The NEW ENGLA ND JOURNAL of MEDICINE

Perspective August 30, 2018

Ending Use of Oral Poliovirus Vaccine — A Difficult Move

in the Polio Endgame
Mark A. Pallansch, Ph.D.​​

W
Ending Use of Oral Poliovirus Vaccine

hen the world embarked on a mission of detection of cVDPV outbreaks was

global polio eradication with the adoption that long-term use of OPV posed
an ongoing risk.2 Over the next
of a World Health Assembly resolution in several years, this finding con-
1988, there was only minimal consideration of what vinced public health experts that
the Global Polio Eradication Ini-
would happen after the eradica- had circulating wild-type virus. tiative (GPEI) needed to include
tion of wild poliovirus (WPV) had This view of the posteradication more than certification and WPV
been certified. Poliovirus eradi- world changed with the first rec- containment; OPV vaccination also
cation efforts have targeted three ognition, in 2000, of an outbreak had to be stopped in order to
distinct serotypes, using two vac- caused by a virus resulting from ensure a polio-free world after
cines, each containing compo- the genetic reversion of one of eradication.
nents against all three types — the strains in OPV, which was A more formal process was
a live attenuated oral poliovirus subsequently named “circulat- therefore begun to develop a
vaccine (OPV) used in more than ing vaccine-derived poliovirus” strategic eradication plan that
100 mostly low- and middle-­ (cVDPV).1 The detection of this explicitly included stopping OPV
income countries worldwide and outbreak was aided by the devel- use.3 Since the last case of WPV
an inactivated poliovirus vaccine opment and implementation of type 2 (WPV2) had occurred in
(IPV) used in most of the devel- improved molecular diagnostics, 1999, the plan for OPV cessation
oped world. Many experts believed which were also used to demon- evolved from concurrently stop-
that vaccination against polio strate that cVDPV outbreaks had ping the use of all three OPV
either would continue to evolve occurred in the past but had been types to a modified serial plan in
with strengthening of routine im- thought to be outbreaks of indig- which the type 2 component of
munization or might be stopped enous WPV strains. OPV would be removed first. The
by countries when they no longer The logical inference from the Global Commission for the Cer-

n engl j med 379;9 nejm.org  August 30, 2018 801

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PERS PE C T IV E
tification of the Eradication of
­Poliomyelitis certified WPV2 erad-
ication in September 2015, and
in April 2016 there was a coordi-
nated global switch from the tri-
valent OPV to a bivalent OPV con-
taining only the type 1 and 3
components.
Such synchronized vaccine ces-
sation was unprecedented, and
there were therefore many uncer-
tainties. The stage was set for the
work described by Blake et al. in
this issue of the Journal (pages
834–845). As the authors note,
the GPEI has a robust surveillance
system for tracking polioviruses
globally and has the ability to
readily distinguish WPV, cVDPV,
and OPV strains. This system
­allows public health officials to
monitor whether, after the switch,
all the OPV-related type 2 viruses
(OPV2 and VDPV2) will ultimately
disappear, as predicted. Because
cVDPV type 2 (cVDPV2) outbreaks
are sometimes not detected right
away, experts predicted that some
outbreaks detected after the
switch would turn out to have
begun before the switch; but new-
ly emergent, postswitch cVDPV
outbreaks were also predicted.
Blake et al. focused on analyz-
ing the surveillance data from
both acute flaccid paralysis and
environmental surveillance sys-
tems to characterize the kinetics
of OPV2 disappearance and to
identify specific instances of
events that were not predicted.
The authors describe the disap-
pearance of the OPV2-related
strains after the switch and the
cVDPV2 outbreaks that were new-
ly detected. To date, these out-
breaks have occurred in geo-
graphic areas where cVDPV and
WPV outbreaks had occurred be-
fore the switch. These high-risk
countries were also the ones
802
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Ending Use of Oral Poliovirus Vaccine
where monovalent type 2 OPV
(mOPV2) was used in response
campaigns. The introduction of
mOPV2 into these populations as
part of an outbreak response re-
sulted in detection of VDPV2 and
OPV2-related viruses and subse-
quent disappearance of these vi-
ruses in the vaccine-coverage areas.
The heterogeneity of experi-
ences at both national and sub-
national levels allowed analysts
to identify specific risk factors
for cVDPV2 emergence and varia-
tions in the rate of disappearance
of OPV2-related strains. One ma-
jor risk factor for emergence
identified by the authors is low
population immunity to type 2
virus. This factor not only was
associated with virus emergence
and circulation, but also had an
influence on the rate of disap-
pearance of OPV2-related strains
after the use of mOPV2 and ac-
counted for some of the hetero-
geneity of the rates observed.
The critical importance to WPV
eradication of population immu-
nity is well understood, and in
models, such immunity has a
strong influence on the success
of cessation of OPV use. The au-
thors provide the first analytic
evidence that population immu-
nity is a critical determinant of
the successful implementation
of the OPV-cessation strategy.
The analysis by Blake et al.
covers the first 2 years after the
switch, when it was too early to
detect any clear trends as a func-
tion of time after the last OPV2 use.
Since, as the authors note, univer-
sal introduction of a single dose
of IPV has not resulted in high
coverage as originally planned,
in part because of a global sup-
ply shortage, several countries
have seen dramatic decreases in
population immunity to type 2
n engl j med 379;9 nejm.org  August 30, 2018
The New England Journal of Medicine
poliovirus among children born
after the switch. How this heter-
ogeneity among countries in de-
creasing immunity will affect the
likelihood and severity of future
outbreaks, the choices made re-
garding outbreak responses, the
risk of new cVDPV emergence,
and the ultimate disappearance
of type 2 poliovirus is not clear
from this analysis. Answers to
these questions not only are im-
portant for the completion of the
OPV2 switch but also could sig-
nificantly affect planning for the
ultimate cessation of all OPV use.
At this point, the type of virus
monitoring and analysis described
by Blake et al. will need to con-
tinue until all type 2 viruses are
no longer detected by the surveil-
lance systems. Since the period
covered by their analysis, new
cVDPV2 outbreaks have been de-
tected in Somalia and Kenya, the
Democratic Republic of Congo,
and Nigeria. Responses to these
outbreaks have resulted in addi-
tional detections of OPV2-related
virus. It will be important to
monitor whether there are any ob-
servable changes over time in the
disappearance of OPV2-related
virus in these regions where new
and past outbreaks have oc-
curred. Each mOPV2 response to
a cVDPV2 outbreak carries a risk
of seeding new cVDPV2 outbreaks.
The unfolding experience follow-
ing the OPV2 switch will provide
lessons that improve our under-
standing of problems confront-
ing the endgame strategy of OPV
cessation.
OPV withdrawal is only one of
the elements of the polio end-
game, which also includes the
goals and challenges of labora-
tory and vaccine-manufacturing
containment of poliovirus and
sustaining of polio surveillance in
PE R S PE C T IV E
order to detect and identify polio-
virus infections. We still need to
maintain a stockpile of polio vac-
cine for outbreak response. The
existence of immunodeficient peo-
ple who chronically excrete VDPV
virus also necessitates an effec-
tive means of detection and in-
tervention. Many of
An audio interview
with Dr. Pallansch
these issues will re-
is available at NEJM.org quire additional re-
search and develop-
ment, including a better vaccine
that produces mucosal immunity
without the risk of VDPV, antivi-
Mitigating Risks of Medicaid Work Requirements
Mitigating the Risks of Medicaid Work Requirements
John Z. Ayanian, M.D., M.P.P., Renuka Tipirneni, M.D., and Susan D. Goold, M.D., M.H.S.A.​​
I n January 2018, the Centers for
Medicare and Medicaid Ser-
vices (CMS) issued a letter to
state Medicaid directors “to as-
sist states in their efforts to im-
prove Medicaid enrollee health
and well-being through incentiviz-
ing work and community engage-
ment.”1 As of June 2018, four
states — Arkansas, Indiana,
Kentucky, and New Hampshire
— had received CMS approval for
Section 1115 waivers to imple-
ment and evaluate work require-
ments for nonelderly adults en-
rolled in Medicaid.
Work requirements are moving
forward in Arkansas, Indiana,
and New Hampshire. However, a
federal district court blocked Ken-
tucky’s implementation of such
requirements, determining that
the secretary of Health and Hu-
man Services had not adequately
considered how the waiver would
affect the state’s ability to provide
coverage to Medicaid enrollees.
Six other states have proposed
n engl j med 379;9 nejm.org  August 30, 2018
The New England Journal of Medicine
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Copyright © 2018 Massachusetts Medical Society. All rights reserved.
Ending Use of Oral Poliovirus Vaccine
rals to treat chronic infections,
and better surveillance tools for
a world that will quickly forget
about polio after eradication is
achieved. Clearly, persistence and
patience will be needed, not only
to complete eradication of WPV,
but also for the polio endgame.
The views expressed in this article are
those of the author and do not necessarily
represent the official position of the Cen-
ters for Disease Control and Prevention.
Disclosure forms provided by the author
are available at NEJM.org.
From the Division of Viral Diseases, Nation-
al Center for Immunization and Respiratory
new Medicaid work requirements
in pending waiver applications to
CMS, and Virginia recently ap-
proved Medicaid expansion with
plans to implement work require-
ments through a Section 1115
waiver.
The four states that have re-
ceived CMS approval to implement
work requirements require at least
20 hours per week or 80 hours
per month of engagement in em-
ployment, job training, job search-
ing, or community service, or
enrollment in an educational pro-
gram.2 In Indiana, Kentucky, and
New Hampshire, caregiving for a
person with a disability satisfies
the work requirement, as does
receiving ongoing treatment for a
substance use disorder. Indiana
and Kentucky apply work require-
ments to both traditional Medic-
aid enrollees and people who are
enrolled under Medicaid expan-
sion; enrollees under 61 and 65
years of age, respectively, are sub-
ject to the requirements. Arkansas
Diseases, Centers for Disease Control and
Prevention, Atlanta.
This article was updated on August 30,
2018, at NEJM.org.
1. Kew O, Morris-Glasgow V, Landaverde
M, et al. Outbreak of poliomyelitis in His-
paniola associated with circulating type 1
vaccine-derived poliovirus. Science 2002;​
296:​356-9.
2. Dowdle WR, De Gourville E, Kew OM,
Pallansch MA, Wood DJ. Polio eradication: the
OPV paradox. Rev Med Virol 2003;​13:​277-91.
3. Polio eradication & endgame strategic
plan 2013-2018. Geneva: World Health Orga-
nization, 2013 (http://polioeradication​.org/​wp​
-­content/​uploads/​2016/​07/​PEESP_EN_A4​.pdf).
DOI: 10.1056/NEJMp1808903
Copyright © 2018 Massachusetts Medical Society.
Ending Use of Oral Poliovirus Vaccine
and New Hampshire limit work
requirements to Medicaid expan-
sion enrollees under 50 and 65
years of age, respectively. In Indi-
ana, Kentucky, and New Hamp-
shire, noncompliant enrollees are
locked out of Medicaid coverage
until the next month when they
satisfy work requirements or qual-
ify for an exemption, whereas in
Arkansas, they are locked out un-
til the next coverage year begins.
We believe there are several im-
portant policy questions related
to Medicaid work requirements
that deserve more attention. First,
what are the potential health
consequences of work require-
ments for Medicaid enrollees?
Second, what role will physicians
play in determining whether en-
rollees are exempted from work
requirements for medical reasons?
Finally, how can policymakers
mitigate the medical risks asso-
ciated with work requirements for
enrollees who could be harmed
by losing Medicaid coverage?
803