"David Wright" wrote:
In article
,
Kulacz wrote:
On Mar 19, 8:51 pm, wrote:
On Mar 19, 6:58 pm, "Jan Drew" wrote:

http://www.who.int/vaccines/globalsu...ScheduleResult...

Just look at the number of vaccinations by age six.

Starting at 12 hours after birth.

We can obviously give big pharma and the pediatricians a big $KACHING$
$ for all that effort, right?

There's no money like easy money, sung to the tune of what?

DrCee
You cannot secure nor restore health with pus or poisons.

All of these vaccines with their added immune adjuncts given to
immature immune systems without clear safety studies is simply
irresponsible
Any responsible scientist evaluating this protocal would agree..

Are you under the impression that there are no studies done of
vaccines before they are released?

Half true.

So *Organzized medicne* and those with vested Interest JAB at 12 hours after
birth, even though
they have not be proven safe. Then they LIE and say they are safe.

This is so-called evident based medicine.

Why would any parent want vaccines BEFORE they are studied?
Advisary commitees...conclude...Their conclusions are based on nothing?
More $$$$$ is the MAIN thing, and kids be damned.

http://www.fda.gov/ola/2000/anthraxvaccine.html

Our confidence in this vaccine, like all vaccines, is based upon four
components: first - the review of manufacturing and clinical trials and
subsequent clinical laboratory experience with the vaccine; second - ongoing
inspections of the manufacturing facility; third - our lot release
requirements; and fourth - our ongoing collection and analysis of adverse
event reports. So far, the data gathered from VAERS reports on anthrax
vaccine do not signal concerns about the safety of the vaccine. The Agency
will continue to closely monitor and investigate reports of serious adverse
events received on all vaccines, including anthrax, to assure that only safe
products are on the market.

[our confidence....more money is our pockets.]

http://hbns.org/getDocument.cfm?documentID=1211


1/25/06 3 p.m: The first paragraph has been changed; the number of children
involved in the review has been corrected.

U.S. health authorities should have waited for more evidence before
recommending routine flu shots for healthy toddlers, according to a new
systematic review of studies involving more than a quarter of a million
children worldwide.

Only a few studies of the vaccine have been conducted in children under 2
years old, and findings suggest that the injection is no better than a
placebo at preventing influenza. Moreover, only one tiny study has looked
specifically at the safety of flu shots in toddlers.

Based on these findings, the reviewers question whether all healthy children
between 6 months and 23 months of age should receive the flu shot as
recommended by the U.S. Centers for Disease Control and Prevention since
2004.

"National policies for the vaccination of healthy young children are based
on very little evidence," say the authors, led by Dr. Sue Smith of Oxford
University.

The review appears in the current issue of The Cochrane Library, a
publication of The Cochrane Collaboration, an international organization
that evaluates medical research. Systematic reviews draw evidence-based
conclusions about medical practice after considering both the content and
quality of existing medical trials on a topic.

Until recently, flu shots were promoted primarily for those with chronic
illnesses, people over age 65 and health-care workers. However, studies have
shown that children under 2 are hospitalized for flu at the same rate as
senior citizens, and the CDC reported that more than 150 children under 18
died from complications of flu during the 2003-2004 season.

The Cochrane review comprised 51 studies of influenza vaccines - including
17 papers translated from Russian for the first time - involving more than
250,000 healthy youngsters under age 16.

Yet only a fraction of these studies focused on children younger than 2. Two
efficacy studies involving about 1,000 toddlers indicate that flu shots
containing inactivated virus - the only vaccine approved for this age
group - are no more effective at preventing the flu than placebo.

Furthermore, the reviewers "found no evidence to back up the claims that the
vaccines prevent deaths from influenza or other serious complications," said
coauthor Dr. Tom Jefferson of the Cochrane Collaboration vaccine program.
"They may do so, but there is no evidence at present."

Nearly three dozen studies on vaccine safety followed a similar pattern. "We
were astonished to find only one safety study of inactivated vaccine in
children under 2 years carried out nearly 30 years ago in 35 children," say
the review authors.

Although 11 studies presented safety data for flu shots in youngsters up to
18 years old, such aggregate data is inadequate for assessing safety among
toddlers, said Jefferson.

For children older than 2, the findings are quite different. More than
15,000 observations from high-quality studies indicate that flu shots
prevent influenza in 59 percent of children who receive them. A nasal spray
vaccine made from live virus - approved since 2004 for children over 5 - is
even better, with 79 percent efficacy.

Safety data for older children were collected and reported in such a wide
variety of formats that no analysis was possible. "There is an immediate
need to standardize safety outcome data," says the review.

Given the paucity of research on children under 2, the review also calls for
more randomized trials on the efficacy and safety of inactivated vaccine in
this age group. "All this homework should be done before the vaccine is
recommended for use in any population, not after," said Jefferson.

Yet devoting too much time to research also has downsides.

"It would be a shame to wait until every study from A to Z is completed
before recommending a vaccination," said Henry Bernstein, M.D., a Dartmouth
Medical School pediatrician and member of the American Academy of Pediatrics
Committee on Infectious Diseases. After all, children may be dying from the
flu in the meantime.

"It's a difference in strategy. We believe the vaccine is safe and effective
in older people, the chronically ill and health-care workers. There's little
reason to believe the same thing wouldn't help in 6- to 23-month olds."
Monitoring of vaccine responses continues long after they are in widespread
use to catch any problems that may unexpectedly appear, he added.

[we believe--little reason to believe they won't help. Monitoring AFTER kids
are jabbed, a bit late.]



Only half of the 180 million Americans who should receive flu vaccine each
year actually do, says Bernstein. "Large research projects can be expensive.
I'd rather spend some of the money on education and making the vaccine
available to all who need it."


http://www.hvtn.org/science/publications_policy.html

HVTN Publication Policy
All HVTN manuscripts and abstracts ("publications") must, before submission,
be reviewed by the Protocol Committee. Manuscripts and abstracts published
without proper review are not counted in a site's NEC annual review. Vaccine
developers have the right to review publications before submission; clinical
trials agreements may specify requirements for authorship and review.

Authorship
All publications must meet the criteria for authorship, disclosure,
scientific integrity, and other requirements of peer-reviewed scientific
journals. The author line must conclude with "and the NIAID HIV Vaccine
Trials Network," and NIAID funding must be acknowledged, specifying the
grant number if applicable. If applicable, the vaccine developer is normally
included as a coauthor.

For core protocol publications (reporting on primary and secondary
objectives of a single trial), the protocol team serves as the writing team,
usually with the protocol chair as lead author. For cross-protocol
publications, leaders of the network or appropriate science committee
typically appoint the lead author. Additional authors may include other
investigators, usually members of the appropriate science committee, and/or
site investigators.

For ancillary publications, the lead author is the investigator who proposed
and carried out the ancillary study. To submit a manuscript involving HVTN
participants or samples, authors must receive written permission from the
protocol chair or (in studies involving more than 1 protocol) from the
appropriate science committee leadership. If the lead author is not an HVTN
member, at least 1 HVTN member (chosen by the chair of the appropriate
science committee) serves as network liaison and is included as coauthor.
Publication of ancillary studies should not precede core protocol
publication, unless agreed to by the protocol chair or chair of the
appropriate science committee.

The protocol chair or other protocol team members present data at scientific
meetings. Vaccine developers are included as coauthors, if appropriate.



Review
HVTN manuscripts and abstracts are reviewed in 3 stages. The first 2 stages
are prerequisites of the third.


1. Consensus of authors
All authors-including vaccine developers-must sign off on a publication
before submitting it to the Protocol Committee. The Protocol Committee will
not review abstracts or manuscripts submitted without this sign-off.

2. Approval by site principal investigator or HVTN associate director for
scientific support
If the lead author of a publication is not a principal investigator, that
author's site PI must approve the publication before submission. Ancillary
publications and cross-protocol publications must be approved by the chair
of the appropriate science committee. Ancillary publications may also
require review by protocol chairs or by protocol teams (including -vaccine
developers). Publications by lead authors in HVTN Core must be approved by
the author's unit chief, then submitted to the associate director for
scientific support.

3. Review by Protocol Committee
The Protocol Committee consists of 3 co-chairs, 6 non-US site investigators,
6 US site investigators, 2 clinic coordinators, a global CAB representative,
a SCHARP representative, a Lab Program representative, and 2 DAIDS
representatives. The Protocol Committee reviews the author line with the
standard criteria for scientific authorship in mind. The lead author should
send his/her manuscript or abstract with a completed submission form to the
Protocol Committee Administrative Assistant with ample time for review
according to the guidelines below.

Manuscripts are assigned a primary reviewer from the Protocol Committee. The
manuscript is returned to the lead author with major comments (required
changes) and minor comments (recommended changes). If there are required
changes, the manuscript must be revised and resubmitted for further review.
This process is repeated until no required changes remain. In case of
persistent disagreement between authors and reviewers, final judgment rests
with the Scientific Steering Committee chair or the chair of the appropriate
science committee.

Abstracts undergo a similar but abbreviated review. They are assigned a
primary reviewer who responds to the lead author within five working days.
If there are required changes, the abstract must be revised and resubmitted.
The abstract is also circulated to members of the Protocol Committee for
comments.

The Protocol Committee Administrative Assistant will notify the lead author
when the review is complete. The lead author should notify the Protocol
Committee Administrative Assistant when the abstract or manuscript has been
accepted and send a final version for filing in the HVTN Publications
Database and posting on the HVTN members website.



Deadlines
Only those review comments received on time will be considered. The clock
starts when the draft publication is sent to reviewers by the Protocol
Committee Administrative Assistant. The author is notified of receipt by fax
or e-mail.

Time allowed for review is 10 working days for manuscripts, 5 for abstracts.
A vaccine developer may be allowed more time for review (often 20 working
days for manuscripts), if specified in the clinical trials agreement.
Submission of abstracts must allow sufficient time for review before
conference deadlines. These timelines also apply to the review processes
outlined in subheadings 1 and 2 above.

For manuscripts reporting results of a specific HVTN trial (covering the
primary and secondary objectives), a complete draft must be produced no more
than 3 months after the study is unblinded and the data are available. If
this is not done, HVTN leadership may assign a new lead author from the
protocol team.



Submission form and tracking
A manuscript/abstract submission form must accompany any submission to the
Protocol Committee. All submissions to the Protocol Committee, at any stage
of review, are made through the Protocol Committee Administrative Assistant.
(Earlier reviews, including those by the vaccine developer, are arranged
directly by the writing team.) Manuscripts and abstracts may be submitted in
hard copy or in a commonly used, editable electronic format such as
Microsoft Word. Submit manuscripts, abstracts, or questions to the Protocol
Committee Administrative Assistant:



The Protocol Committee Admin distributes draft publications for review, and
tracks drafts as well as published products. For tracking purposes, authors
must report the final disposition of publications to the Protocol Committee
Admin.

[must? Who checks to see if they are not??]



Participant identification numbers
Participant ID numbers from trials are not to be used in any publications.
If ID numbers are needed, the SDMC will issue new ones.

[WOW!!Loose cannons.



Reprint distribution
The publications coordinator distributes reprints of published material at
the request of the corresponding author. The request must be in writing and
accompanied by the number of copies to be distributed. Unless otherwise
requested, distribution will be to all authors, DAIDS representatives, the
vaccine developer, and the HVTN Core Operations Center. Additional
distributions may be made as directed by the lead author.

[and the lead author is truthful? HA!]



Publicity and media
Media inquiries and press releases should be referred to the NIAID Office of
Communications Reporting and Public Response (OC/NIAID). The OC/NIAID and
VCRB Program Officer should approve any press releases and responses to
inquiries (t. 301-496-5717). Local media activity should be coordinated with
the NIAID Office of Communications.

[NIAID=*Organized medicine with vested interest!]



-- David Wright :: alphabeta at copper.net

prodigy...comcast--copper....