What did flu vaccine experts talk about before the swine flu pandemic occurred?--from my blog today

[Guest guest]

What did flu vaccine " experts " talk about before the swine flu

pandemic occurred?

DHHS's National Vaccine Advisory Committee (NVAC) met February 5-6,

2009. Here is a section of the NVAC minutes that dealt with the

concept of vaccinating the public for a " Bird Flu " H5N1 pandemic--

vaccinating even before an epidemic occurred! Remember that Bird Flu,

though deadly, has never spread from one person to another, but only

from a small number of birds to a small number of people--and stopped

there. But these experts had already figured out that they could

employ an Emergency Use Authorization so that a Bird Flu vaccine with

novel adjuvants could be used on the American public, pandemic or no,

making use of the stockpile. Read it and weep--Meryl

" Pre-pandemic Vaccination Policy - T. Pavia, M.D.

http://www.hhs.gov/nvpo/nvac/minutes200902.html

Dr. Pavia said NBSB is evaluating the prospect of pre-pandemic

use of pandemic influenza vaccine, which is being considered in other

countries. The WHO's SAGE is performing a comprehensive review of the

topic and will meet to discuss it in April.

Pre-pandemic vaccination involves using H5 or some other vaccine

to prevent a potential pandemic before a true pandemic outbreak

occurs. The United States has a stockpile of pre-pandemic vaccine

that, until recently, offered narrow protection and had limited uses.

The development of novel adjuvants has dramatically altered the

potential uses of the existing vaccine. Large, phase-III studies are

still needed, but consistent evidence has shown three different

adjuvants to be effective. The adjuvants allow use of much less

vaccine to achieve the same immunogenicity and, more importantly, may

induce broad, cross-neutralizing antibodies. Evidence suggests that a

perfect vaccine match is not needed to ensure protection. In addition,

the adjuvants may act as primers; that is, while the first or second

vaccine dose may be a poor match, the use of adjuvants may improve the

response to a later, better-matched vaccine.

Dr. Pavia said NBSB (of which he is a member) was asked by the

BARDA and ASPR to evaluate the policy implications of pre-pandemic

vaccination. Dr. Pavia said NBSB first seeks to define who should be

represented in the subgroup evaluating pre-pandemic vaccine. Dr. Pavia

emphasized the need for input from people with experience in past

episodes involving complex public-health decision-making. The makeup

of the subgroup and format of the meetings remain to be determined,

and Dr. Pavia stressed that the issues are politically sensitive.

Discussion

Dr. Birkhead pointed out that the novel adjuvants are not yet

licensed in the United States and wondered whether they would require

an investigative new drug application process. Dr. Pavia said one

option is to declare an emergency for specific groups and use the

adjuvants under an FDA emergency use authorization. Dr. Baylor said

FDA is discussing the issue with its counterparts around the world. He

believes that data from ongoing research by influenza vaccine

manufacturers will drive the process, but the decision to pursue pre-

pandemic vaccine should be a global one. Dr. Gellin (CDC) said the

United States has the vaccine in its stockpile; the question is

whether the benefits of using it for pre-pandemic vaccination outweigh

the risks. Dr. Baylor (FDA) countered that the decision should be

based on data, not the availability of vaccine in the stockpile. Dr.

Pavia said in the United States, decision-making has not reached that

level.

Dr. Salisbury described the WHO virtual stockpile of H5N1 vaccine

and said the SAGE meeting is intended to address the best uses of the

stockpile. Dr. Pavia emphasized that the biggest challenge is

grappling with the issue of using a non-licensed vaccine for a disease

that does not yet exist. "

Meryl Nass, MD

Mount Desert Island Hospital

Bar Harbor, Maine 04609

W 207 288-5081 ext. 1220

C 207 522-5229

H 207 244-9165

pager 207 818-0708

http://anthraxvaccine.blogspot.com

http://www.anthraxvaccine.org