Yesterday Reuters reported US Merck and Co have taken the very unusual step of discontinuing vaccine trials for Intercell’s MRSA vaccine. The decision was taken after experts advised the V710 vaccine was ‘unlikely to show a significant clinical benefit and expressed concerns about overall mortality and multi-organ dysfunction.’
The vaccine was set to have potential sales of more than $1.47 billion because it was to be a multi-flexible vaccine which could have been used for patients on admission to hospital, during surgery and in care homes for the elderly.
Reuters reported in a press release today:
“Merck is due to present the final detailed findings of the clinical trial at an upcoming medical meeting, the two groups said in a statement.
“This is a significant setback for Intercell, and was the most eagerly anticipated stock catalyst, with V710 seen as potential validation of the company’s technology,” analysts at Jefferies said in a note.”
To read the article http://www.reuters.com/article/2011/06/08/us-intercell-merck-idUSTRE75711P20110608
MRSA, which stands for methicillin-resistant Staphylococcus aureus, is a type of infectious bacterium resistant to the antibiotic methicillin and other related antibiotics of the penicillin class. MRSA infections can be very serious and lead to death although some patients have MRSA on their skin or nose without it doing them any harm.
The numbers of deaths from MRSA, often called the ‘super bug’ have been soaring around the world for many years. In February 2011, CareMans Weblog reported that there were more deaths in the USA in 2005 from MRSA than from HIV Aids and said:
“The JAMA study noted that nearly 95,000 people contracted serious MRSA infections in the U.S. in 2005. The 18,650 MRSA deaths that year would account for almost 20% of that number. “
According to the blog numbers have been slowly continuing to rise ever since. http://careman.wordpress.com/2011/02/03/death-by-mrsa/
Since Merck’s decision to halt the trial, shares in Intercell have plummeted and they have reported that his will lead to significant job losses. A report from Pharma Times released four hours ago said:
“The US major says that in April the independent data monitoring committee looking at the study said it had not met formal futility criteria and recommended that enrollment in the trial be suspended pending completion by Merck of additional analyses on the benefits and risks of vaccination. That review suggests V710 is unlikely to demonstrate a statistically significant clinical benefit, plus there were safety concerns regarding overall mortality and multi-organ dysfunction that occurred with greater frequency in vaccine recipients, compared with placebo.” [CE emphasis]
It would be interesting to know what happened in the trials because it had been reported that Intercell and Merck had already halted patient enrollment in the clinical trial of the vaccine. This decision fell on the heels of a recommendation from the study’s independent data monitoring committee.
Despite MRSA being a very serious disease do we need a vaccine to cure it? I remember a time when this so called ‘superbug’ was virtually unheard of. Of course, this was back in the time of a matron on every ward keeping everything in order. What the pharmaceuticals companies are forgetting it that MRSA is completely avoidable illness. By having clean hygienic wards, with nurses washing their hands after treating each patient and better training on cross infection control it could be almost completely eradicated.
Reading between the lines, it looks as if the MRSA vaccine trials may have led to the early death of more ‘willing volunteers’ than it saved. This was yet another vaccine manufactured for a completely preventable disease.