Are 10-year booster doses of yellow fever vaccine necessary? Peter Teitelbaum, MD Committee to Advise on Tropical Medicine and Travel (CATMAT)

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1 Are 10-year booster doses of yellow fever vaccine necessary? Peter Teitelbaum, MD Committee to Advise on Tropical Medicine and Travel (CATMAT)

2 Disclosure of Potential for Conflict of Interest Peter Teitelbaum, MD CATMAT Yellow Fever Booster Update FINANCIAL DISCLOSURE Grants/Research Support: None Speakers Bureau/Honoraria: None Consulting Fees: None Other: None

3 What WHO concluded In April 2013, the World Health Organization Strategic Advisory Group of Experts on Immunization concluded that a single primary dose of yellow fever vaccine is sufficient to confer sustained immunity and lifelong protection against yellow fever disease, and that a booster dose is not needed.

4 What ACIP/CDC concluded - I US Advisory Committee on Immunization Practices and CDC 2015: A single dose of YF vaccine provides long-lasting protection and is adequate for most travelers.

5 Why did the question arise?

6 Long-term protection did WHO and CDC come to their conclusions?

7 GRADE Grading of Recommendations Assessment, Development and Evaluation

8

9 Paper 1-98% protection at 20 years Paper 2 76% protection at 40 years Paper 3 80% protection at 35 years Paper 4 -. Conclusion: good protection in long-term (Not real results)

10 GRADE Quality Ranking 1 = HIGH 2 = MODERATE 3 = LOW 4 = VERY LOW For each study and then come up with an overall score

11 GRADE Quality Ranking HIGH MODERATE LOW VERY LOW Why does it matter?

12 GRADE Quality Ranking HIGH MODERATE LOW VERY LOW How do we judge that?

13 GRADE Quality Ranking THE TYPE OF STUDY MATTERS MOST Randomized control trials (RCTs) Observational studies Clinical experience, expert opinion

14 GRADE Quality Ranking 1 = HIGH = Randomized control trials (RCTs) or overwhelming evidence from observational studies 2 = MODERATE = RCTs with important limitations, or exceptionally strong evidence from observational studies 3 = LOW = Observational studies, or RCTs with notable limitations 4 = VERY LOW = Clinical experience and observations, observational studies with important limitations, or RCTs with several major limitations

15 GRADE Quality Ranking Overall quality ranking across all papers: LOW

16 Paper 1-98% protection at 20 years Paper 2 76% protection at 40 years Paper 3 80% protection at 35 years Paper 4 -. But low quality evidence (Not real results)

17 GRADE Conclusion The data indicates that the vaccine is protective in the long-term. The quality of the data is low. (Not a real conclusion. For illustration.)

18

19 WHO, CDC, GRADE

20 What did the data show? Let s first look at how they judged the quality of that data before showing it.

21 DATA QUALITY The data we retrieved provides level 2 evidence Moderate. The data we retrieved provides level 4 evidence Very low.

22 How GRADE Rates Studies By evidence type: 1 = Randomized control trials (RCTs) or overwhelming evidence from observational studies 2 = RCTs with important limitations, or exceptionally strong evidence from observational studies 3 = Observational studies, or RCTs with notable limitations 4 = Clinical experience and observations, observational studies with important limitations, or RCTs with several major limitations

23 Randomized Controlled Trials

24 Field study

25 How GRADE Rates Studies Evidence type: 1 = Randomized control trials (RCTs) Overwhelming evidence from observational studies 2 = RCTs with important limitations, Exceptionally strong evidence from observational studies 3 = Observational studies or RCTs with notable limitations 4 = Clinical experience and observations, observational studies with important limitations or RCTs with several major limitations

26 Observational Studies Preferred observational study types Case Control Studies: none Cohort studies: yes, but not strong

27 How GRADE Rates Studies Evidence type: 1 = Randomized control trials (RCTs) or overwhelming evidence from observational studies 2 = RCTs with important limitations, or exceptionally strong evidence from observational studies 3 = Observational studies RCTs with notable limitations 4 = Clinical experience and observations, observational studies with important limitations or RCTs with several major limitations

28 Observational Studies - Immunized people appear to be spared in outbreaks - Epidemics appear to be stopped by mass immunization - Very few cases in the literature of disease in immunized people despite ½ billion doses administered - Serologic studies

29 Observational Studies Immunized people appear to be spared in outbreaks During these outbreaks, yellow fever disease only occurred in unvaccinated individuals and persons who received yellow fever vaccine several decades previously were protected from developing yellow fever disease (Tomori, personal communication).

30 Observational Studies Epidemics appear to be stopped by mass immunization

31 Observational Studies Very few cases in the literature of disease in immunized people despite ½ billion doses administered CDC: Very low quality evidence (level 4) (incomplete case capture)

32 Observational Studies Serologic studies CDC: Very low quality evidence (level 4) WHO: Moderate quality evidence (level 2)

33 Observational Studies What are serologic studies? Seropositivity vs seroprotection

34 PRNT plaque reduction neutralization test

35 PRNT serology - CDC FDA said, and ACIP/CDC agreed: Measuring antibody using PRNT can indicate the presence of yellow fever neutralizing antibody but what titre is protective has never been adequately demonstrated using this test.

36 PRNT serology - WHO [There is] overall agreement in the assumption that titer>1:10 in plaque reduction neutralization test is associated with protective immunity the working group did note issues and concerns with the lack of a clear correlate of protection in the immune response to yellow fever vaccination. seroprotective levels of neutralizing antibodies, using a PRNT, have not been determined

37 Surrogate evidence She s not my real mother.

38 Problem: Did they really measure only yellow fever antibody in all those studies?

39 Problem: Boosters already?

40 Observational Studies Serologic studies Very low quality evidence (level 4) And the overall level of evidence is level 4

41 Sample size Time since last YF immunization R years 76% strongly positive an mouse study years 100% seropositive mou years 96% seropositive mous years 100% seroprotected;, Ma one dose years 93% seroprotected

42 A too-low threshold was app these people seroprotected years 97% navy/air force seroposit personnel seropositive years 74.5% seroprotected years 13 of 19 of people (68.4%) w years; median 14 yrs 95.2% seroprotected; 9 of 10 >25 years years 84% (26/31) of subjects who 20 years previously were se Comment: This appears to be

43 There is a limited amount of data showing protection in the longer term from one dose of yellow fever vaccine The data provides Level 4 (Very Low) evidence for long term protection. My interpretation: The data shows that the vaccine protects in the long term, and that data is not trustworthy.

44 How did WHO & CDC conclude that the vaccine protects for life?

45 And one more thing. Gambia did mass-immunization, 95% of population in 6 months, in Included in childhood immunization schedule to this day, 80% of population Unique geography has Gambia surrounded by Senegal Gambia has reported 1 case of yellow fever involving an unimmunized tourist

46 An epidemic of yellow fever (YF) occurred in the Gambia between May 1978 and January Retrospective case-finding methods and active surveillance led to the identification of 271 clinically suspected cases. A confirmatory or presumptive laboratory diagnosis was established in 94 cases. In nine survey villages in this area (total population 1,531) the attack rate was %, with a mortality rate of 0.8%, and a case fatality rate of 19.4%. If these villages are representative of the total affected region, there may have been as many as 8,400 cases and 1,600 deaths during the outbreak. Am J Trop Med Hyg Sep;29(5): Yellow fever in the Gambia, : epidemiologic aspects with observations on the occurrence of orungo virus infections.

47

48 GAMBIA Incomplete case capture

49 CATMAT s Recommendations What would you conclude about long-term effectiveness? Would you recommend boosters?

50 What will CATMAT recommend? Continued boosters? No boosters except for special groups?

51 Additional considerations The rarity of yellow fever in Canadians. There have been no labconfirmed cases from nature to-date since testing began in this country in 1974 The known adverse events of the vaccine including the very rare risk of yellow fever vaccine-associated neurologic disease in previously immunized individuals The existence of weak evidence of long-term protection from a single dose as presented above. There is no evidence to the contrary. We would name several exceptions which remove the vulnerable population from this new recommendation We would monitor

52 Immunosuppressed travellers The CATMAT secretariat did a literature review looking for longterm data on YF vaccine protection in immunosuppressed persons: No data found

53

54 What ACIP/CDC concluded - II Additional doses of yellow fever vaccine are recommended for certain travelers: Women who were pregnant Persons who received a hematopoietic stem cell transplant after receiving a dose of yellow fever vaccine and who are sufficiently immunocompetent to be safely vaccinated Persons who were infected with human immunodeficiency virus when they received their last dose of yellow fever vaccine should receive a dose every 10 years if they continue to be at risk for yellow fever virus infection

55 What ACIP/CDC concluded - III A booster dose may be given to travelers who received their last dose of yellow fever vaccine at least 10 years previously and who will be in a higher-risk setting based on season, location, activities, and duration of their travel. This would include travelers who plan to spend a prolonged period in endemic areas or those traveling to highly endemic areas such as rural West Africa during peak transmission season or an area with an ongoing outbreak

56 What ACIP/CDC concluded - IV Laboratory workers who routinely handle wild-type yellow fever virus should have yellow fever virus specific neutralizing antibody titers measured at least every 10 years to determine if they should receive additional doses of the vaccine. For laboratory workers who are unable to have neutralizing antibody titers measured, yellow fever vaccine should be given every 10 years as long as they remain at risk.

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