WEBCAST TRANSCRIPT

Transcript of "Smallpox Vaccine Safety and Reporting Adverse Events"\
Presented by Dr. Gina Mootrey, 6 December 2002, on the satellite
broadcast of "CDC Bioterrorism Update: Smallpox Preparedness"

(Associated graphics can be found at\
[www.bt.cdc.gov/agent/smallpox/training/webcast/dec2002/files/safety.ppt](http://www.bt.cdc.gov/agent/smallpox/training/webcast/dec2002/files/safety.ppt)
and
[www.bt.cdc.gov/agent/smallpox/training/webcast/dec2002/files/safety.pdf](http://www.bt.cdc.gov/agent/smallpox/training/webcast/dec2002/files/safety.pdf).)

Gina Mootrey, DO, MPH, Medical Epidemiologist, National Immunization
Program. CDC

(Slides 1 and 2-3 are title and objectives, respectively)

# MOOTREY:

I appreciate the opportunity to speak to you today. From the previous
presentations it should be apparent why vaccine safety is so important.
To complete the vaccine safety discussions, I intend to give you a
programmatic overview of smallpox vaccine safety monitoring and
reporting.

## Slide 4

I will begin with an overview of the process for reporting smallpox
vaccine adverse events. Vaccination clinics and healthcare providers
should report clinically significant and unexpected adverse events to
their state health department. The state health department will, in
turn, report such adverse events to the CDC. A VAERS report should also
be filed for clinically significant and unexpected adverse events; the
VAERS report can be submitted by the clinic, provider, vaccinee, or
state health department.

## Slide 5

Some of you might be unfamiliar with VAERS, so let me take a moment to
explain. VAERS is the national surveillance system for adverse events
following the administration of U.S. licensed vaccines. VAERS is
administered by CDC and the Food and Drug Administration. VAERS data are
routinely analyzed by CDC and the FDA to identify: new or rare vaccine
side effects; increases in rates of known side effects; associations
with specific vaccine lots; and patient risk factors

## Slide 6

Although any adverse event can be reported to VAERS, it is most
important to report the clinically significant or unexpected adverse
events, ideally within 48 hours. What is meant by clinically
significant? Of course, serious adverse events, events that result in
death, hospitalization, permanent disability or are life-threatening are
considered clinically significant. Adverse events that prompt a visit to
a healthcare provider may also be considered clinically significant;
however, that is left up to the judgment of the healthcare provider.
Adverse events other than unexpected or clinically significant can be
reported to VAERS within 7 days.

## Slide 7

Anyone can report to VAERS: vaccinees, healthcare providers, vaccine
manufacturers, and, of course state health departments. For smallpox
vaccine, state health departments should make sure that VAERS reports
have been filed for the clinically significant and unexpected adverse
events. Reports can be sent to VAERS via the web, FAX, or mail. The
VAERS contact information is listed on the screen. The website is
http://secure.vaers.org/VaersDataEntry.cfm. The FAX number is
877-721-0366. Call 800-822-7967 for a report form.

## Slide 8

So much for the reporting of adverse events. Let's spend some time
considering the vaccine safety roles and responsibilities of the
different participants in the vaccination program. At the federal level,
CDC will be responsible for tabulating the reported adverse events, by
number and type of adverse event. We will determine the reported
frequency of known serious adverse events to estimate whether the
reported rates are consistent with the historically reported rates. CDC
will review VAERS reports and information from the states and providers
on a daily basis to monitor for unexpected adverse events. If there are
any unusual adverse events, such as type of event, geographic location,
or population distribution, CDC will conduct special studies to further
investigate any risk factors. CDC will make Vaccinia Immune Globulin or
VIG and cidofovir available under Investigational New Drug (IND)
protocols for selected adverse events. This was stated in an earlier
presentation, but the conditions for which VIG is clearly indicated are
eczema vaccinatum, progressive vaccinia, and severe generalized
vaccinia.

## Slide 9

CDC will also provide technical assistance to state health departments
to support the safest possible use of smallpox vaccine. For example, CDC
will provide assistance for questions regarding screening,
contraindications, vaccination technique, and adverse events. CDC will
provide technical consultation to clinicians in the diagnosis and
management of adverse events after smallpox vaccination, especially if
the adverse events are moderate to severe, unexpected, or are not
following an expected clinical course. And CDC will work with the Food
and Drug Administration to monitor VAERS reports.

## Slide 10

State Health Departments should develop a plan to assure monitoring of
adverse events among smallpox response teams. As part of that plan,
State Health Departments need to identify an individual to oversee,
establish, and coordinate vaccine safety monitoring.

## Slide 11

They should be prepared to communicate with medical organizations within
their state, and to communicate with media on vaccine safety issues
before, during and after the vaccination program. Although states may
designate or recommend certain medical facilities for the assessment of
adverse events, in practice, vaccinees could enter the healthcare system
at many points. Therefore, the state should make sure their healthcare
providers are aware of the vaccination program and know who to contact
if they need to assess, refer, or treat a person with a potential
vaccine adverse event.

## Slide 12

As part of the State Health Department plan for vaccine safety
monitoring, there should be a system developed for rapid reporting and
assessment of adverse events in vaccinees or their contacts. This system
should provide coverage for answering questions posed by vaccinees and
clinicians 24 hours a day, 7 days a week. This system should assure
prompt reporting to CDC for clinically significant and unexpected
adverse events; VIG or cidofovir requests; and for the clinical outcome
following treatment.

## Slide 13

I just mentioned that there should be prompt reporting to CDC for VIG or
Cidofovir requests. However, I'd like to stress that not only is
reporting essential, but discussion of the case with CDC is needed. So,
let me reiterate, CDC MUST be contacted for VIG or Cidofovir requests.
And, the system should assure that all of the reporting and regulatory
requirements for the VIG and Cidofovir INDs are fulfilled.

## Slide 14

Hospitals are major participants in this vaccination program since many
of them will have staff vaccinated as part of smallpox response teams.
The hospitals with smallpox response teams must provide follow-up of
vaccinees, including 24/7 coverage for vaccine adverse event assessment.
It is recommended that hospitals perform daily vaccination site care to
reduce the possibility of contact transmission of the vaccine virus from
the healthcare worker to any patients. Hospitals should identify
subspecialists to assist with assessment of suspected adverse events.
Subspecialty categories would ideally include dermatology, infectious
diseases, neurology, ophthalmology, and allergy/immunology.

## Slide 15

Hospitals should promptly notify their state health department of any
clinically significant or unexpected adverse events and should submit a
case report to the health department.

## Slide 16

As might be expected, vaccination clinics have a number of vaccine
safety responsibilities. Vaccine clinics should be prepared to treat
rare, immediate adverse events, such as anaphylaxis or syncope. The
clinics should be able to educate vaccinees on vaccination site care,
such as with written instructions. Vaccine clinics should assure that
vaccinees have instructions for follow up, such as for vaccine take
checks.

## Slide 17

Not only should the clinics know the reporting process for adverse
events for their own reporting purposes, but they should also be able to
provide vaccinees with information on who to contact for suspected
adverse events. Clinics should tabulate the number of persons
vaccinated. This is helpful for evaluating clinic operations, monitoring
vaccine use, and, for vaccine safety purposes, it facilitates
calculating the rate of reported adverse events. In an earlier
presentation you heard about the Pre-Event Vaccination System or PVS.
One plus of the PVS is that a report of those vaccinated can be easily
generated for each clinic.

## Slide 18

Last in my presentation, but not least among the participants in the
vaccination program, are the individual health care providers. We
acknowledge that most healthcare providers have never seen smallpox
vaccination adverse events. However, with educational programs such as
this broadcast and others, we would anticipate that most providers would
be able to recognize possible adverse events. Many of the adverse events
will be mild and can be managed by primary care physicians. However, for
moderate, severe, or unusual adverse events, healthcare providers should
know how to refer patients as clinically indicated to an appropriate
specialist.

## Slide 19 -- Individual Providers' Roles and Responsibilities

For clinically significant and unexpected adverse events, the provider
must report to the state health department and to VAERS. If a provider
needs to treat a vaccinee or contact with VIG or Cidofovir, the provider
must comply with the IND protocol requirements.

## Slide 20

To obtain VIG or Cidofovir, the treating physician should contact their
designated state official. The State will inform CDC of the request for
VIG and/or cidofovir. After review of the case and indications for use
of VIG or Cidofovir, CDC will release the requested treatment product.

## Slide 21

In summary, CDC, the states, and individual healthcare providers and
medical facilities all have important roles and responsibilities in the
surveillance and reporting of clinically significant or unexpected AEs.
Clinically significant or unexpected adverse events should be reported
promptly to the state health department, which will, in turn, report to
CDC. Clinically significant or unexpected adverse events should also be
reported through VAERS.

## Slide 22

CDC will monitor these reports and provide information to assist the
states in the operation of their vaccination program. Some AEs will
benefit from treatment with VIG or Cidofovir, which are available from
CDC under IND protocols.

## Slide 23

Everyone's participation in this process will be critical to ensure we
learn as much as possible about smallpox vaccine in today's world.
Finally, as mentioned multiple times during the various presentations in
this broadcast, information and resources for smallpox surveillance and
reporting, including vaccine safety, can be found at
www.cdc.gov/smallpox

# MOOTREY

I hope the information presented today has given you an understanding of
the need for, and the steps involved in smallpox vaccine safety
monitoring and reporting. Thank you.

END

For more information, visit
[www.cdc.gov/smallpox](http://www.cdc.gov/smallpox), or call the CDC
public response hotline\
at (888) 246-2675 (English), (888) 246-2857 (Español), or (866) 874-2646
(TTY)