Norovirus Vaccines March 2023

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Last reviewed
March 9, 2023
Content Overview
Norovirus vaccines are not U.S. FDA approved in 2023. Norovirus is a contagious virus that causes vomiting and diarrhea.

Norovirus Vaccines March 2023

While vaccines against norovirus diseases are in demand, developing a broadly effective vaccine in 2023 remains difficult, owing to the vast genetic and antigenic diversity of noroviruses, which have multiple co-circulated variants of different genotypes. As of March 9, 2023, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) had not approved a norovirus vaccine.

Norovirus Vaccine Candidates

HIL-214 is a bivalent vaccine candidate in development for preventing moderate-to-severe AGE caused by norovirus infection. HIL-214 consists of virus-like particles designed to mimic the structure of two major genotypes of norovirus, GI.1 and GII.4, and are co-formulated with an alum adjuvant. 

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. is conducting a phase 1/2a clinical trial evaluating the safety and tolerability of the tetravalent recombinant Norovirus vaccine at different doses. This candidate uses the Pichia pastoris expression system, where the system is used to establish the virus-like particles (VLP) recombinant engineered bacteria for expressing norovirus epidemic strains, which are then cult.

Vaxart’s bivalent norovirus oral tablet candidate is differentiated from other norovirus vaccines because it generates systemic and mucosal immunity, is delivered through the mouth, and is stable at room temperature. In addition, three Phase 1 studies of Vaxart’s norovirus pill vaccine indicated it is well tolerated and generated systemic and local immune responses that are both robust and persistent. 

Norovirus Outbreaks March 2023 

Based on CaliciNet Data, the U.S. Centers for Disease Control and Prevention (CDC) publishes the Norovirus Outbreak Map of confirmed outbreaks in the U.S. as of January 31, 2023. And the CDC posts Norovirus National Trends as of March 2023. The CDC posts current norovirus outbreaks and alerts. For example, the cruise ship Ruby Princess confirmed as of March 5, 2023, about 9.9% of passengers reported being ill during the voyage (RU305P).


Noroviruses are very contagious and are members of the Norovirus genus in the family Caliciviridae, a group of nonenveloped, single-stranded, positive-sense RNA viruses. They are the most common viral pathogens causing epidemic and endemic acute gastroenteritis with typical symptoms of watery diarrhea, vomiting, and stomach cramping, affecting humans in all age groups in both developing and developed countries.