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CDC Recommends that Adults Traveling to Cholera-Affected Destinations Get Vaccinated with Vaxchora™ (Cholera Vaccine, Live, Oral)

REDWOOD CITY, CA – May 11, 2017 – PaxVax announced today that the U.S. Centers for Disease Control and Prevention (CDC) has adopted and published the recommendation of the Advisory Committee on Immunization Practice (ACIP) regarding the use of Vaxchora (Cholera Vaccine, Live, Oral), the only vaccine available in the U.S. for active immunization against cholera.

PaxVax Partners with National Institutes of Health and Department of Defense to Develop a New Virus-Like Particle Vaccine to Fight the Spread of Chikungunya

REDWOOD CITY, CA – January 5, 2017 – PaxVax announced today its partnership with the National Institutes of Health (NIH) and United States Department of Defense (DoD) on its chikungunya vaccine program. According to the terms of the collaboration, PaxVax has in-licensed the NIH virus-like particle (VLP) vaccine technology for chikungunya with plans to bring the vaccine through full commercialization. NIH has already completed a phase 1 trial, and is currently assessing the vaccine in a phase 2 trial.

In the News

05/16/2017
Acute respiratory disease (ARD) due to infection with adenovirus is a major cause of morbidity at military training centers. In addition to ARD, adenovirus infection can cause sore throat, pneumonia, conjunctivitis, and urinary infections. Military recruits are particularly susceptible to illness due to their close living quarters, physical stress, and lack of sleep. When the infection is severe, it disrupts training schedules, can lead to hospitalization, and increases medical costs. This spring, the Vaccine Testing Center at the Larner College of Medicine at the University of Vermont (UVM) will test a modernized vaccine to protect troops against adenovirus. In the 1960s, the Department of the Army developed a vaccine against adenovirus serotypes 4 and 7, the most common causes of illness due to adenovirus. This vaccine was licensed by Wyeth for use in 1980 and as a result, the incidence of ARD in military recruits decreased significantly. When vaccine production ceased in 1996, the incidence of ARD rose. In 2011, Teva Pharmaceuticals obtained licensure and vaccine was again used to prevent adenovirus infection in military recruits. In 2014, the Department of Defense issued a call to modernize the production of this important vaccine. The new formulation is being developed by PaxVax, a biotechnology company based in California. The UVM clinical research team, led by Associate Professor of Medicine, Caroline Lyon, M.D., M.P.H, will evaluate the safety and immunogenicity of this new vaccine. During this study, subjects who meet specific inclusion criteria will receive either the currently used adenovirus vaccine or the new vaccine. Subjects will be monitored as inpatients at the UVM Clinical Research Center for one week. “Our group has significant experience with both vaccine testing and inpatient studies, and we have successfully worked with PaxVax before, which makes us an ideal candidate to carry out this study,” says Lyon. She and her team previously worked with PaxVax on a now licensed cholera vaccine. To obtain more information about this study or to volunteer for future studies, please contact the UVM Vaccine Testing Center recruiting office at 802-656-0013 or visit the Vaccine Testing Center website.
The Hill - 10/31/2016
Two years ago, Americans and Europeans watched in collective horror as a faceless, indiscriminate killer landed in their midst without warning. Fear and widespread anxiety were joined by deep frustration at the apparent unpreparedness to handle a threat of such magnitude. I’m not referring to a terror attack or a natural disaster. And though the killer was faceless, it had a name – Ebola. Of course, the people of Africa were quite familiar with Ebola hemorrhagic fever. National governments,  international organizations, humanitarian aid agencies, including Doctors Without Borders and the International Rescue Committee, and health officials in Guinea, Sierra Leone, Liberia and other affected nations have worked tirelessly to contain the disease, which killed 11,300 people in the region during the 2014 outbreak. It wasn’t until the first cases were diagnosed in the U.S. and Western Europe that developed countries realized the scourge was no longer confined to developing countries. Thankfully, as so often happens in a global health crisis, leaders in public health and government joined forces to develop the protocols needed to stabilize the outbreak. Today, the Zika virus represents a new, potentially devastating pandemic throughout Latin America and the southern U.S. (for now). Fortunately, we’ve had warning to prepare for Zika. Unfortunately, the U.S. is still unprepared to effectively fight it. Centers for Disease Control and Prevention (CDC) Director Tom Frieden told reporters in September that “we are now essentially out of money” and informed policy makers that the U.S. is “about to see a bunch of kids born with microcephaly,” a condition in which babies are born with abnormally small heads and brain defects. Microcephaly is just one of the potentially long-term consequences that may affect babies born with Zika. Frieden’s remarks came as Congress struggled to reach an agreement on a bill proposing more than $1 billion for studies, diagnostic tests, vaccine and drug research and programs to battle Zika. So far in the U.S. more than 730 pregnant women have been found to carry the virus and at least 18 babies have been born with microcephaly. Nearly 3,000 people in the continental U.S. have been infected; the numbers in Puerto Rico and other U.S. territories, and many countries in Latin America, are considerably higher. While the Obama Administration has redirected funding from other health priorities as a temporary measure, and it’s not clear whether any work on a vaccine has been delayed, what we do know is that without a plan and resources, the numbers will only continue to grow across the country and around the world.  The response to Ebola and the current stalemate in Congress over Zika funding help illustrate how critical global-scale planning, collaboration and funding are to preventing epidemics. And they point to the increasingly important role that organizations like the Coalition for Epidemic Preparedness Innovations (CEPI) can play. CEPI is a new public-private alliance dedicated to rapidly creating an arsenal of new vaccines to prevent and contain infectious global health epidemics. The concept is to invest in early development of vaccines in order to dramatically reduce the time it takes to have them ready and prepared before an outbreak occurs. The Norway-based coalition is spearheaded by the Wellcome Trust, the Bill and Melinda Gates Foundation, the World Economic Forum and the governments of Norway and India. CEPI will initially focus on vaccines to treat diseases identified by the World Health Organization as priority public health threats. Some of the diseases CEPI is considering to target include Lassa fever, Marburg fever, MERS, SARS, Nipah virus, Rift Valley fever, chikungunya and other emerging diseases for which there are currently no vaccines. By funding the early stages of research and development, CEPI can help bring many vaccine candidates forward for a variety of diseases. This way, instead of predicting what the next epidemic will be, we will be ready for whichever one actually breaks out and can then move to late stage clinical studies and quickly get a product approved. Despite scientific advancements that have brought us safe and effective treatments for a host of cancers, neurological disorders and other difficult to treat diseases, it seems inconceivable that there are still dangerous infectious diseases for which there are no licensed vaccines. In part, this is due to the long and arduous process of vaccine development. Pre-clinical and clinical development of a vaccine typically takes 12 to 15 years and requires assessment of the safety and efficacy of the vaccine on thousands of patients. There are unpredictable commercial incentives and pathways to regulatory approval as well. And the rarity and remote location of certain outbreaks also makes it difficult for scientists to study a disease or find enough patients to conduct effective vaccine trials. These and other factors all have the potential to deter investment, even for firms that are committed to discovering new medicines for the good of all who need them. With that said, it’s not difficult to recognize that there is a misalignment between how industry works to develop vaccines and what public health needs are. The solution to this dilemma begins with collaboration.  We’ve seen that when working alone, industry players face barriers to vaccine development. Ebola and Zika have taught us that devastating epidemics aren’t just a threat to those in far off lands. It’s time to turn those lessons into action, and find innovative ways to be prepared before outbreaks become pandemics. Nima Farzan is Chief Executive Officer of PaxVax, Inc. and the Biotechnology Innovation Organization (BIO) delegate on the board of the Coalition for Epidemic Preparedness Innovations.    
Associated Press - 06/10/2016
WASHINGTON — Federal health officials have approved the first cholera vaccine intended to protect U.S. travelers from the potentially life-threatening disease. The Food and Drug Administration approved the liquid vaccine, called Vaxchora, for adults ages 18 to 64 who are traveling to countries affected by cholera.