Target Product Profiles

Covid-19 Intranasal Vaccine Target Product Profile

The following documents are target product profiles (TPPs) for mucosal COVID-19 boosters and pan-sarbecovirus vaccines. These documents describe the minimal and ideal characteristics that these next-generation coronavirus vaccines should have, to align expectations between vaccine developers, funders, and regulators.

Pan-sarbecovirus Vaccine TPP, United States

Mucosal COVID-19 Booster Vaccines TPP, United States

Pan-Sarbecovirus Vaccine TPP, International

Mucosal COVID-19 Booster Vaccines TPP, International

Lead coordinator: Aman Patel (aman.patel@pandemicdefense.tech)

Protocol

To develop these TPPs, we followed a protocol inspired by those used in UNICEF/NEST360’s newborn care TPPs.

Initial draft

Drawing on the existing WHO TPP for COVID-19 vaccines, we prepared initial drafts of each TPP.

Written comment phase

We sent the initial drafts of both TPPs to ~180 academic experts, regulators, and industry leaders whose activities or experience were relevant to mucosal COVID-19 boosters or pan-sarbecovirus vaccines. Reviewers were able to provide freeform written comments on each target criterion and propose new target criteria.

We revised both TPP drafts to incorporate received comments.

Consensus meeting

Around 1 month after sending out the drafts for comment, we hosted a virtual consensus meeting. Everyone who was invited to provide written comments on the draft TPPs was also invited to this meeting.

The consensus meeting was structured around freeform discussions of potential revisions to the three targets with least agreement in the written comment phase. If reviewers did not provide written comments on a target criterion, we assumed their agreement with that target.

After discussion of potential revisions to each target, we held a vote to ensure that the suggested changes had consensus from meeting participants. All discussion was under Chatham House rule to facilitate frank conversation.

Final review

We incorporated suggested changes from the consensus meeting into the TPPs, and completed final review and editing of the documents. We invited all participants in the TPP development process to be listed as contributors.