Baxter on verge of revolutionizing flu shot life cycle
DEERFIELD, Ill. — Baxter International on Tuesday announced results of a study published in this week’s issue of The Lancet that demonstrated effectiveness and tolerability of the company’s Preflucel in protecting against seasonal influenza.
If successfully brought to market, the new vaccine would antiquate conventional embryonated chicken egg production with a faster development cycle. That, in turn, would allow greater flexibility in identifying dominant flu strains closer to real-time and close the gap between projected supply versus actual demand. Presently, the Centers for Disease Control and Prevention helps project expected dominant flu strains for an ensuing season in the spring.
The vaccine also should help expand the market for flu shots; Preflucel is free of preservatives, antibiotics and egg proteins, and is suitable for people with egg or antibiotic allergies.
The study data showed nearly 80% protective efficacy against the influenza strains contained in the vaccine and a low adverse event profile. Preflucel is manufactured using Vero cell technology, offering an innovative method of vaccine production, compared with conventional embryonated chicken egg production, which has been used for decades.
Investigators studied the safety, immunogenicity and protective efficacy of Preflucel through a randomized, double-blind, placebo-controlled phase-3 trial, conducted in more than 7,200 healthy volunteers in the United States during the 2008-2009 influenza season.
Study results indicated that participants responded positively to the vaccine, with 78.5% protective efficacy against culture-confirmed influenza infection and robust immune responses against the three viral strains contained in the vaccine: A/H1N1- (88.0%), A/H3N2- (93.3%) and B-specific (97.1%) strains.
In addition to protection, study investigators found significantly reduced duration and severity of influenza symptoms in infected subjects in the vaccinated group, as compared with the placebo group in a subsequent analysis. The vaccine was well-tolerated, with no treatment-related serious adverse events reported during the trial.
Preflucel currently is available in Austria and Czech Republic for the 2010-2011 influenza season. Baxter expects to receive approval of Preflucel in additional countries in Europe in 2011 through a repeat mutual recognition procedure.
Preflucel clinical studies involved more than 15,000 participants, of which more than 9,000 adult and elderly participants received the vaccine. The most common undesirable effects observed were pain at the injection site, headache, fatigue, myalgia and malaise.
Lansinoh to control manufacturing assets for three of its products
ALEXANDRIA, Va. — Lansinoh Labs on Tuesday announced the acquisition of certain operational and manufacturing assets from En-Ko Electronic Control Systems in Izmir, Turkey. The acquisition will allow Lansinoh to directly control the manufacturing of the Lansinoh Affinity double electric breast pump, Lansinoh Affinity breast-milk storage bottles and Lansinoh ComfortFit flanges.
The new company will operate as Lansinoh Laboratories Medical Device Design and join other Lansinoh company assets, including the Lansinoh and Momma brands.
“This acquisition is a significant milestone for our company and brands,” stated Kevin Vyse-Peacock, Lansinoh CEO. “Lansinoh Laboratories Medical Device Design provides a platform of resources that supports our existing breast-pump business, and also permits Lansinoh to develop ideas for innovative new products.”
Cahit Ustundag will lead the operation and report to Richard Thome, Lansinoh COO.
Clorox gives quick, dirty advice on keeping bachelor pads clean
OAKLAND, Calif. — Clorox recently launched the "Quick & Dirty" cleaning guide for bachelors on its website.
In line with Valentine’s Day, Clorox incorporated its line of cleaning products into the guide. The line was developed after a Clorox-sponsored study, conducted by Charles Gerba, a microbiology professor at the University of Arizona, found that some bachelor pads may contain more than 15 times the amount of bacteria than the homes of bachelors’ female counterparts. Of the surfaces tested in bachelors’ apartments, coffee tables and remote controls harbored the most bacteria.
To download the Clorox guide, click here.