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By Josh Bloom — April 17, 2019
Will Pills Stop The Ills? Photo: Max Pixel
No need to keep the mop handy. At least yet.
Vaxart Inc., a San Francisco based vaccine biotech just announced that it would begin dosing subjects in a Phase Ib study (1) of the company's bivalent oral experimental vaccines against norovirus - the cause of the so-called "stomach flu." The two components of the vaccine, VXA-G1.1-NN and VXA-G2.4-NS will be tested in volunteers, who will receive either vaccine alone, both together, or neither.
But none of the 86 volunteers will get sick; none of them will be exposed to live virus. This trial is designed to study only the safety and immunogenicity of the vaccines, not efficacy. If the 1b trials look promising enough to continue, volunteers will be challenged with a live virus in Phase II. There may be a slightly different mindset regarding the two trials...
Writer's rendition of recruits for Phase Ib trials (Left) and Phase II trials (Right). Photos: The Guardian, The Mind of RD REVILO
The trial will be conducted in two parts. Part 1 will begin with an open-label (not blinded) administration to six subjects. If there are no safety issues at day eight, the trial will then be double-blinded, and the other volunteers will receive either vaccine alone, or placebo and be monitored (for safety and immune response) for four weeks. In Part 2 the volunteers who got both vaccines in Part 1 will get a booster (open-label) four months later and be monitored for safety for one year. The vaccines are tablets, not injections.
There is no way to prevent norovirus (2), which makes life miserable for 20 million Americans every year, mostly during winter months. Treatment options are mostly limited to rehydration, maybe witchcraft. Sometimes an antiemetic drug, such as Zofran, can be helpful. Norovirus is also one of the most infectious of all pathogens, which is why it goes around schools, hospitals, nursing homes, and cruise ships so readily.
A successful vaccine would be a substantial medical advance. Norovirus is more than a nuisance; it kills 50,000 children worldwide each year and the price tag for treatment and lost productivity in the US alone is $2 billion.
Knock 'em dead, guys.
(1) Phase I trials can be divided into Ia and Ib. Both trials are (usually) for safety. In Ia, volunteers get a single dose, which is raised in increments if no adverse effects are apparent. In Ib, volunteers are given multiple doses of the drug, which are also raised incrementally. Phase II volunteers are given what is expected to be therapeutic doses and efficacy is usually the endpoint.
(2) The best advice for prevention is soap and water. You and I both know that's not good enough.
By Josh Bloom
Dr. Josh Bloom, the Director of Chemical and Pharmaceutical Science, comes from the world of drug discovery, where he did research for more than 20 years. The field of drug discovery involves chemistry, biochemistry, toxicology, and pharmacology - skills that he has used to write on a wide variety of topics since he joined ACSH in 2010. One of the topics he has tackled is the so-called "opioid crisis." He is now recognized as an expert in this area and was the first journalist to write a nationally published opinion piece about the unintended consequences of a governmental crackdown on prescription pain medications (New York Post, 2013). Since that time he has published more than 20 op-eds in regional and national newspapers on different aspects of the crisis. In that same year, he testified at an FDA hearing, where he noted that fentanyl was the real danger, something that would be proven years later. At that time almost no one had heard of the drug.
He was also the first writer (2016) to study, dissect and ultimately debunk the manipulated statistics used by the CDC to justify its recommendations for opioid prescribing, which have resulted in Draconian requirements for prescribing pain medications as well as government-mandated, involuntary tapering of patients receiving opioid treatment, both of which have caused great harm and needless suffering to chronic pain patients. His 2016 article, "Six Charts Designed to Confuse You," is the seminal work on CDC deception and has been adopted by patient advocacy groups and individuals and has been sent to governors and state legislatures.
Dr. Bloom earned his Ph.D. in organic chemistry from the University of Virginia, followed by postdoctoral training at the University of Pennsylvania. His career in drug discovery research began at Lederle Laboratories, which was acquired by Wyeth in 1994, which itself was acquired by Pfizer in 2009. During this time he participated in research in a number of therapeutic areas, including diabetes and obesity, antibiotics, HIV/AIDS, hepatitis C, and oncology. His group discovered the novel antibiotic Tygacil®, which was approved by the FDA for use against resistant bacterial infections in 2005. He is the author of 25 patents, and 35 academic papers, including a chapter on new therapies for hepatitis C in Burger's Medicinal Chemistry, Drug Discovery and Development, 7th Edition (Wiley, 2010), and has given numerous invited lectures about how the pharmaceutical industry really works.
Dr. Bloom joined the American Council on Science and Health in 2010 as ACSH's Director of Chemical and Pharmaceutical Sciences, and has since published more than 60 op-eds in numerous periodicals, including The Wall Street Journal, Forbes, New Scientist, The New York Post, National Review Online, The Boston Herald, and The Chicago Tribune, and given numerous radio and television interview on topics related to drugs and chemicals. In 2014, Dr. Bloom was invited to become a featured writer for the site Science 2.0, where he wrote more 75 pieces on a broad range of topics.
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