GACVS sub-committee on novel OPV2 safety

Terms of Reference

On  Friday 13th November, 2020, the type 2 novel oral polio vaccine (nOPV2) became the first vaccine authorized by WHO for use under Emergency Use Listing (EUL)[i]. This will allow its rollout for limited initial use in countries affected by circulating vaccine-derived poliovirus type 2 (cVDPV2) outbreaks. The role of nOPV2 is to protect against type 2 poliovirus – to rapidly prevent and minimize outbreaks, prevent infection and paralysis, save lives, and ultimately, to contribute to polio eradication.

The GACVS Sub-Committee was established in time with nOPV2 initial use under EUL, to ensure that an independent group of experts provides a systematic, timely and coordinated ongoing review of safety data and outcomes related to nOPV2 use in the field. The GACVS Sub-Committee on nOPV2 Safety will advise WHO and its Member States on safety outcomes following the use of initially pre-licensed type 2 novel oral poliovirus vaccine, during the EUL period, prior to the availability of Phase III clinical trial results.[ii] This will ensure that the overall decision to accelerate the timeline to roll out nOPV2 from its initial to wider use under EUL and beyond, will be informed and based on sound evidence.

Specifically the GACVS Sub-Committee will be asked to:

  1. Establish safety considerations for the use of nOPV2, to complement i) criteria used to recommend transition from initial to wider use of nOPV2 under EUL; and ii) criteria for discontinuing nOPV2 use
  2. Convene regularly to review the analyses of routine safety data from the field, during the initial use of nOPV2 under EUL period (approx. from 3-6 months following its initial implementation, until closure of the EUL period, approx. 12-18 months after implementation)
  3. Convene on an ad-hoc basis as needed, in the event that severe safety signals are reported
  4. Provide expert input, recommendations and guidance on the safety aspects of nOPV2 based on the review of available safety data after each of two mass vaccination campaign rounds deployed for outbreak response; and to formally share these recommendations and updates with the GACVS, Polio Working Group, and SAGE.[iii]

Composition

Members / Experts

  • Co-Chair – Rita Helfand (Centers for Disease Control and Prevention, GA, USA; Chair of the Global Advisory Committee on Vaccine Safety/GACVS);
  • Co-Chair – Peter Wright (Geisel School of Medicine, Dartmouth Medical School, NH, USA; Chair of the WHO Polio Data Safety and Monitoring Board);
  • Dure Samin Akram (Health, Education and Literacy Program, Karachi, Pakistan; Vice Chair of the Global Advisory Committee on Vaccine Safety/GACVS).
  • Narendra Kumar Arora (The INCLEN Trust International, New Delhi, India; Member of the Global Advisory Committee on Vaccine Safety/GACVS);
  • Fred Zepp (University Medical Center of Johannes Gutenberg University Mainz, Germany; Member of the nOPV2 Data Safety and Monitoring Board);
  • Zubairu Ilyasu (Bayero University, Kano State, Nigeria; Aminu Kano Teaching Hospital, Kano, Nigeria)
  • Beckie Tagbo University of Nigeria, Ituku-Ozalla Campus, Enugu State Nigeria; University of Nigeria teaching Hospital, Ituku-Ozalla, Enugu State, Nigeria);
  • Elizabeth Brickley (Dartmouth College, NH, USA London School of Hygiene & Tropical Medicine, UK; Member of the WHO Polio Data Safety and Monitoring Board).

WHO secretariat

  • Carolyn Sein
  • Madhav Balakrishnan

Related documents

Declarations of Interest

All members completed a declaration of interests form. Three members reported relevant interests. All interests were assessed and deemed not to constitute a conflict to participating in meetings. The reported relevant interests are summarized below:

Peter Wright

  • He serves as Chair of the Polio DSMB to review safety events and data related to WHO polio clinical trials. This interest was perceived as non-personal, non-specific and financially non-significant.
  • He served on the nOPV Scientific Advisory Board 4 years ago. This interest was perceived as non-personal, specific and financially non-significant*.
  • His academic institution provides laboratory support to handle and process Sabin and nOPV2 samples with funding from research grants. This interest was perceived as non-personal, specific and financially significant for the institution*.
  • His academic institution has submitted a grant proposal to provide laboratory support to handle and process nOPV1 and nOPV3 samples. This interest was perceived as non-personal, non-specific*.

Fred Zepp

He serves as the Chair of the nOPV2 DSMB to review safety events and data related to nOPV2 clinical trials. This interest was assessed as non-personal, specific and financially insignificant*.

Elizabeth Brickley

  • She serves as on the Polio DSMB to review safety events and data related to WHO polio clinical trials, with specific expertise in epidemiology. This interest was assessed as non-personal, non-specific and financially insignificant*.
  • She reviewed and conducted in-depth analysis related to nOPV2 candidate vaccines for Phase I and contributed to the preparation of scientific manuscript related to this analysis as a first author, which was submitted and is currently under review. This interest was assessed as non-personal, specific and financially non-significant*.

[i] http://polioeradication.org/news-post/novel-oral-polio-vaccine-type-2-nopv2-granted-interim-emergency-use-listing-recommendation/
[ii] https://www.who.int/immunization_standards/vaccine_quality/EUL/en/
[iii] https://www.who.int/immunization/sage/meetings/2020/october/en/
https://www.who.int/wer/2020/wer9548/en/
* According to WHO’s Guidelines for Declaration of Interests (WHO expert), an interest is considered “personal” if it generates financial or non-financial gain to the expert, such as consulting income or a patent. “Specificity” states whether the declared interest is a subject matter of the meeting or work to be undertaken. An interest has “financial significance” if the honoraria, consultancy fee or other received funding, including those received by expert’s organization, from any single vaccine manufacturer or other vaccine-related company exceeds 5,000 USD in a calendar year. Likewise, a shareholding in any one vaccine manufacturer or other vaccine-related company in excess of 1,000 USD would also constitute a “significant shareholding”.