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Monday, January 25, 2010

Study Reports Deaths Due to H1N1 Vaccines Low in Number

A ProMED-mail post

ProMED-mail is a program of the
International Society for Infectious Diseases

In this update:
[1] USA (vaccine safety)
[2] Mongolia

[1] USA (vaccine safety)
Date: Sat 16 Jan 2010
Source: Dept. of Health and Human Services, Centers for Disease
Control and Prevention (CDC) [edited]

Summary of 2009 Monovalent H1N1 Influenza Vaccine Data � VAERS:
Data through 8 Jan 2010
The Centers for Disease Control and Prevention (CDC) and the FDA (Food
and Drug Administration) provide weekly updates on our vaccine safety
monitoring activities in an effort to put the data that are publicly
available through the Vaccine Adverse Event Reporting System (VAERS)
() and the CDC's website, WONDER
() in context. The following
information summarizes adverse event reports to VAERS after the
administration of [pandemic] 2009 H1N1 monovalent influenza vaccine
(either by nasal spray or injection).

An adverse event is a health problem that is reported after someone
gets a vaccine or medicine. Note that persons may experience adverse
events shortly after vaccination which may or may not be caused by the
vaccine. While VAERS is an important system for helping to find
potential signs, VAERS is primarily used to detect signals that may
require further investigation, but is not able to determine if an
adverse event was caused by vaccination.

VAERS Summary:
- As of 8 Jan 2010, more than 110 million doses of [pandemic] 2009
H1N1 vaccine had been shipped to vaccination providers in the United
States, although the precise number of vaccines administered is unknown.

- As of 8 Jan 2010, VAERS had received 7814 adverse event reports
following 2009 monovalent H1N1 vaccination.

- The vast majority (94 percent) of adverse events reported to VAERS
after receiving the 2009 monovalent H1N1 vaccine are classified as
"non-serious" (e.g., soreness at the vaccine injection site).

- Of the 7814 reports, 477 (6 percent) were reports that were
classified as "serious" health events (defined as life threatening or
resulting in death, major disability, abnormal conditions at birth,
hospitalization, or extension of an existing hospitalization)*.

- The percentage of reports involving what would be considered serious
health events is not different between 2009 H1N1 and seasonal
influenza vaccines. Additionally, no new or unusual events or pattern
of adverse events have emerged.

- VAERS reports continue to be monitored as more vaccine is administered.

- Among the 477 reports of serious health events, there were 33
reports of death.

- As with all reports of serious adverse events and deaths, the 33
VAERS reports that involve deaths are under review by the CDC, the FDA
and the states where the reported deaths occurred. Preliminary
findings do not indicate a common cause or pattern (such as
similarities in age, gender, geographic location, illness surrounding
death, or underlying medical conditions) to suggest that these deaths
were associated with the vaccine. These cases are under further review
pending additional medical records (e.g., autopsy reports, medical

- VAERS has received 46 reports of Guillian-Barre syndrome (GBS), for
which follow-up assessments are underway. In the United States, about
80-160 cases of GBS are expected to occur each week, regardless of

VAERS Limitations
When reviewing data from VAERS, please keep in mind what the system is
designed to do and what it is unable to do:

- VAERS is a national reporting system, in which reports are submitted
voluntarily by people who think an adverse event occurred after
vaccination. VAERS does not solicit reports in any systematic way from
all people who have been vaccinated. Reports can be submitted by
anyone, including health-care providers, patients, or family members.
Because of this feature, VAERS reports may and often do include
incorrect and incomplete information. VAERS reports often lead to more
complete follow-up and review of medical records.

- VAERS staff follow-up on all serious and other selected adverse
event reports and obtain additional medical, laboratory, and/or
autopsy records when available. As a result of the follow-up/review
process, coding terms (e.g., serious or non-serious) for individual
VAERS reports may change based on the information received. These
changes are reflected in the weekly updates of VAERS data in the
WONDER database. VAERS data in WONDER should be used with caution
because numbers and conditions are often updated. Events reported in
VAERS should not be viewed as evidence that the vaccine directly
caused the event. Data does not infer causality. Further investigation
is warranted.

- Underreporting, or failure to report events, is also one of the main
limitations of VAERS. Serious medical events are more likely to be
reported than minor events.

- Most importantly, VAERS cannot determine cause-and-effect. VAERS
accepts all reports without regard to whether or not the event was
caused by the vaccine. The report of an adverse event to VAERS does
not mean that a vaccine caused the event. It only indicates that the
event occurred some time after administration of the vaccine. Proof
that the event was caused by the vaccine is NOT required in order for
VAERS to accept the report.

- No reports are deleted from VAERS. Therefore, it is possible to have
more than one VAERS report on an individual case (e.g., a physician
and a patient may have filed separate reports for the same case).

- For all reports of serious adverse events, VAERS staff seeks
follow-up medical records on each case and medical officers review
them closely to determine if any additional action or studies may be

- The most reliable information about vaccine side effects can be
found in the manufacturers' vaccine package insert
vaccine information statements (VISs), or the Advisory Committee on
Immunizations Practices' (ACIP's ) statements on vaccines at

Actions taken by the CDC and the FDA
- The CDC and the FDA take every adverse event report seriously and
individually review all reports of serious adverse events so that
potential problems can be quickly evaluated.

- The CDC, the FDA and their partners are using many systems to
monitor the safety of 2009 monovalent H1N1 influenza vaccine. Two
primary systems that are in use are VAERS, which is jointly operated
with the FDA, and the Vaccine Safety Datalink (VSD) Project

- Additionally, the CDC and the FDA are collaborating with various
agencies, departments (e.g., Departments of Defense and Veterans
Affairs), and other partners (e.g., professional organizations,
academic institutions) to conduct surveillance of adverse events

- These federal agencies and departments, in cooperation with state
and local health departments, healthcare providers, and other partners
work closely with the CDC to monitor the safety of all vaccines
licensed for use in the United States, including 2009 H1N1 and
seasonal influenza vaccines.

- In an effort to be able to provide accurate and timely data on the
safety of the [pandemic] 2009 monovalent H1N1 influenza vaccine, the
federal government, along with local, professional, and academic
partners, has enhanced the existing vaccine safety monitoring systems

- The National Vaccine Advisory Committee (NVAC) created the H1N1
Vaccine Safety Risk Assessment Working Group to review 2009 H1N1
vaccine safety data
. This working
group of outside experts will conduct regular, rapid reviews of
available data from the federal safety monitoring systems and present
them to the NVAC and federal leadership for appropriate policy action
and follow up.

- A summary of the Federal Plans to Monitor Immunization Safety for
the Pandemic 2009 H1N1 Influenza Vaccination Program is available at

Facts about VAERS
- VAERS is a program that is jointly administered by the CDC's
Immunization Safety Office and the FDA. VAERS receives information
from different sources (vaccine recipients, parents, other family
members, doctors, other health-care workers, and the vaccine
manufacturer) across the United States who choose to report an adverse
event occurring after vaccination. VAERS is designed to identify
potential adverse events that warrant additional study.

- Serious adverse event and other selected reports are reviewed by
medical officers, nurses, and trained staff at both the FDA and the
CDC. VAERS receives reports of many events that occur following
immunization. It serves as an early warning system that can detect
patterns in reports and determine whether further investigation is

- An adverse event is a health problem that is reported after someone
gets a vaccine or medicine. It may or may not have been caused by the
vaccine or medicine. Some of these events may occur by chance or
during the period following vaccination, while others may actually be
caused by vaccination.

- Anyone who thinks that they may have had an adverse event after
receiving 2009 monovalent H1N1 influenza vaccine (or any vaccine)
should file a VAERS report. This can be done online, by regular mail,
or by fax.

[An adverse event, as defined by the Code of Federal Regulations, is
considered serious if it is life threatening, or results in death, a
persistent or significant disability or incapacity, congenital anomaly
or birth defect, hospitalization, or prolongation of existing

Communicated by:

[Taking into consideration the caveats expressed in the preceding
document it is clear that the rate of vaccine adverse events (VAE)
during the pandemic (H1N1) 2009 vaccination campaign is comparable to
that observed during the course of seasonal influenza vaccination. The
number of Guillain-Barre syndrome cases recorded is less than the
weekly average expected in the USA irrespective of vaccination. There
is no evidence that the 33 deaths recorded had any connection to the
vaccine. During the course of vaccination of 100 million people there
are likely to be a small number of coincidental deaths. Although not
noted in this document, it must be presumed that the mode of
vaccination and the origin of the vaccine were not causes for concern.
- Mods.JW/CP]

[2] Pandemic (H1N1) - Mongolia
Date: Fri 15 Jan 2010
Source: UB Post, Ministry of Health statement [edited]

H1N1 Mongolian Update
According to the Ministry of Health [of Mongolia], the number of
laboratory-confirmed cases of H1N1 has reached 1259. The death toll
caused by the pandemic (H1N1) 2009 virus has now reached 29. Of those
deaths, 15 were recorded in Ulaanbaatar City, 5 in Uvurkhangai, 2 in
Dornogobi and one in Arkhangai, Bulgan, Sukhbaatar, Dundgobi and
Bayan-ulgii provinces each.

As we previously reported, the WHO delivered 100 thousand doses of
[pandemic] H1N1 vaccine. In the 1st phase, vaccines were planned to be
provided to pregnant women. Accordingly, the districts' united
hospitals are currently providing vaccines to pregnant women. Children
were immunized with 60 thousand doses vaccine for A subtype
[pandemic?] influenza H1N1 virus.

32 thousand doses of vaccine were divided among public servants and
starting since yesterday [14 Jan 2010], the General Emergency Agency
and the State Professional Control Agency's staff were involved in the

And beginning today [15 Jan 2010], newsmen who are at constant risk of
infection because of their regular communication with the public are
now being vaccinated. According the Ministry of Health, 270
journalists will be involved in the vaccination.

Communicated by:

[Identification of journalists as a priority group for vaccination is
an unusual decision. A map of Mongolia showing the capital Ulaanbaatar
and the other cities can be accessed at:
. - Mod.CP]

[see also:
Influenza pandemic (H1N1) 2009 (123): vaccine safety 20091205.4152
Influenza pandemic (H1N1) 2009 (112): Canada (MB), vaccine reaction
Influenza pandemic (H1N1) 2009 (67): vaccine delivery 20091011.3515
Influenza pandemic (H1N1) 2009 (63): USA military vaccine 20091002.3437
Influenza pandemic (H1N1) 2009 (55): vaccine formulation 20090925.3359
Influenza pandemic (H1N1) 2009 (54): vaccine availability 20090921.3325
Influenza pandemic (H1N1) 2009 (53): vaccine donation 20090919.3290
Influenza pandemic (H1N1) 2009 (49): FDA vaccine update 20090917.3254
Influenza pandemic (H1N1) 2009 (21): vaccine prioriities 20090730.2669
Influenza pandemic (H1N1) 2009 (11): vaccine issues 20090722.2595
Influenza pandemic (H1N1) 2009 (10): vaccine 20090720.2577
Influenza pandemic (H1N1) 2009 (05): vaccine 20090716.2540
Influenza pandemic (H1N1) 2009 (03): vaccine 20090713.2505]
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