Table 1 Target product profile for malaria chemoprevention

Indication for use

• Prevention against P. falciparum malaria

• Prevention against malaria caused by any Plasmodium species or mixed infection^a

Target population

• Children ≥ 3 months to 10 years

• OR pregnant women (second and third trimester)

• OR non-immune individuals

• All age groups and populations at risk^b

• Pregnant women in all trimesters and breastfeeding women

Dosing regimen

• Oral: once daily dosing for 3 consecutive days per month

• Injectable: once every 3 months

• Oral: supervised single dose per month

• Injectable: once every 6 months

Formulation

• Oral: co-packaged child-friendly formulation; tablets for adults

• Injectable: intramuscular injection; volume injected and needle size in line with current standard for vaccines; partner drugs can be injected separately

• Oral: child-friendly fixed dose combination; tablets for adults

• Injectable: liquid pre-filled injection device for intramuscular or subcutaneous injection; fixed dose combination of the drugs

Anti-malarial effects

• Two blood schizonticide drugs

• At least one drug with causal prophylactic, gametocytocidal or sporontocidal activities

Efficacy

• Clearance of existing asymptomatic infections

• Paediatrics and non-immune: preventive efficacy against symptomatic malaria infections ≥ 90% over 1 month, or ≥ 80% over 4 months for orals; and ≥ 80% over 3–4 months for injectables

• Pregnancy: preventive efficacy against symptomatic malaria infections in the mother of ≥ 75% over 6 months

• Paediatrics and non-immune: preventive efficacy against symptomatic malaria infections ≥ 75% over 6 months

• Pregnancy: adverse pregnancy outcomes comparable to standard-of-care

Drug resistance

• Partner drugs with different modes of action

• Active against known drug-resistant clinical isolates

• Partner drugs with similar pharmacological duration of efficacy^c

Safety and tolerability

• Favourable risk–benefit profile, with safety and tolerability comparable to WHO recommended preventive treatment or standard-of-care

• Highly favourable risk–benefit profile with improved safety and tolerability versus WHO recommended preventive treatment or standard-of-care

Food effect (for oral medication)

• Easily implementable food recommendation

• No food recommendation

Drug–drug interactions

• Minimal interactions manageable with dose adjustments

• No clinically significant interactions

Cost of treatment course^d

• Oral: $1 for adult, $0.25 for children ≤ 2 years

• Injectable: equivalent or lower than malaria vaccine

• Oral: Lower than standard-of-care

• Injectable: ≤ $1 for infants, ≤ $2 for children, ≤ $4 for adults

Stability^e

• ≥ 2 years at ICH zone IVa/IVb conditions

• ≥ 3 years at ICH zone IVa/IVb conditions