Serum Institute of India Pvt Ltd.

FDA Requests Additional Trial for Novavax COVID-19 Vaccine Before Full Approval

a month ago

• The FDA has asked Novavax to conduct an additional randomized, controlled study of its COVID-19 vaccine NVX-CoV2601 before considering full approval, despite the vaccine having emergency use authorization since 2022. • Interim results from a phase 2/3 study showed Novavax's updated XBB.1.5 variant vaccine generated 5.8 times higher neutralizing antibody levels compared to the original formulation, with a favorable safety profile. • The FDA's request represents a significant setback for Novavax, which had expected approval based on prior conversations with regulators and had already passed its April 1 PDUFA date.

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.

Dynavax Reports Strong Growth with HEPLISAV-B Revenue Up 26% in 2024, Advances Pipeline Programs

3 months ago

• HEPLISAV-B achieved record net product revenue of $268.4 million in 2024, representing a 26% year-over-year growth, with market share reaching 44% in the U.S. hepatitis B vaccine market. • Dynavax expects to report top-line results from its Phase 1/2 shingles vaccine trial in Q3 2025 and plans to initiate a Phase 2 plague vaccine trial in collaboration with the U.S. Department of Defense. • The company projects HEPLISAV-B net product revenue to reach $305-325 million in 2025 and anticipates completing its $200 million share repurchase program by year-end.

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.

Safety and Efficacy of the Blood-Stage Malaria Vaccine RH5

7 months ago

A recent clinical trial, registered under ClinicalTrials.gov ID: NCT05790889, has been conducted to evaluate the safety and efficacy of the RH5 malaria vaccine. The study received ethical approvals from the National Ethical Committee of the Ministry of Health in Burkina Faso and the Oxford Tropical Research Ethics Committee in the UK. Funding for this research was provided by several organizations, including the European and Developing Countries Clinical Trials Partnership and the Wellcome Trust.