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ACCV/DVIC Report - Dr. Geoffrey Evans
Dr. Evans noted that he had new and improved post-1988 monthly statistical (stat) reports. The monthly stat sheets would focus only on the post-1988 period for vaccines given after the program became operational in October 1988. The pre-1988 program was for anything before this and all claims have been adjudicated. The final payout for the pre-1988 program was $900 million. He noted that with all of that out of the way, what remains is the thimerosal/autism/MMR vaccine aspect of the litigation, which is now part of the program and categorized as autism thimerosal or non-autism thimerosal.
Most of the activity is now with autism litigation and this is something that has been ongoing since 2002. There are currently all kinds of discovery proceedings going on and information specifically from CDC and FDA has been gathered. A hearing date will hopefully by set in 2005 that will address the merits of causation, and this would just be for autism, not for developmental disabilities or other kinds of neurological disorders; it will be for MMR and thimerosal allegations, and the target illness will be autism. They will hopefully have a result from these proceedings within the next year and a half that will be applied to the more than 4,300 clients.
Dr. Evans then discussed adjudication and noted that 100 claims were dismissed. As reported last time, he was aware of about a couple dozen cases where the petitioners opted to leave and go into the tort system. Some may have left for other reasons, such as legal insufficiency. Several dozen have declared that they have gone on to exercise their right to go into the tort system, which they can do within 240 days. The post program has paid out over $600 million, most of which has been for petitioners’ awards, and all together, over 1,800 families have received compensation.
In June, ACCV has unanimously voted to add influenza vaccine to the program based on the fact that CDC now recommends it for the routine vaccination of children, and there is still discussion on whether there will be an injury or medical condition to go with that.
Excise tax legislation is pending in both houses. A couple of bills were passed that contain excise tax legislation for influenza, trivalent influenza vaccines, as well as hepatitis A vaccine. If they get a bill signed by the President, they will be able to cover influenza vaccine and the effective date of coverage will depend on whatever version of the language is passed.
With respect to the ACCV meeting on November 9-10, 2004, the first day will be the first time the Commission is going to sit in on a workshop put on by the U.S. Court of Federal Claims at their annual judicial conference. The workshop will be on vaccine causation. They will be listening to a vaccine epidemiologist, attorneys, DOJ officials, and the Chief Special Master. They will discuss how they approach the very challenging questions of how they legally make decisions about vaccine causation. They will be meeting for a half-day in Rockville, Maryland on the second day.
VRPBAC/FDA Report - Dr. Gary Overturf
Dr. Overturf noted that at the September 22-23, 2004 VRPBAC meeting, they recommended approval for the Aventis Pasteur meningococcal diphtheria conjugate vaccine, which has the same antigens that as the polysaccharide vaccine. The vaccine was approved only for individuals between 11 to 55 years of age based on data for 7,600 patients; of which, about half received the conjugate vaccine and based on non-inferiority in terms of immunological response.
The vaccine may not have been licensed because there were a number of issues. FDA asked for more information. There was considerable discussion about the need for post-licensure surveillance for adverse events. Furthermore, only a fairly small number of individuals had received the vaccine. A good deal of information is needed on immunological memory and boosting, which raises the issue of the vaccine’s safety and efficacy in boosting, particularly for those who had already received the polysaccharide vaccine. Much information is still not available. There are ongoing pediatric studies, and there is still a need for more pediatric data, minority data, immune deficiency data, and data on other special groups who may need protection from meningococcal disease. There are little or no data on compatibility with other vaccines that adolescents, young adults, or children might receive at the same time. Most of data will be reviewed by FDA staff and will not come back to VRPBAC unless there are specific questions.
Dr. Overturf noted that the second day of the meeting was a presentation of the U.S. Army sponsored HIV vaccine trial. This was a large study with a planned enrollment of 16,000. There has been a great deal of discussion between FDA, the U.S. Army, and the Thai government because this could lead to the possible licensure of the vaccine in Thailand. Because the study was not set up as an efficacy trial, it will not meet any of the requirements for licensure. It has now been changed to a “proof of concept,” the definition of which is currently unclear. It appears that it will evaluate immunological parameters which may yield some clues about the potential efficacy of the vaccine. This was probably not presented initially because it was not a vaccine trial that would lead to efficacy and because it involves another country and FDA has been involved along with the U.S. Army. They felt they needed additional support for opinions they had previously expressed.
NIH Report - Dr. George Curlin
Dr. Curlin commented that influenza will be in the news for some time, but the good news is that it might get people to pay attention to the pandemic influenza planning. The initial media coverage was superb, and the officials did an excellent job stating the case. There has been very responsible reporting of the event thus far. The important message was picked up, and that was the potentially contentious issue of deferring vaccination of healthy people and how physicians or clinics will respond when a healthy person demands the vaccines. He added that the way the story plays out could generate a demand that completely outstrips supply even with the new priorities.
Dr. Curlin referred to a study in 2001 during the last influenza vaccine shortage. The study was put together by the Vaccine Treatment Evaluation Units (VTEUs) and the serology was done by CDC and FDA. The study looked at a half-dose of the recommended vaccine. This was a very robust study in that up to 20 percent reductions were statistically significant, and looking at the reverse cumulative plots, the study will provide on a scientific basis on which a rational decision can be made to offer healthy people a half dose of vaccines as an alternative.
In the conference call with ACIP on the previous day, someone commented that this would require an IND and that the study would have to be repeated with this year’s vaccines. Dr. Curlin noted that some of the target groups are listed as healthy – healthcare personnel, child caregivers, and DoD. About two-thirds of the DoD vaccines were purchased from Chiron.
He made clear that he was not recommending things, but just presenting data. The study was very encouraging, but he was not promoting it.
Dr. Overturf noted that the problem is that without some kind of recommendation, especially with vaccines, physicians and infection control practitioners will be very reluctant to do this because of liability and indemnification issues.
Dr. Curlin agreed and noted that this is only if the issue evolves, they are backed into a corner, and there is a consensus. This would also require the close, enthusiastic participation with Aventis Pasteur.
Dr. Gellin noted that this falls into the theme of looking at every possible avenue to increase supply.
Dr. Helms asked if there was anyone wanted to make public comment. There were no additional public comments.
Dr. Helms adjourned the meeting.
|Food and drug administration national institutes of health advisory Committee on: transmissible spongiform||Veterinary medicine advisory committee|
|Ranch hand advisory committee||Medical Devices Advisory Committee|
|Advisory committee on immunization practices||Wildlife Diversity Policy Advisory Committee|
|External Advisory Committee on Cities and Communities||Peer reviewed by the Arizona Department of Commerce Economic Research Advisory Committee|
|Advisory Committee, Cuyahoga Valley School-to-Career Consortium, Broadview Heights, Ohio 1996-2002||Jane D. Siegel, md; Emily Rhinehart, rn mph cic; Marguerite Jackson, PhD; Linda Chiarello, rn ms; the Healthcare Infection Control Practices Advisory Committee|