June 2013 ACIP Webinar FINAL Handout...
Transcript of June 2013 ACIP Webinar FINAL Handout...
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APhA Immunization Update from the June 2013 ACIP Meeting
Stephan L. Foster, Pharm.D.
CAPT (Ret) U.S.P.H.S.
Professor and Vice Chair
University of Tennessee College of Pharmacy
Liaison Member
CDC Advisory Committee on Immunization Practices (ACIP)
Accreditation
The American Pharmacists Association is accredited by the
Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This activity, APhA Immunization Update from the June 2013 ACIP Meeting, is approved for 1.0 hours of continuing pharmacy education credit (0.10 CEUs). The ACPE Universal Activity Number assigned by the accredited provider is: 0202‐0000‐13‐105‐L04‐P.
To obtain continuing pharmacy education credit for this activity, participants will be required to actively participate in the entire webinar and complete an online evaluation and CPE recording form located at www.pharmacist.com/education by April 1, 2013.
Initial Release Date: June 28, 2013
Target Audience: Pharmacists
ACPE Activity Type: Knowledge‐Based
Learning Level: 1
Free CPE credit is brought to you by your APhA membership. Non‐members will be assessed a $25 CPE activity fee for this webinar.
Learning Objectives
Identify changes to vaccine recommendations necessary for compliance with standards of practice
Apply recent changes to guidelines to their vaccination program
Evaluate information on new or future vaccines for potential use in their practice
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Disclosures
Stephan L. Foster, PharmD, FAPhA, serves on the speaker bureau for Merck.
APhA’s editorial staff declare no conflicts of interest or financial interests in any product or service mentioned in this activity, including grants, employment, gifts, stock holdings, and honoraria. For complete staff disclosures visit www.pharmacist.com/education
Disclaimer
• This contains data presented at the ACIP meeting
• Some of this data is unpublished
• If there is a slide without a reference, then it contains such data
• Do not quote this specific data until it is published
• ACIP meeting minutes will be on the ACIP website in the near future, along with the meeting slides– www.cdc.gov/vaccines/recs/acip/default.htm
Advisory Committee on Immunization Practices
• Members
– 15 Experts in the field of Immunization
• Voting Members
– Ex‐officio Members (9)
– Liaison Members (33)
• Mission
– Provide advice and Guidance to CDC
– Develop written recommendations
– Reduce the incidence of vaccine‐preventable disease
• Meets 3 times a year
– More often in subcommittees
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Japanese Encephalitis
• Disease– Mosquito‐borne flavivirus– Neurologic infection
• 67,000 cases annually• 20‐30% die• 30‐50% with sequelae
– Maily children in rural areas– 1973‐2011
• 65 cases in travelers– 10 died, 24 sequelae
• Mainly extensive time in endemic areas (especially rural)
– No treatment
ACIP Recommendations (2009)
• Travelers advised about risk• Precautions for mosquitos• Risk depends on season. Location, duration and activities
• Vaccination if >1 month in endemic area
• Give to short‐term traveler with risks– Not given for short‐term, urban areas
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Japanese Encephalitis Vaccine (JE‐VC)
• JE‐Vax (JE‐MB)– No longer available
• IXIARO (Novartis)– Inactivated vero‐cell culture; suspension
• Contains aluminum hydroxide and protamine sulfate
– Approved > 17 years of age• No efficacy studies• No ADE triggers
– 2 dose series (0 and 28 days)– May booster after 1 year– May 2013 FDA licensed for 2‐16 years
• Based upon 3 trials
– Dose• 0.25ml administered at 0 and 28 days for 2month – 2 years of age• 0.5ml. Administered at 0 and 28 days for >3 years of age• Booster after 1 year from completion of series for over 17 years of age
– Not evaluated in children
Ixiaro Use in Children
• Safety– ADE
• Children ‐ Fever, irritability, and diarrhea• Adolescents and adults ‐ Pain and tenderness• Adults ‐ Headaches and myalgias
• Efficacy– No efficacy data – Based upon immunogenicity studies
• JE virus 50% plaque reduction neutralization test• (PRNT50) titer >10
• GRADE criteria applied
Recommendations
• JE‐VC is effective using seroprotection and safe in children 2 months to 16 years
• Propose to extent current recommendations (2009)in include children >2 months of age.– 1 month or longer in endemic area
– Short term travelers if travel outside urban area or if outbreaks occurring in the area
– Not recommended in short‐term travelers who visit is restricted to urban areas or it is outside of the JE season.
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Revision
• Introduction• Timing and spacing of immunobiologics• Contraindications and precautions• Preventing and managing adverse reactions• Reporting adverse events after vaccinations• Vaccine administration• Storage and handling of immunobiologics• Altered immunocompetence• Special situations• Vaccination records• Vaccinations programs• Vaccine information sources
June Topics
• Introduction• Timing and spacing of immunobiologics• Contraindications and precautions• Preventing and managing adverse reactions• Reporting adverse events after vaccinations• Vaccine administration• Storage and handling of immunobiologics• Altered immunocompetence• Special situations• Vaccination records• Vaccinations programs• Vaccine information sources
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Remaining Topics
• Introduction• Timing and spacing of immunobiologics• Contraindications and precautions• Preventing and managing adverse reactions• Reporting adverse events after vaccinations• Vaccine administration• Storage and handling of immunobiologics• Altered immunocompetence• Special situations• Vaccination records• Vaccinations programs• Vaccine information sources
General Recommendations on Immunization
Tentative Vote on entire document June 2014
General Recommendations on Immunization
Preventing and Managing Adverse Reactions
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Preventing Adverse Reactions
• Allergy
– Effective history
– Look‐up vaccine components
– Use Package inserts
– Referral as option
– Have capacity to recognize and manage ADRs
Managing adverse reactions
• Providers– Providers familiar with identifying immediate reactions
• Local or generalized urticaria
• Respiratory
• Hypotension and shock
– Be competent in treating events• Epinephrine and other options
• Separate tables for adults and children
– Emergency plan
Persons having previous reactions
• Egg allergy– Specific to vaccine
• Influenza, Yellow fever – different approaches• Varicella, MMR ‐ irrelevant
• Other severe reactions– Refer to allergist
• Apply algorithm– Symptoms– Risk– Skin testing– Vaccination under control
• Thimerosal, Neomycin, Latex– Contact allergy– Not a contraindication unless reaction deemed severe
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Contraindications and Precautions
• Presented at Feb. 2013 ACIP meeting
• General contraindications not changed
– “Severe allergic reaction (e.g. anaphylaxis) after a previous dose or to a vaccine component”
• Flexibility to provider
– Based upon severity
• Contact allergy usually not severe
• Exception– LAIV and allergy with respiratory component (i.e. wheeze)
Pertussis Outbreak Continues
• United States– 16,858 in 2009
– 27,555 in 2010
– 15,216 in 2011
– 41,880 in 2012• 18 deaths (most > 3 months of age)
• Highest Recorded since 1955– 62,786
• Highest incidence of disease in 10 year‐olds
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History
• Vaccines
– Whole‐cell vaccine (DTwP) – 1940’s
– DTaP (1990s)
– Tdap (2005)
• Coverage
– High among children 19‐35 months
– Increasing among adolescents (78% in 2011)
– Low among adults (12.5% in 2011)
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Current Tdap Vaccines
Trade Names, manufacturer
Age approvedfor use (yrs)
Antigen (ug) Toxoid (Lf)
PT FHA PRN FIM 2 & 3
Diphtheria Tetanus
AdacelSanofi pasteur
11‐64 2.5 5 3 5 2 5
BoostrixGSK
10 and older 8 8 2.5 ‐ 2.5 5
PT – Pertussis toxin; FHA – filamentous haemagglutinin; PRN – pertactin; FIM ‐ fimbriae
Current Tdap Recommendations
• Single Tdap dose
– Adolescents
– All adults
• Every Pregnancy
• Td booster every 10 years
– 5 years for wound management
Summary
• Pertussis increasing
• Resurgence of childhood disease despite high DTaP coverage
• Re‐emergence of adolescent disease despite Tdap
• The switch to aP vaccines is changing pertussis epidemiology.
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Persistance
• Pertussis incidence has increased– Resurgence high despite DTaP
• Excellent initial effectiveness
• Waning of immunity of pertussis antibodies– Rapid decline in first 1‐2 years
– Slower decline over 5‐10 years
– Close to prevaccination levels at 10 years
• Re‐emergence of adolescent disease despite Tdap– Tdap boost of DTaP wanes rapidly
• Switch to aP is changing pertussis epidemiology
• Tetanus and diphtheria antibodies persist
Tdap Effectiveness
• Vaccine effectiveness 66‐78% in observational studies
• Effectiveness wanes within 3‐4 years
• Effectiveness consistent with epidemiology
• No evidence of herd immunity
Tdap Revaccination
• Studies presented at both 5 and 10 years
• Safety
– Local reactions common – mild to moderate
• Comparable to first Tdap
– Serious ADE not vaccine related
• Immunogenicity
– Response to Tetanus and diphtheria robust at 5‐10 years with high levels of protection
– Pertussis response robust with 2nd dose similar to 1st.
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WG Conclusions
• Revaccination safe at 5 and 10 years• Immunogenic at 5 and 10 years
– 10 year interval sufficient for T and d– Substantial waning at 2‐4 years but above seroprotection levels for T and d
– Pertussis levels higher than prevaccination but no defined correlation to protection
• Data available for 2nd dose, but no more• Several scenarios were considered
– Tdap every 10 years– Tdap twice 5 or 10 years apart and Td every 10 years– Consider “at‐risk” population
Cost effectiveness Analysis
• Applied to revaccination at 16 or 21 years of age• Factors
– Incidence, efficacy estimates, waning, coverage for both doses, and a discount of 3%
• Number of cases prevented– Age 16 = 284– Age 21 = 168
• Program costs– Age 16 = $181,327,646– Age 21 = $204,822,286
• Disease grossly under‐reported which would change numbers, however still too costly
WG Conclusions
• Data does not support a recommendation for a second dose of Tdap
• Need to focus on preventing pertussis in infants
– Tdap during pregnancy
• Consider “at risk” populations
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HPV vaccine
• Pregnancy Registry (Merck)– No clustering of malformations– No pattern of birth defects– Rates of Sab, fetal deaths, and congenital anomalies were at or
below background cases– Registry discontinued
• Update MMWR recommendations– Issues to be discussed are future ACIP meeting
• Vaccination rates– Increasing yearly but leveling off (29% in 2011
• Outcomes– Early results showing decrease in detection of HPV in vacinees
Rotavirus Vaccine
• Intussusception
– Slight increase in vaccinees
– 0.5 – 1.5 cases per 100,000 vaccinated infants for RV5
– 5.4 cases per 100,000 for RV1
• Impact
– Reduction of rotavirus‐positive tests by 73%
– Decrease of 30,000‐70,000 hospitalizations
• Recommendation
– Vaccine benefits greatly outweighs small risk
The Role ofCommunity Pharmacies/Pharmacists
in Vaccine Delivery in the United States
Presentation by
Mitchel C. Rothholz, RPh, MBA
Chief Strategy Officer
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Scope of discussion
• History and focus of Pharmacy‐based Immunizations
• “Immunization Neighborhood”
• Training of immunizing pharmacists
• Process of care
• Legal/regulatory considerations
• Scope of Immunization activities
• Documentation/Communication
• On the Horizon
Number of States Authorizing Pharmacists to Administer Influenza Vaccine&
Number of Pharmacists Trained to Administer Vaccines
Updated January 2013; Source: American Pharmacists Association
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Herpes Zoster Working Group
• Issues– Evaluation of persistence
– Safety
– Booster doses
– Immunocompromised conditions
– Inactivated investigational vaccine
– Adjuvanted vaccines
• This information will be shared at a future ACIP meeting.
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Summary
• Peaked earlier
• Type A early and Type B late
• High rates of hospitalization
• Highest visits for ILI since 1997
• Highest pediatric deaths since reporting began
– Excluding pandemic
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Influenza Viruses CirculatingOct 1, 2012‐May 18, 2013
• CDC characterized 2,455 samples
– 249 H1N1
• 98.8% A/California/7/2009‐like (Vaccine Strain)
– 1,319 H3N2
• 99.6% A/Victoria/361/2011‐like (Vaccine Strain)
– 879 Influenza B
• 66.3% B/Yamagata Lineage (Vaccine Strain)
• 33.7% B/Victoria Lineage
Influenza A(H7N9)
• New Strain in China (April 1, 2013)– Mainly poultry
• Most show no signs of illness
– Human cases• 132 laboratory‐confirmed cases (June 20,2013)
• Severe illness– 39 Deaths (30%)
– No cases outside of China
– No sustained human‐to‐human spread
– No new cases after May 21, 2013
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• 5 study sites (Flu VE Network)
• Dec 3, 2012‐ Jan 2, 2013
• 1155 children and adults
• Estimated VE 62%
http://www.cdc.gov/mmwr/pdf/wk/mm6202.pdf
Vaccine Effectiveness
• Adjusted VE 52% (46‐58%)
• Vaccination reduced visits
– Outpatient
• 44% due to A(H3N2)
– Except age 9‐17 years and 65+ years
• 62% due to B– Similar VE against both B lineages
– Inpatient visits VE 57‐72%
Vaccine Safety (VAERS Reports)
TIV LAIV HD ID
Total Reports 7,121 494 730 391
Serious Reports
6.4% 8.3% 8.8%70% Female
9%75.4% Female
Non‐Serious Reports
93.4% 91.7% 91.2% 91%
GBS 1.0% 0.4%
Anaphylaxis 0.4% 1.0%
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Egg Allergy
• 4 patients reviewed– 3 TIV and 1 LAIV
• 3 cases did not meet criteria for existing egg allergy
• 1 case– 12 month old male
– History of atopic dermatitis
– History of egg allergy (prick test)
– Urticaria, dypnea, cough, wheeze, angioedema
Vaccine Safety Datalink
• TIV doses given – 3,672,076
– HD – 31,257
– ID – 4,713
• LIAV doses given – 264,262
• No signals in Rapid Cycle Analysis
Prevention and Control of Influenza with Vaccines: Interim Recommendations of the Advisory Committee
on Immunization Practices (ACIP), 2013
• MMWR 2013(May 10);62(18):356
• All persons > 6 months of age
• Change of abbreviations– IIV (IIV3 or IIV4)
– RIV3 – recombinant hemagglutinin (Flublok)
– LAIV4(Quad only)
– CCIIV3 – cell cultured (Flucelvax)
– Available products• http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6218a3.htm
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Quadrivalent Influenza Vaccine (QIV)
• Influenza B viruses
• Circulates globally each year
• Two lineages– B/Yamagata
– B/Victoria
– Cross protection unclear
• Vaccine Match– 5/10 years
– 2012‐13 (Both Strains Circulating)
FluMist® (MedImmune)
• Currently transitioning to Q/LAIV
• Approved by FDA 2/29/12
• Same formula as TIV with additional B strain
– Immunogenicity non‐inferior to T/LAIV
– High immune response to additional B strain
– Same safety profile
• Same dose and delivery
• Will not affect supply
GlaxoSmithKline ‐ GSK• Current TIV
– Fluarix D‐TIV
• Manufactured in Dresden, Germany
– FluLaval Q‐TIV
• Manufactured in Quebec, Canada
• FDA Approved – D‐QIV– Safe and immunogenic
– Approval December 4, 2012 (Fluarix Quadrivalent)
– Age 3 years and older
• Q‐QIV– FDA approval anticipated in 2013
– Q‐TIV available for 2013‐14 season
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Sanofi‐Pasteur
• Fluzone Quadrivalent
– Immunogenic and safe
– Ages 6 months and older
– FDA approval June 7, 2013
– Supply
• TIV orders will be completed
• Can not discuss with providers until FDA approved
• May not be used much next season
Flucelvax (Novartis)
• Cell Cultured IIV– ≥ 18 years– Trivalent for 2013-14 season
• Alternative to eggs– Production by potentially vulnerable avian species
• Subunit virus vaccine propagated in canine kidney cells
• Immunogenic and safe compared to other TIV
• Plans– Produce in Holly Springs, NC
Flublok (Protein Sciences Corp)
• FDA approved 1/16/2013• Trivalent inactivated for 18‐49 year olds• This is where it gets different!
– Insect virus (baculovirus) expression system and recombinant DNA technology
• Produces hemagglutinin (HA)
– No eggs and No flu virus used– 44.6% effective against all circulating strains
• Even those not in the vaccine!
• Shelf Life = 16 weeks• Expect 3‐5 million doses next season
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Final Influenza Recommendations
• Will all Fluzone Quadrivalent to table
• Include information about Trivalent and Quadrivalent
• Clarify egg allergy recommendations to include RIV
2013‐2014 Vaccine Strains
• A/California/7/2009 (H1N1)‐like• A/Victoria/361/2011 (H3N2)‐Like• *B/Massachusetts/2/2012‐like virus.• ****B/Brisbane/60/2008‐like virus
– * Yamagata Lineage– **** (Quadrivalent) Victoria Lineage– Note: B Strain differs from 2012‐2013
Summary and Conclusions
• Next ACIP Meeting October 23‐24, 2013 in Atlanta
• If questions, please contact:– Stephan L. Foster, Pharm.D.E‐mail: [email protected]
• Questions/comments
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