Vaccine Development and Manufacturing

Zika vaccine development is hindered by technical challenges and funding shortfalls.

The Phase I trial will test Bavarian Nordic’s vaccine, which is manufactured using a vaccine vector based on smallpox.

The vaccine candidate has also won a Priority Medicines (PRIME) status from EMA.

The company will collaborate with the Walter Reed Army Institute of Research to co-develop a Zika vaccine candidate.

Two recently published studies suggest that pre-exposure to the dengue virus (DENV) could predict a person’s reaction to the Zika virus (ZIKV) because of of the antigenic similarity between the viruses. One study was published on June 23, 2016 in Nature Immunology and the other on June 27, 2016 in Proceedings of the National Academy of Sciences of the United States of America (PNAS). Dengue and Zika are both mosquito-borne flaviviruses that are cross-reactive.

MilliporeSigma and the International Vaccine Institute in Seoul, South Korea aim to develop more robust, scalable vaccine manufacturing processes.

Studying broadly neutralizing antibodies in infants may lead to new pathways in HIV vaccine development.

A new indication for Emergent BioSolutions’ BioThrax will give the drug market exclusivity through November 2022.

The vaccine alternative, manufactured with a GE FlexFactory system, could be associated with fewer adverse reactions than the live vaccine option

Phase I clinical trials of PfSPZ revealed it may protect healthy adults, who have not been exposed to Malaria before, for more than on year.

MilliporeSigma expands its Carlsbad, California-based GMP capacity for viral and gene-therapy products by nearly 90%.

Traditional methods of measuring the effectiveness of vaccines against the flu are called into question by new findings from the NIH.

Even though the organizers of New York’s Tribeca Film Festival decided not to air the anti-vaccine film by discredited British researcher Andrew Wakefield, the so-called documentary is getting a healthy run and further perpetuating the myth of a link between childhood vaccination and autism.

Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing

Proven science-based strategies can help to accelerate vaccine development.

Global outbreaks energize vaccine R&D and drive production modernization.

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.