OREGON HEALTH AUTHORITY

IMMUNIZATION PROGRAM
ROTAVIRUS VACCINES
Live Virus Vaccine
Revisions as of July 2012
History of Severe Combined Immunodeficiency Disease (SCID) is being
added to contraindications for both RotaTeq and Rotarix vaccines
(Section V, p. 5).
A previous history of intussusception is being moved from a precaution
to a contraindication for both rotavirus vaccines (Section V, p. 5).
Added Appendix A (p. 8) for visual images of reconstitution and oral
administration of Rotarix vaccine.

I.

ORDER:
1. Screen for contraindications.
2. Provide the current Vaccine Information Statement (VIS), answering
any questions.
3. Obtain a signed Vaccine Administration Record (VAR).
4. Rotavirus vaccines are for oral use only.
o RotaTeq (RV5) is administered orally in a 3-dose series.
o Rotarix (RV1) is administered orally in a 2-dose series.
5. Both rotavirus vaccines can be administered simultaneously with other
childhood vaccines indicated at the same visits, including HIB, IPV,
Hepatitis B, PCV, and DTaP vaccines.

_________________________________________________________
Signature

Health Officer or Medical Provider

July 2012

Last Reviewed: July 2012

Last Updated: July 2012

Date

Rotavirus page 2 of 9

II. INSTRUCTIONS FOR ORAL ADMINISTRATION OF VACCINES

A) RotaTeq (RV5)
o Administer as soon as possible after removing vaccine from refrigerator
and protect from light.
o Tear open the pouch and remove dosing tube
o Clear fluid from dispensing tip by taping cap
o Puncture dispensing tip by screwing cap clockwise
o Remove cap by turning it counterclockwise
o Administer the 2 ml suspension of oral RotaTeq vaccine into the patients
mouth by gently squeezing the liquid toward the inner cheek until dosing
tube is empty. (A residual drop may remain in the tip of the tube).
o Discard the empty tube and cap in approved biological waste containers
o If an infant regurgitates, spits out, or vomits during or after administration of
vaccine, re-administration is not recommended.
o There are no restrictions on the infants consumption of food or liquid,
including breast milk, either before or after vaccination with PRV.
B) Rotarix (RV1) (Images in Appendix A, pp. 89)
o Reconstitute only with accompanying diluent.( which can be
refrigerated or stored at room temperature)
o Administer within 24 hours of reconstitution.
o Remove vial cap and push transfer adapter onto the vial (lyophilized
vaccine).
o Shake oral applicator containing liquid diluent vigorously. The suspension
will appear as a turbid liquid with a slow settling white deposit.
o Connect oral applicator to transfer adapter.
o Push plunger of oral applicator to transfer diluent into vial.
o Withdraw reconstituted vaccine into the oral applicator.
o Twist and remove oral applicator.
o With the infant seated in reclining position administer the 1 ml. dose orally
inside the cheek.
o Dispose of applicator and vaccine vial in biohazard waste container.
o If an infant regurgitates, spits out, or vomits during or after administration
of vaccine, re-administration is not necessary.

Rotavirus page 3 of 9

III. LICENSED LIVE ROTAVIRUS VACCINES

Product Name
RotaTeq1,2
(Merck)

Rotarix1,2
(GSK)

Acceptable
Age Range

Vaccine components
5 human-bovine
reassortant virus strains:
G1, G2, G3, G4, and P1[8]

Dose/route

632 weeks3

2 ml
Orally

Human strain G1P[8]

624 weeks3

1 ml
Orally

Live virus vaccines that replicate in the small intestine and induce immunity.
Store and transport refrigerated at 28C (3646F) and protect from light.
3
Although these are the FDA-approved age ranges found in the package inserts, ACIP has
recommended a 6-weeks-to-8-months range for both vaccines (Section V p. 4).
2

IV. RECOMMENDATIONS FOR USE

Infants
o All infants should be immunized with a 2-dose series if using Rotarix and
a 3-dose series if using RotaTeq. The series should start no earlier than 6
weeks of age and finish no later than 8 months 0 days of age. The first dose
should not be given 15 weeks of age.
Special Situations
o Premature Infants (i.e., those born at <37 weeks gestation) can be
immunized if they:
1. are at least 6 weeks of age,
2. are being or have been discharged from the hospital nursery,
and
3. are clinically stable.
o Infants living in households with persons who have or are suspected of
having an immunodeficiency disorder or impaired immune status may be
vaccinated.
o Infants living in households with pregnant women may be vaccinated.
Interchangeability of Rotavirus Vaccines
o ACIP recommends that the rotavirus vaccine series be completed with the
same product whenever possible. However, the vaccine provider should
continue or complete the series with the product available.
o If any dose in the series was RotaTeq or the product is unknown for any
dose in the series, a total of three doses of rotavirus vaccine should be
given.

Rotavirus page 4 of 9

V. RECOMMENDED ROTAVIRUS VACCINE SCHEDULE1

Dose
1
2
3

RotaTeq Age
2 months
4 months
6 months

Rotarix Age
2 months
4 months
-----------

Dosage Intervals and Ages for Rotavirus Vaccines1

RV5 (RotaTeq)
RV1 (Rotarix)
Number of doses in series
3
2
st
,2,3
Minimum age for 1 dose
6 weeks
st
Maximum age for 1 dose
14 weeks 6 days4
Interval between doses2
4 weeks
Maximum age for last dose
8 months 0 days
1

If any dose in the series was RotaTeq or the product is unknown for any dose in the
series, a total of three doses of rotavirus vaccine should be given
2
For retrospective checking, doses that violate the minimum spacing or age by 4 or
fewer days do not need to be repeated
3
Premature Infants (i.e., those born at <37 weeks gestation) can be immunized if they
a) are 6 weeks of age,
b) are being or have been discharged from the hospital nursery, and are clinically
stable.
c) are clinically stable.
4
Vaccination should not be initiated for infants 15 weeks of age. However, for infants in
whom the 1st dose of a rotavirus vaccine is inadvertently administered off label at age
15 weeks, the rest of the vaccination series can be continued and completed per the
schedule as long as the infant is 8 months of age.

Rotavirus page 5 of 8

VII. PRECAUTIONS3
VI. CONTRAINDICATIONS
A. History of severe allergic
Altered immunocompetence
reaction(e.g., anaphylaxis)
o Infants with blood dyscrasias,
after a previous dose of
leukemia, lymphomas of any type,
rotavirus vaccine or to a
or other malignant neoplasms
vaccine component
affecting the bone marrow or
B. Since latex rubber is contained
lymphatic system
in the Rotarix oral applicator,
o Infants on immunosuppressive
infants with a severe
therapy (including high-dose
anaphylactic latex allergy
systemic corticosteroids)
should not receive Rotarix.
o Infants with primary and acquired
immunodeficiency states, including
(RotaTeq is latex free).
HIV/AIDS or other clinical
C. RotaTeq and Rotarix:
manifestations of infection with
history of severe combined
human immunodeficiency viruses;
immunodeficiency disease
1
cellular immune deficiencies; and
(SCID)
hypogammaglobulinemic and
D. Previous history of
2
dysgammaglobulinemic states.
intussusception
o Infants with indeterminate HIV
status who are born to mothers with
HIV/AIDS
o Infants who have received a blood
transfusion or blood products,
including immunoglobulins, within
42 days
Acute, moderate or severe
gastroenteritis or other acute illness.
1

SCID is a severe defect in both the T- & B-lymphocyte systems. This usually results in the onset
of one or more serious infections within the first few months of life. This contraindication is in
both package inserts.
2
Infants with a history of intussusception are at a higher risk for a repeat episode.
3
The decision to vaccinate if a precaution is present should be made on a case-by-case risk and
benefit basis by the medical provider.
Reference for above contraindications and precautions: 2012 (12th Edition) Pink Book, p. 270.

Rotavirus page 6 of 9

VIII. ROTAVIRUS VACCINE ADVERSE REACTIONS

RotaTeq(RV5) Adverse Reactions in first 7 days of any dose1
Vaccine Recipients
Placebo Recipients
Vomiting
Diarrhea
Nasopharyngitis
Fever

15%
24%
7%
43%
1

14%
21%
6%
43%

No serious adverse reactions were reported

MMWR 2006; 55(RR-12)113

RotaTeq (RV5) Vaccine and Intussusception

Vaccine Recipients
Placebo Recipients
N = 34,035
N = 34,003
Within 42 days of
6 cases
5 cases
Vaccination
Within 1 year of
Vaccination

12 cases

15 cases

New Eng J Med 2006; 354: 2333

Rotarix Adverse Reactions within 8 days of Dose 1 and Dose 2

Dose 1
Dose 2
Adverse Reactions
Rotarix %
Placebo% Rotarix%
Placebo%
Fussiness/irritability
Cough/runny nose
Fever 100.4F rectally
or 99.5F oral
Loss of appetite
Vomiting
Diarrhea

52
28
25

52
30
33

42
31
28

42
33
34

25
13
4

25
11
3

21
8
3

21
8
3

2008 Rotarix package insert p. 6

Rotavirus Vaccine and Intussusception

Vaccine
Placebo
No. of Infants
Recipients
Recipients
RV1 (Rotarix) 63,225
7 cases
7 cases
RV5 (RotaTeq) 69,625
6 cases
5 cases
RV1: 630 days after either dose
RV5: 042 days after any dose

Reference: 2012 (12th edition) Pink Book, p. 272.

Rotavirus page 7 of 9

IX. OTHER CONSIDERATIONS

A Hospitalization after Vaccination: If a recently vaccinated child is
hospitalized for any reason, no precautions beyond the routine universal
precautions need be taken to prevent the spread of vaccine virus in the
hospital setting.
B Immunosuppressive therapies including irradiation, antimetabolites,
alkylating agents, cytotoxic drugs and corticosteroids may reduce the
immune response to vaccine.
C Infant Feeding: breast feeding OK; no evidence that breast feeding
reduced the protection against rotavirus afforded by Rotarix. No
restriction on infants liquid consumption before or after vaccination.
X. ADVERSE EVENT REPORTING
Adverse events following immunization should be reported by public
providers to the Oregon Health Authority Immunization Program by
FAX (971-673-0278) or mail according to state guidelines. Public
provider reporting forms are available at:
http://bit.ly/PublicProvidersVAERSform. Private providers report
adverse events directly to VAERS at www.vaers.hhs.gov.
XI.

REFERENCES

1. CDC. Prevention of rotavirus gastroenteritis among Infants and children

Recommendations of the Advisory Committee on Immunization Practices (ACIP).
MMWR 2009; 58(RR-02):125. Available at:
www.cdc.gov/mmwr/preview/mmwrhtml/rr5802a1.htm,
2. RotaTeq package insert. Available at:
www.merck.com/product/usa/pi_circulars/r/rotateq/rotateq_pi.pdf.
3. Rotarix 2008 package insert. Available at:
www.fda.gov/Cber/label/rotarixLB.pdf
4. ACIP. VFC Resolution No. 6/08-1: Vaccines to prevent rotavirus gastroenteritis.
Available at:
www.cdc.gov/vaccines/programs/vfc/downloads/resolutions/0608rotavirus.pdf.
5. Ruiz-Palacios GM, Prez-Schael I, Velzquez FR, et al. Safety and efficacy of an
attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med 2006;
354:1122.
6. Rotavirus. In: Epidemiology and Prevention of Vaccine-Preventable Diseases
(Pink Book). Atkinson W, Hamborsky J, Wolfe S, eds. 12th ed. Washington, DC:
Public Health Foundation, 2012: 26374. Available at:
hwww.cdc.gov/vaccines/pubs/pinkbook/index.html
For more information or to clarify any part of the above order, consult with your
Health Officer or call the Oregon Health Authority Immunization Program at
971-673-0300.

To download a copy visit our website at

http://1.usa.gov/OregonStandingOrders

Rotavirus page 8 of 9

APPENDIX A

Reconstitution Instructions for Oral Administration of

Rotarix
Remove vial cap and push transfer
adapter onto vial (lyophilized vaccine)

Shake diluent in oral applicator

(white, turbid suspension). Connect
oral applicator to transfer adapter.

Push plunger of oral applicator to transfer

diluent into vial. Suspension will appear
white and turbid.

Withdraw vaccine into oral applicator.

Twist and remove the oral

applicator.

APPENDIX A CONTINUED

Rotavirus page 9 of 9

Ready for oral administration

Do not use a needle with ROTARIX.

Not for Injection

To request this material in an alternate format (e.g., Braille),

please call 971-673-0300.