The recent declaration of a public health emergency in New York State after a case of

paralytic poliomyelitis caused by a circulating vaccine-derived poliovirus (cVDPV), along

with cVDPV detection in wastewater both in New York and in London, is a sobering
reminder that polio still represents a threat even in countries that have not seen it for decades.1
Silent circulation of poliovirus was not unexpected: such circulation was previously observed
in countries using inactivated polio vaccine (IPV). Unlike oral polio vaccine (OPV), IPV does
not induce the robust mucosal immunity that is important for preventing circulation. The
continued circulation of wild and attenuated polioviruses suggests that the approach used by
the polio-eradication campaign needs reevaluation.

The Global Polio Eradication Initiative (GPEI), launched 34 years ago, aimed to eradicate
poliomyelitis by 2000.2 The chosen strategy was to stop circulation of wild polioviruses,
following the successful example of smallpox eradication. The task, however, turned out to be
much more challenging than eradicating smallpox had been, since there are hundreds of
asymptomatic poliovirus infections for each paralytic case that occurs, which substantially
complicates critical surveillance. Aside from challenges inherent in vaccine delivery in some
countries, another reason for the failure to eradicate polio were outbreaks caused by cVDPV
strains that emerged from viruses used in OPV.3 Thus, to actually eradicate poliovirus, the use
of OPV must also be stopped.

The conundrum was how to withdraw OPV that was essential to eradication efforts without
jeopardizing their success. Stopping all immunizations after the disease is eradicated, as was
done with smallpox, is a nonstarter because it’s impossible to ensure that no live virus
remains loose anywhere in the world, and polio can easily be synthesized in laboratories. The
absence of virus circulation and paralytic cases cannot be sustained without universal and
comprehensive population immunity. The lack of immunity would result in global
vulnerability, and reintroduction of the virus could start a pandemic with potentially
catastrophic consequences. A preview of this scenario was provided by the 2016 switch from
trivalent to bivalent OPV that omitted the serotype 2 OPV (OPV2) component4; this move
created immunity gaps that led to the dramatic proliferation of mutated type 2 viruses. In
contrast to what modeling had predicted, the targeted use of monovalent OPV2 to control
outbreaks only seeded additional ones, creating a Catch-22.

Fortunately, the visionary thinking of some scientists as well as public health experts at the
Bill and Melinda Gates Foundation and the World Health Organization (WHO) resulted in
concerted efforts to develop a more genetically stable strain of vaccine poliovirus. The
resulting novel OPV2 was introduced for outbreak control in 2020 and was found to be more
stable than the original serotype 2 Sabin strain.5 More than 500 million doses have been
distributed, and the vaccine has seeded no cVDPV outbreaks. Similar genetically stable
strains of serotypes 1 and 3 were created and are undergoing clinical evaluation.

This important development fostered hope that cVDPV outbreaks that occur primarily in
Africa and south central Asia might soon be controlled. But the New York case and the
discovery of the silent circulation of poliovirus in high-income countries that use IPV demand
reassessment of our approach to polio eradication. Although IPV provides excellent
protection against paralytic disease, it does not prevent silent circulation of the virus that can
eventually infect unimmunized and immunocompromised people. We need to develop new
long-term immunization policies that will not only protect vaccinees from paralytic disease
but also minimize silent circulation of polioviruses.
The current plan is to withdraw bivalent OPV within 3 years after the circulation of wild type
1 poliovirus is stopped, and then continue immunizations with IPV only. Unlike the 2016
switch from trivalent to bivalent vaccine, the decision to withdraw OPV should be made not
on the basis of the perceived absence of poliovirus circulation, but rather on the basis of
availability of ample supply of IPV and the readiness of vaccine-delivery infrastructure.

According to the recommendation of the WHO Strategic Advisory Group of Experts on

Immunization, the IPV-only phase should continue for 10 years after the withdrawal of OPV,
at which time the question of whether polio immunization may become optional can be
discussed. This plan may be the biggest flaw in the current strategy, because it is imperative
to maintain the highest possible population immunity level indefinitely. Putting off the
decision until the distant future sends a number of wrong messages.

First, setting a time horizon for the elimination of polio vaccines discourages manufacturers
from investing in research and development of better vaccines. There are several options for
such vaccines. Genetically stable novel OPV might be the best solution for countries with
high poliovirus transmission. Inexpensive and easy to deliver, it would create comprehensive
immunity that would protect people from paralysis and minimize virus circulation without
triggering cVDPV outbreaks. Highly effective combination vaccines such as hexavalent
vaccines containing IPV along with diphtheria–tetanus–pertussis, Hemophilus influenzae type
b, and hepatitis B antigens could be most useful for high- and middle-income countries. In
addition, there are several innovative polio vaccines in development — for example, some
based on virus-like particles, mucosal vectored vaccines, and RNA vaccines. But unless a
clear signal is sent to vaccine manufacturers, these innovative products will never reach the
market.

___________________________________________

Second, cessation of polio vaccination sends a wrong signal to the general public that
vaccination against polio is not needed if there is no detected virus circulation, thereby
contributing to vaccine hesitancy and immunity gaps.

There are serious scientific questions that must be addressed if we are to formulate future
immunization policies tailored to different parts of the world. High-income countries will
most likely continue using IPV-containing combination vaccines, but is there also a role for
novel OPV to close the gaps in mucosal immunity and stop silent virus circulation? What is
the best policy for middle- and low-income countries, and how can a sustainable scheme for
supporting the vaccination programs in resource-limited countries be created?

All these policy decisions must be based on solid science. In the past, the GPEI’s strategic
thinking was guided by a scientific advisory committee, but that committee was disbanded
years ago, in part because of the perception that science was no longer needed because
eradication was just around the corner. This wishful thinking has prevailed for the past 30
years and has proven counterproductive.

The original 1988 World Health Assembly declaration called for eradication of poliomyelitis,
emphasizing that “eradication efforts should be pursued in ways which strengthen the
development of the Expanded Programme on Immunization as a whole, fostering its
contribution, in turn, to the development of the health infrastructure and of primary health
care.”2 We believe the GPEI should revert to the declaration’s original intent of eradicating
the disease by creating universal immunity to polio rather than continue pursuing viral
eradication that has been unsuccessful. It is important to engage the entire scientific and
public health communities in developing a rational and sustainable future polio-immunization
strategy. We urge the WHO and all their partners, including Rotary International and the Bill
and Melinda Gates Foundation, to initiate an open dialogue with scientists about the strategy
for preventing polio.