1. Adult Vaccinations: An Update
Bernard J Dunn School of Pharmacy
Shenandoah University
03/13/2013

2. Objectives
● Evaluate pneumococcal vaccine Menveo®
● Compare Menveo® with other meningococcal
vaccines
● Provide new Advisory Committee on Immunization
Practices (ACIP) recommendations for vaccinations

3. Menveo®
● FDA approved 2010 for active immunization against
invasive meningococcal disease caused by Neisseria
meningitidis serogroups: A, C, Y and W-135.
● Initially, Menveo® was only indicated for use for persons
11-55 years old. Coverage expanded in June 2011 to
include children ages 2-10.
● Administered as a single dose IM.
Menveo package insert, 2011

4. Menveo - Efficacy
Clinical Trial for the safety and efficacy of Menveo in children 2-10 years old
study design
MENVEO in subjects 2-55 years old was assessed by comparing
the serum bactericidal antibody (SBA) responses to immunization
with Menveo®
● Two randomized, multicenter, active controlled clinical studies
comparing the hSBA responses following one dose of Menveo® or
Menactra®.
● Primary endpoint - hSBA seroresponse to each serogroup 28 days after
vaccination. Seroresponse was defined as:
- post vaccination hSBA titer of ≥1:8 for subjects with a baseline hSBA titer of <1:4 OR
at least 4-fold higher than baseline titers for subjects with a pre-vaccination hSBA titer ≥1:4.
Menveo package insert, 2011

5. Menveo - Efficacy
● Population – (1170) Menveo® and (1161)
Menactra®
● Demographics were similar between the two
groups

6. Menveo - Efficacy
● Results (28 days after vaccination)
Ages 2-5 (seroresponse in %)
Menveo® was non-inferior to Menactra® for subjects with a
seroresponse for serogroups C (60 vs. 56), W-135 (72 vs. 58) and Y
(66 vs. 45) , but not for serogroup A (72 vs. 77)
Ages 6-10
Menveo® was non-inferior to Menactra® for subjects with a
seroresponse for serogroups C(63 vs. 57), W-135 (57 vs. 44) and Y
(58 vs. 39) , but not for serogroup A (77 vs. 83)

7. Menveo - Efficacy
Ages 11-18
Menveo® was non-inferior to Menactra in all four serogroups A
(75 vs. 66), C (76 vs. 73), W-135(75-63) and Y(68 vs. 41) for the
proportion of subjects with a seroresponse.
Ages 19-55
Menveo® was non-inferior to Menactra in all four serogroups A
(67 vs. 68), C (68 vs. 60), W-135(50-41) and Y(56 vs. 40) for the
proportion of subjects with a seroresponse.

8. Menveo® - Safety
Study design
● Ages 2-10: four randomized clinical trials.
● Population - 3181 subjects received Menveo® and 2116 received either Menomune®
or Menactra®.
● 51% male in both populations and mean age was 5.2 years old.
● Safety of a second dose of Menveo administered 2 months following a first dose was
assessed in 351 children ages 2-5 years old.
● Ages 11-55: five randomized trials.
● Population - 5286 subjects received Menveo® , 209 subjects received Menomune®
and 1757 patients Menactra®.
● Average ages on Menveo® were 23.5 years (SD 12.9 years), Menacta® 29.2 years (SD
13.4), Menomune® 14.2 years (sd 1.8 years)
● Subjects were monitored for 7 days following vaccinations, 28 days for adverse
events and serious adverse events 6 months after vaccination.

9. Menveo
● Results - Adverse reactions
Ages 2-10
Injection site pain(31%), erythema (23%), irritability (18%),
induration (16%), sleepiness (14%), malaise (12%), and
headache (11%)
Ages 11-55
Injection site pain (41%), headache (30%), myalgia (18%),
malaise (16%) and nausea (10%)
These adverse reactions when compared to Menactra
were not significantly different.

10. Menveo®-pregnancy
● Pregnancy Category B – Animal Studies performed in females rabbits at a dose 20x
the human dose revealed no evidence of impaired fertility or harm to the fetus.
● Among 5065 adolescent and adult women enrolled:
– 43 were found to be pregnant during the 6-month follow-up period after
vaccination.
– 37 pregnancies occurred among 3952 Menveo® recipients
7 spontaneous abortions, no congenital anomalies
– 6 pregnancies occurred among 1113 Menactra® recipients
no spontaneous abortions, one congenital anomaly (hydrocephalus)
● Women who are pregnant or become aware that they are pregnant at the time of
Menveo injection should contact the Novartis Vaccines and Diagnostics Inc.
pregnancy registry at 1-877-311-8972

11. Menveo® vs Menactra®
Menveo® Menactra®
Pathogen N. meningitidis N. meningitidis
Serotypes A, C, Y, W-135 A, C, Y, W-135
Age 2-55 y/o 9 months – 55 y/o
Cost 5 pack-single dose vials:
$110.72
5 pack-single dose vials:
$112.72
Bottom Line:
●Menveo is non inferior to Menactra in the prevention of serogroups A, C, Y, W-135
caused by N. meningitidis. At this moment, based on cost and its age of approval, I
would not recommend it for the addition to the formulary. More studies on its long-
term safety profile would be beneficial for re-evaluation.

12. Menveo® vs. Menomune®
Menveo® Menomune®
Pathogen N. meningitidis N. meningitidis
Serotypes A, C, Y, W-135 A, C, Y, W-135
Age 2-55 y/o ≥2 y/o
Cost 5 pack-single dose vials:
$110.72
5 pack-single dose vials:
$112.72

13. Menhibrix®
● Approved June 2012 for infants and children ages 6
weeks - 18 months, for prevention of invasive
disease caused by Neisseria meningitidis serogroups
C and Y and Haemophilus influenzae type b.
● Administered as four IM doses at 2, 4, 6 and 12
through 15 months of age. The first dose may be
given as early as 6 weeks of age. The fourth dose
may be given as late as 18 months of age.

14. New vaccines 2013
● Flublok® (influenza vaccine)
● Approved January 2013
● Trivalent influenza vaccine made using an insect virus (baculovirus) expression
system and recombinant DNA technology – does not use the influenza virus or eggs
in its production.
● Indication - active immunization against influenza virus subtypes A and type B
● Flublok® is approved for use in persons 18 through 49 years of age.
Flublok® package insert, 2013

15. Vaccine recommendation updates
Pneumoccocal Polysaccharide Vaccine
2012
● Individuals 65+ y/o vaccinated with PPSV23 before age 65 years and for whom at least 5 years has
passed since their previous dose should be vaccinated with PPSV.
2013
● Individuals who have received 2 doses of PPSV23 before age 65 years are recommended to receive
PPSV23 at age 65 years, as long as it has been 5 years since the most recent dose.
● Pneumococcal Conjugate Vaccine 13 (PCV13) vaccine – recommended for adults aged 19 years or
older with immunocompromising conditions including chronic renal failure, cerebrospinal fluid
leaks and cochlear implants.
● Individuals not previously vaccinated with PCV13 or PPSV23 should receive a single dose of PCV13

16. Vaccine recommendations updates
Pneumoccocal Polysaccharide Vaccine
Notes
- Individuals 65 years and older, individuals ages 2-64 with long term
health problems including: heart disease, lung disease, sickle cell disease,
diabetes, alcoholism, cirrhosis, leaks if CSF should get the vaccine.
● Individuals ages 2-64 with immunocopromising conditions e.g. kidney
failure, HIV, organ transplant should also be vaccinated.
● Individuals ages 2-64 who on long term steroids, oncology drugs should
also be vaccinated.
● Adults 19-64 years old who are either smokers or have a history of asthma

17. Vaccine recommendations updates
Influenza
2012
● Infants 6 months or older can receive trivalent inactivated vaccine (TIV).
● Health care professionals caring for persons in a protected environment should receive TIV.
● Health care professionals younger than 50 y/o may receive either the live attenuated
influenza vaccine or TIV as long as they do not have any contraindications.
2013
● The influenza vaccination footnote (footnote 2) will now use the acronym IIV for inactivate
influenza vaccine.
● The acronym TIV has been dropped for trivalent inactivated vaccine.
● 2013–14 influenza season – LAIV will be available only in a quadrivalent formulation; IIV may
be available in both trivalent and quadrivalent formulations.
Notes
- Pregnant women, children 6 months and older, health care personnel, persons living in a
nursing home, individuals with a weakened immune system or have a long term chronic
illness should be vaccinated.

18. Vaccine recommendations updates
Tetanus, Diptheria, Pertussis (Tdap)
2012
● Persons who are close contacts of infants younger than 12 months of age e.g.
parents, grandparents, and child care providers and who have not received Tdap
previously are recommended to receive the vaccine.
● ACIP recommends pregnant women to receive the vaccination preferentially after 20
weeks gestation.
● Other adults in close contacts of children younger than 12 months are also advised to
receive a one-time dose of Tdap vaccine.
2013
● Adults aged 65 years or older should receive the vaccine.
● Pregnant women are now recommended to receive the Tdap vaccine with each
pregnancy.
Notes
● Recommended as a booster to the DTaP vaccine in children 11-12 years old.
● Adults 19-64 years old should also receive one dose of Tdap and a booster Td
vaccine every 10 years.

19. Vaccine recommendation updates
Human Papillomavirus (HPV) vaccine
2012
● While the HPV vaccine is not recommended for health care
employees, they should receive the vaccine if they are in
the specified age group.
● Males 11-12 years or males 13-21 years requiring catch up
vaccination may receive the quadrivalent human
papillomavirus (HPV4) vaccine.
● Males aged 22 to 26 years may also be vaccinated with
HPV4 vaccine.
2013
● No changes

20. Vaccine recommendation updates
Human Papillomavirus (HPV) vaccine
Notes
Gardasil® is approved for:
- Females ages 9-26 to protect against cervical cancer
and to prevent genital warts
- Males ages 9 - 26 to prevent genital warts
Cervarix® is approved for:
- Females age 10 - 26 to help protect against cervical
cancer

21. Vaccine recommendations updates
Herpes Zoster vaccination
2012
● Although zoster vaccination is not specifically
recommended for health care employees, they should
receive the vaccine if they are in the recommended age
group.
● The Herpes Zoster vaccine is FDA-approved for use in
persons aged 50 years or older – however ACIP continues
to recommend that vaccination begin at age 60 years.
2013
● Persons ≥ 60 years with or without underlying health
conditions are recommended to receive the Zoster vaccine.

22. Vaccine recommendations updates
Mumps, Measles, Rubella (MMR) Vaccine
2013
● A health care provider diagnosis of measles, mumps, or rubella is not considered
acceptable evidence of immunity.
● Previously, a provider diagnosis of measles or mumps but not rubella was considered
acceptable evidence of immunity.
Notes
- Children 12-15 months should get the vaccine and a second shot should be
administered when the child is 4-6 years old
- Adults born after 1956 should be vaccinated

23. Vaccine recommendations updates
Hepatitis A and B
2012
● Hepatitis B vaccination is now recommended for
individuals with diabetes who are ≤60 years or if
over 60 and requires glucose monitoring.
2013
● The hepatitis A vaccination is now recommended
for persons with a history of either injection or
non-injection illicit drug use.

24. Vaccine recommendations updates
Hepatitis A
Notes
- Recommended for all children 1 year and older, people travelling to Asia, Africa,
South America and the Caribbean
- Also recommended for individuals at higher risk including IV drug users, persons
with chronic liver disease, men who have sex with other men, employees of child
daycare centers, persons living in long term care facilities
- If you have had hepatitis A in the past this vaccination is not required.
Hepatitis B
Notes
- High risk individuals including health care workers, persons on dialysis, people

25. Vaccines in pregnancy
Recommended
Influenza (Inactivated), Tdap
Contraindicated
Influenza (LAIV), MMR, Varicella, Zoster
● Hepatitis B may be recommended in some circumstances: HIV
risk, treatment for STD, recent or current injection drug use
● Meningococcal and Pneumococcal lack sufficient data for
recommendation during pregnancy

26. References
1. Novartis Vaccines and Diagnostics, Inc. Menveo® package insert. Cambridge, MA:
2011, January
2. Anon. CDC Vaccine Price List. (http://www.cdc.
gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/index.
html) . Updated 7 March 2013. Accessed 19 March 2013.
3. GlaxoSmithKline Biologicals, Inc. Menhibrix® package insert. Pixensart, Belgium:
2012
4. Anon. Recommended Adult Immunization Schedule: United States, 2012*. Ann
Intern Med. 2012 Feb;156(3):211-217.
5. Anon. Recommended Adult Immunization Schedule: United States, 2013* . Ann.
Internal Med. 2013 Feb;158(3):191-199.
6. Anon. Guidelines for Vaccinating Pregnant Women. (http://www.cdc.
gov/vaccines/pubs/preg-guide.htm#hepa) Updated March 2013. Accessed 19
March 2013.
7. Anon. Protein Science Corp. Flublok® package insert. Meriden, CT:2013, January

27. Questions