Emergent BioSolutions Inc. said on Monday it received marketing authorization for its oral typhoid vaccine Vivotif in five European Union nations including France, Portugal, Poland, Czech Republic and Slovakia.
Typhoid fever is a potentially severe and life-threatening infection caused by the bacterium Salmonella enterica serovar Typhi (Salmonella Typhi) and is contracted by ingesting contaminated food or water. It is unique to humans and commonly found where sanitation is deficient. Millions of people are affected by typhoid fever annually, and if left untreated, serious complications such as hemorrhaging may occur.
Emergent’s vaccine — Typhoid Vaccine Live Oral Ty21a — is the only oral vaccine that stimulates an immune response against Salmonella Typhi in adults and children aged five years and older. In the EU, it is taken as a three-capsule regimen with a single capsule being taken on days 1, 3, and 5. More than 150 million doses of Typhoid Vaccine Live Oral Ty21a have been marketed worldwide. It is licensed for sale in 26 countries.
“We are excited about the expanded approval of our oral typhoid vaccine in Europe enabling more patients to access this important product,” said Abbey Jenkins, senior vice president and vaccines and anti-infectives business unit head at Emergent BioSolutions.
Many travelers in the UK prefer an oral vaccine over an injection, according to a survey recently conducted by the company. “The results of the online survey of 2,007 participants indicated that 48 percent of participants would opt for oral, while 43 percent would choose an injection. The results also indicated that 79 percent of participants expected to be given a choice of travel prevention options by their nurse or pharmacist,” Jenkins said.
The company also said it received approval of harmonized prescribing information in the EU also known as the Summary of Product Characteristics or SmPC. The harmonized SmPC aligned the age indication and expanded the revaccination interval from one to three years following the most recent vaccination.