London-based GlaxoSmithKline?s Hiberix, a haemophilus influenzae Type b (Hib) vaccine, was approved by the US Food and Drug Administration.
London-based GlaxoSmithKline’s Hiberix, a haemophilus influenzae Type b (Hib) vaccine, was approved by the US Food and Drug Administration as a booster dose for children 15 months through 4 years old. Hiberix recieved accelerated approval because there was not enough of Hib vaccine on the market.
A nationwide shortage of Hib vaccine began in December 2007 following a voluntary recall by Merck & Co. and subsequent production suspension of its PedvaxHIB and COMVAX, two of four Hib vaccines licensed in the US. This shortage resulted in a recommendation by the US Centers for Disease Control and Prevention to temporarily defer the Hib vaccine booster dose for children who were not at high risk for infection, until the vaccine supply could be restored.
“This approval will provide an additional safe and effective vaccine to help ensure that there is an adequate Hib vaccine supply during necessary catch-up vaccinations,” said Karen Midthun, acting director of the FDA’s Center for Biologics Evaluation and Research.
As part of the approval, GSK will conduct a post-market study in the US to evaluate the safety and immunogenicity of primary and booster vaccination with Hiberix compared to a Hib vaccine already licensed in the US.
The Future of Cleanroom Construction: How Hybrid Solutions are Changing the Game
May 14th 2025Imagine a world where cleanroom facilities—essential for pharmaceutical manufacturing, biotechnology, and high-tech industries—are built with unparalleled speed, precision, and efficiency. That world is here, thanks to the hybrid construction approach. By blending traditional stick-built methods with modular and prefabricated solutions, companies are overcoming the limitations of conventional construction while ensuring compliance with stringent industry regulations. In this interview, we explore how hybrid cleanroom construction is transforming the industry, offering faster project timelines, improved quality control, and significant cost advantages. Join us as we delve into this game-changing approach with industry experts who are leading the charge in revolutionizing cleanroom infrastructure.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.