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Officials are taking another look at the controversial anthrax vaccine, Betty Ann Bowser reports.
BETTY ANN BOWSER:
The rash of anthrax scares and deaths have prompted health officials to recommend that lab workers and others at risk of exposure to anthrax be inoculated against the deadly disease. Dr. Anthony Fauci of the National Institutes of Health explained the reasoning behind that.
DR. ANTHONY FAUCI:
That in fact is classical public health strategy, when you have a vaccine for a particular disease and you're going to have health care people, laboratory people, or even people like firemen or others who are going to go into a potential disaster zone, that those are the individuals that you want to be protected because of the repeated exposure that they might have.
There have also been suggestions that some members of the general public be given the shots. All this has reopened an old controversy. In 1998, the Pentagon announced it would protect all 2.5 million of its men and women against anthrax by giving them the series of six shots. Then Defense Secretary William Cohen had his picture taken to send a symbolic message that the vaccine was safe. But almost from the beginning the program ran into trouble. Hundreds of military personnel all over the country said the shots made them sick; they complained of a variety of symptoms. Many describe problems later diagnosed as auto immune in nature, similar to what's now known as Gulf War Syndrome.
Robin Groll was in the Michigan National Guard.
I had tremors on the right side of my body that remained consistent every day for three months. They still come and go, the joint aches.
Some military personnel went before Congress to tell their stories.
Swelling on my hands and feet, dizziness, memory loss, sleep disorders, one blackout, night sweats, chest pains.
But the Pentagon repeatedly defended the vaccine, and said only a handful of people had suffered adverse reactions.
It works, we know it works.
Lt. General Ronald Blanck was surgeon general of the army two years ago at the height of the controversy.
LT. GENERAL RONALD BLANCK:
In the over 340,000 individuals who have received this immunization we have had reported to us– and we require this reporting — 72 cases of significant reactions and side effects which is a very, very small reaction. Nonetheless, we look very carefully at each and every one.
Still, the perception that the vaccine wasn't safe persisted. Hundreds of pilots in Air and National Guard units around the country refused to take the shots. For some, like Major Tom Rempfer, a pilot with the Connecticut National Guard, that refusal meant the end of a military career.
Eight of us went on the record in Congressional hearings saying it was exclusively because of the anthrax policy and if it weren't for that policy, we'd all still be flying today.
Last year, a Congressional subcommittee recommended the Pentagon's vaccination program be halted, saying there were too many unanswered questions about it. And just last month, the Government Accounting Office said in a report to Congress that the process for manufacturing the vaccine was altered in 1990, a change that increased the potency of some batches by as much as 100 percent. This has led to speculation by opponents of the Pentagon's vaccine program that some of the doses given the military weren't safe, and might be a reason some people got sick. There have also been questions about the only company licensed to make the vaccine, Bioport of Lansing, Michigan. Bioport was closed for renovation in 1998. Since then, the Food & Drug Administration has twice found numerous flaws in quality control and sterility. But in a Senate subcommittee hearing held after September 11, Bioport President Robert Kramer said the company's problems have been fixed.
We completed the renovation process, resumed production in May of 1999, and submitted our biologics license application supplement to the FDA The FDA subsequently conducted a pre-approval inspection, and identified more work in order to get the facility approved. We submitted our amended biologics license application supplement to the FDA on Friday, October the 12th of this year, and are confident that this submission, the culmination of 20 months worth of work, satisfies all FDA requirements and will allow the agency to complete its comprehensive review and approval process.
Secretary of Defense Donald Rumsfeld said he was hopeful the vaccine program could be salvaged.
We're going to try to save it, and try to fashion some sort of an arrangement whereby we give one more crack at getting the job done with that outfit. It's the only outfit in this country that has anything under way, and it's not very well under way, as you point out.
If Bioport passes an FDA inspection, it could resume manufacturing immediately. Bioport currently has a stockpile of about five million doses, which may be used if questions about potency and sterility can be resolved. But Congressman Christopher Shays, a Connecticut Republican who led a series of hearings on the Pentagon's program, isn't convinced the vaccine's safe for the military or for civilian use.
REP. CHRISTOPHER SHAYS:
My concern is that because of the crisis we find ourselves in, there's going to be a lot of compromising. First off you basically have about five million vaccines in the possession of Bioport. About three million are the old vaccines that were made before they renovated their plant. Some of those three million don't have the potency they should have and some of them simply aren't clean, they're just not pure enough. There's questions about the safety of some of those vaccines. Then you have about two million new batches. It's still old technology, but they're new batches. And, you know, FDA in the past has simply said to us that this isn't ready for general public use.
Ultimately if civilians are going to need protection against anthrax, the answer may be found in a new vaccine. Dr. Fauci thinks the events of September 11 will speed that process.
In usual times, that is a process that takes years and years. It likely will take more than a year, or maybe two now, but I can tell you the amount of time that it's going to take given the urgency of the situation to translate from an observation that's basic science to a usable product, if you were, is going to be markedly truncated because of the urgency of the situation.
Fauci said a new vaccine would clear up all the nagging questions about the old vaccine's safety. Meanwhile, because of Bioport's problems, there isn't enough vaccine in the Pentagon's stockpile to continue a mass inoculation program. So the plan to vaccinate U.S. forces has been scaled back dramatically.
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