Big Pharma stockholders think so
San Diego-based Vical, a firm who is developing an H1N1 vaccine under an agreement with the U.S. Navy saw company shares climb 45 cents, to $2.65 on positive clinical trial news this week. Vical researches and develops biopharmaceutical products based on thier patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Vical’s stock shot up 20 percent on the news that their swine flu jab sailed through an animal study with positive results. Vical’s H1N1 vaccine is now ready for a human study — marching into the clinic in record time.
Financial analysts are noticing uptick for successful H1N1 Vaccine manufactures
Reni Benjamin, analyst with Rodman & Renshaw (a leading investment banking firm to the capital intensive biotechnology sector, that includes specialty pharmaceutical, medical device and other life science companies) noted speed of the H1N1 vaccine’s development. Vical received a sample of swine flu from the Centers for Disease Control and Prevention on April 30, shortly after the H1N1 strain emerged. In a recent report he wrote, “These results provide additional validation for Vical’s technology platform, demonstrating not only efficacy and but also speed in generating a vaccine to an influenza strain that emerged in April 2009.”
All the rabbits and mice injected with the H1N1 vaccine were protected in the preclinical study and three out of four hit a key protection mark after a single dose. Those were the numbers Vical needed to get a human study underway, and the company says it’s ready to start large scale manufacturing needed to produce a vaccine for clinical trials.
Researchers at vaccine developers have been racing to get a new flu vaccine ready for mass production in anticipation that the worldwide demand for a new H1N1vaccin is likely to be overwhelming. Vical is only one of many vaccine manufactures racing to cash in on the World Health Organization declared Swine Flu Pandemic. Protected from adverse reaction liabilities by the mandated H1N1 influenza immunization policies of WHO and participating country’s various public health organizations, the ailing balance sheets of Big Pharma’s walking wounded are in for a big shot in the arm. (pun totally intended.) This vaccine is on a fast track production schedule, where speed can compromise safety, in a liability-free zone. Financial analysts breathlessly report that it only took Vical two months to take a swine flu sample and jump ahead to a clinical trial. This may be great for the stockholder, but is it really good news for the folks who may be forced to line up for a mandatory injection that flew from the butt of a mouse to our shoulder in few months of intense trial, and perhaps error.
Does anyone else remember that the last time we all ran around with our hair on fire about an impending influenza pandemic?
The year was1976. 19-year-old Army Pvt. David Lewis of Ashley Falls, Mass. sudden death was attributed to Swine Flu. The same Swine flu that took over 500,000 American lives immediately after World War 1. The label, Swine Flu, was certainly enough to cause public concern. It took the Ford administration to turn that concern into a full fledged panic.
The CDC’s reaction and mass inoculation program it developed and administered would become known to some medical historians as a fiasco and to others as perhaps the finest hour of America’s public health bureaucracy. The swine flu case of 1976 forever reduced confidence in public health pronouncements from the government and helped foster cynicism about federal policy makers that continues to this day.
Only young Lewis died from the swine flu itself in 1976. But as the critics are quick to point out, hundreds of Americans were killed or seriously injured by the inoculation the government gave them to stave off the virus.
If you wish to glimpse the future simply review the past, read:
The Epidemic That Never Was: Policy-making and the swine flu scare by Richard E Neustadt;
and watch the decision processes of those public health officials and regulators who have forgotten or ignored the lessons of history.
Vical researches and develops biopharmaceutical products based on our patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases.
Vical’s proprietary Vaxfectin® adjuvant has demonstrated safety and effectiveness in a number of animal models. In July 2008, we announced preliminary clinical trial data demonstrating that Vaxfectin®-formulated DNA vaccines can safely achieve significant immune responses against H5N1 pandemic influenza in humans. References to published data are included in the Vaxfectin® Publications page.