The US Food and Drug Administration has agreed to undertake a speedy review of an experimental Clostridium difficile vaccine being developed by Pfizer.
The jab, which is currently dubbed PF-06425090, is being tested in Phase II trials for preventing illness associated with the superbug, such as life-threatening diarrhoea and pseudomembranous colitis.
In the US every year there are around 250,000 cases of C. difficile-associated disease, leading to 14,000 deaths, and as yet no vaccinations have been approved to prevent infection.
The fast-track review means that the FDA believes the vaccine could fulfil an unmet medical need.
French drugmaker Sanofi is currently testing its own C. difficile jab in Phase III trials.
Paediatric OK for Gaucher drug
Meantime, Pfizer and partner Protalix BioTherapeutics have been boosted by FDA approval for its type 1 Gaucher disease drug Elelyso (taliglucerase alfa) for paediatric patients.
The latest approval for Elelyso, which got the green light in the USA in May 2012 for adults, is based on two trials involving 14 paediatric patients. Gaucher, an inherited lysosomal storage disorder, consists of varying degrees of severity and has been sub-divided into three subtypes; type 1, the most common, is found at a higher frequency among people of Ashkenazi Jewish ancestry.
