Flu-Lanta - The Advisory Committee on Immunization Practice (ACIP), Influenza Sessions. Atlanta, Century Center Mariott. October 27, 2004.
dbratl
I attended the CDC, ACIP morning influenza sessions with the intent of getting a better background on the current flu vaccine shortage, and steps being taken to mitigate it. These are my notes presented in descending order from most interesting/newsworthy, to least. The comments I present here are compiled from the different presentation along with Julie Gerberding's post-session press conference (which I was almost literally a fly on the wall of) held at 11:00 am. First, I provide the list of sessions, presenters, and affiliations of the morning sessions, and then summarize what was said under different headings and questions. When possible, I've tried to throw in detailed about the personalities involved. (Presentation List at End)
Whose to blame?
JL Gerberding said some fairly controversial thing, the types of things that to my eyes would only be said by someone who knows they are losing their job regardless and is trying to set the record strait before they go.
Gerberding's, Office of the Director (OD) is jokingly referred to as the Office of the Diva, by CDC staff due to her penchant for $5,000 Channel jackets, and her appearances in Vogue Magazine. Another funny nickname is for her is J. Lu, based on her insistence on being referred to as Julie Louise, as opposed to simply Julie.
Anyway, referencing a question brought up by the audience regarding earlier concerns from past years regarding sufficient supply of Flu vaccine and methods to mitigate risk, Gerberding was asked by a TV News reporter if "Public Health had dragged it's feet in responding to the crises?"
J. Lu responded by saying that Public Health has been "sounding the alarm about this issue for decades", and that the public has largely ignored it. She said that coverage of all vulnerable populations was expensive, and she asked the questions "What are we as a society willing to pay to insure coverage of the vulnerable?"
Pretty bold statements from someone who must ultimately answer to the Bush Administration. She must be watching the polls as closely as we are. Either that or (as is the Atlanta rumor) this Flu Vaccine shortage has effectively ended her CDC tenure as Director even in the event Bush is reelected.
What's the Scale of the Shortage?
From Gerberding's comments it was possible to piece together the scale of the potential shortage. Some facts:
- CDC targeted 94 million patients as "at-risk" and recommended for vaccine.
- Including any potential vaccine that may come into supply, we can expect a total supply of approximately 61 million doses
- 32 million doses were distributed prior to the knowledge of the Chiron crises
Using these fact to estimate the shortfall - Given the assumption of 100% demand by those recommended for the vaccine (a level of demand double that experienced in previous years), the shortage can be estimated as between 30 million doses (if all pre-Chiron doses went to those at risk) to 62 million doses (if none of the pre-Chiron doses went to those at risk.
Given an assumption of demand at last year's level, and an assumption that all pre-Chiron doses went to high-risk patients (assumptions that we know to be false and error on the optimistic side), we should expect a vaccine shortage of in the area of 15 million doses of vaccine. The true number is likely in excess of this. In other words, a big shortage even under conservative assumptions.
The next set of notes are from the open meeting:
How much additional vaccine can we expect from other countries, and when are they coming?
Short answer, not much. Despite a complicated explanation from Dr. Gellin, that made the issue somewhat difficult to follow, Dr. Norman Baylor from FDA reiterated that the quantity of additional vaccine expected through FDA expedited review of foreign vaccines will be in the areas of 1 to 2 million doses, far below the expected shortfall.
When pressed by the ACIP Chair, Dr. Levin (who at the start of the meeting acknowledged potential conflicts of interest due to Pharma funding from Chiron among others), to state when this "extra" vaccine might be expected in terms of weeks or months, Dr. Baylor responded "We're talking months, perhaps January at the earliest."
When Judging credibility of these statements it should be considered that Gellin is the representative of the National Vaccine Program Office, operated out of the Department of Health and Human Services. This is essentially the office responsible for PR'ing this mess for the White House.
Dr. Baylor in contrast is a career civil servant, a microbiologist, and the Director of the Division of Bacterial, Parasitic and Allergenic Products. You be the judge regarding how much new vaccine is on the way.
What's going on at the local level?
Somewhat shockingly, Dr. Levin introduced the National Association of County and City Health Officials (NACCHO), Dr. J. Hershey, as "Someone I'm not too familiar with, so maybe when he comes up here he can illuminate us as to who he is."
Well, illuminate he did, as well as illuminating the subject of what the heck a 15 to 30 million dose shortage of vaccine in the United States looks like.
According to Dr. Hershey state and local (S&Ls) health departments (City, County, etc) are actively rationing the vaccine they have in stock. There are variations in the supply of vaccine between health departments (depending on who they ordered their original stock AVP or Chiron, and when it was delivered), but many S&L's are in a position of sub-prioritizing who to give vaccine to among those identified by ACIP as high risk.
In practice this translates into choosing between giving vaccine to members of the following groups:
- Otherwise healthy children aged six months to two years
- Otherwise healthy HIV patients taking ARVs
- Otherwise healthy diabetics
- Otherwise healthy elderly
- Otherwise healthy patients with other chronic diseases under management
Hershey argued that recommendations regarding subprioritization should have been made by CDC/ACIP at the time they announced the Chiron crises. This would have greatly alleviated the burden on S&L's and led to more efficient vaccine distribution. Of course it also would have required an immediate recognition and acknowledgement that the Chiron crises would result in vaccine shortages that would require rationing at the S&L level. In the absence of recommendations S&L's have relied on ad-hoc distribution based on methods as extreme as lotteries.
The situation is even more messed up. Dr. Hershey suggested that subprioritization at this point would lead to confusion at the S&L level in places that have already made rationing decisions that are in conflict with the potential CDC/ACIP recommendations.
Dr. Birkhead from the NY State Department of Health essentially confirmed what Dr. Hershey was saying, while using more diplomatic language to do so.
CDC Plans For Now
At the beginning of the morning, Lance Rodenwald and J. Santoli from CDC's National Immunization Program, outlined their progress in identifying available AVP vaccine prior to shipment, identifying flu distribution groups (Private provider offices, public health departments, hospitals, etc) based on the proportion of high-risk patients they serve, and reallocating vaccine where it is needed.
Long story short, CDC and the National Immunization Program has done an excellent job trying to clean up this mess and vaccine is now being directed to those who need it most. However, the bottom line is, there is not enough vaccine to meet demand, and further there won't be in the future.
Implications for a Pandemic Flu
There were several comments from the floor regarding how this crisis could foreshadow what might happen in a pandemic flu. The general conclusion is that unless we get better public control over vaccine manufacturing, purchasing, and distribution, there is NO chance we will b able to handle the surge of demand, and associated rationing likely needed in a pandemic situation.
Currently, only about 10% of flu vaccine is purchased by public sector entities (excluding private purchases backed by VFC funds).
Anyway, please add your comments, I found this public discourse to be fascinating, though I doubt you'll get this account of it in the news.
Presentation List:
9:30 - overview of CDC Response to Influenza Vaccine Supply Issues - Dr. JL Gerberding (CDC Director)
9:40 - CDC Actions and Plans, Vaccine Supply Situation - Dr. Lance Rodewald (NIP)
- Vaccine Distribution Plan - Dr. J. Santoli (NIP)
9:55 - FDA Perspective on other vaccine sources - Dr. Norman Baylor (FDA)
10:10 - HHS, NVAC, and NVPO perspective on Vaccine Supply - Dr. B. Gellin (NVPO)
10:25 - Local and State Issues - Dr. J. Hershey (NACCHO)
- Dr. G. Birkhead (NY State Dept. of Health)
In separate room:
11:00 - Press Conference - JL Gerberding