Vaccine Development and Manufacturing

A phase 2 controlled human infection trial has found that two doses of WRSs2, a live-attenuated oral vaccine candidate against Shigella sonnei, achieved 89% protection — the highest efficacy reported for any Shigella vaccine candidate — with no serious adverse events, advancing a century-long quest for a licensed vaccine against the diarrheal pathogen.

The supplemental approval is based on immunogenicity data from the STRIDE-13 phase 3 trial and, according to Merck, makes the vaccine the only one of its type specifically indicated for this at-risk pediatric population in the United States.

The company reported that phase I data show approximately 40% of patients remained cancer-free at 10 years, while 2 phase 2 trials are ongoing.

NeoVac first-in-human data suggest that optimized lipid nanoparticles may improve mRNA tolerability, enabling repeat dosing and broader therapeutic use.

The European Commission’s approval of GSK’s Arexvy for adults 18 years and older expands the respiratory syncytial virus vaccine market and signals broader adoption of adult immunization strategies.

The CDC has narrowed pediatric vaccine guidance, resetting evidence expectations and signaling potential shifts in vaccine uptake and market demand.

FDA’s internal findings raise new concerns over pediatric vaccine safety and signal potential regulatory shifts affecting future COVID-19 vaccine development.

Progress in vaccine development is closely tied to advancements in biopharmaceutical technologies, regulatory landscapes, and quality assurance methodologies.

Regulators and manufacturers face new uncertainty as shifting CDC vaccine language raises concerns for evidence-based oversight and biopharma compliance.

Cellevate’s nanofiber technology enables higher viral vaccine titers in adherent cell cultures, advancing efficiency in large-scale biomanufacturing.

Naobios and Olon France create custom HCP ELISA to advance vaccine trials and strengthen global biopharmaceutical manufacturing capacity.

ACIP votes to separate MMR and varicella vaccines (MMRV) for children to cut febrile seizure rates.

Moderna’s updated Spikevax and mNEXSPIKE COVID-19 vaccines target the LP.8.1 variant of SARS-CoV-2 for high-risk groups and older adults.

FDA will review GSK’s application to expand the use of its respiratory syncytial virus vaccine, Arexvy, to adults aged 18–49 who are at increased risk.

The next-generation monoclonal antibody could potentially be used to prevent and treat active COVID-19 infections, according to its developer, providing a non-vaccine option.

The spray-dried formulations for Ethris’ mRNA vaccine candidates will be developed at Lonza’s Bend, Ore., Center of Excellence in accordance with GMP standards.

The partnership will advance the accessibility, scalability, and affordability of RNA-based vaccines.

Pointing to the continued circulation and evolution of COVID-19, WHO published a statement on the COVID-19 vaccine antigen composition to respond to variants of the virus.

Using Orexo’s powder-based drug delivery technology, the companies will develop mucosal vaccines in an inhaled formulation.

This article looks at how the MAPPs assay works, how it integrates with other immunogenicity assays, and just how it can be flipped to help in vaccine design.

Pfizer’s bivalent RSV prefusion F vaccine has been approved by FDA to prevent lower respiratory tract disease resulting from the respiratory syncytial virus in adults 18 to 59 years of age who are at increased risk.

Evonik's plant-based squalene, PhytoSquene, used in parenteral drug delivery applications, won the CPHI Excellence in Pharma Award in the “Sustainability” category.

There is potential to effectively marry the best aspects of mRNA as a modality, to other existing or nascent exciting platforms, such as gene editing.

The agency is recommending the extension of the smallpox and mpox vaccine, Imvanex, to adolescents aged 12 to 17.

A coordinated and international response is needed to help control the latest mpox outbreak in Africa.