I was of the opinion that was required for Approval, but that H.S. could act on their own, which they infer in their releases.
I wonder how such a safety trial is run. I would believe the researchers working on the development of the vaccine on Plum Island would have already done safety and efficacy trials to the extent it can be tested. I don't know if they actually give the vaccine then attempt to infect the animals, or not. I know one of the reasons for isolating the research is to prevent disease spread, but not they're giving up keeping it offshore on an Island. I hope they know what they're doing. If I'm not mistaken, outbreaks in England can be directly attributed to Merial (sp) mistakes.
One question it would be interesting to hear peoples answer on is, if H.S. does order for a strategic reserve, how much would they be expected to order for each strain of FMD. I really have no idea if the intent would be to have millions of doses, so that massive innoculations can be given in the event of an outbreak, or mearly tens or hundreds of thousands to try to prevent the spread and protect the area around where a case is found.
I believe we'll learn more by November, whether there's a buy or not.
I do know that DOD has internal approval for drugs that our soldiers get. If the Navy contract for the Malaria Vaccines is determined to be effective, the DOD can order vaccine and either use it, or stockpile it for use if soldiers are going into places where those specific types of malaria are found.
Hopefully further trials, previously announced, will result in FDA approval, but that could take years longer than a DOD decision to order the Vaccines.
I once worked with a Navy Commander who was having some medical problems. He was totally being stonewalled in trying to find out what experimental drugs he was given just after being recruited. His Drs. were concerned that his problems 20 years later may have been caused by one or more of these drugs, but they couldn't get the records. We frankly shouldn't treat our soldiers this way, while this incident occurred over 10 years ago, I don't know that anything's changed, or if he ever got the information.
Gary
Gary
News 
Market Data 
Discover 
