GPEI-Eradicate, transition and contain

The poliovirus takes a beating at WHA 2018. © Sini Ramo/WHO

28 May 2018, Geneva, Switzerland: ‘Eradicate first’ was the mantra at last week’s World Health Assembly (WHA). While holding detailed discussions to plan for a polio-free world, delegates emphasized the need to finish the job of eradication.

With wild poliovirus transmission levels lower than ever before, Ministers of Health and delegates reviewed progress being achieved through national emergency action plans in the remaining endemic countries. As at May 2018, only eight cases due to wild poliovirus had been reported globally, from just two countries: Afghanistan and Pakistan.

To prepare for a polio-free world, Member States adopted a landmark resolution on poliovirus containment. A limited number of facilities will retain poliovirus after eradication, to serve critical national and international functions such as the production of polio vaccine or research. It is crucial that these poliovirus materials are appropriately contained under strict biosafety and biosecurity handling and storage conditions, to ensure that virus is not released into the environment, either accidentally or intentionally, to again cause outbreaks of the disease in susceptible populations.

WHO and countries that are currently funded by the Global Polio Eradication Initiative (GPEI) face significant financial, human resource, and programmatic risks as a result of the scaling down of the GPEI budget (2017-2019) and its eventual closure. Hence, Member States requested the Director-General to develop a strategic action plan on polio transition that will mitigate these risks, as well as strengthen country health systems. Delegates considered the resulting 5-year strategic action plan on polio transition, which has 3 key objectives: (i) sustaining a polio-free world after eradication of polio virus; (ii) strengthening immunization systems, including surveillance for vaccine-preventable diseases; and (iii) strengthening emergency preparedness, detection and response capacity in countries to ensure full implementation of the International Health Regulations. The strategic action plan outlines how essential polio functions like surveillance, laboratory networks, and some core infrastructure can support the implementation of the Post Certification Strategy to sustain a polio-free world, and can be integrated into the immunization or health emergencies’ programme, or mainstreamed into national health systems. The plan provides detailed costing for the integration of essential polio functions into WHO’s Thirteenth General Programme of Work, and some financing options. The three polio-endemic countries (Afghanistan, Pakistan and Nigeria) and a few high-risk countries battling outbreaks have been excluded from transition planning until eradication. All other GPEI-funded countries are expected to plan for polio transition.

Member States expressed overwhelming commitment to fully implement and finance all strategies to secure a lasting polio-free world in the very near term. Rotary International, speaking on behalf of the GPEI, which includes WHO, Rotary, CDC, UNICEF and the Bill & Melinda Gates Foundation, offered an impassioned plea to the global community to eradicate a human disease for only the second time in history, and ensure that no child will ever again be paralysed by any form of poliovirus anywhere.

© Sweden National Authority for Containment

A vaccine manufacturer in Stockholm has taken the first step towards becoming a certified Poliovirus Essential Facility (PEF), leading the charge in global efforts to safely and securely contain type-2 poliovirus. This facility has been awarded a Certificate of Participation co-signed by the National Authority for Containment (NAC) in Sweden and the Global Commission for the Certification of Poliomyelitis Eradication (GCC). The Certificate is the first of its kind to be issued, indicating formal engagement in the global containment certification process.

Wild poliovirus type-2 was declared eradicated by the GCC in September 2015, however, there is risk of the virus resurging. Following the removal of the type-2 component from oral polio vaccine (OPV) and the discontinuation of type-2 containing OPV from routine use in April 2016, countries around the world have been asked to safely and securely destroy their type-2 polio samples. As a further precaution, countries continue to immunize against type 2 polioviruses with inactivated polio vaccine. For facilities needing to retain the virus for vaccine production or for critical research, stringent containment measures need to be followed. The first step is getting a Certificate of Participation.

Handling of infectious virus. © Sweden National Authority for Containment

“We are pleased to see Sweden leading the way in demonstrating conforming with the processes to minimize the risk of releasing type-2 poliovirus into the environment. Participation in the Containment Certification Scheme shows that both the facility and the host country are serious about taking on and implementing the safeguard measures necessary to become a PEF,” said Prof. David Salisbury, Chair of the GCC and of the Commission’s European regional body.

“Handling and storing an eradicated pathogen is a risk and responsibility – a leak or breach could have devastating consequences,” said Michel Zaffran, Director of Polio Eradication at the World Health Organization. “We commend Sweden for its commitment towards ensuring safety standards are met and protocols are in place to help minimize risk, and for paving the road for the containment certification process,” he said.

“The issuance of a Certification of Participation formally engages a designated PEF in the containment process. Provided that the facility meets the requirements outlined in Global Action Plan III for the containment of polioviruses (GAPIII) within given time frames, it can then progress to achieving an Interim Certificate of Containment and finally, a full Certificate of Containment to become an accredited PEF,” said Prof. Salisbury. “Countries planning to retain type-2 poliovirus will need to establish their NACs as soon as possible, and by no later than the end of 2018. The GCC urges all countries that plan to have PEFs to get the ball rolling in this process,” he said.

Since April 2016, most facilities around the world have opted to destroy their type-2 poliovirus materials rather than contain them. Twenty-nine countries, however, plan to continue to handle and store their materials in 92 designated PEFs.

WHO will propose a resolution for consideration by the World Health Assembly in May to seek international consensus on accelerating containment efforts globally.

To supplement Global Action Plan III for the containment of polioviruses, WHO has published guidance for non-polio facilities to help them identify, destroy, or safely and securely handle and store sample collections potentially infectious for poliovirus.

Dr Mark Pallansch from CDC explains what the guidance means for facilities worldwide.

Poliovirus potentially infectious materials (PIM) include fecal, nasopharyngeal, or sewage samples collected in a time and place where wild polioviruses/vaccine-derived polioviruses (WPV/VDPV), or OPV-derived viruses were circulating or oral polio vaccines (OPV/Sabin) were in use. Non-polio research facilities with a high probability of storing such materials include those working with rotavirus or other enteric agents, hepatitis viruses, influenza/respiratory viruses, and measles virus. Other facilities could include those conducting nutrition research or environmental facilities.