Transcript Hot Topics - ct

Hot Topics In
Infectious Diseases
Robert S. Baltimore, MD
Professor of Pediatrics and
Epidemiology
Annual School Health
Conference
May 20, 2010
Outline-Issues
• 1. Review of Novel Influenza virus H1N1
2009-2010
• 2. Recommendations for influenza
prevention for 2010-2011
• 3. New vaccine to prevent pneumococcal
infection--- Prevnar 13
PHIL ID #11214
Photo Credit: C. S.
Goldsmith and A. Balish,
CDC
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Resolution
Description:
Negative stain EM image
of the 2009 H1N1
Influenza A/CA/4/09
National
Institutes
of Health;
Structure of the influenza virion. The hemagglutinin (HA) and
neuraminidase (NA) proteins are shown on the surface of the
particle. The viral RNAs that make up the genome are shown as red
coils inside the particle and bound to ribonucleoproteins (RNPs).
Influenza: Antigenic Drift and Shift
Hemagglutinin
Neuraminidase
Drift
Shift
Influenza Virus
N Engl J
Med
360;25
june 18,
2009
CT Data
As of 4 Dec 2009
1 May 2010
Childhood Deaths
• Since April 2009, the CDC has received reports
of 329 pediatric deaths that have been
confirmed to be associated with the influenza
virus.
• Of these pediatric deaths, 278 have been
confirmed to be associated with the 2009 H1N1
virus.
• This represents much more pediatric mortality
associated with influenza than is seen during a
typical influenza season.
Pandemic (H1N1) 2009 - WHO Update 98
- -----------------------------------As of 25 Apr 2010, worldwide more than 214 countries and overseas
territories or communities have reported laboratory confirmed cases
of pandemic influenza H1N1 2009, including over 17919 deaths. The WHO
is actively monitoring the progress of the pandemic through frequent
consultations with the WHO Regional Offices and Member States and
through monitoring of multiple sources of information.
Situation update:
- ----------------The current situation is largely unchanged since the last update. The
most active areas of transmission of pandemic influenza H1N1 virus
continue to be parts of West and Central Africa with some focal areas
of activity in South and Southeast Asia. Pandemic influenza activity
H1N1 remains low in much of the temperate areas of both the northern
and southern hemispheres. Seasonal influenza type B virus is the
predominant influenza virus, though also at low levels of
circulation, across East Asia, Northern and Eastern Europe. Influenza
type B viruses have also been detected in Central Africa and this
week in West Africa. Seasonal influenza H3N2 viruses have continued
to be detected in South and Southeast Asia, as well as sporadically
in some countries of West and Central Africa, and Eastern Europe.
Schools
Connecticut State Department of Education
October 2009
Reminders and Updates on H1N1 Influenza Guidance for Schools
The Connecticut Department of Public Health (DPH) along with the Connecticut
State Department of Education (CSDE) has developed guidance for school nurses
regarding H1N1 influenza which is available at
http://www.ct.gov/ctfluwatch/lib/ctfluwatch/h1n1/school_nurse_guidance.pdf.
Reporting School Closures: School districts are asked to
report all school closings due to H1N1 influenza to the
CDC through the CSDE Web site at
http://www.sde.ct.gov/sde/cwp/view.asp?a=
2604&Q=322396. The CDC provides updates on school
closures to the CSDE as they are reported.
Schools- CDC Recommendations
• Encourage Vaccination Against Flu
• Advise the sick to stay home
• Separate sick students and staff (for those ill separate
room—go home)
• Discourage attendance at school events by sick people
• Respiratory etiquette and hand hygiene
• Perform environmental cleaning (no additional
disinfection beyond routine cleaning)
• Early treatment of students and staff at high risk for
complications
• Consider selective school dismissal
Consider school dismissals: School and health officials should
work closely to balance the risks of flu in their community with the
disruption dismissals will cause in both education and the wider
community and should clearly state the reason for school dismissal.
Reactive dismissals might be appropriate when schools are not
able to maintain normal functioning for example, when a significant
number and proportion of students have documented fever while at
school despite recommendations to keep sick children home.
Preemptive dismissals can be used proactively to decrease the
spread of flu. CDC may recommend preemptive school dismissals if
the flu starts to cause severe disease in a significantly larger
proportion of those affected.
CDC Guidance for State and Local Public Health
Officials and School Administrators for School
(K-12) Responses to Influenza during the 20092010 School Year
February 22, 2010, 4:30 PM ET
Why were older people largely
spared?
Seroprevalence studies, which monitor antibodies
that react with the virus, suggest an explanation for
this. Serum samples taken in England before the
start of the pandemic show that older people had
stronger antibody reactions to H1N1 than young
people, probably as a result of previous exposure to
strains with similarities to the new virus
Q. How can healthcare facilities eliminate
sources of infection and transmission within
their facilities?
Healthcare facilities will want to use a multi-level approach,
called the hierarchy of controls, that includes both
administrative controls and engineering controls to eliminate
sources of infection and prevent transmission within their
facility.
To ensure a comprehensive infection control strategy, healthcare
facilities will want to:
• Vaccinate their workforce with seasonal and 2009 H1N1
vaccines.
• Keep sick workers at home.
• Enforce respiratory hygiene and cough etiquette.
• Enhance hand hygiene compliance.
• Establish facility access control measures and triage
procedures.
• Manage visitor access and movement within the facility.
• Control patient placement and transport.
• Apply isolation precautions.
Q. What personal protective
equipment should be worn by
healthcare personnel?
• Standard precautions should be followed for all
patient care. For any activity that might
generate splashes of respiratory secretions,
gowns along with eye protection should be
worn. Healthcare workers who are in close
contact with patients suspected or confirmed to
have 2009 H1N1 influenza should wear a fittested, disposable N95 respirator.
Update on Influenza Vaccine
CDC Recommendations for
childhood flu vaccination
• Before 2002
• 2002-2004
• 2004-2005
• 2006• 2010
Only children >6 months
with certain medical
conditions
6-23 months
encouraged when
feasible
6-23 months
recommended
6- 59 months
recommended
Everyone over 6 months
old
This new recommendation includes all healthy people 19 through
49 years of age, the only portion of the U.S. population not included
in previous ACIP influenza immunization recommendations. Before
this new universal policy, the vaccine already was earmarked for about
85% of the population, based on age, having a chronic health
condition or being in contact with someone in a high-risk group.
Risk-based priorities will be eliminated once the universal
recommendation takes effect in the 2010-’11 seasonal influenza
season.
Universal vaccination against influenza is especially beneficial for
infants younger than 6 months of age because they are at high risk
for significant morbidity and mortality due to the virus, but cannot
be given influenza vaccine. When everyone in an infant’s immediate
environment has been vaccinated, this “cocooning” effect reduces
the infant’s exposure to the virus.
Influenza Virus
Type of nuclear
material
Neuraminidase
Hemagglutinin
A/Fujian/411/2002 (H3N2)
Virus
type
Geographic
origin
Strain
number
Year of
isolation
Virus
subtype
The 2010-2011 Flu Vaccine
•The three strains of influenza virus to be included in
the 2010-’11 vaccine include:
•The 2009 H1N1 influenza virus, which will be
called “A/California/7/2009 (H1N1),”
•An A/Perth/16/2009 (H3N2)-like virus
•and a B/Brisbane/60/2008-like virus
•A seasonal influenza A (H1N1) component is not
included in the 2010--11 formulation,
•
Previous recommendations include: (ACIP)
2 doses of vaccine to all children aged 6 months--8 years if they
have not been vaccinated previously at any time with either LAIV
(doses separated by >4 weeks) or TIV (doses separated by >4
weeks), if possible completed by December.
• children aged 6 months--8 years who received only 1 dose in
their first year of vaccination receive 2 doses the following year
• all persons, including school-aged children, who want to reduce
the risk of becoming ill with influenza or of transmitting influenza
to others should be vaccinated
• immunization providers should offer influenza vaccine and
schedule immunization clinics throughout the influenza season
• encourage health-care personnel vaccination as a measure of
patient safety and quality improvement programs. (e.g.,
obtaining signed statements from HCP who decline influenza
vaccination)
New Flu Vaccine for “Elderly”
• On December 23, 2009, the FDA licensed an
injectable inactivated trivalent influenza vaccine
(Fluzone High-Dose, Sanofi-Pasteur) containing an
increased amount of influenza virus hemagglutinin
antigen compared with other inactivated influenza
vaccines it is licensed as a single dose for use among
persons aged ≥65 years and will be available
beginning with the 2010--11 influenza season
• The Advisory Committee on Immunization Practices
(ACIP) reviewed data from prelicensure clinical trials
on the safety and immunogenicity of Fluzone HighDose and expressed no preference for the new
vaccine over other inactivated trivalent influenza
vaccines.
Why Vaccinate Young Children?
Glezen observed that influenza hospitalization rates in the
youngest children are equivalent to those in the elderly.
Glezen WP. Serious morbidity and mortality associated with influenza
epidemics. Epidemiol Rev 1982. 4:25-44.
Using a large database of children in Tennessee,
investigators more recently showed that showed that in a
typical year that 6-15% of children under 15 years of age
visit a physician and 3-9% receive antibiotics as a
consequence of influenza
Neuzil KM, Mellen, et al. The effect of influenza on
hospitalizations, outpatient visits and courses of antibiotics in
children. N Engl J Med 2000;342:225-31
Why Vaccinate Young Children?
In Northern California and the state of Washington, the rate
of hospitalization for influenza for healthy children under 2
years of age was 193-231 per 100,000, which is 12 times as
high as the rate for healthy children 5-17 years and
approaches that for children 5-17 years with chronic health
condition
Izurieta HS, et al. Influenza and the rates of hospitalization for respiratory disease
among infants and young children. N Engl J Med 2000;342:232-9.
School aged children and children in daycare have a central
role in the spread of influenza virus because they have high
attack rates and shed virus at higher titers and for twice as
long as adults
Reichert TA, et al The Japanese experience with vaccinating schoolchildren against
influenza. N Engl J Med 2002;344:889-96.
Glezen WP,et al. Influenza virus infections in infants. Pediatr Infect Dis J
1997;16:1065
Other Pediatric Recipients of Influenza Vaccine
High Risk Medical Conditions:
–Chronic cardiac or pulmonary disorder
–Diabetes mellitus
–ESRD/renal insufficiency
–Immunosuppression
–Sickle-cell disease
–Long-term aspirin therapy
2
Thimerosal and Flu Vaccine
•Most experts (including AAP) view the
protection of more children against the
known risks of influenza more important
than the theoretic risk of small amounts of
thimerosal in influenza vaccine.
•Removal of thimerosal from TIV results in
wastage of one third of doses produced.
Influenza Vaccination of Pregnant and
Breastfeeding Women
Several studies have documented increased risk of complications,
hospitalization, and death from influenza during pregnancy.
A study of over 2,000 pregnant women vaccinated with influenza
vaccine showed no adverse effects, although additional studies are
needed to confirm the safety of vaccination during pregnancy.
In a study only of OBGYNs 39% gave influenza vaccine to pregnant
patients.
Pregnant women with medical conditions that increase risk for
complications from influenza should be vaccinated regardless of the
stage of pregnancy
Breast-feeding is not a contraindication for influenza vaccine.
Prevnar 13
In February 2010, a new 13-valent
pneumococcal conjugate vaccine (PCV13)
was licensed by the Food and Drug
Administration and recommended by the
Advisory Committee on Immunization
Practices (ACIP) for prevention of invasive
pneumococcal disease in children; PCV13
succeeds the 7-valent (PCV7) used in the
routine childhood immunization schedule since
2000.
Prevnar 13
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
Prevnar 13 is a vaccine approved for use
in children 6 weeks through 5 years of age
(prior to
the 6th birthday).
Prevnar 13 is indicated for active
immunization for the prevention of invasive
disease caused by
Streptococcus pneumoniae serotypes 1, 3,
4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and
23F.
Prevnar 13 is also indicated for the
prevention of otitis media caused by
Streptococcus pneumoniae serotypes 4,
6B, 9V, 14, 18C, 19F, and 23F. No otitis
media efficacy
data are available for serotypes 1, 3, 5, 6A,
7F, and 19A.
From May Pediatrics
Serotype-specific antipolysaccharide IgG antibody and
functional opsonic antibody responses…. PCV13 is at least
as immunogenic as PCV7 for the 7 common serotypes and is
notably more immunogenic for the additional 6 serotypes.
Despite the increased antigenic load, PCV13 does not
interfere with immune responses to concomitantly
administered vaccine antigens, and its safety and tolerability
profile seems to be similar to that of PCV7.
PCV13 should supplant the current PCV 7 for routine use in
infants to broaden coverage against major pneumococcal
serotypes important in invasive pneumococcal disease and
Bryant, K.A., et al Safety and
acute otitis media.
Immunogenicity of a 13Valent Pneumococcal
Conjugate Vaccine.
Pediatrics 2010; 125: 866
(May)
ACIP recommendation
Based on available safety, immunogenicity and disease
burden data, ACIP recommends that a single
supplemental PCV13 dose be given to healthy children
aged 14–59 months and to children with underlying
medical conditions up to age 71 months who already
have completed a schedule of PCV7. In one study, a
single dose of PCV13 in children aged ≥12 months who
had received 3 previous doses of PCV7 induced an
antibody response comparable to the 3-dose infant
PCV13 series, and the safety profile of this
supplemental dose was comparable to that after a
fourth dose of PCV13
Pfizer told the committee it would charge $108 a
dose for the new product, 30 percent higher than
the $83 a dose it charged for Prevnar 7.