post marketing surveillance - was rotavirus vaccine?

[Guest guest]

At 06:27 AM 8/6/2007 -0700, you wrote:

>according to my doc the nex vax had been out for appox 18-20 months..

does that make our babies guinea pigs?

no vaccine is ever tested very long

All vaccines make your babies guinea pigs

They supposedly rely on post marketing surveillance but don't pay any

attention to what is found outPost Marketing Surveillance

Before the release of a vaccine into the marketplace there are studies

'done' .........previous lessons showed the inadequacy of those.(even

though they say differently below - the are WOEFULLY inadequate.

Post-marketing surveillance is what they also use and 'say' they rely on -

but as we know, they don't pay attention, they deny, they ridicule, they

ignore data that comes in after the fact.

http://www.cdc.gov/nip/vacsafe/research/ap.htm

excerpt

" Clinical trials, despite their admittedly methodological purity and

elegance, are limited in sample size, duration, and population

heterogeneity. Rare or delayed adverse reactions, or reactions in

sub-populations can only be detected after product licensing and general

use. One of the major concerns with the safety of whole-cell pertussis

vaccination relates to rare serious events such as acute encephalopathy,

estimated to occur at 0.0-10.5 per million doses. The size of the phase

I/II trials (in the hundreds to low thousands) and phase III trials (in the

low tens of thousands) for acellular pertussis vaccines in infants are

clearly too small to address such an issue. While the greater safety of

these vaccines in prelicensing clinical trials are promising, the safety of

each vaccine regarding association with the most serious adverse events can

only be examined by postlicensure monitoring.

Traditionally, post-marketing surveillance systems have relied on

essentially passive monitoring such as the Vaccine Adverse Event Reporting

System (VAERS) in the United States (1). Such surveillance systems,

however, have great difficulty in distinguishing causal from coincidental

events and surveillance artefacts..”

---- Although the clinical trial data presented at this meeting clearly

show that the acellular pertussis vaccines as DTaP are safer than the

whole-cell pertussis vaccine as DTP, several important questions about the

safety of DTaPs remain to be answered. In the Swedish Stockholm trials I

and II, the apparent high incidence of hypotonic, hyporesponsive episodes

(HHE) observed warrants continued study to understand better the

characteristics of these events and the recovery status of these infants.

In addition, the change in pertussis vaccine exposure in Sweden since the

1980's and the availability of various disease registries makes Sweden an

attractive site to conduct ecological or other studies examining

relationship between pertussis vaccination and certain adverse events with

insidious/delayed onset (e.g., asthma, diabetes mellitus).

While the efficacy of various DTaPs have been compared critically by

several speakers, similar critical comparison of the " safety profiles "

between the DTaPs have been limited. Almost all the discussion on safety at

this meeting has focused on comparison of DTaP vs. whole-cell DTP and DT.

The NIH-sponsored phase II trials of acellular pertussis vaccines did not

show important differences in the frequencies of common local and systemic

reactions. Nevertheless, a meta-analysis or summary paper which focuses on

comparison of rates of more serious events (seizures, fever>40oC., HHE's)

would be helpful.

Clinical trials, despite their admittedly methodological purity and

elegance, are limited in sample size, duration, and population

heterogeneity. Rare or delayed adverse reactions, or reactions in

sub-populations can only be detected after product licensing and general

use. One of the major concerns with the safety of whole-cell pertussis

vaccination relates to rare serious events such as acute encephalopathy,

estimated to occur at 0.0-10.5 per million doses. The size of the phase

I/II trials (in the hundreds to low thousands) and phase III trials (in the

low tens of thousands) for acellular pertussis vaccines in infants are

clearly too small to address such an issue. While the greater safety of

these vaccines in prelicensing clinical trials are promising, the safety of

each vaccine regarding association with the most serious adverse events can

only be examined by postlicensure monitoring.

Traditionally, post-marketing surveillance systems have relied on

essentially passive monitoring such as the Vaccine Adverse Event Reporting

System (VAERS) in the United States (1). Such surveillance systems,

however, have great difficulty in distinguishing causal from coincidental

events and surveillance artefacts. Review of VAERS data from 1991-1993

provides a first perspective on the safety of DTaP vaccines in widespread

use . During this period, five million net doses of DTaP have been

distributed in the U.S. for the fourth and fifth doses and the overall

reporting ratio for serious adverse events in children age 1-4 years

appeared to have declined to one third that of whole-cell DPT vaccine (2).

Similar surveillance after use of DTaP in infants, as well as any new

combination vaccines, will be needed. Comparison of the " safety profile " in

VAERS reports by each DTaP vaccine type may also provide some greater

insights into their relative safety. The development and use of standard

protocols for follow-up of serious adverse events may improve the

scientific use of such reports.

Passive surveillance systems will always be severely limited, however, by

their biases and limited information content. Active surveillance or

definitive epidemiological studies are required to provide validation of

signals of concern generated by passive surveillance (3). Ad hoc studies

(e.g., National Childhood Encephalopathy Study) cannot be done on a very

timely basis and are also limited in the small number of hypothesized

adverse events that can be studied. Pharmacoepidemiologists studying

treatments have been relying on pre-organized Large-Linked DataBases (LLDB)

to provide more flexible and timely studies on the safety of drugs (3). In

the U.S., CDC has worked with several health maintenance organizations

since 1991 to create the Vaccine Safety Datalink (VSD) project. The VSD

currently conducts comprehensive surveillance on approximately 500,000

children under seven years of age (2% of the U.S. age-specific population)

annually. The computerized vaccination records (lot-specific) on these

children are linked with medical outcomes (hospital, outpatient, emergency

room, laboratory), and covariates (e.g., from census data tapes) for

epidemiological studies (4). About 100,000 doses of DTaP have been given to

this population to date. As more DTaP is used, the VSD should provide a

more rigorous means of monitoring vaccine safety. Other countries (e.g.,

U.K., Sweden, Denmark) have also begun or are planning to embark on LLDB

studies.

Finally, several lessons are available to us on the importance of

monitoring vaccine safety. The first is that public confidence, once lost,

is difficult to regain (3). This painful lesson was learned with public

concerns regarding safety of DTP in many countries during the 1970's and

1980's. Furthermore, the principles of primum non nocere(first do no harm)

are, if anything, more important in public health than in clinical

medicine, since vaccines, unlike most drugs, are given to healthy persons,

usually infants. The World Health Organization's Expanded Programme on

Immunizations (EPI) has recently called for all national immunization

programs to conduct surveillance of vaccine adverse events following

vaccination (5).

The area of risk communications will become increasingly important as

immunization programs successfully reduce vaccine-preventable diseases to

the point where the frequency of vaccine-associated adverse events exceeds

that of the disease. Risk communications will be challenging when most

health care providers as well as parents have never seen a case of

vaccine-preventable disease. In this new era, it may be more productive for

us to speak of " vaccine safety " research, a positive concept vs. " adverse

event " research. We always speak of " safety and efficacy " of a vaccine,

placing safety before efficacy; we should never forget that.

References

1. Chen RT, Rastogi SC, Mullen JR, S, Cochi SL, Donlon JA, Wassilak

SG. The Vaccine Adverse Event Reporting System (VAERS). Vaccine

1994;12:542-50.

2. Rosenthal S, Chen R, Hadler SC. The safety of acellular pertussis

vaccine versus whole cell pertussis vaccine: a post-marketing assessment.

Arch Dis Child (in press).

3. Chen RT. Special methodological issues in pharmacoepidemiology studies

of vaccine safety. In: Strom BL, ed. Pharmacoepidemiology. Sussex:

Wiley & Sons, 1994.

4. Chen RT, Glasser JW, P et al. The Vaccine Safety Datalink

Project: A new tool for improving vaccine safety monitoring in the United

States. Pediatrics 1997 (in press).

5. Expanded Programme on Immunization. Surveillance of adverse events

following immunization: field guide for managers of immunization programs.

Geneva:WHO/EPI/TRAM/93.2; 1993.

*****

http://www.fda.gov/cber/summaries/cber101032204mb.htm

CBER 101:

Introduction to the Center for Biologics Evaluation and Research

March 22-24, 2004 - Slide Presentation

******

http://archive.mail-list.com/hbv_research/msg01771.html

************

VAERS - Post Marketing Surveillance

http://www.vaers.org

Introduction

Welcome to the Vaccine Adverse Event Reporting System (VAERS) Web site.

The Vaccine Adverse Event Reporting System is a cooperative program for

vaccine safety of the Centers for Disease Control and Prevention (CDC) and

the Food and Drug Administration (FDA). VAERS is a post-marketing safety

surveillance program, collecting information about adverse events (possible

side effects) that occur after the administration of US licensed vaccines.

This Web site provides a nationwide mechanism by which adverse events

following immunization (AEFI) may be reported, analyzed and made available

to the public. The VAERS Web site also provides a vehicle for disseminating

vaccine safety-related information to parents/guardians, healthcare

providers, vaccine manufacturers, state vaccine programs, and other

constituencies

http://www.vaers.org/vaers.htm

Frequently Asked Questions

About VAERS

· What is VAERS?

· Who can report to VAERS?

· Why should I report to VAERS?

· How do I report to VAERS?

· What events should I report to VAERS?

· How are VAERS reports analyzed?

· Are all events reported to VAERS caused by vaccinations?

· What if I can't tell if a reaction was caused by a vaccine or another

medication?

· How do I find out if a vaccine adverse event has been reported to VAERS?

· How can I get information on VAERS?

· Is VAERS involved in the Vaccine Injury Compensation Program?

· Does VAERS provide general vaccine information?

What is VAERS? top

The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine

safety surveillance program co-sponsored by the Centers for Disease Control

and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS

collects and analyzes information from reports of adverse events following

immunization. Since 1990, VAERS has received over 123,000 reports, most of

which describe mild side effects such as fever. Very rarely, people

experience serious adverse events following immunization. By monitoring

such events, VAERS helps to identify any important new safety concerns and

thereby assists in ensuring that the benefits of vaccines continue to be

far greater than the risks.

Who can report to VAERS? top

Anyone can report to VAERS. The majority of VAERS reports are sent in by

vaccine manufacturers (42%) and health care providers (30%). The remaining

reports are obtained from state immunization programs (12%), vaccine

recipients (or their parent/guardians, 7%) and other sources (9%). Vaccine

recipients or their parents or guardians are encouraged to seek the help of

their health care professional in filling out the VAERS form.

Why should I report to VAERS? top

Each report provides valuable information that is added to the VAERS

database. Accurate and complete reporting of post-vaccination events

supplies the information needed for evaluation of vaccine safety. The CDC

and FDA use VAERS information to ensure the safest strategies of vaccine

use and to further reduce the rare risks associated with vaccines.

How do I report to VAERS? top

You should use a VAERS report form to report any adverse event. You can

obtain pre-addressed postage paid report forms by calling VAERS at

1-800-822-7967. You may use photocopies of the form to submit reports. You

may also download printable copies of the VAERS form as well as other

information about the VAERS Program from the following Internet sites:

· The VAERS Web site at http://www.vaers.org/

· The Food and Drug Administration's Web site at

http://www.fda.gov/cber/vaers/vaers.htm

· The Centers for Disease Control and Prevention Web site at

http://www.cdc.gov/nip/

What events should I report to VAERS? top

VAERS encourages the reporting of any clinically significant adverse event

that occurs after the administration of any vaccine licensed in the United

States. You should report clinically significant adverse events even if you

are unsure whether a vaccine caused the event.

The National Childhood Vaccine Injury Act (NCVIA) requires health care

providers to report:

· Any event listed by the vaccine manufacturer as a contraindication to

subsequent doses of the vaccine.

· Any event listed in the Reportable Events Table that occurs within the

specified time period after vaccination.

A copy of the Reportable Events Table can be obtained by calling VAERS at

1-800-822-7967 or by downloading it from http://www.vaers.org/pubs.htm.

How are VAERS reports analyzed top

Both the CDC and the FDA review data reported to VAERS. The FDA reviews

reports to assess whether a reported event is adequately reflected in

product labeling, and closely monitors reporting trends for individual

vaccine lots. Copies of published reviews are available from VAERS. Many

different types of events occur after vaccination. Approximately 85% of the

reports describe mild events such as fever, local reactions, episodes of

crying or mild irritability, and other less serious experiences. The

remaining 15% of the reports reflect serious adverse events involving

life-threatening conditions, hospitalization, permanent disability, or

death, which may or may not have been truly caused by an immunization.

Are all events reported to VAERS caused by vaccinations? top

No. VAERS receives reports of many events that occur after immunization.

Some of these events may occur coincidentally following vaccination, while

others may truly be caused by vaccination. Studies help determine if there

is more than a temporal (time) association between immunization and adverse

events. The fact that an adverse event occurred following immunization is

not conclusive evidence that the event was caused by a vaccine. Factors

such as medical history and other medications given near the time of the

vaccination must be examined to determine if they could have caused the

adverse event. It is important to remember that many adverse events

reported to VAERS may not be caused by vaccines.

What if I can't tell if a reaction was caused by a vaccine or another

medication top

We encourage you to report any reaction following vaccination to VAERS,

regardless of whether or not you can tell if the vaccine or another product

caused it. Reports sent to the VAERS program that also make reference to

non-vaccine pharmaceutical products are shared with MedWatch, the FDA's

drug safety surveillance system.

How do I find out if a vaccine adverse event has been reported to VAERS? top

You can request information about adverse events reported to VAERS by

faxing requests to (301) 443-1726, or by sending requests to:

Food and Drug Administration

Freedom of Information Staff (HFI-35)

5600 Fishers Lane

Rockville, MD 20857

(301) 827-6500

How can I get information on VAERS? top

There are four ways to obtain information about the VAERS program:

· Send e-mail inquiries to info@...

· Visit the VAERS Web site at: http://www.vaers.org

· Call the toll-free VAERS information line at (800) 822-7967

· Fax inquiries to the toll-free information fax line at (877) 721-0366

Is VAERS involved in the Vaccine Injury Compensation Program? top

No. The National Childhood Vaccine Injury Act created the Vaccine Injury

Compensation Program (VICP) to compensate individuals whose injuries may

have been caused by vaccines recommended by the CDC for routine use. VICP

is separate from the VAERS program. Reporting an event to VAERS does not

file a claim for compensation to the VICP.

A petition must be filed with VICP to start a claim for compensation. For

more information call (800) 338-2382, or go to http://www.hrsa.gov/osp/vicp.

Does VAERS provide general vaccine information? top

No. VAERS concentrates on collecting and analyzing the report data. For

general information about vaccines and vaccine safety, immunization

schedules for children and adults, publications on vaccine-preventable

diseases, and more:

· Call the CDC National Immunization Hotline at:

o (800) 232-2522 (English)

o (800) 232-0233 (Spanish)

· Visit CDC's National Immunization Program Web site at

http://www.cdc.gov/nip/.

VAERS Mailing Address:

VAERS

P.O. Box 1100

Rockville, MD 20849-1100

Download a copy of these frequently asked questions (PDF 146K).

Download a copy of the VAERS form (PDF 23K).

--------------------------------------------------------

Sheri Nakken, R.N., MA, Hahnemannian Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

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