Office of Risk Management and Compliance


Poliovirus Infectious Materials (PV IMs) &

Poliovirus Potentially Infectious Materials (PV PIMs)



 
1. INTRODUCTION
  The Global Polio Eradication Initiative (GPEI) led by World Health Organization (WHO) was founded in 1988 with the aim to prevent incidence of paralytic poliomyelitis through the complete eradication and containment of polioviruses1. More information on The WHO’s global action plan for poliovirus containment is provided in the document, WHO Global Action Plan for poliovirus containment (GAPIII).2
  In March 2015, Ministry of Health (MOH) conducted a national survey to establish the national inventory of poliovirus types 1, 2 and 3 infectious materials (IMs), in preparation for the containment of poliovirus materials (MOH Ref. No.: MH 78:70, letter dated 14 Mar 2015 entitled Surveillance of Poliovirus Inventory).
  In October 2018, MOH conducted a national survey on poliovirus potentially infectious materials (PIMs) as such materials also pose a risk of accidental poliovirus reintroduction into the community e.g. from the laboratory, in the post-eradication era. (MOH Ref. No.: MH 34:18, letter dated 29 Oct 2018 entitled Survey to Update the National Inventory of Poliovirus Materials).
  A Guidance to Minimize Risks for Facilities Collecting, Handling or Storing Materials Potentially Infectious for Polioviruses3 was published by WHO in 2018 to provide guidance on collecting, handling or storing of PIMs.

In January 2019, MOH conducted an Information session on poliovirus potentially infectious materials4 and MOH required each facility that has poliovirus IMs and/or PIMs to submit a completed Facility Reporting Form 1 to MOH, and facilities retaining oral poliovirus vaccine (OPV)/Sabin type 2 PIMs are required to submit a Risk Mitigation Plan to MOH.


2. DEFINITION OF POLIOVIRUS INFECTIOUS MATERIALS (PV IMs) AND POLIOVIRUS POTENTIALLY INFECTIOUS MATERIALS (PV PIMs)

The definition of poliovirus IMs or poliovirus PIMs is available in MOH’s presentation slides, Information Session on Poliovirus Potentially Infectious Materials.4 In summary:
  a.    Poliovirus infectious materials (PV IMs) are defined as any sample that has been tested or is known to contain poliovirus e.g. wild poliovirus (WPV), vaccine-derived poliovirus (VDPV), and oral poliovirus vaccine/Sabin (OPV/Sabin).

b.    Poliovirus potentially infectious materials (PV PIMs) are defined as faecal, respiratory, concentrated sewage samples or derivatives of such samples, collected at a time of poliovirus circulation in the community, or when live, attenuated poliovirus vaccine is used; regardless of the purpose of sample collection.
  1.       i.    Wild poliovirus (WPV) PIMs: Any of the above sample types or derivatives of such samples, collected at a time of wild poliovirus circulation in the community.

  2.       ii.    Vaccine-derived poliovirus (VDPV) PIMs: Any of the above sample types or derivatives of such samples, collected at a time of vaccine derived poliovirus outbreak in the community.

  3.      iii.    Oral poliovirus vaccine (OPV)/Sabin PIMs: Any of the PV PIM sample types or derivatives of such samples, collected at a time when live, attenuated poliovirus vaccine is used in the community.
   
 3. POLIOVIRUS INFECTIOUS MATERIALS (PV IMs), WILD POLIOVIRUS POTENTIALLY INFECTIOUS MATERIALS (WPV PIMs) OR VACCINE-DERIVED POLIOVIRUS POTENTIALLY INFECTIOUS MATERIALS (VDPV PIMs)
  Facilities in possession of or intending to acquire/obtain poliovirus IMs, WPV PIMs or VDPV PIMs are required to contact OSHE for advice, as these facilities need to be certified as poliovirus-essential facility (PEF).
   
4. ORAL POLIOVIRUS VACCINE (OPV) / SABIN POTENTIALLY INFECTIOUS MATERIALS (PIMs)

People who receive OPV may shed the virus and can infect others, especially those who are not vaccinated. In areas with low vaccination rates, the OPV virus can continue to infect new individuals. In rare cases, the OPV virus can accumulate changes over time and become like WPV. These new viruses are called VDPV and can cause polio disease.

Facilities that collect, handle and store clinical and environmental samples present a poliovirus transmission risk if the samples were collected where WPV or VDPV was circulating, or OPV was being used.

Any faecal, respiratory secretion or concentrated sewage samples collected in the community and stored by a facility are considered as Poliovirus Potentially Infectious Materials (PV PIMs), which include:
•    faecal or respiratory secretion samples and their derivatives (e.g. stool suspensions, extracted nucleic acids, etc.) collected for any purpose in a geographic area where wild poliovirus (WPV)/circulating vaccine-derived poliovirus (cVDPV) is present or OPV is being used at the time of collection;
•    products of such materials (above) from PV-permissive cells or experimentally infected polio-susceptible animals;
•    uncharacterized enterovirus-like cell culture isolates derived from human specimens from countries known or suspected to have circulating WPV/VDPV or use of OPV at the time of collection;
•    respiratory and enteric virus stocks derived from PV PIM and handled under conditions conducive to maintaining the viability or enabling the replication of incidental PV; and
•    environmental samples (i.e. concentrated sewage, waste water) collected from areas known or suspected to have circulating WPV/VDPV or use of OPV at the time of collection
  Respiratory tract samples include saliva and oral swab which are defined under “nasopharyngeal, oropharyngeal and other upper respiratory tract secretions” mentioned on page 10 of the WHO guidance document.3

In addition to sample type, determining whether samples are WPV2/VDPV2 or OPV/Sabin2 IM or PIM is based on collection period and country of origin. Refer to Annex 2 of WHO guidance document3 for country and territory-specific poliovirus data.

The flow chart below provides a summary on the process to determine PV PIMs.
 

  Source: WHO’s Guidance to Minimize Risks for Facilities Collecting, Handling or Storing Materials Potentially Infectious for Polioviruses4

Please refer to WHO’s Guidance to Minimize Risks for Facilities Collecting, Handling or Storing Materials Potentially Infectious for Polioviruses4 for detailed information for guidance on OPV/Sabin PIM samples.


5. REGISTRATION AND DE-REGISTRATION OF PV PIMs

MOH requires each new facility retaining PV PIM to complete and submit a copy of the Facility Reporting Form 1 to MOH once collection of PV PIM samples begin. Please submit the completed Facility Reporting Form 1 to OSHE and OSHE will facilitate the submission to MOH on behalf of the facility.

Submission of the reporting form is not required for a facility that collects PV PIM that will be disposed upon collection and immediate use, i.e. no retention of PV PIM or its derivatives.

The Facility Reporting Form 1 is available here.

Declaration to MOH is required for destruction of specific PV PIM type or all existing PV PIM inventory. Please submit either MOH Form A or Form B to OSHE and OSHE will facilitate the submission to MOH on behalf of the facility.

  • •    MOH Form A: to notify MOH of destruction of all existing PV PIM inventory (complete), with no intention for collection, handling and/or storage of such materials in future;

  • •   MOH Form B: to notify MOH of the destruction of specific inventory type (partial)
6.
 NUS RISK MITIGATION PLAN FOR OPV/SABIN TYPE 2 PIMs

The NUS Institutional Biosafety Committee has released an NUS Risk Mitigation Plan for Oral Poliovirus Vaccine/Sabin Type 2 Potentially Infectious Materials and it is available here. All NUS laboratories/facilities in possession of and/or handling OPV2/Sabin2 PIMs shall comply with all the relevant requirements in the NUS Risk Mitigation Plan.


7. POLIOVIRUS POTENTIALLY INFECTIOUS MATERIALS TRANSFER FORM

MOH requires facilities to inform MOH of OPV2/Sabin2 PIM transfer, either between two NUS facilities or from NUS to an external facility, as well as to communicate to the recipient to comply with the relevant risk mitigation measures. To assist the notification of transfer to MOH and communication of MOH’s requirements to the recipient, the NUS IBC has released a Poliovirus Potentially Infectious Materials Transfer Form. The NUS transferor shall complete a Poliovirus Potentially Infectious Materials Transfer Form and send a copy of the completed form to the recipient and OSHE. OSHE will then assist to notify MOH on the transfer of OPV2/Sabin2 PIM on behalf of the facility.

This form only needs to be filled in once if the same type of samples is transferred to the same recipient.

The Poliovirus Potentially Infectious Materials Transfer Form is available here.


8. CONTACT PERSON

For enquiries on Facility Reporting Form 1 or Poliovirus Potentially Infectious Materials Transfer Form, please contact Dr Suzette De Leon at oshdlsn@nus.edu.sg / 66011703.
  For enquiries on NUS Risk Mitigation Plan for Oral Poliovirus Vaccine/Sabin Type 2 Potentially Infectious Materials, please contact Dr Lim Cheh Peng at oshlimcp@nus.edu.sg / 65167088.


9.
 REFERENCES

[1]    World Health Organization, "Global Polio Eradication Initiative," [Online]. Available: http://polioeradication.org/.

[2]    World Health Organization, "WHO Global Action Plan for poliovirus containment (GAPIII)," 2015. [Online]. Available: http://polioeradication.org/wp-content/uploads/2016/12/GAPIII_2014.pdf.

[3]    World Health Organization, "Guidance to Minimize Risks for Facilities Collecting, Handling or Storing Materials Potentially Infectious for Polioviruses," 2018. [Online]. Available: http://polioeradication.org/wp-content/uploads/2016/07/PIM-guidance-20190122-EN.pdf.

[4]    Ministry of Health, “Information Session on Poliovirus Potentially Infectious Materials”, 2019. [Online]. Available: https://www.moh.gov.sg/biosafety/newsupdate/newsdetail/Index/Information%20Session%20on%20Poliovirus%20Potentially%20Infectious%20Materials