3 June 2008
New Delhi, India
By Kounteya Sinha
May Stockpile On Vaccine To Counter The Biological Weapon
The drug controller general has allowed a pharmaceutical company to import the only US FDA licensed human anthrax vaccine into the country for testing before it can be available in the country.
Around 20 vials of the vaccine BioThrax has just reached the Central Drug Laboratory (Kasauli) which will test the vaccine’s potency and sterility. Each vial contains 10 doses of the vaccine.
Joseph Chettiar of the Hyderabad–based distribution partner for the original makers of Biothrax, says only after CDL gives its final report on the vaccine will the DCGI decide whether to allow the company to import the vaccine for potential buyers like the defence ministry.
A Union health ministry official told TOI, “India needs to be prepared against a bio–terrorist attack”. That’s why we are looking at allowing the company to import Biothrax only for limited use, like for the military and not for general civilians. CDL will first look at the protocol, its manufacturing quality control and test the vaccine’s potency and sterility on animals before DCGI gives final marketing authorisation.
Chettiar said, “Several countries in South–East Asia, US and Europe have started stockpiling Biothrax. It is essential for their bio–terrorism preparedness, especially for its first responders like the military. The vaccine won’t be used on humans at CDL which will only look at the quality control parameters and its pharmaceutical components.”
Anthrax has been used as a biological weapon in the United States in 2001. It was deliberately spread through the postal system by sending letters with powder containing anthrax. This caused 22 positive cases of inhalation anthrax infection, half of whom died.
The Centers for Disease Control and Prevention (CDC), Atlanta, classifies agents with recognised bio–terrorism potential into three priority areas – ‘A’, ‘B’ and ‘C’. Anthrax is classified in category ‘A’ – agents that pose the greatest possible threat for a bad effect on public health having the capability to spread across a large area.
Even though Biothrax is known to be highly protective against anthrax, its vaccine schedule involves a cumbersome six–dose injection regimen over a period of 18 months to induce a protective immune system response. This has to be then followed by annual booster doses.
“The vaccine can’t be injected to all civilians, but only to the first responders to reach the spot of attack – like the military and laboratory workers who may enter or re–enter contaminated areas. Countries are now preparing such battalions and vaccinating them in advance so that they develop complete immunity against anthrax before such an attack occurs. Inhalation anthrax is the most lethal form with fatality rates reaching up to 90 per cent,” Chettiar added.
Because of their small size, anthrax spores can be easily aerosolized and enter through the lower respiratory mucosa in humans. Therefore, experts say, aerosolized anthrax spores are the form most likely to be used in an anthrax bio–terrorism attack. BioThrax works by stimulating the immune system to produce protective antibodies against protective antigen, thereby neutralising the toxins produced by the bacteria, Bacillus anthracis.
The vaccine does not contain the bacteria but the protective antigen protein. Since 2006, over 6.3 million doses of BioThrax have been administered to over 1.6 million people.