What the Vaccine Advisory Committee is talking about (H1N1)

[Guest guest]

I changed the topic on this so all interested could see. Check this out:

" The need to actively monitor vaccine recipients for vaccine adverse events is

critical given that the vaccine candidates will all contain a new antigen and

may be combined with adjuvants that are not part of licensed vaccines in the

US. "

and what does this mean?

" Relevant parties of HHS should develop appropriate procedures for linking

exposure and outcome data in as large a population base as feasible, including

consideration of subpopulations targeted for vaccine use. In order to do this,

accurate exposure to vaccine and adjuvant type for each dose administered (with

lot numbers, if possible) must be linked to outcome data. The current vaccine

safety infrastructure is unlikely to be sufficient to accomplish this. "

I think it means they are going to be able to minimize the adverse events by

using some of the nasal spray vaccine, some without thimerosal, and some of the

" kicker " vaccines with everything. If the adverse events are all bundled, it

won't seem as bad? What do they mean " including consideration of subpopulations

targeted for vaccine use " ? That they are going to include the numbers whether

or not vaccinated?

They sure do have a plan for blaming vaccine reactions on other things though

don't they? (more below)

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> BIG FAT RED FLAGS

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http://www.hhs.gov/nvpo/nvac/documents/H1N1VaccineSafetyMonitoringRecommendation\

..doc

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> 1. NVAC recommends that the Assistant Secretary for Health and the Department

of Health and Human Services (HHS) develop, and where possible test in advance,

a strong and organized response to scientific and public concerns about vaccine

safety that may emerge during the 2009 H1N1 vaccination campaign. The challenge

will be to communicate effectively and to differentiate rapidly between adverse

events that may be causally related to the vaccine and those which would be

expected by chance alone. Such a response could involve:

>

> a. Assembling information on background rates in the general population of

anticipated events that, when occurring after immunization, might represent an

adverse event including stratification by age group if possible.

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> b. Organizing drills or practice scenarios for how the government will respond

to concerns about adverse events temporally related to H1N1 vaccination,

including identifying data resources and strategies for communications. Events

reported among pregnant women are especially likely to generate concern. There

are special challenges around identifying possible adverse events, determining

background rates, determining causality and effectively communicating in this

population. Therefore, NVAC suggests that practicing a scenario of possible

pregnancy associated events would be particularly valuable.

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> These activities will allow agencies to plan responses in advance so that they

are able to promptly and effectively investigate and make policy decisions and

communicate about H1N1 vaccine safety to the media and the public.

>

> 1. A clear Federal plan to monitor 2009H1N1 influenza vaccine safety

is needed both for proper planning purposes in the Federal government and to

provide information to the public and stakeholders (including states) about

important vaccine safety activities. A comprehensive and detailed plan should

be developed and disseminated that outlines the HHS plan for monitoring vaccine

safety. This plan should include:

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> Specific activities under development with acknowledgement of gaps and

limitations. Specific studies planned to be carried out should also be

included.

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> An organization chart outlining who is involved, what their responsibilities

are, the flow of information, how coordination will be achieved between

different Federal office and agencies, who makes which decisions, who is

responsible, and other relevant roles.

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> A clear timeline of planning processes, completion of preparations, and

execution of activities.

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> Involvement and role of other Federal agencies such as Department of Defense

and the Veterans Administration.

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> 2. The need to actively monitor vaccine recipients for vaccine adverse

events is critical given that the vaccine candidates will all contain a new

antigen and may be combined with adjuvants that are not part of licensed

vaccines in the US. Relevant parties of HHS should develop appropriate

procedures for linking exposure and outcome data in as large a population base

as feasible, including consideration of subpopulations targeted for vaccine use.

In order to do this, accurate exposure to vaccine and adjuvant type for each

dose administered (with lot numbers, if possible) must be linked to outcome

data. The current vaccine safety infrastructure is unlikely to be sufficient to

accomplish this. Consideration should be given to the following strategies for

active vaccine safety surveillance:

>

> 1. Utilizing existing mechanisms that are used for vaccine adverse event

surveillance but may need to be enhanced or refined.

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> 2. Exploring existing databases that have not yet been used for vaccine

adverse event monitoring but could be.

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> 3. Developing novel strategies, although a process for collecting and vetting

is needed given the short timeframe anticipated.

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> A clear timeline should be developed for finalizing necessary arrangements.

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> 3. Consideration should be given to a transparent and independent

review of vaccine safety data as it accumulates. This Vaccine Safety Assessment

Committee (VSAC) would be an independent group of outside experts with a charge

to advise the ASH and/or ASPR on the presence, investigation, interpretation,

and implications of possible side effects of H1N1 vaccines. The committee should

be reviewing pre- and post-licensure vaccine safety data accumulated in a timely

way and not await activation when a specific signal is declared. The VSAC

should advise on distinguishing spurious from genuine side effects; anticipating

and responding to coincident (non-causal) events; evaluating the occurrence,

frequency, and seriousness of possible side effects associated with vaccine;

programmatic and policy steps to take in response to purported or demonstrated

safety concerns; strategies and content of communication about vaccine safety;

and such other matters related to vaccine safety that the ASH/ASPR would find

useful. Such an external review would involve an independent group of experts

with no professional or commercial stake in the vaccines or conduct of an

immunization program, to speed and improve response to possible vaccine side

effects, to enhance public confidence, and to provide focused advice on what can

become a scientifically and politically contentious issue. The VSAC may be made

up of members of an existing Federal advisory committee, such as NVAC, and

supplemented by other vaccine safety experts. The committee would only assess

risks (not consider vaccine benefits) and the committee would be only advisory

and not decision making. The ASH/ASPR would be responsible for assuring

programmatic response to the assessment of risk.

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> > >

> > and went TWICE to try to get a shot but both times there was a problem at

the pharmacy where they were giving them and she couldn't get it. I'm worried

she doesn't have the backbone to stand up to all these people pressuring her.

She asked me for prayer on what to do. Anyone have any advise?

> > > .....

> > She is worried because she works around kids....

> > ......

> > to protect the baby from...the swine flu or the swine flu vaccination.

> > > Please advise!!!!!

> > >

> > >

> > >

[Guest guest]

It is so very telling that HHS/CDC puts so much effort in to developing and

tracking adverse events AFTER the vax is introduced in to the population. What

are they expecting?

And then they say all vaccines are safe? Doesn't make sense. It sounds like

they are flying by the seat of their pants.

Isn't there a saying that goes something like " It is easier to beg for

forgiveness than to ask for permission. " ? Just slam out a vaccine to make

yourselves look good and hope nothing bad happens.

Pam

> > > >

> > > and went TWICE to try to get a shot but both times there was a problem at

the pharmacy where they were giving them and she couldn't get it. I'm worried

she doesn't have the backbone to stand up to all these people pressuring her.

She asked me for prayer on what to do. Anyone have any advise?

> > > > .....

> > > She is worried because she works around kids....

> > > ......

> > > to protect the baby from...the swine flu or the swine flu vaccination.

> > > > Please advise!!!!!

> > > >

> > > >

> > > >

[Guest guest]

Response in the post:

> > > >

> > > and went TWICE to try to get a shot but both times there was a problem at

the pharmacy where they were giving them and she couldn't get it. I'm worried

she doesn't have the backbone to stand up to all these people pressuring her.

She asked me for prayer on what to do. Anyone have any advise?

> > > > .....

> > > She is worried because she works around kids....

> > > ......

> > > to protect the baby from...the swine flu or the swine flu vaccination.

> > > > Please advise!!!!!

> > > >

> > > >

> > > >