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| As appeared in the April 2010 issue of Needle Tips |
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Click here for PDF version
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| Q: |
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On Oct. 17, 2009, The Lancet
published a study that found that infants who received 3 doses of
acetaminophen following
immunization had reduced immune responses to certain vaccines.
Based on these findings, should we stop recommending
acetaminophen for fever or discomfort after infant immunization? |
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| A: |
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Evidence from this study discourages the prophylactic use of
paracetamol (acetaminophen) prior to or immediately following
vaccination. Acetaminophen can be used to treat pain or fever if
it should occur following vaccination. In the upcoming 2010
General Recommendations on Immunization, CDC will remove all
recommendations for prophylactic use of acetaminophen or other
analgesics BEFORE or AT THE TIME OF vaccination. AAP has already
removed such recommendations from the Red Book. |
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| Q: |
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Why were U.S.
healthcare providers recommended to temporarily suspend
administering Rotarix rotavirus vaccine (RV1; GSK) in
late March 2010? |
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| A: |
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GSK reported to FDA that an independent academic research team
using a novel technique to look for viruses had discovered DNA
components from porcine circovirus type 1 (PCV1) in Rotarix
vaccine. GSK conducted additional studies and confirmed that DNA
from PCV1 is present in the finished Rotarix vaccine (as well
as in the cell bank and seed from which the vaccine is
derived)
and that it has been present since the early stages of the
vaccine's development. FDA decided to suspend the vaccine's
use
while learning more about the situation and until further
studies are done. PCV1 is not known to cause disease in people
or
animals. PCV1 was not found in RotaTeq rotavirus vaccine (RV5;
Merck). |
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| Q: |
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Was FDA's decision to temporarily
stop the use of Rotarix vaccine based on safety
concerns? |
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No. Based on what is currently known, the presence of PCV1 is not
a safety issue. Rotarix has been extensively studied, both
before and after its licensure, and has had an excellent safety
record. |
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| Q: |
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Do children who have received
Rotarix vaccine need medical follow-up? |
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| A: |
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No. FDA does not believe medical follow-up is warranted for
children who have been vaccinated with Rotarix. Extensive
studies
involving tens of thousands of vaccine recipients support the
safety and effectiveness of this vaccine. |
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| Q: |
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How should we complete the
rotavirus vaccine series in infants who have already received
1 dose of Rotarix? |
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| A: |
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If you started an infant on Rotarix, complete the series by
administering 2 doses of RotaTeq. RotaTeq is routinely given
using a 3-dose schedule at ages 2, 4, and 6 months. It is
important that you keep infants on schedule as they must
complete
the third and final dose by age 8 months, 0 days. |
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| Q: |
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Should we return our existing
supply of Rotarix to the manufacturer or distributor where we
bought it? |
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| A: |
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No. FDA will be convening an expert advisory committee to
review available data and will then issue subsequent
recommendations. For now, you should keep it in proper storage
(i.e., store the lyophilized Rotarix at refrigerated
temperatures [35° to 46°F; 2° to 8°C] and store the diluent at
room temperatures [68° to 77°F; 20° to 25°C]). |
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| Q: |
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Where can I find the
most up-to-date information about that status of Rotarix
vaccine? |
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| Q: |
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Has the World Health
Organization (WHO) also recommended temporary suspension of
the use of Rotarix? |
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No. WHO issued a statement on March 22 titled "WHO does not
recommend any change to use of Rotarix vaccine." It includes
the
following: "...WHO concurs with the views of the FDA and EMA
[European Medicines Agency] that the findings do not present a
threat to public health. Moreover, rotaviruses are the most
common cause of severe diarrhoeal disease in young children
throughout the world, with an estimated 527,000 deaths among
children under five years old, most of whom live in low-income
countries. Therefore, WHO does not recommend any change to use
of the vaccine..." To read the full WHO statement on Rotarix,
go to
www.who.int/immunization/newsroom/news_rotavirus_vaccine_use/en. |
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| Q: |
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Please tell me about the new
pneumococcal conjugate vaccine, Prevnar 13. |
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On February 24, FDA licensed the 13-valent pneumococcal vaccine,
PCV13 (Prevnar 13; Pfizer). It contains the 7 Streptococcus
pneumoniae serotypes included in the first pneumococcal conjugate
vaccine (PCV7, Prevnar), plus 6 additional serotypes (1, 3,
5, 6A, 7F, and 19A). Together, these 13 serotypes account for the
majority of invasive pneumococcal disease (IPD) in the
U.S., including serotype 19A, which is now the most common IPD-causing
serotype in young children. On February 24, ACIP voted
to approve recommendations for the use of PCV13, and on March 12
the recommendations were published in MMWR. To access them,
go to
www.cdc.gov/mmwr/PDF/wk/mm5909.pdf, and see pages 258–261. |
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| Q: |
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What vaccination schedule should
we follow for PCV13? |
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Generally, you should follow the same 4-dose schedule you followed
for PCV7, administering doses at ages 2, 4, 6, and 12–15
months. Following are additional recommendations concerning PCV
13: |
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For children who have begun a series of PCV7, replace all
remaining doses with PCV13. If you are unsure how to assess and
complete the pneumococcal conjugate vaccine immunization schedule
for children who may have fallen behind, consult the
pneumococcal vaccine catch-up schedule that can be found at
www.immunize.org/shop/views/childsched_pg4.pdf. |
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For children who have completed an age-appropriate 4-dose
series of PCV7 do the following: |
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Give 1 additional dose of
PCV13 to all healthy children who have not yet reached
their fifth birthday. |
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Give 1 additional dose of PCV13 to children with underlying
medical conditions who have not yet reached their sixth
birthday. |
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For children ages 6
through 18 years with functional or anatomic asplenia
(including sickle cell disease), HIV infection or other
immunocompromising condition, cochlear implant or CSF
leak, consider giving 1 dose of PCV13 regardless of
previous history of PCV7 or pneumococcal polysaccharide
vaccine (PPSV). |
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I continue to see conflicting
advice for giving pneumococcal vaccine to patients who do not have
a spleen. Do they get re-immunized with pneumococcal polysaccharide vaccine (PPSV) every 5
years, or do they get only 1 additional dose in their
lifetime? |
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Giving pneumococcal vaccine every 5 years is a widespread myth;
ACIP has never recommended an every-5-year schedule. People
with asplenia age 2 years and older should receive a lifetime
total of 2 doses of PPSV separated by a minimum of 5 years.
Here is a good resource:
www.immunize.org/catg.d/p2015.pdf. |
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We have a newly diagnosed diabetic
who was given the first dose of PPSV at age 65 years. Should I
give him a second dose in 5
years because of his chronic disease? |
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No. For people age 65 years and older, one-time revaccination is
recommended only for those who are at highest risk for
serious pneumococcal infection and those who are likely to have a
rapid decline in pneumococcal antibody levels. This
includes people with functional or anatomic asplenia (e.g., sickle
cell disease), HIV infection, leukemia, or other
conditions associated with immunosuppression. It does not include
diabetics. |
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| Q: |
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Now that the Hib vaccine shortage
is over, should we recall patients who missed their 15-month Hib
booster dose or simply
wait for them to return for a well-child visit? |
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Recall the children who have fallen behind. Because of an increase
in Hib vaccine production and the entrance of new Hib
vaccine products into the market, CDC notified healthcare
providers in July 2009 that the Hib vaccine shortage was over and
to resume giving the Hib booster dose. Since September 2009, CDC
has recommended that providers recall patients in need of a
Hib booster dose. (See
www.cdc.gov/mmwr/preview/mmwrhtml/mm5836a5.htm).
For the booster dose, providers can use any of the currently
available Hib-containing vaccines such as ActHIB (sanofi),
Pentacel (sanofi), PedvaxHIB (Merck), and Hiberix (GSK). |
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| Q: |
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If an 8-year-old child who needed
IPV and Td vaccines was mistakenly given a dose of DTaP-IPV (Kinrix;
GSK), will that count
as a valid dose of polio and Td vaccine? |
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Kinrix is licensed and recommended only for use in children ages 4
through 6 years, so you should take measures to prevent
this error in the future. However, you can count the IPV dose as
valid as long as it has met the minimum interval (4 weeks
between doses except for the final dose in the series, which
should be 6 months from the previous dose). With regard to the
mistaken administration of the DTaP in a child older than age 6
years, the dose can be counted and does not need to be
repeated with Td. |
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| Q: |
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Please tell me about the newly
licensed meningococcal conjugate vaccine, Menveo. |
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FDA licensed Menveo (Novartis) on Feb. 19. It is a quadrivalent
meningococcal conjugate vaccine intended for use in people
ages 11 through 55 years. Menveo protects against Neisseria
meningitidis serogroups A, C, Y, and W-135. The vaccine consists
of two components, a lyophilized vaccine (containing the serogroup
A conjugate) and a buffered saline diluent (containing the
C, W-135, and Y conjugates) used for reconstitution. The
reconstituted vaccine should be used immediately but may be held
at
or below 77°F (25°C) for up to 8 hours. Menveo is administered as
an intramuscular injection.
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ACIP recommends meningococcal conjugate vaccine for all people
ages 11–18 years and for people ages 2–55 years who are at
increased risk for meningococcal disease. These include (1)
college freshmen living in dormitories, (2) microbiologists who
are exposed routinely to isolates of Neisseria meningitidis, (3)
military recruits, (4) people who travel to or reside in
countries where meningococcal disease is hyperendemic or epidemic,
(5) people who have persistent complement component
deficiencies, and (6) people with anatomic or functional asplenia.
Menveo or Menactra (sanofi pasteur) may be used in people
ages 11–55 years. People ages 2–10 years who are recommended to
receive a meningococcal vaccine should receive Menactra
(which is licensed for this age group), and people older than age
55 years should receive meningococcal polysaccharide
vaccine (MPSV). |
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| Q: |
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I have a pediatric patient who has
functional asplenia. I gave her a dose of Menactra meningococcal
conjugate vaccine when
she was 3 years old. Do I need to give her a booster at some time? |
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Yes. Since asplenia places her at highest risk for meningococcal
infection, you should give her another dose 3 years after
the date you gave her the first dose. Then, give her additional
doses every 5 years. (Note: The interval between dose #1 and
#2 is determined by the child's age when dose #1 was given. For
children who received dose #1 at ages 2 through 6 years,
separate doses #1 and #2 by 3 years. For children who received
dose #1 at age 7 years or older, separate doses #1 and #2 by 5
years.) |
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| Q: |
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I've heard that the
recommendations for influenza vaccination have been expanded for
the 2010–11 season. Tell me more. |
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At its February 2010 meeting, ACIP voted to recommend routine
annual influenza vaccination for all people age 6 months and
older, beginning with the 2010–11 influenza vaccination season.
This change expands the existing recommendations to include
all healthy adults ages 19 through 49 years who hadn't previously
been included in routine vaccination recommendations. On
March 2, the provisional influenza vaccine recommendations were
posted on CDC's website at
www.cdc.gov/vaccines/recs/provisional/downloads/flu-vac-mar-2010-508.pdf. |
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Will we need to give H1N1 vaccine
as a separate vaccine in the next season (2010–11)? |
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No. The 2009 H1N1 virus will be incorporated into the 2010–11
seasonal influenza vaccine formulation. The three influenza
viruses in the vaccine are A/California (H1N1) [formerly known as
the 2009 H1N1], A/Perth (H3N2) [replacing the 2009–10
A/Brisbane (H3N2)], and B/Brisbane [same as in the 2009–10
vaccine]. |
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| Q: |
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I would like to help establish a
policy of mandatory vaccination for healthcare workers in our
facility and would like to
learn from others. Can you help? |
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You will be happy to know that more and more healthcare facilities
are adopting mandatory vaccination policies for their
employees. IAC has included many of these on its Honor Roll for
Patient Safety, which gives special recognition to
institutions that enforce mandatory vaccination for all personnel
who are in the vicinity of a patient (e.g., including
volunteers, housekeeping staff). To read about the policies of the
various facilities included in the Honor Roll, go to
www.immunize.org/honor-roll. We hope reviewing these
policies will give you the information you need to assist you
in developing a policy for your facility. |
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We have a mandatory vaccination
policy in our facility; however, we allow employees to choose not
to be vaccinated after
filling out and signing an informed declination form. What can we
do to achieve assurances that patient safety is still
maintained? |
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Though vaccination is the most effective means of protecting your
patients from influenza, there may be instances where
employees are not vaccinated for medical or personal reasons. In
these instances, you may want to consider reassigning
unvaccinated workers to non-patient areas or requiring that they
wear masks throughout the influenza season. |
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When should we stop giving H1N1
influenza vaccine for the 2009–10 season? |
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The answer is the same for both H1N1 and seasonal influenza
vaccines–providers are encouraged to continue vaccinating
patients into the spring months (e.g., through May), as long as
they have vaccine in the refrigerator and unvaccinated
patients in their office. No one knows for sure how the H1N1
influenza epidemic will progress; some experts predict a third
wave of cases in the spring. Be sure to check the expiration date
before administering 2009 H1N1 vaccine–some lots expire
earlier than seasonal influenza vaccine. Expired vaccine should
never be administered. |
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The new Zostavax vaccine (Merck)
package insert says that Zostavax should not be given
simultaneously with pneumococcal
polysaccharide vaccine (PPSV). What does ACIP say about this? |
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ACIP has not changed its recommendation on the simultaneous
administration of these two vaccines (i.e., they can be given at
the same time or any time before or after each other). |
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Now that there is a second vaccine
licensed for the prevention of Japanese encephalitis (JE) among
travelers, where can I
find the recommendations for its use? |
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CDC recently published updated recommendations of the Advisory
Committee on Immunization Practices for the use of both
vaccines–JE-VAX (sanofi) and Ixiaro (Intercell Biomedical
distributed by Novartis)–in MMWR 2010;59(RR-1):1-26. You can find
them on CDC's website at
www.cdc.gov/mmwr/pdf/rr/rr5901.pdf.
Ixiaro is licensed for use in persons 17 years and older. JE-VAX
is no longer being produced, and remaining supplies are reserved
for children ages 1 through 16 years. |
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| Q: |
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My patient got JE-VAX 5 years ago
and is now returning to Asia. Can I use Ixiaro as a booster dose? |
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| A: |
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There are no data on the use of Ixiaro as a booster for JE-VAX. If
a previously vaccinated person age 17 years or older needs
a booster dose, you should administer a full series (2 doses
separated by at least 28 days) of Ixiaro. |
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