Laboratory containment

Laboratory containment

SEARO / IVD
© Credits

Overview

As global eradication approaches, comprehensive work has begun on polio laboratory and facility containment which is an integral part of the strategy to keep the world safe from polioviruses. It includes biosafety and biosecurity requirements for laboratories, vaccine production sites, or any other facility that handles or stores eradicated polioviruses, to minimize the risk of these viruses being released into the community. Requirements and strategies are specified in the WHO Global Action Plan to minimize poliovirus facility-associated risk (GAPIII).
Link to GAPIII

Containment of polioviruses in the South-East Asia Region

The WHO South-East Asia Region has been free from endemic polio since 2011. The wild virus is no longer circulating and causing illness in the Region, and it is endemic in only three remaining countries worldwide. Wild poliovirus type 2 was officially declared as globally eradicated in September 2015. To protect against the slight risk of emergence of vaccine-derived strains in areas with low coverage all countries in the Region have shifted to bivalent oral polio vaccine (bOPV) against poliovirus type 1 and 3 in 2016 and added a dose of inactivated polio vaccine, as part of the global polio vaccine “switch” in 2016.

After each type of poliovirus is eradicated, certain laboratories and facilities will continue to retain the virus for critical activities such as vaccine production and research. These poliovirus-essential facilities (PEF) will be the only place the virus continues to be found. The accidental or deliberate release of the virus from one of these facilities following eradication could result in the return of polio.

Currently containment refers mainly to poliovirus type 2 as the wild type has been eradicated many years ago. If poliovirus type 2 is released into communities, the strain could resurge and again cause paralysis and death. This is especially a risk in areas where polio vaccination coverage is low. However, even in countries with high levels of polio vaccination coverage, some people may not be vaccinated or fully protected against polio, putting them at risk of infection if they are exposed.

Key ways to minimize risk are: destroy unneeded poliovirus materials, or safely and securely contain needed poliovirus materials in a PEF. A PEF is a facility designated and determined by its host country to be serving critical national or international functions such as polio vaccine production or research, that involve the handling and storage of poliovirus.

GAPIII describes the requirements for PEFs to safely and securely handle and store eradicated polioviruses. PEFs and their host countries are responsible for appropriate containment of eradicated polioviruses. Facilities must meet the requirements for safe and secure handling and storage of poliovirus, and the host countries must ensure high population immunity levels and environmental sanitation. Facilities must be certified to handle and store poliovirus type 2. Only PEFs holding containment certificates, approved by their respective National Authority for Containment (NAC) and endorsed by the Global Certification Commission (GCC), will be permitted to handle and store eradicated polioviruses.

WHO developed the GAPIII Containment Certification Scheme (GAPIII-CCS) to help countries put in place the appropriate mechanisms to certify that facilities have met the requirements in GAPIII. The GAPIII-CCS offers three levels of containment certification: (1) certificate of participation (CP) is awarded to facilities in countries that have demonstrated compliance with the required secondary and tertiary safeguards described in GAPIII and are recognized by their NACs to engage in the GAPIII-CCS process (2) an interim containment certification (ICC), which allows facilities to continue conducting critical activities such as vaccine production and research, while addressing remaining requirements for full containment certification (within given timelines), and (3) certificate of containment is awarded when the facility is fully compliant with GAPIII.

Many specimens may potentially be infected with poliovirus type 2. Samples (e.g. stool, respiratory secretion specimens, sewage) collected at times and in geographic areas where wild poliovirus type 2, vaccine-derived poliovirus type 2, oral polio vaccine type 2 or Sabin type 2 viruses were circulating, are likely to harbour these viruses. ‘Non-poliovirus facilities’ may unknowingly be handling and storing specimens potentially infected with polioviruses. Examples include facilities working with stool, respiratory or environmental sewage specimens to carry out rotavirus, hepatitis, influenza, measles, diarrhoeal disease or nutrition research. Tailored guidance for these non-poliovirus facilities has been developed to help them identify specimens potentially infected with polioviruses, and to implement appropriate measures for their destruction or safe and secure handling and storage.

Link to documents:

Once eradicated, wild poliovirus types 1 and 3 must be destroyed or contained. The last case of wild poliovirus type 3 occurred in Nigeria in 2012 and the GCC declared global eradication in October 2019. As such countries need to begin destroying unneeded wild poliovirus type 3 or safely and securely contain remaining viruses in certified poliovirus-essential facilities. Wild poliovirus type 1 circulates in only two countries (Pakistan and Afghanistan). Once the eradication of wild poliovirus types 1 has been declared, containment requirements will apply as well. Eventually, the GCC will certify the world as polio-free, marking the start of the full containment of wild polioviruses.