2009-2010 Seasonal and Pandemic Influenza Vaccine Update

Kelly L. Moore, MD, MPHMedical Director, Immunization Program

TN Department of HealthTennessee Hospital Association Webinar

July 27, 2009

Objectives

• Seasonal vaccine– One dose, LAIV (nasal spray) or TIV (injection)– Will arrive in clinics first– ~115 million doses for the season

• Pandemic vaccine– Expected 2 doses, at least 3 weeks apart– LAIV or TIV– Could start shipping by mid-late October– Up to 600 million doses, if demand exists

2009-2010 Seasonal Influenza Vaccine

• an A/Brisbane/59/2007 (H1N1)-like virus • an A/Brisbane/10/2007 (H3N2)-like virus• a B/Brisbane/60/2008-like virus (new)

Production on schedule:

Majority of doses distributed by the end of October (though distribution likely to continue into December)

Seasonal Influenza Vaccination Advice

• Critical importance of seasonal vaccine is undiminished by pandemic virus

• Seasonal strains more likely to kill elderly• Seasonal strain drug resistance

– Seasonal H1N1 resistant to oseltamivir– Seasonal H3N2 resistant to adamantanes (M2

blockers)

• Seasonal viruses continue to circulate in Southern Hemisphere season

• Opportunities for genetic recombination

Seasonal Influenza Vaccination Advice

• Vaccinate as soon as supplies permit– Protection will not wane through season– Get inventory out of the way before pandemic vaccine

arrives – Easier to attribute cause of adverse events if not co-

administered with pandemic vaccine– Use opportunity to educate about pandemic influenza

and forthcoming vaccine – Treat both pandemic and seasonal vaccine as

important and essential for safe patient care

Pandemic H1N1 Virus

• Circulating through the summer

• Expected to increase when school resumes

• An early fall wave 2 is likely

• Vaccine distribution expected by mid-late October (after disease prevalent)

• Clinical trials beginning

Pandemic Vaccine Manufacturers

• Novartis (45.7%)- Also manufactures MF59 adjuvant for potential pre-

formulation with vaccine

• Sanofi Pasteur (26.4%)

• CSL (18.7%)

• MedImmune (5.8%)

• GSK (3.4%)- Also manufactures ASO3 adjuvant in a separate vial for

potential mixing at the place of administration

Vaccine products (general)

• Unadjuvanted multidose vials*

• Unadjuvanted p-free pre-loaded syringes†

• Nasal sprayers (live attenuated)†

Potentially• Multidose vials pre-formulated with adjuvant • Multidose vials formulated for adjuvant to

be mixed at the place of administration (separate antigen and adjuvant vials)

*All multidose vials will contain thimerosal preservative†Up to 20% of vaccine may be p-free pediatric formulation

Vaccine ancillary supplies: provided with the vaccine

• Needle/syringe units for multidose vials

• Sharps containers

• Alcohol pads

• Mixing syringes if adjuvanted vaccine is used

Emergency Use Authorization: Maybe, Maybe Not

“… use of an unapproved medical product or an unapproved use of an approved medical product during a declared emergency …”

- Unadjuvanted pandemic H1N1 vaccine may be licensed in a manner similar to a seasonal flu vaccine strain change and therefore would not need an EUA

- Adjuvanted vaccines, if used (for the 2009-10 flu season), will be administered under an EUA

Vaccine purchase, allocation, and distribution

• Vaccine procured and purchased by US government

• Vaccine will be allocated across states proportional to population

• Vaccine will be sent to state-designated receiving sites: mix of local health departments and private settings

Vaccine planning assumptions:

• Vaccine available starting mid-October• Initial amount: 40, 80, or 160 million doses

distributed in the first month• Subsequent weekly production: 10, 20 or 30

million doses distributed• 2 doses required (21 or 28 days apart)

Vaccine planning assumptions: probable target groups if early supplies are limited

• Students and staff (all ages) associated with schools (K-12) and children (age >6 m) and staff (all ages) in child care centers

• Pregnant women, children 6m-4yrs, new parents and household contacts of children <6 m

• Non-elderly adults (age <65) with medical conditions that increase risk of complications

• Health care workers and emergency services personnel

(because illness is distinctly uncommon in elderly, they will not be a priority)

Monitoring vaccine safety

• Vaccine Adverse Event Reporting System (VAERS) (1-800-822-7967, http://vaers.hhs.gov/contact.htm ) for signal detection

• Network of MCOs representing ~3% of U.S. pop., the Vaccine Safety Datalink (VSD) to test signals.

• Active surveillance for Guillain Barre Syndrome through states in Emerging Infections Program (including TN).

Monitoring vaccine effectiveness (VE)

• VE for prevention of PCR-confirmed medically attended influenza at 4 community-based sites

• VE for prevention of influenza hospitalizations diagnosed by provider-ordered clinically available tests at 10 sites nationwide through the Emerging Infections Program (includes TN)

• DoD will be assessing VE in active duty service members

Vaccine Delivery Model

• Public health-coordinated effort

• Blends vaccination in public health-organized clinics and in the private sector (provider offices, workplaces, retail settings)

• Tennessee will pre-register all non-public health facilities needing vaccine directly shipped (including all hospitals)

Tennessee Pre-Registration for Pandemic Vaccine Information/Shipment

• No cost, no obligation to order vaccine• Only for facilities considering providing

vaccine• Includes hospitals, medical clinics,

immunizing pharmacists, contract mass vaccinators

• Expected to go live about August 5• Updates emailed to registrants,

including ordering instructions

Tennessee Pre-Registration for Pandemic Vaccine Information/Shipment

• 2-step registration– Register to use the Tennessee Web Immunization

System (TWIS), “Registry”– Takes about 2 days to receive user id and

password for TWIS– After log-on with user id / password, prompted to

register for pandemic vaccine information – All registered providers will have full access to

TWIS resources, including self-guided tutorial (renewal would be necessary in 1 year)

TN Pre-Registration for Pandemic Vaccine, contd.

• Registration serves multiple purposes:– Obtain contact information

• Authorized Immunization Provider • Primary Point of Contact (will receive MOA and ordering

instructions• Shipping Contact (to receive shipments)

– Establish shipping record– Enable direct communication of new info

(email/fax)– Gauge interest in the private sector

• Estimate number of healthcare staff, others the facility plans to vaccinate

Provider Registration

• Hospitals will need to register• Programming underway • Notice will come through THA once system is

live (within 2 weeks)• Hospitals are priority vaccine recipients, will

have to submit orders, follow reporting reqts.– Weekly Survey Monkey questionnaire on total doses

administered by age category, dose #1 or #2– Not required to record doses in TWIS, but may be

valuable

Pandemic Vaccine Planning

• Cannot predict when vaccine will arrive, size of initial shipments

• Begin planning strategies– Seasonal vaccine (Sept-Oct)– Pandemic #1 (Oct-Nov)– Pandemic #2 (3-4 weeks after #1)– Storage space? Communications? Time and

locations?

• Much has yet to be decided - make plans practical and flexible

Discussion

Thank you!

Kelly Moore, MD, MPH

Kelly.moore@tn.gov

615-741-7247

Update on Infection Control

Marion Kainer MD MPH

Director, Hospital Infections Program,

Tennessee Department of Health

Recent Infection Control Breaches in TN

• Multiple instances of NO precautions (no PPE at all) taken by HCWs in looking after patients with fever and respiratory distress (later confirmed H1N1)

• Intubation, bronchoscopy, open suctioning• Hundreds of HCWs exposed: PEP

– Some HCW infected, some severely ill– Infected HCWs went to work & exposed

co-workers and patients

• H1N1 was considered in the differential diagnosis (specimen taken), but NOT communicated to IP or other staff

• Patient NOT placed in isolation• Patient did NOT receive antivirals• One patient died

• Improve communications (consider closing loop with laboratory notifying IP if H1N1 test is ordered)

Think H1N1: Just because it is not in the media,

it has NOT disappeared

Current Published CDC Guidelines

• Respiratory etiquette

• Hand Hygiene

• N-95 respirators for all direct patient contact if suspected/confirmed H1N1

• Prefer negative pressure room if performing aerosol-generating procedure

Current TDH Guideline• Similar to WHO and Health Canada:• http://www.who.int/csr/resources/public

ations/infection_control/en/index.html.

• For all patients with a febrile respiratory illness (FRI) (i.e., not just suspect or confirmed cases of H1N1):

Current TDH Guideline- All FRI:

• Practice good hand hygiene (patient and staff)

• Practice good respiratory hygiene (patient and staff)

• Practice standard precautions (i.e., treat all body-fluids as potentially infectious, including stool; wear gown, gloves and eye-protection if risk of splash)

Current TDH Guideline: All FRI• Wear surgical mask if within 6 feet if:

– the patient is compliant (willing and able) with respiratory hygiene practices or

– the patient has a weak or no cough • individuals who may have a weak cough are the frail

elderly and pediatric patients.

• Wear a N-95 respirator (fit-tested); • Eye-protection (face-shield or goggles); • Gown and gloves

– IF conducting aerosol-generating medical procedures

OR– WHEN the patient is coughing forcefully AND the

patient is unable/unwilling to comply with respiratory hygiene (e.g., coughing patient who is unable or unwilling to wear a surgical mask)

Current TDH Guideline

• Face-shields are preferred over goggles because:– goggles may alter facial contours and

impair the proper fit of N-95 respirators that were fit-tested without wearing goggles

– face-shields are easier to clean than goggles

• Face-shields should cover the eyes and preferably extend over the chin

CDC Guidelines May Change• APIC/SHEA position statement

• HICPAC voted for following recommendation to CDC:– Standard precautions– Droplet precautions– N-95 + Eye protection for aerosol-

generating procedures

• Waiting for IOM report – (8/11 meeting; report by 8/30)

• September 1: possible guideline change

Aerosol-Generating Procedures (HICPAC: 7/23/2009)

• Intubation

• Bronchoscopy

• Induced Sputum

• Open Suctioning

• CPR