**Centers for Disease Control and Prevention's**

**Immunization Safety Office Scientific Agenda:**

**Draft Recommendations: Addendum on April 10, 2008**

**EMBARGOED UNTIL 9AM EST ON APRIL 11, 2008**

This draft document was prepared for the National Vaccine Advisory
Committee (NVAC) Vaccine Safety Working Group for its scientific review
on April 11, 2008. It does not represent Centers for Disease Control and
Prevention (CDC) or Department of Health and Human Services policy, nor
does it necessarily reflect which ideas will be incorporated into CDC's
final Immunization Safety Offices Scientific Agenda.[^1]

**Section 3: 5-Year Research Needs**

**[Table 3B: ISO 5-Year Research Needs: Vaccines and Vaccination
Practices]{.underline}**

+----+-------------------+---------------------------------------------+
| ** | **Thematic Area** | **Background**                              |
| It |                   |                                             |
| em |                   |                                             |
| ** |                   |                                             |
+====+===================+=============================================+
| ** | **Safety of       | -   Within the same vaccine category,       |
| B- | different         |     certain vaccines are available from     |
| VI | products within   |     different manufacturers; these vaccines |
| ** | the same vaccine  |     have different antigen and non-antigen  |
|    | category**        |     compositions.                           |
|    |                   |                                             |
|    |                   | -   Some examples of vaccines with more     |
|    |                   |     than one formulation on the US market   |
|    |                   |     are: trivalent inactivated influenza    |
|    |                   |     vaccines (TIV), diphtheria and tetanus  |
|    |                   |     toxoids and acellular pertussis (DTaP)  |
|    |                   |     vaccines, and rotavirus vaccines. A     |
|    |                   |     quadrivalent human papillomavirus (HPV) |
|    |                   |     vaccine is routinely recommended; a     |
|    |                   |     bivalent HPV vaccine is under FDA       |
|    |                   |     review for licensure.                   |
|    |                   |                                             |
|    |                   | -   The ACIP recommends that "for vaccines  |
|    |                   |     in general, vaccination should not be   |
|    |                   |     deferred because the brand used for     |
|    |                   |     previous doses is not available or is   |
|    |                   |     unknown," (CDC, ACIP, 2006).            |
|    |                   |                                             |
|    |                   | -   Information about the interchangeable   |
|    |                   |     use of vaccine of the same category     |
|    |                   |     form different manufacturers is         |
|    |                   |     generally limited.                      |
+----+-------------------+---------------------------------------------+
| *  | **Off label use   | -   Off label use is defined as use of a    |
| *B | of vaccines**     |     product other than the                  |
| -V |                   |     [indication](http://                    |
| II |                   | cancerweb.ncl.ac.uk/cgi-bin/omd?indication) |
| ** |                   |     for which it was approved by the Food   |
|    |                   |     and Drug Administration.                |
|    |                   |                                             |
|    |                   | -   Off label use may be inadvertent or     |
|    |                   |     intentional. Examples of off label use  |
|    |                   |     might include use of a product in an    |
|    |                   |     age group outside the recommended age   |
|    |                   |     group or use in a population for whom   |
|    |                   |     the vaccine is contraindicated. For     |
|    |                   |     example, administering live, attenuated |
|    |                   |     influenza vaccine (LAIV) to a person    |
|    |                   |     with asthma would be an off-label use.  |
|    |                   |                                             |
|    |                   | -   Safety data about the off label use is  |
|    |                   |     generally not available at the time of  |
|    |                   |     licensure.                              |
+----+-------------------+---------------------------------------------+
| ** | **Vaccine-drug    | -   From the standpoint of safety, few      |
| B- | interactions**    |     vaccine-drug interactions have been     |
| VI |                   |     systematically studied.                 |
| II |                   |                                             |
| ** |                   | -   Jackson et al. conducted a cohort study |
|    |                   |     in adults on warfarin therapy. The      |
|    |                   |     results, "do not suggest that           |
|    |                   |     vaccinations lead to clinically         |
|    |                   |     significant alterations in coagulation  |
|    |                   |     measures among adults on chronic        |
|    |                   |     warfarin therapy" (Jackson,             |
|    |                   |     Pharacoepimemiology and Drug Safety,    |
|    |                   |     2007).                                  |
|    |                   |                                             |
|    |                   | -   Oral contraceptive use is a known risk  |
|    |                   |     factor for venous thromboembolic events |
|    |                   |     (VTE) (Petitti, NEJM, 2007). In 2002,   |
|    |                   |     31% of the US women aged 15--44 years   |
|    |                   |     used oral contraceptives (CDC, National |
|    |                   |     Center of Health Statistics, 2007). The |
|    |                   |     Vaccine Adverse Event Report System     |
|    |                   |     (VAERS) has received reports of         |
|    |                   |     thromboembolic events in women who were |
|    |                   |     vaccinated with human papillomavirus    |
|    |                   |     (HPV) vaccine who were taking oral      |
|    |                   |     contraceptives (CDC, ACIP presentation, |
|    |                   |     2007).                                  |
+----+-------------------+---------------------------------------------+

**References**

CDC, National Center for Health Statistics, Health, United States, 2007
with Chartbook on Trends in the Health of Americans

Hyattsville, MD: 2007.

CDC. General Recommendations on Immunization: Recommendations of the
Advisory Committee on Immunization Practicies (ACIP).
2006;55(RR15):1-48.

CDC. Advisory Committee on Immunization Practices (ACIP) Presentation,
Quadrivalent HPV Vaccine Safety Update, June 28, 2007, available at
<http://www.cdc.gov/vaccines/recs/ACIP/slides-jun07.htm#hpv>, accessed
on April 9, 2008.

Jackson ML, Nelson JC, Chen RT et al. Vaccines and changes in
coagulation parameters in adults on chronic warfarin therapy: a cohort
study. . Pharmacoepidemiol and Drug Safety 2007;16(7):790-796.

Petitti DB. Combination Estrogen--Progestin Oral Contraceptives. New
England Journal of Medicine. 2003;349:1443-1450.

[^1]: Address comments to CDC Immunization Safety Office Scientific
    Agenda: <isoagenda@cdc.gov> or 404-639-8256