Slide 1 Hello, my name is Lisa Johns, Pandemic Influenza Preparedness for Local Health Departments: and I am a registered nurse and clinical consultant with the North Vaccines Carolina Immunization Branch. I will be your host today for the vaccine module of the Pandemic Influenza Preparedness Training for Local Health Departments. I Lisa Johns, RN, BSN hope the information provided NC Immunization Branch today will be helpful to you in your work. Slide 2 After completing this training, Learning Objectives you should be able to meet the following objectives: No script, Upon completion of this module, the learner will be read text from slide able to: Understand the key differences between seasonal influenza vaccine and pandemic influenza vaccine Recognize the key challenges that arise when planning for the use of pandemic influenza vaccine Describe newer technology being developed to address some of these challenges Slide 3 To start this session, lets talk Seasonal Flu Vaccine about seasonal flu vaccine. No script, read text from slide Two types of flu vaccine: ♦ Trivalent influenza vaccine (TIV) Intramuscular injection ♦ Live Attenuated Influenza Vaccine (LAIV) Administered intranasally Slide 4 Each year the World Health Deciding on the Antigen Content Organization makes recommendations for the flu • World Health Organization (WHO) makes vaccine content for the following recommendations yearly for the upcoming flu season, based on the flu season vaccine based on the circulating strains of flu vaccine circulating flu strains throughout the world. in the world. These • FDA reviews these recommendations recommendations are then along with surveillance information from U.S. for previous year. May adopt WHO reviewed by the FDA along with recommendations or change them surveillance information from the previous flu season. Then the FDA decides if they will adopt the WHO recommendations or make their own. Slide 5 Currently, the manufacturing Manufacturing Seasonal Flu process for seasonal flu vaccine Vaccine is quite lengthy about nine Nine month production cycle months to complete the entire Requires large quantities of eggs production cycle. Viruses are Often, yield of virus grown in eggs is grown in fertilized eggs requiring unpredictable large quantities of eggs to be Must go through purification process available. The virus strains must Cannot be administered to anyone with an be purified after growing in the allergy to eggs egg. Small amounts of egg Does produce an effective vaccine protein usually still remain, which makes the vaccine contraindicated for persons with an allergy to eggs. Though the production method is lengthy and does have drawbacks, the vaccine produced is very effective against the flu. Slide 6 Because of staggered delivery Recommended Priority Groups for schedules, and sporadic Seasonal Flu Vaccine shortages of vaccine, for the • Infants 6 months – 36 months of age past several flu seasons the • Children and adults with chronic illnesses CDC has recommended that the • Caregivers of infants less than 6 months of following groups be given priority age for receiving seasonal flu • Household contacts of the above groups vaccination. No script, read text • Healthcare workers providing direct patient from slide care Slide 7 There are several differences Differences Between Seasonal and between seasonal flu vaccine, Pandemic Vaccines and vaccine that would be Seasonal Pandemic produced and used during a Contains three strains of flu Contains one strain of virus influenza virus pandemic. No script, read text Can be prepared in advance Cannot be prepared until from slide of the flu season the pandemic occurs Antigens in vaccine may not Will match the circulating match what is circulating strain unless the strain during flu season mutates again Production plants are Will require building new currently set up for this production plants type of manufacturing Slide 8 The most likely influenza strain The Top Candidate to cause a pandemic at this time is the H3N1 avian strain. H3N1 strain of avian influenza is considered However the virus would have to the most likely candidate to cause a mutate in order for it to be pandemic at this time passed from human to human. Would have to mutate to be transmitted from Cases of bird to human human to human transmission of this virus have a High mortality rate in bird to human cases high mortality rate. It is possible Commonly referred to as the “bird flu” however that a pandemic could be caused by another flu virus. Slide 9 The World Health Organization Strains of H5N1 Used for (WHO) identified 3 strains of Vaccine Development H5N1 virus to be used for development of an egg-based • A/Vietnam/1203/2004 pandemic flu vaccine. These • A/Vietnam/1194/2004 three strains are : No script, read • A/Hong Kong/213/03 text from slide. These strains were isolated from humans with • Identified by the World Health actual cases of avian influenza. Organization (WHO) Slide The National Institute for 10 Vaccine Development Allergies and Infectious Diseases at the National • NIAID/NIH awarded contracts to sanofi- Institutes of Health awarded pasteur and Chiron to use reference virus contracts to several to produce vaccine for clinical trials. pharmaceutical manufacturers to • First clinical trials for safety and efficacy take these reference viruses and started April, 2005, on healthy subjects produce vaccines (using current 18-64 years old,64 years and older and 2- 9 years old. egg-based technology) for clinical trials. The first clinical trials for safety and efficacy of these vaccines started in April 2005, on three groups of healthy subjects – those 18-64 years old, 64 years old and over, and children 2-9 years of age. Slide No script, read text from slide 11 Variations in Testing Vaccine formulations tested: Varying amounts of antigen Giving one dose or two of vaccine Given intradermally instead of intramuscularly With and without adjuvants Slide For those of you not familiar with What is an adjuvant? the term, and adjuvant is a 12 substance that helps the body to • An adjuvant is a substance added to a produce a more vigorous vaccine that causes the body to respond immune response to the vaccine, more vigorously to the vaccine, but the but does not have any effect of substance does not have any effect of its its own. The most commonly own. used adjuvants in vaccines are • Most commonly used vaccine adjuvants are aluminum salts the aluminum salts – aluminum hydroxide, aluminum phosphate and aluminum potassium sulfate. Slide No script, read text from slide 13 Results of Initial Clinical Trials • Vaccine elicited immune response but required large amount of antigen • Works best with two doses given 3-4 weeks apart • Vaccines containing adjuvants work better • Adjuvants that work best are aluminum salts and Chiron’s MF59 Slide Recognizing the need to develop What’s Next for H5N1 Vaccine a more efficacious pandemic flu 14 vaccine and one that can be • In May 2006, federal government awarded produced more quickly the one billion dollars in contracts to federal government awarded one companies to develop H5N1 vaccines that billion dollars in contracts to do not require eggs or adjuvants several pharmaceutical • Cell based technology used would be manufacturers to develop H5N1 similar to current method used to produce vaccines that do not require inactivated polio vaccine (IPOL) eggs for production or adjuvants. This is of particular importance if a pandemic were caused by the avian flu strain as this might make it difficult to get adequate numbers of fertilized chicken eggs to use in vaccine production. It would also make the pandemic flu vaccine contraindicated for anyone who is allergic to eggs. Cell based technology, similar to what is currently used to manufacture inactived polio vaccine will be used to produce this new generation of vaccines. Slide No script, read text from slide 15 What is Cell-based Technology? Flu viruses are grown in mammal cells instead of eggs Cells can be made in advance of an epidemic and frozen, or developed very rapidly Reduces the risk of contamination of vaccine More reliable, flexible and expandable than egg- based technology Vaccine can be produced in a matter of weeks! Slide No script, read text from slide How Will Vaccine Be Distributed 16 During a Pandemic? • Assumptions: No vaccine available for several months When available, supplies very limited Prioritization of administration will be necessary Could possibly come through SNS or a private distributor Slide The federal government has Priority Groups for Pandemic 17 established priority groupings Critical assumptions: The greatest risk of death from pan flu will be in infants, the should a pandemic event occur. elderly and those with underlying health conditions. Healthcare system will be severely taxed if not overwhelmed These groupings were based on Critical infrastructure of communities will be severely taxed Vaccine and antiviral production must be maintained at the critical assumptions that: No capacity script, read text from slide For a complete list of the pandemic priority groups go to www.pandemicflu.gov Slide No script, read text from slide 18 Security of Vaccine • Significant issue during a pandemic • Vaccine must be kept in a secure, locked area with limited access. • May need to store vaccine at an alternate, more secure site such as a hospital. Slide No script, read text from slide 19 Learning Activities 1. Assess storage capacity at your agency for pandemic flu vaccine. Keep in mind the following: Location must be secure Reliable refrigeration Functional disaster back-up plan Unlikely you will need large amount of space Slide No script, read text from slide 20 More Learning Activities 2. Locate a copy of the state and federal prioritization plans for a pandemic situation. 3. Determine how these priority groups would need to be adjusted to meet the needs of your county. Slide A question for you to think about 21 Think About This… – No script, read text from slide During a pandemic influenza outbreak, you are told that 100 doses of vaccine is coming to your county. You are responsible for distribution of this vaccine. How would you handle this challenge? Slide To see an extensive array of 22 Need More Info? information on pandemic flu planning visit these websites The CDC and HHS are the primary sources regularly. The information is of information on pandemic flu planning. updated on a regular basis. Their websites are: www.cdc.gov/flu www.pandemicflu.org Slide This concludes our module for 23 Thanks for all you do! today. Thank you for listening, and thank you for all you do everyday to protect the health of the citizens of North Carolina.