall sales growth. • The company's pipeline advanced with four regulatory approvals, including Dupixent for COPD in the US and China, and four positive Phase 3 data readouts, including tolebrutinib for nrSPMS. • Based on strong Q3 business performance, Sanofi has raised its 2024 business EPS guidance to at least a low single-digit percentage growth at CER.

SIILTIBCY Receives Positive CHMP Opinion for Tuberculosis Detection in Europe

7 months ago

• The European Medicines Agency's CHMP has recommended SIILTIBCY, a novel tuberculosis skin test, for approval in Europe. • SIILTIBCY is designed to accurately detect TB, irrespective of prior BCG vaccination status, addressing a key diagnostic challenge. • Phase 3 clinical trials involving over 2,500 participants demonstrated the accuracy and safety of SIILTIBCY in diagnosing TB. • Upon European Commission approval, SIILTIBCY will be available in EU Member States, with SLS Europe managing authorization and BBio handling distribution.

Bavarian Nordic's Mpox Vaccine Shows Promise in Adolescents, Securing EMA Approval

8 months ago

• Bavarian Nordic's mpox vaccine, MVA-BN (Imvanex), has received EMA approval for use in adolescents aged 12-17, potentially expanding access in Africa. • A NIH-sponsored clinical trial demonstrated that adolescents showed non-inferior immune responses and similar safety profiles to adults after two doses. • The WHO has prequalified Imvanex for 'off-label' use, which may facilitate its use in infants, pregnant women, and immunocompromised individuals during outbreaks. • Bavarian Nordic is planning a Phase II clinical trial to assess the immunogenicity and safety of MVA-BN in children aged 2-12 years.

WHO Prequalifies First Mpox Vaccine to Combat Outbreak in Africa

8 months ago

• The World Health Organization (WHO) has prequalified the MVA-BN vaccine, manufactured by Bavarian Nordic, as the first vaccine against mpox. • This prequalification is expected to facilitate increased access to the vaccine in communities with urgent needs, particularly in Africa, to reduce transmission. • The MVA-BN vaccine can be administered in two doses to individuals 18 years and older, with an estimated 82% effectiveness, or a single dose with 76% effectiveness. • WHO's prequalification will help accelerate procurement by governments and international agencies like Gavi and UNICEF, and fast-track regulatory approvals worldwide.