global implementation of rotavirus vaccines progress and ... · 50 100 150 200 250 number of...
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![Page 1: Global Implementation of Rotavirus Vaccines Progress and ... · 50 100 150 200 250 Number of diarrhea deaths Month-Year Age ≤11 months Age 12-23 months Age 24-59 months 13 Vaccine](https://reader034.vdocuments.site/reader034/viewer/2022052016/602ed1992df5a83aba675f2e/html5/thumbnails/1.jpg)
Global Implementation of Rotavirus VaccinesProgress and Challenges
Umesh D. ParasharChief, Viral Gastroenteritis BranchCDC, Atlanta, [email protected]
TM
1
Fourth Roger Glass Lecture
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Scientific Program Committee
2
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Viral Gastroenteritis Team, CDC
Daniel Payne
Jackie Tate
Margaret CorteseJon Gentsch
Mike Bowen
Baoming Jiang
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RotaTeq and Rotarix licensed in 2006
4
•Large trials (~70,000 infants) in US, Europe, and South America
•No increased risk of intussusception
•85-98% efficacy against severe rotavirus disease
Vesikari et al and Ruiz-Palacios et al, NEJM 2006
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More than 90 countries have implemented national rotavirus vaccination programs
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How well will vaccines performin routine use?
Will there be unanticipated benefits?
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2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Hos
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All-cause AGE Rotavirus
Impact on all-cause AGE and rotavirus-specific AGE hospitalizations in US children
Vaccine
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Reduction in AGE hospitalizations in older unvaccinated children and adults in the US
Lopman et al. J Infect Dis 2011:204:980Gastanaduy et al JAMA 2013
Lopman et al. JID 2011
Pre-vaccine
Post-vaccine
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Lower rates of hospitalization with rotavirus or unspecified gastroenteritis in vaccinated households in Persons 20-29 years Females 20-29 years (2008/2009) Males 30-39 years (2009/2010)
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Vaccinated children had ~20% reduction in risk of seizures requiring hospitalization or ED care compared with unvaccinated children during the year following vaccination
Reduced risk of childhood seizures associated with rotavirus vaccination (1)
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Reduced risk of childhood seizures associated with rotavirus vaccination (2)
Compared to rotavirus-unvaccinated children, seizure risk reduced 24% (95% CI, 13% – 33%) in fully vaccinated 14% (95%CI, 0% – 26%) in partially vaccinated
12
Analysis of 1.7 million children with 2950 seizures
Burke et al, CID, in press
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Num
ber o
f dia
rrhe
a de
aths
Month-Year
Age ≤11 months
Age 12-23 months
Age 24-59 months
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Vaccine Introduced(May 2007)
2008
2009
Richardson et al, NEJM 2010
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Diarrhea-associated mortality declined by 31% (95% CI, 1%-52%)
Vaccine effectiveness against diarrhea mortality 34% (95% CI, -28%-66%)
Lancet Global Health
Bar-Zeev et al, Lancet Global Health 2018
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How well will live oral rotavirus vaccines work in the developing world?
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171 dot = 100 deaths
The vast majority of the ~200,000 annual deaths from rotavirus occur in developing countries
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Moderate efficacy seen in trials in low income African and Asian countries
Vaccine Region Countries Efficacy (95%CI)
RotaTeq Africa Ghana, Kenya, Mali 64% (40%-79%)
RotaTeq Asia Bangladesh, Vietnam 51% (13%-73%)
Rotarix Africa South Africa, Malawi 62% (44%-73%)
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19%20%
19% 19%
12% 13%
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2009 2010 2011 2012 2013 2014
% o
f Tot
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ospi
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dmis
sion
s fro
m A
GE
Num
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f Adm
issi
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Total Hospital Admissions AGE Admissions % of Admissions Due to AGE
VACCINE
Decline in proportion of childhood hospitalizations caused by diarrhea in Rwanda
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Decline in rotavirus hospitalizations after vaccine implementation in Ghana
Armah et al CID 2016
50% RV+
26% RV+
28% RV+ 24%
RV+
Rotavirus vaccine introduction, April
2012
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Rotavirus remains the leading cause of severe diarrhea in developing countries after rotavirus vaccine introduction
Cryptosporidium6%
Rotavirus55%Norovirus
5%
ETEC6%
Other28%
22
Cryptosporidium
14%
Rotavirus22%
Norovirus12%ETEC
3%
Other49%
Before vaccine After vaccine
Plats Mills et al JID 2017
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How can we improve rotavirus vaccine performance in developing countries?
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Multiple factors affect rotavirus vaccine efficacy
Poor response to
oral rotavirus vaccine
Transplacentaland breast milk
rotavirus antibodies
Nutrition
Gastrointestinal pathogens
Intestinal microbiota
Environmental enteropathy
Interference of OPV co-
administration
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Withholding breastfeeding (~1 hr) at time of vaccine administration did not improve immune response
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0
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Groome, 2014 (South Africa) Rongsen-Chandola, 2014 (India) Ali, 2015* (Pakistan)
Breastfeeding withheld Breastfeeding encouraged
Sero
conv
ersio
n %
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Delaying 2-dose schedule or adding 3rd dose slightly improved vaccine response
26
0
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60
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90
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Ali, 2014 (Pakistan) Armah, 2016* (Ghana)
6 + 10 weeks 10 + 14 weeks 6 + 10 + 14 weeks
Sero
conv
ersio
n %
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Supplementing with both Zn and probiotics slightly improved vaccine response
0
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No supplement Zinc alone Probiotic alone Zinc and probiotic
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Sero
conv
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RCT of 3 doses of RV3-BB given as either• Neonatal schedule (0-5 days, 8 weeks, 14 weeks)• Infant schedule (8 weeks, 14 weeks, 18 weeks)
Vaccine efficacy• 75% (95% CI, 7%-76%) for the neonatal schedule• 63% (95% CI, 34%-80%) for the infant schedule
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Booster rotavirus vaccine dose around 1 year of age?
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Booster rotavirus vaccine dose around 1 year of age?
Rotarix
RotaTeq
• No interference with concomitantly administered vaccines
• Increase in rotavirus antibody (IgA and IgG) in vaccinated children
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Withdrawal of OPV should benefit rotavirus vaccines
0
50
100
150
200
250
RV1+mOPV1 RV1+bOPV RV1+tOPV
Geo
met
ric m
eant
tite
r (G
MT)
RV-IgA geometric mean titer
p=0.037** p=0.010**
0
20
40
60
80
100
RV1+mOPV1 RV1+bOPV RV1+tOPV
% s
eroc
onve
rsio
n
RV-IgA seroconversion
p=0.035*p=0.035*
Emperador D et al. CID 2016
Concomitant OPV and rotavirus vaccine
Staggered OPV and rotavirus vaccine
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Microbiome composition correlated with RV immunogenicity in Ghana
Harris et al, JID, 2017
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34Kazi et al, JID, 2017
Histo-blood group antigens expressed on enterocytes are proposed receptors for rotaviruses
Seroconversion rates in Pakistani infants given Rotarix 19% among nonsecretors 30% among secretors with non-blood group O 51% among secretors with O blood group
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Like polio – Injectable rotavirus vaccine?
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How well will vaccines protect against range of rotavirus strains?
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RotaTeq is pentavalent & Rotarix is monovalent
37
G1 G3
G2 G4
P[8]
Five bovine-humanrotavirus strains
G1P[8]
Single human rotavirus strain
RotarixRotaTeq
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Monovalent rotarix (G1P8) efficacy similar against vaccine & non-vaccine strains in Africa
59.759.155.270.9
51.556.964.4
83.879.264.1
0
20
40
60
80
100
G1 G2 G3 G8 G9 G12 P[4] P[6] P[8] NonG1Rotavirus serotypes
Effic
acy
Steele et al. BMC Pediatrics
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Increase in G2P4 after implementation of monovalent Rotarix (G1P8) in Brazil
*Nakagomi et al, Arch Vir 153(3); 2008
*Gurgel et al, EID, 13(10), 2007
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El SalvadorRotarix, 2006(opposite of Brazil)
Guatemala(no vaccine)
Honduras (no vaccine)
Patel et al. EID 2009
2005 2006 2007
P[8]G996%
P[8]G994%
P[8]G940%
P[4]G281%
P[4]G272%
P[4]G268%
P[8]G191%
P[8]G190%
P[8]G168%
Is increasing prevalence of G2P[4] in Brazil caused by vaccine pressure or is it just natural variation?
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• Unique scenario with states using different rotavirus vaccines
• Decade prior to vaccine use, G1P[8] strains dominated nationally
• Decade after vaccine use•G12P[8] dominant in RotaTeq states•G3P[8] and G2P[4] in Rotarix states
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Will new rotavirus vaccinescause intussusception?
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Post-Licensure Intussusception Data
Low risk of intussusception found in several high and middle income countries (Mexico, US, Australia, UK)
~1-6 cases per 100,000 vaccinated
With both vaccines
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RISKSBENEFITS
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Benefits vs. Risks of Vaccination
Diarrhea Hospitalizations
(Deaths) Prevented
Intussusception Cases (Deaths)Caused
Mexico 11,600 (663) 41 (2)
Brazil 69,600 (640) 55 (3)
Australia 7,000 (0) 6 (0)
US 53,000 (16) 48 (0)
45*
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No intussusception risk in large studyin 7 low income African countries!
46NEJM. April 2018
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Who Will Supply Rotavirus Vaccineto the World?
Big Pharma
Merck
GSK
Emerging Manufactures
Brazil
Indonesia Germany
IndiaChina
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ORAL ROTAVIRUS VACCINES WHO PQ
DCVMs include:Bharat SerumBioFarma HillemanPolyvac WuhanShanta ButantanLangzhou
Liquid presentationBharat Biotech
ROTAVACBharat Biotech
Live
-att
enua
ted,
ora
l Lamb rotavirusLanzhou Institute of Biological Products
Liquid BRV Serum Institute
Liquid BRVShantha Biotechnics
Human rotavirus Polyvac, Vietnam.
ROTASIILSerum Institute
RV3-BBBiofarma, Indonesia
Liquid BRV WUHAN China
Liquid BRV BUTANTAN Brazil
Discovery & preclinical Phase 2 Phase 3 MarketPhase 1
Live
-att
enua
ted
oral
(WHO
PQ
)
ROTATEQMerck
ROTARIXGSK
Heat stable pentavalentHilleman
MSD, India
Dormant Nationallicense
Slide: C Kirkwood & D Steele, BMGF
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• 2 New Vaccines from India– Rotavac (WHO prequalified)– Rotasiil
• Prime Minister Modi “Government of India will provide a rotavirus vaccine to all Indian children”
India is taking the leadfor RV vaccines
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Drug firms cut vaccine prices to the developing world*
United States PAHO GAVI / UNICEF
GSK $120 –$200/child
$15/child $5/child[up to 125 M doses;
over 5 yrs]
Merck $120 –$200/child
$15.45/child
$10.50/child[for volume over 30
M]
Bharat Biotech
– – ~ $3/ child
50
• 3 doses/child: Merck, Bharat Biotech• 2 doses/child: GSK* Applies to GAVI tenders
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2006-2018Incredible years for new rotavirus vaccines!....
And great promise for the future!!