Immunizations: new and sometimes confusing recommendations MARK H. SAWYER, MD UCSD SCHOOL OF MEDICINE AND RADY CHILDREN S HOSPITAL SAN DIEGO

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1 Immunizations: new and sometimes confusing recommendations MARK H. SAWYER, MD UCSD SCHOOL OF MEDICINE AND RADY CHILDREN S HOSPITAL SAN DIEGO

2 Disclosures I have no financial disclosures related to this presentation My 3 children are fully immunized I did not have my college-age daughter immunized with meningococcal B vaccine I got a second Tdap even though it isn t recommended for healthcare providers

3 Protecting Children from Serious Disease through 1st and 2nd Generation Pneumococcal Conjugate Vaccines (PCV) Source: Pneumococcal Disease Surveillance and Reporting. 7

4 Measles Cases Reported in the U.S. Although year-round transmission has been eliminated from the U.S., measles cases are still reported in the U.S., including among adults. - Most cases importation-related Measles is still common in many parts of the world including some countries in Europe, Asia, the Pacific, and Africa. The majority of people who got measles were unvaccinated. Number of Measles Cases by Year Year Cases * *As of February 24, 2018 Measles Cases and Outbreaks. Morbidity and Mortality Weekly Report (MMWR), Notifiable Diseases and Mortality Tables. 16

5 Mumps Cases Reported in the U.S. Number of Mumps Cases by Year 2016: 6,366 mumps cases reported in 47 states and D.C. - Highest number of cases in a year since : provisional 5,629* mumps cases reported in 48 states and D.C. Year Cases , , , , , ** *-As of February 24, 2018 *Preliminary data reported to CDC s National Center for Immunization and Respiratory Diseases, updated monthly. Mumps outbreaks are not reportable. Mumps Cases and Outbreaks. Morbidity and Mortality Weekly Report (MMWR), Notifiable Diseases and Mortality Tables. 18

6 It can be a little confusing. We used to promote the live attenuated nasal influenza vaccine, then we weren t using it at all, and now we are using it again?!? We have two types of meningococcal vaccine, one is routinely recommended while the other is not one is routinely recommended for a small subset of infants but the other is not; one is recommended for HIV-infected adolescents and one that is not. One of the Men B vaccines can now be given as either a 2-dose or a 3-dose vaccine. HPV vaccine can be given as either a 2-dose or 3-dose vaccine There are two different types of pneumococcal vaccine. Some children need one, some need the other, and some need both

7 Objectives Explain the difference between the two available meningococcal vaccines and the recommendations for their use Explain the difference between the two available zoster vaccines and the recommendations for their use Describe the appropriate window for administration of the birth dose of hepatitis B vaccine Explain what is different about the new adjuvanted hepatitis B vaccine List what age groups should receive hepatitis A vaccine for pre- and postexposure prophylaxis 7

8 Meningococcal vaccines-be careful! Two very different vaccine types Men ACWY (Menveo, Menactra) Men B (Trumenba, Bexero) Two very different recommendations Men ACWY-routine for adolescents and high-risk individuals including infants Men B-routine only for a subset of high-risk individuals and not infants Men ACWY products-difference in recommendations for use under 2 years of age due to vaccine interference Men B vaccines-two very different vaccines products Different schedules and different intervals between doses Can t be interchanged

9 College students-most disease is now serogroup B ACIP Meeting. February 2018

10 Increased risk of meningococcal B disease in college students ACIP Meeting. February 2018

11 College Outbreaks ACIP Meeting. February 2018

12 Should we be giving meningococcal B vaccine to everyone?

13 What about everyone else? A Men B vaccine series MAY be administered to adolescents and young adults aged years to provide SHORT-TERM protection against MOST strains of serogroup B meningococcal disease. The preferred age for Men B vaccination is years. Macneil J, ACIP presentation June 2015

14 Meningococcal B Vaccines: Who should you give them to? year olds who request it Kids whose college or other institution requires it College students? Those living in dormitories or other crowded conditions? Those who smoke or drink alcohol? Everyone? Nobody?

15 We have a problem! A disease that affects 1/3 of all adults A disease that is extremely painful A disease that can be debilitating for months A disease that we can prevent So why aren t we preventing this disease?!?!?!?

16 Zoster=Shingles

17 WHAT IS ZOSTER? WHY DOES IT LOOK LIKE THAT? Zoster is your varicella/chickenpox coming back to haunt you Varicella virus remains latent in your spinal cord for decades Reactivation occurs when your immune system is suppressed, either naturally or because of disease or medication. Incidence rises with age About 15% of people who get zoster suffer from post-zoster neuralgia that can last for months or longer Zoster should become less common because we now prevent varicella in children through immunization 17

18 Dooling, ACIP Meeting, October 2017

19 Zoster is a worldwide problem Incidence rises dramatically with age Kawai, BMJ Open Access dx.doi.org/ /bmjopen

20 New subunit zoster vaccine (Herpes Zoster/su) Recombinant Zoster Vaccine (Shingrix) Licensed by FDA, October dose subunit vaccine Recommended by ACIP beginning at age 50 Preferred over the current live attenuated vaccine

21 Two different zoster vaccines ZOSTER VACCINE LIVE (ZVL)-ZOSTAVAX Live virus vaccine Can t be used in people with compromised immune systems Stored frozen Given as a single dose subcutaneously Recommended routinely starting at age 60 years Recommended even if you have had zoster Overall effectiveness for the prevention of zoster=50% RECOMBINANT ZOSTER VACCINE (RZV/HZ- SU)-SHINRIX Recombinant subunit glycoprotein E vaccine Contains a novel adjuvant (ASO1 B ) Stored refrigerated Given as two doses intramuscularly, 2-6 months apart Recommended routinely starting at 50 years Recommended even if you have had zoster or received ZVL before Increased local side effects

22 Dooling, ACIP Meeting, October 2017

23 Dooling, ACIP Meeting, October 2017

24 Dooling, ACIP Meeting, October 2017

25 Dooling, ACIP Meeting, October 2017

26 Why does this vaccine work better?

27 The Immune system

28 Adjuvants and the immune system The immune system responds to some things better than others Live, replicating agents induce better immunity than inert subunit protein or carbohydrate (MMR>tetanus) Proteins are better than carbohydrates (PCV13>PPSV23) More complex formulations better than purified formulation (Whole cell pertussis>dtap) Certain molecule structures stimulate the immune system (Virus like particles [e.g.hpv vaccine]) Adjuvants Alum Liposomes Squalene Nanocarriers CpG oligonucleotides Lipid molecules LPS Natural toxins

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30 Adjuvants-concerns Enhanced local reactions Swelling Tenderness Redness Enhanced systemic reactions Fever Malaise Achiness Autoimmune reactions (theorhetical)

31 RZV local side effects

32 RZV systemic reactions

33 RZV recommended routinely starting at the age of 50 years Should be given to persons with a history of zoster Should give to persons with chronic medical conditions and mile immunosuppression (e.g. <20 mg/day prednisone No specific recommendation for immunocompromised persons RZV can be given concomitantly with other vaccines Counsel your patients about local and systemic reactions Additional safety studies ongoing Could need to modify concomitant use of multiple adjuvanted vaccines (e.g. adjuvanted influenza vaccine-fluad, adjuvanted hepatitis B vaccine-heplisav) Not recommended for prevention of varicella Dooling, MMWR 2018;67:

34 RZV recommended in people who have already received ZVL Interval not clearly specified RZV has been studied 5 years following ZVL No reason to be concerned about shorter intervals One reasonable consideration is the age of the patient when they received ZVL (decreased effectiveness in those >70 years of age Minimum interval following ZVL is 2 months Dooling, MMWR 2018;67:

35 RZV recommended preferentially over ZVL Improved effectiveness and probably improved duration of protection ZVL is still available and can still be used

36 Our challenge

37 WE SHOULD BE DOING BETTER 33% of adults >60 years of age had received zoster vaccine in 2016 Dooling, ACIP Meeting, October 2017; MMWR 2018;67:

38 Hepatitis-What can possibly be new? Hepatitis A Hepatitis B

39 Why hepatitis B is a problem Chronic hepatitis B infection occurs in approximately 90% of infected infants 30% of children infected at <5 years of age <5% of children infected at 5 years of age or older Risk of premature death from cirrhosis or hepatic cancer 25% if infected during childhood 15% if infected as an adult Mast et al, MMWR 2005; Goldstein et al, Int J Epidemiology 2005; Schillie ACIP presentation 2016

40 Recommendations for birth dose of Hep B vaccine All babies should get a birth dose of Hep B vaccine and the dose should be given within 24 hours of birth Schillie, ACIP October

41 Why push for a birth dose of hepatitis B vaccine? Hep B vaccine works better in preventing perinatal transmission when given on day 1 than it does when given later Infants born to mothers with unknown or discrepant Hep B status are less likely to be immunized at birth than infants born to mothers with clear status During the period following the 1999 recommended delay in birth doses of Hep B vaccine for infants born to known HBsAg-negative mothers, babies who should have been immunized were not, due to errors in record keeping Mistakes happen and babies keep falling through the cracks in our systems and get infected Smith, Pediatrics 2012;129:609

42 What about babies that don t respond to Hepatitis B vaccine?

43 Single dose revaccination Nelson, ACIP presentation, February 2017

44 Adjuvanted Hepatitis B vaccine

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48 Schillie, ACIP presentation February 2018

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50 Schillie, ACIP presentation February 2018

51 Schillie, ACIP presentation February 2018

52 New Hepatitis B Vaccine 2-dose regimen Predicted to increase seroconversion rates in adults Predicted to induce higher immune responses in adults Licensed by FDA on 11/9/2017 ACIP has recommended this vaccine as an option Can interchange with current vaccines but if you do 3 total doses will be needed

53 Hepatitis A Infants 6 months of age of older travelling abroad need MMR vaccine Immune globulin (historically given to protect infants from hepatitis A) interferes with MMR vaccine Thus, Hepatitis A vaccine now recommended for infants 6 through 11 months of age travelling abroad Hepatitis A vaccine recommended post-exposure prophylaxis for individuals 12 months of age or older Hepatitis A vaccine now also recommended for adults 40 years of age and older for postexposure prophylaxis (+/- IG)

54 Nelson, ACIP Meeting February 2018

55 Summary Be careful with the meningococcal vaccines. They are recommended at different ages and for different subgroups. New adjuvanted zoster and hepatitis B vaccines offer better protection for older adults The birth dose of hepatitis B vaccine should be given at birth (<24 hours) For infants who don t respond to hepatitis B vaccine, now a single revaccination dose followed by serology is an option Expanded use of hepatitis A vaccine in infants 6-11 months of age and in adults >40 years of age

56 Questions or Comments