A single line often inverts meaning once you see what it
answers, so neighbouring messages are always shown.
-
September 27, 2002 NOTE TO CAROL KUNTZ From: Anthony S. Fauci, M.D. Director National Institute of Allergy and Infectious Diseases National Institutes of Health Carol: As per your request, I will summarize below the information that I discussed with you over the phone and will provide as attachments (1 through 5) some data sheets: 1) The question arises whether the rate of serious complications due to primary vaccinia vaccination is greater in children versus adults and whether, because children will be obviously excluded from the cohort of health worker and first responder vaccinees, this will result in a lower than anticipated rate of complications for the first 2 stages of the vaccine program, i.e. up to 10,000,000 people. My reference is Lane JM et al: Complications of smallpox vaccination, 1968. National surveillance in the United States. N Engl J Med 281:1201, 1969. I worked from Table 1 of the paper (attachment #1) and analyzed the "Primary vaccinations". I divided the cohort into 2 groups of <1 yr to 9 yrs old and 10 through 20+ yrs old in order to compare the actual rate per million complications in each group. I found the following: There were 4,900,000 individuals in the <1 to 9 yr olds and 694,000 individuals in the 10 to 20+ yr olds. The rate of complications in the 2 groups were as follows: <1 - 9 y.o. 10 - 20+ y.o. per million Postvaccinial encephalitis 3 1 Vaccinia necrosum 0.4 4.0 Eczema vaccinatum 10 14 Generalized vaccinia 22 26 Accidental inoculation 26 10 Deaths 1 1.44 Therefore, one can conclude from this analysis that the younger group has a higher incidence of encephalitis, but the older group is similar, if not slightly worse off, when compared to the younger group with regard to the other complications of primary vaccination. HOWEVER, the critical issue as I see it is the major difference between previously unvaccinated and previously vaccinated individuals with regard to the frequency of vaccine-related complications. Whether you look at the figures from the 1969 paper referred to above (attachment #2) or the 2001 MMWR (attachment #3), the rate of complications in the previously unvaccinated group is considerably higher than that in the previously vaccinated group. For example, in the Table 6 of the 1969 New England Journal of Medicine paper (attachment #2), the complications per million are as follows comparing previously unvaccinated versus previously vaccinated: Encephalitis - 2.9 versus 0; vaccinia necrosum - 0.9 versus 0.7; eczema vaccinatum 10.4 versus 0.9; generalized vaccinia - 23.4 versus 1.2. The differences are even more impressive in the Table from the 2001 MMWR (attachment #3) 2) Since the differences are so striking between previously unvaccinated and previously vaccinated individuals with regard to the incidence of serious adverse events associated with smallpox vaccination, I calculated the percent of people in the work force that we could predict would be previously vaccinated or not. I used the most recent US Census (2000) (attachment #4). I consider the work force to be individuals from 20 through 64 years old (this corresponded to natural breaks in the census data). In 2000, there were 281,421,906 people in the USA. I found that there were 59 million people or 21% of the total population and 36% of the work force between the ages of 20 and 34 years. These people will have not been previously vaccinated. Routine vaccinations stopped in 1972 and most children would not have been vaccinated before age 5 and so 34 years old is the cut off point. I further found that 107 million people between the ages of 35 and 64, i.e. 38% of the population and 64% of the work force were likely vaccinated. Thus, 64% of the people that we would be vaccinating in the first responder/health care worker category would fall into a group that historically has a much lower rate of serious adverse events than the previously unvaccinated group. I believe that this must at least be taken into consideration in our policy decisions. 3) You asked a question about residual immunity in people vaccinated decades ago. If you look at laboratory immunity (i.e. antibody levels and cell-mediated immune function), there is no question that the vast majority of studies indicate that there are variable levels of residual laboratory immunity in people who were immunized even decades ago. The question remains whether the laboratory immunity is totally reflective and correlated with clinical immunity to an actual exposure. There are several studies that indicate that previous immunization, even decades ago, provides real, but variable, degrees of protection against death (i.e. lower case fatality rates) compared to unimmunized individuals. It is impossible to determine the effect on actual infection without death. Some of these studies such as the 1902-1903 Liverpool outbreak study is partially flawed in that there was some smallpox circulating in the community that might have boosted immunity. However, several studies that are summarized in a paper by Mack TM et al: Smallpox in Europe 1950-1971. J. Infect. Dis. Vol.125, number 2, Feb. 1972 (attachment #5) indicate that case fatality rates are significantly less in individuals vaccinated even more than 2 decades before. I personally do not believe that all of these people were protected because that were intermittently boosted by naturally occurring San smallpox. There just were not that many widespread smallpox outbreaks to boost the population of Europe consistently during that time frame. In fact, from 1950 through 1971, there were only 680 cases of smallpox in the countries in question. Therefore, I would have to conclude (not definitively, but likely) that previously immunized people do have a variable, but significant, degree of residual protective immunity against death from smallpox. I hope that you find this information useful. Please give me a call if you have any questions at (301) 496-2263. Thank you and best regards. Sincerely, Anthony S. Fauci, M.D.
-
Sept. 29, 2002 - Received ICAAC Award and gave the ICAAC Award lecture in San Diego on "Bioterrorism in the spectrum of emerging and re-emerging diseases". Audience was 10,000 people and received rave reviews for the lecture.
-
Sept. 30, 2002 - Got another top secret briefing from the CIA. Apparently Russia is still making genetically modified microbes for offensive use. Also, was briefed on Iraq's capabilities. It is my impression that the CIA information is really very soft. They have sources, but they are difficult to validate.
-
Oct. 4, 2002 - Engaged with Julie Gerberding, Jerry Hauer, Kevin Keane in a briefing of State and local Public Health officials on the likely roll out plan of smallpox vaccination in3 stages (500,000 smallpox response teams and emergency personnel, then 10,000,000 health care workers, primary care people, police and fireman, etc. followed by making vaccine available to general public after the Acambis product is licensed in early 2004. This was followed by a press conference, which did not go well since Jerry Hauer said that we were not going to make any "announcements". Note that there have been many leaks about the 3 stage plan and the press was clearly annoyed that the press conference started with a statement that we were not going to tell them anything important. However, Julie proceeded to get up and say that we recommended the above plan. She left the stage for a few minutes and I corrected her (politely) by saying that we are not "recommending" anything, we are merely giving a likely option. The Secretary recommends something to the President and that is confidential. The reason for this is that we do not want to put the President in the position of possibly going against his top health advisors, i.e. boxing in the President. Julie returned and confirmed my correction. The press rightfully thought that we were sloppy (not me, but DHHS). We called the main players - Larry Altman, Laura Mackler of AP, Ceci Connolly of Washington Post and Sheryl Stolberg of NY Times to clarify the situation. All of this is happening because the WH is taking so long to come out with a policy and we are compromised because if we do not say that we favor a certain plan, then it looks like we do not know what we are doing. How can we not favor a certain plan if we have been working on this problem for months???
-
2002-10-08 00:00
Anthony S. Fauci
Oct. 8 - 22, 2002 - Washington, D.C. area being terrorized by a sniper who has already shot 12 people and killed 9.
-
Oct. 10, 2002 - Had 2 important meetings at the White House today: First - meeting with Gary Edson, Jay Lefkowitz and Robin Cleveland about the comprehensive AIDS implementation plan for prevention, treatment, and care for developing nations for possible consideration by the President. This was in response to a call from Jay about 1 week ago asking to spread out the plan from 5 years to 7 years and to calculate how much money would be spent for each prevention intervention, i.e. condom distribution versus sex worker education versus needle exchange versus family counseling. The point is that they feel that the request might be too much for the 5 years (Total = $9.987 billion over 5 years, including up to $1.0 billion for the Global Fund). They want us to spread it out so that the early years will be less. Also, they want us to assume that countries other than Russia, China, and India (which will contribute 50%) would be contributing some proportion. We figured Botswana and South Africa could contribute 30% each Namibia and Guyana 20% and Uganda 10%. Furthermore, they anticipate that the President is going to ask just what the money is going for and if it is for Condoms, sex workers and IV drug users, he should at least know that. Obviously, the right wing in the WH would be against this. We crunched the number and I presented this. Right off Robin mentioned that Jim Capretta (OMB PAD) had mentioned to Mitch Daniels that something was cooking vis-à-vis international AIDS and that this would require new money. Mitch immediately said no chance and that no matter what we give, we will be criticized. Robin then left for another meeting. I suggested to Jay and Gary that another alternative would be to do this through the Global fund with the stipulation that they work from our plan with suggestions from them. My reason was as follows. The WHO group just met in Geneva with Bernard Schwartlander to try to galvanize a plan and support for a global program. Mark Dybul went to that meeting. It appears that they will ask for a 3 year plan to treat 3 million people at a cost of $10-15 billion with $4.6 billion from USA. They want to announce this on World AIDS Day (Dec. 1). This could pre-empt the President. In other words, we will be pressured to give $4.6 billion to do someone else's plan. This would be less that our 5 year and 7 year plan. Why not announce that we will give $4.6 million to the global fund if they coordinate their activities through our plan? The President could announce this and get credit for leadership as well as for contributing to the Global AIDS Fund. Also, it would avoid the impression that we Americans are going off on our own. Gary and Jay liked the plan very much and asked me to put together a 3-pager for Josh Bolten. They made me swear to tell no one about this, not even Mark, Terrell or TGT. I finally convinced them that I really needed to tell Mark since he is necessary to put these things together. I am very uncomfortable about not telling Terrell. Second meeting was a briefing of Vice President Cheney's Staff on the NIAID efforts on biodefense, i.e. what is our "vision" for spending the $1.75 billion as well as our longterm vision. At the meeting were Carol Kuntz, Seth Carus and Noreen Hynes (all from Cheney's senior staff) and Jerry Hauer (from the DHHS). The meeting went extremely well. I wowed them with a passionately delivered presentation. I told them that we at NIAID could transform the way the country deals with bioterrorism threat from a 1 document (see yer who has already research and public health standpoint. They loved it and asked what powers I needed that I do not have to execute this. I mentioned that we should have a fund to purchase vaccines and drugs so that the pharmaceutical industry would have an incentive to get involved. Also, I said the FDA needed to be more flexible.
-
Oct. 17, 2002 - Sent down the 3-pager that Jay and Gary wanted (see above). It calls for the USG taking the lead and committing a considerable amount of money THROUGH the Global Trust Fund, but under the stipulation that other countries join us and implement our plan. The plan would cost approximately $18.8 billion of new money over 5 years. In the covering memo to Jay and Gary, I mentioned that I was uncomfortable about not telling Terrell what we are doing since I am supposed to me representing her and TGT at these meetings. Of note, Gary and Jay usually respond almost immediately to me when I send material such as this. However, over the subsequent 2 days (Oct 18,19), I have heard nothing from them. I suspect that they are put aback by my mentioned my discomfort about not telling Terrell about this. We shall see what happens. Also, received a call from Stewart Simonson who said that Vice-President Cheney wants a meeting with me about my Biodefence Research Vision on Wednesday, Oct . 23. The White House has set up the meeting.
-
Oct. 20, 2002 - Gary Edson contacted me and likes very much the revised document (see above). We are closing in on it and he will soon show it to Josh Bolten.
-
Oct. 22, 2002 - Had a terrific visit and briefing of Vice President Cheney in the West Wing of the WH. Present were the VP, "Scooter" Libby, Carol Kuntz, Noreen Hynes, Seth Carus, (Gen.) Phil Russell, and Stewart Simonson. I went over our NIAID Research Agenda and Strategic plan for biodefense. As I did in my briefing of Carol Kuntz (see above), I stressed that we can and will do the job. I stressed that we needed help in getting greater regulatory flexibility, having the power to sole source contracts, and we need to provide major incentives for industry. We must work more closely with industry the same way that the automobile industry made our planes and tanks during World War II. It was a very easy and enjoyable interaction with the VP. Of note, when we discussed briefly the policy for smallpox vaccination, it was clear that Libby is the driving force for mass vaccination sooner rather than later. The VP seemed rather measured on the subject. On the way out of the WH, I ran into Gary Edson in Josh Bolten's office (Josh's assistant had seen me walking by and asked me to come in to say hello to Josh). Josh and Gary were actually working on the plan that Mark and I had just sent to them. They like it very much and I think that something is going to happen with it.