Idaho Public Health Infectious D isease U pdate

1. Idaho Public Health Infectious Disease Update Mike Taylor MHE, CHES Surveillance Epidemiologist Eastern Idaho Public Health District Christine Hahn, MDIdaho Division of Public Health

3. Incidence rate of pertussis in Idaho and United States, 2002 – 2012 YTD Idaho U.S.

4. 2012: A difficult year

5. 2012 Experience Source: http://www.cdc.gov/pertussis/outbreaks.html#trends

7. Waning Protection after Fifth Dose of Acellular Pertussis Vaccine in ChildrenN Engl J Med 2012; 367:1012-1019 September 13, 2012 • California study compared 277 children, 4 to 12 years of age, who were PCR-positive for pertussis with 3318 PCR-negative controls and 6086 matched controls. • PCR-positive children were more likely to have received the fifth DTaP dose earlier than PCR-negative controls (P<0.001) or matched controls (P=0.005). • Comparison with PCR-negative controls yielded an odds ratio of 1.42 (95% confidence interval, 1.21 to 1.66), indicating that after the fifth dose of DTaP, the odds of acquiring pertussis increased by an average of 42% per year

8. Percentage of PCR Tests That Were Positive for Pertussis from January 2006 through June 2011, According to Age and Time since Vaccination. Klein NP et al. N Engl J Med 2012;367:1012-1019.

9. Take home messages • Immunity after infection or vaccination is not long lasting. • Endemic adolescent and adult disease is responsible for the cyclic pattern in unvaccinated children. • B pertussis circulation is not being controlled by present immunization programs. • The best strategy at present is universal child and adolescent immunization and vigorous cocooning (immunization of adults who have contact with children).

10. Looking forward • Continued increases in Dtap and Tdap recommendations (now, pregnant women) • Growing awareness that public health measures (prophylaxis of contacts, restricting sick persons) has only limited value, and will not ultimately reduce rates • Increasing awareness of need for a better vaccine!!

16. Who should get the shot? • Annual influenza vaccination is recommended for all persons aged 6 months and older.

17. Vaccination of HCW • During the 2009-2010 influenza season, an estimated 61.9% of health care workers received seasonal influenza vaccine. • During the 2010-2011 influenza season, coverage for influenza vaccination among health care workers was estimated at 63.5%. • Coverage was 98.1% among health care workers who had an employer requirement for vaccination. • In the absence of requirements, increased vaccination coverage was associated with employers offering vaccination onsite, free of charge, for multiple days.

18. 2012-2013 Algorithm for Children 6 mos. - 8 yrs.

19. Available Vaccine Brands 2012-2013 Season Brand names of the vaccines and manufacturers licensed to produce flu vaccines for the upcoming flu season are: • Fluzone, manufactured by Sanofi Pasteur • Agriflu, manufactured by Novartis Vaccines and Diagnostics • Fluvirin, manufactured by Novartis Vaccines and Diagnostics • Fluarix, manufactured by GlaxoSmithKline Biologicals • FluLaval, manufactured by ID Biomedical Corporation • Afluria, manufactured by CSL Limited • FluMist, manufactured by MedImmune Vaccines • Fluzone High-Dose and • Fluzone Intradermal, both manufactured by Sanofi Pasteur

21. What’s on the horizon? • No new vaccine products anticipated this season • Quadrivalent live attenuated influenza vaccine, FluMist Quadrivalent® (MedImmune) was approved February 2012 • Live, attenuated influenza vaccine • Administered as a nasal spray • Approved for use in people ages 2 through 49 years • The first to contain four strains of the influenza virus -- two influenza A and two influenza B lineage strains. • Anticipated to be available for 2013-2014 US season.

22. Vaccine Strain Selection Process • 130 national influenza centers in 101 countries conduct year-round surveillance for influenza and send influenza viruses to the 5 WHO Influenza collaborating centers : • Atlanta, GA (CDC) • London, UK(National Institute for Medical Research) • Melbourne, Australia (Victoria Infectious Diseases Reference Laboratory) • Tokyo, Japan (National Institute for Infectious Diseases) • Beijing, China (National Institute for Viral Disease Control and Prevention) • Experts from the FDA, the WHO, the CDC, and other public health experts identify virus strains likely to cause the most illness during the upcoming flu season.

23. Vaccine Strains for 2012-2013 • The strains selected for inclusion in the 2012-2013 flu vaccines are: • A/California/7/2009 (H1N1)-like virus • A/Victoria/361/2011 (H3N2)-like virus • B/Wisconsin/1/2010-like virus.

24. Influenza A (H3N2) Variant Virus Outbreak • Found in U.S. pigs in 2010 and humans in July 2011 • One case in April 2012 in Utah • Since July 2012, the number of human cases has picked up considerably with cases reported from 10 states • Indiana (138), Ohio (101), Hawaii, Illinois, Maryland, Michigan, Minnesota, Pennsylvania, West Virginia, Wisconsin • 290 confirmed cases • 15 hospitalizations • 1 death

25. Influenza A (H3N2) Variant Virus Outbreak • Appears to spread more easily from pigs to people than other variant viruses • Main risk factor is exposure to pigs, mostly in fair settings • Most cases have occurred in children • Only limited person-to-person spread with this virus has occurred • Symptoms are similar to seasonal flu • People at high risk of serious complications include: • children < 5 • people with chronic conditions like asthma, diabetes, heart disease, weakened immune systems, pregnant women and people >65 years • These people are urged to avoid pigs and pig arenas at fairs this season. • Seasonal influenza vaccine not expected to protect against this virus

26. H3N2v precautions

28. Fungal meningitis outbreak 2012

29. Meningitis following epidural steroid injection • Sep 21, 2012: CDC notified by Tennessee Department of Health of a patient with onset of fungal meningitis ~19 days following epidural steroid injection at a Tennessee ambulatory surgical center. Quickly more reports came in, involving 11 patients • Sep 25: three lots of methylprednisolone acetate recalled • Sep 28, 2012: investigators identified a case in North Carolina • Currently on CDC website: 214 cases with 15 deaths from 15 states • 212 central nervous system cases; 2 peripheral joint infections • All infected patients received preservative-free methylprednisolone acetate from among the 3 lots recalled by the New England Compounding Center (NECC) in Framingham, MA, September 26th • An estimated 13,000 patients were injected with the contaminated lots nationwide

30. States Receiving Recalled Methylprednisolone Acetate from New England Compounding Center

32. Dates of onset

33. Case Definitions for Meningitis and Septic ArthritisOctober 12, 2012 3:30 PM EDT Probable Case: A person who received an injection with methylprednisolone acetate produced by the New England Compounding Center who developed any of the following: 1.Meningitis1 of unknown etiology following epidural injection after May 21, 2012. 2.Stroke following epidural injection after May 21, 20122, who has not received a diagnostic lumbar puncture. 3.Spinal osteomyelitis or epidural abscess of unknown etiology at the site of injection following epidural or sacroiliac injection after May 21, 2012. 4.Osteomyelitis or worsening inflammatory arthritis of a peripheral joint (e.g., knee) of unknown etiology diagnosed following joint injection after May 21, 2012. 1 Clinically diagnosed meningitis meaning 1 or more of the following symptoms: headache, fever, stiff neck, or photophobia, in addition to a cerebrospinal fluid (CSF) profile showing pleocytosis (>5 white blood cells, adjusting for presence of red blood cells by subtracting 1 white blood cell for every 500 red blood cells present) regardless of glucose or protein levels. 2 These people, if possible, should have a lumbar puncture. Confirmed Case: A probable case with evidence of a fungal pathogen (by culture, histopathology, molecular, or antigen-based assay) associated with the clinical syndrome. Patients under investigation: A person who developed an infection of a normally sterile site (e.g., blood, CSF, pleural fluid, peritoneal fluid, pericardial fluid, surgical aspirate, bone, joint fluid, or internal body site [e.g., lymph node, brain]) following use of a product labeled as sterile prepared by the New England Compounding Center.

34. Implicated fungi Exserohilumrostratum Aspergillus fumigatus

35. Idaho Situation • Facility A in PHD7: received 150 doses • Appears 52 doses gone; the rest discarded after recall • 39 patients have been identified as exposed; all have been contacted and are being clinically evaluated • 8+ have had symptoms worrisome enough for more extensive evaluation including spinal taps • 1 patient diagnosed Oct 10 with meningitis • Facility B in PHD3: received 5 doses • 4 patients were injected; one dose discarded after recall • 1 of the 4 patients received spinal tap: not suggestive of CNS infection

36. FDA statement to medical providersOct 15, 2012 • The FDA had previously issued guidance for medical professionals that all products distributed by NECC should be retained, secured, and withheld from use. Based on the new information described above, out of an abundance of caution, FDA advises you to follow-up with patients for whom you administered an injectable product, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by NECC after May 21, 2012. FDA does not urge patient follow-up at this time for NECC products of lower risk such as topicals (for example, lotions, creams, eyedrops not used in conjunction with surgery) and suppositories. • You should inform patients who received the NECC products noted above of the symptoms of possible infection and instruct them to contact you or another healthcare provider immediately if they experience any of these symptoms. • The FDA recognizes that some health care professionals may receive a high volume of calls from patients or be concerned about having to notify many patients as a result of today's announcement. We ask you to use your clinical judgment in deciding which patients are at risk and contact those patients in whatever communications mode you prefer, whether it is email, phone or letter. Face-to-face communication with patients is not necessary. • Clinicians are also requested to report any suspected adverse events following use of these products to FDA's MedWatch program at 1-800-332-1088 or www.fda.gov/medwatch6.

37. CDC resources

38. Epidural spinal injection Source: http://patients.dartmouth-hitchcock.org/pain_mgt/epidural_steroid_injection.html

39. Compounding Pharmacies • State regulators, federal agencies and the pharmacy industry all share some responsibility for monitoring compounding pharmacies. • These facilities can slide through the cracks because no one entity has full responsibility for overseeing them. • Compounding pharmacies were initially set up to provide solutions to individual patient needs, such as preparing liquid formulations for people who couldn’t swallow pills; NECC (and other compounding pharmacies, possibly) acted more as a pharmaceutical company, “making” and selling drugs to providers at cheaper rates

40. Questions?