Vaccine Development and Manufacturing

In light of the current COVID-19 pandemic, the agencies co-chaired the first global regulators meeting to facilitate development of vaccines against SARS-CoV-2, which causes COVID-19.

Emergent BioSolutions will help develop and manufacture an oral vaccine candidate and will develop plasma-based antibody therapeutics.

An NIH study of a COVID-19 vaccine is enrolling Seattle-based healthy adult volunteers.

Through the agreement, Emergent will manufacture the vaccine, which is formulated based on Novavax’s proprietary recombinant protein nanoparticle technology platform and its Matrix-M adjuvant to boost immune responses.

WuXi Vaccines, WuXi Biologics’ joint venture with Shanghai Hile Bio-technology, has signed a 20-year vaccine manufacturing contract with a global vaccine leader for $3 billion.

Sanofi will use a recombinant DNA platform that produces a genetic match to proteins found on the surface of COVID-19 to formulate the vaccine.

The research community is moving quickly to launch clinical trials of potential countermeasures, while regulatory authorities aim to support product development through regulatory flexibility.

The vaccine is designed to provide active immunity against the influenza A (H5N1) strain and can be easily deployed in a pandemic event.

J&J’s Janssen Pharmaceutical Companies seeks to develop a vaccine candidate against the novel coronavirus.

FDA has granted fast track designation for Novavax’s NanoFlu, a recombinant quadrivalent flu vaccine, for use by adults age 65 years and older.

Sanofi Pasteur will expand clinical development and manufacturing of an adjuvanted recombinant pandemic vaccine at its site in Pennsylvania.

CPI has partnered with ImmunoBiology (ImmBio) for the development of a heat-stabilized formulation of a mutli-antigen vaccine candidate against Pneumococcal diseases.

Countries and partners have announced commitments to vaccinate 450 million children against polio each year and overcome barriers to reaching all children.

The plant in Singen, Germany will be used for formulation, filling, and packaging of Takeda’s vaccine candidate.

Scientists from the University of Texas Medical Branch in Galveston and Profectus BioSciences of New York have developed the candidate quadrivalent VesiculoVax vaccine, an investigational vaccine that protected monkeys against four types of hemorrhagic fever viruses endemic to overlapping regions in Africa.

The authors of this study demonstrate an innovative method that is useful and complements traditional HA assays.

Limitations in traditional flu vaccine manufacturing methods underline the need for shifting to modern technologies.

CHMP has recommended that Ervebo (rVSVΔG-ZEBOV-GP), a vaccine for active immunization against Ebola, be granted conditional marketing authorization in the EU.

The agency announced that FDA scientists have developed candidate vaccine viruses that may be used to produce influenza vaccines.

The authors provide an introduction to aluminum adsorbed vaccines, review studies of antigen stability, and propose test methods for the analysis of aluminum vaccine release and stability analysis.

The project will focus on the development of an influenza vaccine that protects against multiple strains of the influenza virus in a single dose.

In parallel to the priority review designation for its biologics license application, Merck plans to scale up its doses of the investigational Ebola vaccine to meet global outbreak response needs.

The company has received breakthrough therapy designation for its prophylactic respiratory syncytial virus vaccine candidate for treating adults aged 60 years or older.

Valo Therapeutics has acquired a technology from Helsinki University that is expected to broaden its approach and expand the capability of its cancer vaccines platform, PeptiCRAd.

The new facility, located in Ness Ziona, Israel, will support clinical phage manufacturing and can be expanded in the future to support commercial-scale manufacturing.