A QUANTUM OF SCIENCE
Making vaccines both optimally effective and optimally safe may be an easier task in the near future
Vaccines have an overwhelming track record when it comes to preventing illness, and thanks in part to conservative rules put in place by the federal agencies regulating them vaccines have also been extremely safe. Still, there’s an unadvertised trade-off in that compromise: vaccines would be even more effective than they are today if they could be made with heat-inactivated pathogens rather than highly purified microbial proteins generated in non-toxic bacteria, but that elevates the risk of possible immune reactions and side effects in those who take the vaccine.
To help improve the effectiveness of vaccines even when not using the heat-inactivated pathogens, scientists have long used compounds known as adjuvants to "boost" the body’s immune response. In essence, adjuvants are sensitizers that tell the body to be ready for an invader; when given as part of a vaccination, adjuvants significantly increase the vaccine’s protective effects both in duration and potency. But the only adjuvant ever approved for use in humans, aluminum hydroxide (or alum), is far from the most effective compound for the job. To date the FDA has been extremely reluctant to approve other, more powerful adjuvants for use with vaccines because of concerns about toxicity and possible side-effects.
Now scientists at Oregon State University have developed an adjuvant based on lecithin, a common food product, that shows six-fold greater immune response when administered as part of a vaccine as compared to alum-based treatments. Lecithin is part of a category of food products termed "generally recognized as safe" by the FDA, meaning that it is non-toxic in almost any dosage. This could mean a fast track to approval and, very possibly, vaccines that would be more effective, for longer periods of time, with smaller doses and fewer injections.
For more information:
New adjuvant could hold future of vaccine development
Adjuvant (Wikipedia article)
Strong antibody responses induced by protein antigens conjugated onto the surface of lecithin-based nanoparticles (Sloat et al)
© AQOS / P. Smalley (2009)
Reproduction with attribution is appreciation
Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts
Tuesday, September 15, 2009
Wednesday, July 8, 2009
Food Safety Overhaul: Chickens and Eggs
A QUANTUM OF SCIENCE
Sweeping and ambitious, administration regulations would enact mandatory oversight and tracking of critical foods
Today the Obama administration announced a major overhaul of the US food safety system. Overseen almost entirely by the FDA, some 150,000 individual commercial food producers would be subject to sweeping new regulations that would require traceability for all food and food additives sold in the US. This is a significant increase in the level of government oversight of the food industry and is a response to several high-profile outbreaks of food poisoning in the last several years. These include recent E. coli and Salmonella outbreaks leading to the recall of tremendous amounts of food throughout the US. Notably, Salmonella in peanut products and E. coli in ground beef both originated in US commercial food manufacturers as a result of poor hygiene and lack of mandatory safety regulations. Worse still, it took unconscionably long for the FDA to track down exactly where the problem started, leading to a much larger outbreak than necessary.
To prevent this from happening again, the new legislation calls for a Reportable Food Registry to be established and overseen by the FDA. This registry would ensure that any outbreak of food poisoning or adulterated food would be instantly reported to the FDA, which would then be able to use the registry to track down where the adulterated food came from, what other foods it might have come in contact with or been used in, and what distributors to alert. Not only would this increase the response time of the FDA, it would also allow traceability for the agency such that random testing of large numbers of those 150,000 individual commercial food manufacturers would not be required. If a tomato in Denver turned up positive for Salmonella, FDA scientists could quickly determine that it came from a wholesaler in Texas who purchased it from a grower in Louisiana. From there, all tomatoes that came from that grower or that passed through that wholesaler would be identified and the distributors notified to pull the tomatoes off their shelves.
This is a massive undertaking but a significant benefit to the food safety network in the US. Previously it might have taken FDA scientists weeks to trace a single infected tomato back to that grower in Louisiana, and in that time panicked distributors might destroy untold volumes of perfectly safe tomatoes, costing the food industry huge amounts of money. With the Registry, that process might take less than 48 hours, and the cost savings to distributors and wholesalers is the reason that the food industry generally supports this legislation.
One particular area of concern for the Obama administration is eggs – specifically, chickens, eggs, and Salmonella. It has been known for twenty years that infected chicks produce Salmonella-laden eggs that cannot be detected easily by the current food safety inspection systems in place. The new legislation mandates that egg growers take steps to eliminate rodents (a prime source of Salmonella contamination) and only purchase chicks from growers who also take steps to monitor Salmonella among their stock. Additional regulations require refrigeration during more of the lifespan of an egg, something that about half of all egg producers already do voluntarily and which would reduce the potential for Salmonella growth. As mentioned above, egg growers are generally in favor of these regulations – even though it will cost them some money for testing and prevention, they believe the increase in public confidence will more than make up for the estimated one-cent per dozen increase in the cost of eggs.
They’re almost certainly right. In this case, it doesn’t matter whether the chicken or the egg came first, so long as both of them come before the Salmonella.
For more information:
FDA Reportable Food Registry
Article from The Washington Post on the new legislation
New York Times article focusing on egg safety regulations
© A Quantum of Science / P. Smalley
Reproduction with attribution is appreciation
Sweeping and ambitious, administration regulations would enact mandatory oversight and tracking of critical foods
Today the Obama administration announced a major overhaul of the US food safety system. Overseen almost entirely by the FDA, some 150,000 individual commercial food producers would be subject to sweeping new regulations that would require traceability for all food and food additives sold in the US. This is a significant increase in the level of government oversight of the food industry and is a response to several high-profile outbreaks of food poisoning in the last several years. These include recent E. coli and Salmonella outbreaks leading to the recall of tremendous amounts of food throughout the US. Notably, Salmonella in peanut products and E. coli in ground beef both originated in US commercial food manufacturers as a result of poor hygiene and lack of mandatory safety regulations. Worse still, it took unconscionably long for the FDA to track down exactly where the problem started, leading to a much larger outbreak than necessary.
To prevent this from happening again, the new legislation calls for a Reportable Food Registry to be established and overseen by the FDA. This registry would ensure that any outbreak of food poisoning or adulterated food would be instantly reported to the FDA, which would then be able to use the registry to track down where the adulterated food came from, what other foods it might have come in contact with or been used in, and what distributors to alert. Not only would this increase the response time of the FDA, it would also allow traceability for the agency such that random testing of large numbers of those 150,000 individual commercial food manufacturers would not be required. If a tomato in Denver turned up positive for Salmonella, FDA scientists could quickly determine that it came from a wholesaler in Texas who purchased it from a grower in Louisiana. From there, all tomatoes that came from that grower or that passed through that wholesaler would be identified and the distributors notified to pull the tomatoes off their shelves.
This is a massive undertaking but a significant benefit to the food safety network in the US. Previously it might have taken FDA scientists weeks to trace a single infected tomato back to that grower in Louisiana, and in that time panicked distributors might destroy untold volumes of perfectly safe tomatoes, costing the food industry huge amounts of money. With the Registry, that process might take less than 48 hours, and the cost savings to distributors and wholesalers is the reason that the food industry generally supports this legislation.
One particular area of concern for the Obama administration is eggs – specifically, chickens, eggs, and Salmonella. It has been known for twenty years that infected chicks produce Salmonella-laden eggs that cannot be detected easily by the current food safety inspection systems in place. The new legislation mandates that egg growers take steps to eliminate rodents (a prime source of Salmonella contamination) and only purchase chicks from growers who also take steps to monitor Salmonella among their stock. Additional regulations require refrigeration during more of the lifespan of an egg, something that about half of all egg producers already do voluntarily and which would reduce the potential for Salmonella growth. As mentioned above, egg growers are generally in favor of these regulations – even though it will cost them some money for testing and prevention, they believe the increase in public confidence will more than make up for the estimated one-cent per dozen increase in the cost of eggs.
They’re almost certainly right. In this case, it doesn’t matter whether the chicken or the egg came first, so long as both of them come before the Salmonella.
For more information:
FDA Reportable Food Registry
Article from The Washington Post on the new legislation
New York Times article focusing on egg safety regulations
© A Quantum of Science / P. Smalley
Reproduction with attribution is appreciation
Subscribe to:
Posts (Atom)
