Vaccines

In other words, if a vial of measles vaccine contains 10 child doses, if should be vaccum sealed to a slab of cardboard on which are 10 autodestruct syringes.

Diary Prequel Package, p.18 · original PDF · in context

The reasons were not so much about the likelihood the vaccines would work (nobody thought they would), but concerns that people who received the vaccines would then put themselves and their partners at higher risk, based on the assumption that they were at least somewhat protected.

Diary Prequel Package, p.18 · original PDF · in context

NIH and CDC have spent loads of money trying to figure out how to counsel vaccine volunteers, what to say about safe sex, etc.

Diary Prequel Package, p.18 · original PDF · in context

It has been an ENORMOUS concern in the vaccine arena --- well in advance of actually having a product worth testing.

Diary Prequel Package, p.18 · original PDF · in context

People at the DHHS meetings include Stewart Simonson (Chief of Staff to Claude Allan), Scott Lillibridge, Claude Allan (deputy Secretary), Tom Month of Acambis company that is making smallpox vaccine, D.A.

Diary Prequel Package, p.33 · original PDF · in context

We discussed and provided 'White Papers" a) to justify our not agreeing to the renewal of the 1992 Bioweapons Convention because it is un enforcible and would also hinder our legitimate scientists workiing on biomedical research on these organisms. b) justification for not destroying the smallpox stores since we need them to do research to counter effects of a smallpox terrorism attack with diagnostics, vaccines, and therapy.c) Short and long range plans for countering an immediate or distant bioterrorism attack.

Diary Prequel Package, p.33 · original PDF · in context

I will prepare a vaccine report for anthrax similar to the one that I prepared for smallpox (see above).

Diary Prequel Package, p.36 · original PDF · in context

Dec. 16-19, 2001 - Much controversy and last minute scrambling in getting the consent form and the protocol out for the discretionary use of anthrax vaccine in exposed people who had been receiving antibiotics, but who are coming off their 60 day course.

Diary Prequel Package, p.41 · original PDF · in context

I had been working all day and into the night on Dec.16-19 revising the consent forms and helping people get straight why DHHS is offering the vaccine to people.

Diary Prequel Package, p.41 · original PDF · in context

I have exhaustively reviewed the data (with Cliff Lane as a great help) and come to the conclusion that vaccine + antibiotics is no better than antibiotics alone for post-exposure.

Diary Prequel Package, p.41 · original PDF · in context

John Eisold (the Navy physician who takes care of Capitol Hill people) is insisting that the Senate staffers also get the vaccine.

Diary Prequel Package, p.41 · original PDF · in context

Laura Petrou from Senator Daschle's staff on Dec. 19, 2001 enraged that we were taking so long in getting the vaccine to the staffers.

Diary Prequel Package, p.41 · original PDF · in context

Therefore, we are offering, but not recommending the vaccine for any of the 9000 people who were put on 60 antibiotic course.

Diary Prequel Package, p.41 · original PDF · in context

They completely miss the point that no one really is telling them that they should take the vaccine.

Diary Prequel Package, p.42 · original PDF · in context

In contrast, the staffers from Daschle's office have a high % of people who are taking the vaccine.

Diary Prequel Package, p.42 · original PDF · in context

We have CIA intelligence that Iraq has smallpox and everyone in DHHS and the WH are scrambling to get together an immunization plan that will go well beyond what the ACIP is recommending (i.e. pre-emptively vaccinate only about 10,000 - 20,000 health workers and rely on ring vaccination in the event of an attack).

Diary Prequel Package, p.50 · original PDF · in context

After that and depending on the adverse event rate and the perception of threat, we will make vaccine available for the entire USA population on a voluntary basis.

Diary Prequel Package, p.50 · original PDF · in context

There will be very intense discussions over the next couple of weeks with the WH and DHHS that involve me regarding smallpox vaccine policy.

Diary Prequel Package, p.50 · original PDF · in context

We are advancing towards the 3 stage policy that ultimately would allow voluntary vaccination for anyone who wants it.

Diary Prequel Package, p.53 · original PDF · in context

We reviewed the pre-emptive plan for vaccination that will be presented to Pres.

Diary Prequel Package, p.54 · original PDF · in context

Carol was concerned that she was getting different signals from different people about varying toxicities among children versus adults, primary vaccinees versus re-vaccinees.

Diary Prequel Package, p.54 · original PDF · in context

My reference is Lane JM et al: Complications of smallpox vaccination, 1968.

Diary Prequel Package, p.55 · original PDF · in context

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.

Diary Prequel Package, p.55 · original PDF · in context

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.

Diary Prequel Package, p.55 · original PDF · in context

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.

Diary Prequel Package, p.55 · original PDF · in context

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.

Diary Prequel Package, p.55 · original PDF · in context

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.

Diary Prequel Package, p.59 · original PDF · in context

The Pentagon will imminently announce that 250,000 to 500,000 troops will be vaccination with vaccinia (Dryvax).

Diary Prequel Package, p.60 · original PDF · in context

However, I feel that although we should make available the vaccine for the general public, given that the threat assessment is very soft, we should recommend that they not take the vaccine unless they feel very strongly that they do not want to take any chances.

Diary Prequel Package, p.60 · original PDF · in context

I have convinced them that we should not recommend to the general public that they take the vaccine give the non-quantifiable risk.

Diary Prequel Package, p.62 · original PDF · in context

Rather, we should say that as a group the vaccine should be offered to them, but since this is a heterogenous group, the actual recommendation to take it or not should rely on discussions between the CDC and the State and local public health officials in light of the particular needs and situation within a given jurisdiction.

Diary Prequel Package, p.62 · original PDF · in context

Clearly, the Stage 1 group (500,000 smallpox response teams) should have a recommendation to take the vaccine voluntarily. -ourt

Diary Prequel Package, p.62 · original PDF · in context

Phone call with Jay Lefkowitz and Keith Hennessey and Doug Badger called wanting to know why we needed a vaccine trust fund as opposed to other mechanisms to guarantee purchase of vaccines.

Diary Prequel Package, p.63 · original PDF · in context

At the same time there is a lot of buzz as to when the President is going to announce his vaccine policy.

Diary Prequel Package, p.64 · original PDF · in context

The vaccine policy roll-out is under very close hold at the WH.

Diary Prequel Package, p.64 · original PDF · in context

I insisted that they emphatically emphasize that we do not recommend vaccine to the general public; however, we will make it available to those who feel they still want it even though it is not recommended.

Diary Prequel Package, p.64 · original PDF · in context

Big surprise was that we learned the President would get the vaccine himself since he felt that as Commander-in-Chief of the Armed Forces, he could not order the troops to do something that he himself would not do.

Diary Prequel Package, p.64 · original PDF · in context

Clearly, Scooter Libby and the VP are in favor of pushing for the Vaccine Trust Fund.

Diary Prequel Package, p.66 · original PDF · in context

The OMB had agreed several days ago to creating a "Permanent and Indefinite (first it was definite) appropriations authority to purchase vaccines for BioT for a total of $4.2 billion.

Diary Prequel Package, p.67 · original PDF · in context

Constituencies still upset that NIAID will have to do advanced development and some procurement of rPA anthrax vaccine to the tune of about $250 million even though the Congress removed the $250 million from our budget that OMB put in to do this.

Diary Prequel Package, p.79 · original PDF · in context

Embedded: unnamed Tony: Background on Mark Buller presentation in Geneva re so-called US development of lethal new viruses In 2000, Australian investigators, while pursuing a contraceptive development program for controlling mice, serendipitously discovered that by engineering ectromelia (mousepox) to include mouse IL-4, the new virus was more virulent and could evade normally protective vaccination (Dryvax).

Reading Room Production, p.374 · original PDF · in context

Given that the data were in the public domain and the study design was not optimal from a virologic perspective, it was felt to be both important and appropriate to verify these data and to explore ways to control this new virulent virus, utilizing either a vaccine or a therapeutic.

Reading Room Production, p.374 · original PDF · in context

Tony: « Mark Buller has an animal model contract from us to evaluate vaccine and antiviral candidates.

Reading Room Production, p.368 · original PDF · in context

The contact was let to evaluate vaccine and antiviral candidates.

Reading Room Production, p.364 · original PDF · in context

Nov. 28, 2003 - Significant Influenza A activity already with a variant strain (Fujian) that is not contained in current vaccine.

Diary Prequel Package, p.85 · original PDF · in context

Vaccine has run out and people are panicking. 83 million doses distributed.

Diary Prequel Package, p.88 · original PDF · in context

Gary and I proposed the possibility of highlighting the HIV Vaccine Enterprise that Rick Klausner and I have been working on for the past year.

Diary Prequel Package, p.94 · original PDF · in context

We will work with Gates (Patty Stonesifer) to endorse this, but the Gates Foundation is going to want us to promise even more money for an AIDS vaccine.

Diary Prequel Package, p.95 · original PDF · in context

First regarding the issue of the HIV Vaccine Enterprise and whether we should make this an initiative for the POTUS to present at the upcoming G-8 Summit in Sea Island, GA.

Diary Prequel Package, p.95 · original PDF · in context

May 4, 2004 - White House (West Wing) - Me with Gary Edson and Patti Stonecifer regarding the HIV Vaccine Enterprise and the upcoming G-8 meeting in Sea Island, GA.

Diary Prequel Package, p.99 · original PDF · in context

The USG will not promise an new money over and above the $500+ million that we already spend on HIV vaccine research (this is about 5/6 of the world's total of $640 million).

Diary Prequel Package, p.99 · original PDF · in context

The White House (Gary Edson et al) wants me there to answer press questions regarding the HIV Vaccine Enterprise Proposal that the President will make to the G-8.

Diary Prequel Package, p.99 · original PDF · in context

Purpose was to brief Fran on the experiments that were being proposed regarding genetically engineered monkeypox virus to duplicate what was shown in the mousepox model where inserting the IL-4 gene into mousepox made it lethal and elusive for both vaccine and therapy.

Diary Prequel Package, p.101 · original PDF · in context

We heard about this abruptly this AM as we (Julie gerberding and I) were getting ready to testify at House Hearing on Thimerasol in Influenza vaccines.

Diary Prequel Package, p.107 · original PDF · in context

We further discussed other issues about how we can get more vaccine from AVP or from Canada or from anyone else.

Diary Prequel Package, p.108 · original PDF · in context

President Bush in turn is claiming that liability issues are the cause of Pharma not getting into the vaccine business and that Kerry supports trial lawyers who are the problem (VP candidate Edwards is a liability lawyer).

Diary Prequel Package, p.109 · original PDF · in context

Major points are what we have been discussing for the past few weeks about providing incentives for PHARMA to get involved and stay in flu vaccine field.

Diary Prequel Package, p.109 · original PDF · in context

We (DHHS team) are proposing back end guaranteed purchases for overflow doses; liability protection, tax breaks, research to develop cell culture based and recombinant DNA approaches to replace egg-based approaches; advanced purchase and stockpiling of vaccine for children.

Diary Prequel Package, p.109 · original PDF · in context

We're improving the safety of the food we eat and import. * We're developing the new medicines and vaccines to protect our citizens from disease or bioterrorism. * Our children are healthier than ever, with health coverage and immunization rates at record highs and childhood drug usage going down. * We turned America's attention to disease prevention, motivating Americans to eat better and exercise more in order to improve their health and quality of life. * And we're waging a bold new global fight against HIV/AIDS, committing an unprecedented $15 billion toward eradicating this scourge.

Diary Prequel Package, p.110 · original PDF · in context

We are trying to reconcile the budget projects for FY 05 and 06 and 07 with the purchase needs for stockpiles of H5N1 vaccine and tamiflu.

Diary Prequel Package, p.117 · original PDF · in context

We already have 2 million doses of vaccine in bulk and we plan to buy 20 million more vaccine doses.

Diary Prequel Package, p.117 · original PDF · in context

I presented that we actually had a vaccine sine the results of the dosing shows a clear dose-response curve for the prime-boost.

Diary Prequel Package, p.118 · original PDF · in context

Typical Washington phenomenon ensued - two days later they proposed an amendment to a Defense Bill for $4 billion dollars for H5N1 preparedness emphasizing buying Tamiflu instead of the balanced Vaccine/Therapy approach that we had suggested.

Diary Prequel Package, p.129 · original PDF · in context

In addition, they knew (we told them) that we were preparing a big ($7-9 Billion) supplemental request for the HHS FY2006 budget for vaccines/drugs.

Diary Prequel Package, p.129 · original PDF · in context

Leavitt and I helped POTUS in the Roosevelt room talk with the CEOs regarding how we can engage them in building a vaccine production capacity.

Diary Prequel Package, p.130 · original PDF · in context

Others that took part in the Opening Ceremony were Job Cohen (Mayor of Amsterdam), Hans Hoogervorst (Dutch Minister of Health), Princess Mabel van Oranje-Nassau (Director, EU Affairs, Open Society Institute), Jean-Francois Rischard, Former VP of the World Bank, and David Salisbury (Director of Immunization, UK Department of Health).

Diary Prequel Package, p.144 · original PDF · in context

In addition, although we are still years away from a vaccine, the most recent candidate has entered a phase 2 trial internationally (including Africa).

Diary Prequel Package, p.152 · original PDF · in context

Heard real bad news regarding the Merck AIDS vaccine trial 502 in which adenovector HIV was immunogen.

Diary Prequel Package, p.160 · original PDF · in context

I have become increasingly interested and supportive of malaria including my long-term support of Stephen Hoffman (Sanaria) and his irradiated sporozoite vaccine.

Diary Prequel Package, p.161 · original PDF · in context

Sanaria is Biotech company making an irradiated sporozoite malaria vaccine.

Diary Prequel Package, p.162 · original PDF · in context

The POTUS in his usual generous way with me kept introducing me to people at the reception as one of the world's greatest scientist who will get us an AIDS vaccine.

Diary Prequel Package, p.164 · original PDF · in context

Of this $20 million is on TB Vaccine Research - this is about 25% of world's TB vaccine research spending with Gates spending about 45% (they spend most of their TB money on vaccine).

Diary Prequel Package, p.166 · original PDF · in context

Dec. 28, 2007 - Jan. 4, 2008 - The White House is getting excited about the possibility of pushing my TB vaccine research intitative for the G-8 and for the SOTU Address.

Diary Prequel Package, p.167 · original PDF · in context

Now they have asked me to put together a malaria vaccine and malaria drug discovery proposal.

Diary Prequel Package, p.167 · original PDF · in context

Went to show the flag, meet with African investigators from Uganda (Rakai) and see vaccine presentations.

Diary Prequel Package, p.168 · original PDF · in context

Ron Desrosiers gave his talk about the imbalance between discovery and development in vaccine agenda and said there is no evidence that any existing vaccine candidate will work.

Diary Prequel Package, p.168 · original PDF · in context

The PAVE 100 trial (VRC-Gary Nabel) is also using a T cell vaccine approach with 3 DNA-gag, pol, nef, env prime/boost followed by an Ad5-gal pol env 4" shot.

Diary Prequel Package, p.169 · original PDF · in context

Subject was how do we protect against drug resistant anthrax and vaccine resistant anthrax.

Diary Prequel Package, p.170 · original PDF · in context

May 2 - Went to Sommerville, NJ to a Merck retreat to help them decide what they are going to do with their HIV vaccine program following the disappointing results of the STEP study.

Diary Prequel Package, p.175 · original PDF · in context

May 30 -- AIDS Vaccine Research Subcommittee (AVRS) meeting in Bethesda to discuss decision of whether to proceed with the PAVE 100 study of the VRC.

Diary Prequel Package, p.175 · original PDF · in context

July 17, 2008 - Made what some are saying is a "landmark decision not to proceed with the PAVE 100 HIV vaccine trial of the NIAID VRC product.

Diary Prequel Package, p.178 · original PDF · in context

We are being very careful to uncouple the decisions about going ahead to produce the vaccine for administration next Fall and Winter from the decision to actually administer the vaccine next Fall and Winter.

Diary Prequel Package, p.209 · original PDF · in context

Visited the Township of Gugulethu and participated in the launching of the SAAVI102/HVTN 073 vaccine trial, which is a collaboration between the NIAID and the South Africans on a DNA prime MVA boost vaccine.

Diary Prequel Package, p.212 · original PDF · in context

We will start in early August and do trials on healthy adults, elderly, children to determine immediate safety, immunogenicity, dosage and number of doses, and sequence of administration vis-à-vis seasonal flu vaccine.

Diary Prequel Package, p.214 · original PDF · in context

July 28, 2009 - ACIP will recommend to CDC regarding vaccination program.

Diary Prequel Package, p.214 · original PDF · in context

She was a nerd who said we should not vaccinate anyone with flu vaccines since they do not work and they are dangerous.

Diary Prequel Package, p.215 · original PDF · in context

Of note the vaccine had no effect on viral load of those that did get infected.

Diary Prequel Package, p.218 · original PDF · in context

There was significant controversy surrounding the role-out of this vaccine a couple of weeks ago (see above).

Diary Prequel Package, p.220 · original PDF · in context

Just on October 23-25 I was on 11 major networks and cable trying to explain the vaccine supply problem - Today Show, NBC Nightly News, multiple MSNBCs, CNN Situation Room, CNN American Morning, Charlie Rose, NPR, WTOP, Good Morning America, Jim Lehr's The NewsHour, BBC, etc.

Diary Prequel Package, p.220 · original PDF · in context

Oct. 28-29, 2009 - Press is jumping all over HHS for delay in vaccine distribution.

Diary Prequel Package, p.221 · original PDF · in context

Nov. 5, 2009 - Image and message issues continue to deteriorate when it was announced today that workers from Goldman Sachs, Citibank and other Wall Street firms had gotten lid220 H1N1 vaccine as pregnant women wait in line.

Diary Prequel Package, p.221 · original PDF · in context

Since the Wall Street firms have large clinics, they can easily distribute vaccine to their pregnant employees and those with underlying conditions.

Diary Prequel Package, p.221 · original PDF · in context

This is the new version of the Infectious Diseases Institute started by merle Sande and funded by Pfizer.

Diary Prequel Package, p.223 · original PDF · in context

Of note, all over Europe there are tens of millions of doses of vaccine that countries like France, Germany, Italy are turning back to the company since they are unused.

Diary Prequel Package, p.225 · original PDF · in context

Jan. 25, 2010 - Had strategy meeting in Building 31, Room 7A24 and subsequent dinner at Positano restaurant in Bethesda to determine the Institute's strategy for vaccine research following the RV144 Thai trial results.

Diary Prequel Package, p.226 · original PDF · in context

Will continue this discussion next week with the AIDS Vaccine Research Subcommittee (AVRS).

Diary Prequel Package, p.226 · original PDF · in context

Merck started by reminding folks that they had in fact bid on the contract award for the cell culture derived smallpox vaccine, but had not been successful.

Reading Room Production, p.450 · original PDF · in context

One concrete example of how better understanding of a path to approval would affected a company's effectiveness in producing countermeasures was given by Novartis regarding use of an adjuvant to increase immunogenicity of a vaccine.

Reading Room Production, p.450 · original PDF · in context

Liability It was noted by Merck that adequate liability is afforded to the industry on childhood vaccines (National Childhood Vaccine Injury Act), but that similar liability protections are not provided for adult vaccines.

Reading Room Production, p.450 · original PDF · in context

Feb. 2, 2010 - Had AIDS Vaccine Research Subcommittee (AVRS) meeting at the Bethesda North Marriott Hotel to discuss the way forward following the Thai trial (RV144).

Diary Prequel Package, p.227 · original PDF · in context