Most Common Cause of Gastroenteritis May Soon be Preventable

A norovirus vaccine developed by Takeda is the first and only one to be tested in human trials.

A Phase 2b, double-blind, randomized, placebo-controlled trial will test the efficacy of a norovirus vaccine (TAK-214) in preventing moderate to severe acute gastroenteritis brought on by norovirus. The trials will include healthy male or female adults between the ages of 18-49 years of age. Developed by Takeda Pharmaceutical Company Limited, TAK-214 uses virus-like particle (VLP) antigens from genotypes GI.1 and GII.4, which represent the two genogroups that contribute to the majority of norovirus illnesses. The vaccine was well tolerated and resulted in reduced disease symptoms as well as disease severity in patients enrolled in Phase I and II human challenge studies.

Rajeev Venkayya, MD, president of Takeda Vaccines stated in an official press release, “We are excited to be on the frontline of development of a vaccine against norovirus… The progress of our norovirus program, along with our efforts in dengue, polio, and hand foot and mouth disease, demonstrates our commitment to tackling important infectious diseases that affect populations everywhere.”

The Centers for Disease Control and Prevention (CDC) reports that norovirus is the cause of approximately 21 million cases of acute gastroenteritis per year in the United States. Norovirus is also responsible for almost 600,000 deaths per year nationwide, the majority of whom are younger children and older adults. In addition, a recent study showed that the economic burden of the virus is approximately $4.2 billion in healthcare costs and $60.3 billion in societal costs.

Recently, a suspected norovirus outbreak has caused 11 GOP staffers to be quarantined. To prevent the spread of infection to approximately 500 members of the California delegation, the effected Republicans are being held in their hotel, outside of Cleveland, Ohio. The delegates who presented with norovirus-like symptoms are currently being tested for the virus.