TPP: For COVID-19 Vaccines

Indication

Minimum/Acceptable: For immunization to prevent severe disease and death caused by COVID-19. Preferred/Optimal/Ideal: For immunization to prevent severe disease and death caused by COVID-19. Activity against other coronaviruses (including other sarbecoviruses) and/ or potential future variants is highly preferred.

Target population

Minimum/Acceptable: Adults, including elderly and others at risk of severe disease. Preferred/Optimal/Ideal: Adults, including elderly and others at risk of severe disease. Pediatrics (with appropriate dosing). Data should support administration to important groups.

Efficacy

Minimum/Acceptable: For initial vaccination series, efficacy against symptomatic disease with ~50% point estimate and lower 95% confidence interval ≥30% OR efficacy against severe disease with 70%-80% point estimate and 30% lower bound. For booster doses (doses after primary schedule), additional or booster doses (whether of the same or different vaccines) should be considered when vaccines no longer meet or appear to meet the severe disease criterion, and additional/booster doses must reach the severe disease criterion. Preferred/Optimal/Ideal: For initial vaccination series, efficacy against symptomatic disease with ~70% point estimate and lower 95% confidence interval ≥50% OR efficacy against severe disease with 90% point estimate and 70% lower bound. For booster doses (doses after primary series), additional or booster doses (whether of the same or different vaccines) should be considered when vaccines no longer meet or appear to meet the severe disease criterion, and additional/booster doses must reach the severe disease criterion vaccines with efficacy against transmission are preferred. For previously infected, evidence of >70% effectiveness against severe disease.

Safety

Minimum/Acceptable: Safety and reactogenicity whereby vaccine benefits outweigh safety risks. Preferred/Optimal/Ideal: Substantial evidence of safety and efficacy, sufficient to support a highly favourable benefit/risk profile.

URL

https://www.who.int/publications/m/item/who-target-product-profiles-for-covid-19-vaccines

Product type

Vaccine

Status

Active

Safety

Formulation/presentation:: Minimum/Acceptable: Multi- or mono- dose presentations are acceptable. Preferred/Optimal/Ideal: Multi-dose presentation is preferred for ease of use in campaigns. Lack of need for reconstitution. Barcodes on secondary packaging. Including serialization, GTIN, expiry and lot number. For parenteral, dose volume of 0.5 mL preferred, with AD syringes that are WHO prequalified. Dose regimen:: Minimum/Acceptable: Two-dose regimen. Preferred/Optimal/Ideal: Single- or two-dose primary series. Ability to use vaccine as part of a heterologous regimen. Route of administration:: Minimum/Acceptable: Any typically used route of administration is acceptable, if vaccine is safe and effective. Preferred/Optimal/Ideal: Non-parenteral (syringe/needle or other adjunct equipment-avoiding) is preferred for ease of rapid administration and other logistical issues. Durability of protection:: Minimum/Acceptable: Regimens requiring booster doses in order to retain protection against severe disease are permitted. Durability data is not required, but immunogenicity data to support likely duration of protection is desirable. Preferred/Optimal/Ideal: Confers protection against severe disease for at least 1 year in healthy adults and children. Lower frequency (Yearly or less frequently) of booster doses is preferred. Stability and storage:: Minimum/Acceptable: Minimum storage condition of -20 to -25 °C for longer-term storage. Demonstration of at least 30 days stability at 2-8°C and several hours stability at 25-30°C. Preferred/Optimal/Ideal: Higher storage temperatures and higher thermostability (e.g., longer storage at refrigerator temperatures) supported by relevant VVM type on the primary container (e.g., temperature indicator VVMs). Demonstration of at least 2-month stability at 2-8°C. No freeze sensitivity/potential damage.

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