Industry Watch [to 25 June 2016]

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:: CDC Advisory Committee On Immunization Practices Votes To Recommend Vaxchora, PaxVax’s Single-Dose Oral Cholera Vaccine
Vaxchora™ is the only licensed vaccine in the U.S. for protection against cholera
June 23, 2016
REDWOOD CITY, Calif.–(BUSINESS WIRE)–PaxVax today announced that the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted yesterday on a recommendation for the use of Vaxchora™, a single-dose oral, live attenuated cholera vaccine indicated for use in adults 18 to 64 years of age. Vaxchora received marketing approval from the United States (U.S.) Food and Drug Administration (FDA) on June 10, 2016.

The ACIP voted unanimously at their June 22 meeting to recommend Vaxchora for the prevention of toxigenic Vibrio cholerae O1 for travelers to areas of active cholera transmission. The Category A recommendation made by the ACIP for Vaxchora will be forwarded to the director of the CDC and the U.S. Department of Health and Human Services for review and approval. Once approved, the recommendations will be published in the Morbidity and Mortality Weekly Report (MMWR). Category A recommendations are made for all persons in an age- or risk-factor-based group.

“Cholera is an underestimated disease that is found in many popular global travel destinations in the Caribbean, Africa and Asia. Until now, U.S. travelers have not had access to a vaccine to help protect against this potentially deadly pathogen,” said Lisa Danzig, M.D., Vice President, Clinical Development and Medical Affairs. “We are very proud to offer the only licensed vaccine against cholera and are encouraged by the ACIP’s recommendation which recognizes the value of Vaxchora as an important option for the protection of adults traveling to cholera-affected areas.”…

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:: Takeda Initiates World’s First Norovirus Vaccine Field Trial
Vaccine candidate will target the leading cause of acute gastroenteritis around the globe
June 20, 2016
OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (“Takeda”) today announced that it has dosed the first subject in a Phase 2b field efficacy trial of Takeda’s norovirus vaccine candidate (TAK-214), the only norovirus vaccine candidate in human clinical trials.

The Phase 2b, double-blind, randomized, placebo-controlled trial involves healthy male or female adults aged 18 – 49 years. It will evaluate the efficacy of intramuscular administration of Takeda’s norovirus vaccine candidate against moderate or severe acute gastroenteritis (AGE) due to norovirus, a common intestinal infection marked by watery diarrhea, vomiting, abdominal cramps, nausea and sometimes fever that may lead to clinically significant dehydration.1,2

Norovirus is recognized as the leading cause of acute gastroenteritis across the age spectrum.3 It is estimated that norovirus causes nearly 700 million cases of illness3 with significant morbidity and social burden worldwide. More than 200,000 deaths per year are estimated to result from norovirus illness, primarily in low-income countries.”…