Vaccine Development and Manufacturing

The Human Vaccines Project brings together academic research centers, industrial partners, nonprofit organizations, and governments to address the primary scientific barriers to developing new vaccines and immunotherapies.

During a clinical trial of 48 participants, 100% of those that received the TV003 vaccine were protected from infection.

Vaccine R&D has grown exponentially in recent years, spurred by ethical and medical needs to combat lethal infectious outbreaks and increased funding from public and private agencies and organizations.

Seqirus, CSL Limited’s influenza vaccine business, announced the opening of their corporate headquarters in the United Kingdom.

Panelists at the meeting will focus on clinical trial design, immunogenicity, and enhancing implementation plans for administering already-licensed vaccines to this patient population.

South Africa’s Biovac Institute, which develops and produces vaccines for the country, launched a public-private partnership with Pfizer to enable local manufacturing of Prevenar 13, a vaccine against pneumonia-causing bacteria.

Univercells will integrate its single-use bioprocess with the Takeda vaccines production platform to allow local production.

Novovax’s investigational vaccine targeting respiratory syncytial virus (RSV) demonstrated clinical effectiveness in animal models.

CMC Biologics will manufacture monoclonal antibodies (mAbs) and provide process development services for the PATH Malaria Vaccine Initiative.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has announced a positive scientific opinion for GlaxoSmithKline’s (GSK’s) malaria candidate vaccine Mosquirix (RTS,S) for use outside of the European Union (EU) in children aged 6 weeks to 17 months.

GSK accelerates delivery timeline for US quadrivalent flu vaccine.

The European Medicines Agency reviews the safety of human papillomavirus vaccines.

The European Pharmacopoeia has incorporated new provisions to encourage the use of in-process quality control methods.

The divestment of Nimenrix and Mencevax was to satisfy regulatory clearances when GSK gained Novartis’ vaccines business in an asset swap in March 2015.

IDT Biologika acquired Aeras' vaccine manufacturing facility, and the companies will work together on tuberculosis vaccine development.

Medicago's new production facility will make plant-based vaccines and therapeutics.

A vaccine patch may eliminate the need for traditional means of vaccine distribution, according to an article in NPR.

GSK notifies CDC and FDA that it is recalling the remaining doses of its 2014–2015 flu vaccine, Flulaval Quadrivalent Thimerosal-free Pre-Filled Syringes, due to decreased potency.

GlaxoSmithKline announces global vaccines research and design facility to be based in Rockville, MD, USA.

NIH announced positive safety results from the vaccine, VSV-ZEBOV, and found that all patients in the study experienced a strong antibody response.

Second-generation needle-free injection systems will make parenteral drug administration more convenient, efficient, and safe.

Emergent BioSolutions announced FDA approval of Anthrasil, an inhalable treatment that targets Anthrax toxins, as well as a contract with BARDA to develop NuThrax, an anthrax vaccine candidate.

The agency will employ a ring vaccination method similar to the one used to eradicate smallpox.

Scientists and industry experts seek effective preventive therapies to combat global disease.

The pharmaceutical manufacturer pledged to freeze vaccine prices for Gavi-eligible countries for a decade.