Market (feasibility)

Available vaccines, licensing status, prequalification status, presentation, formulation, dosage and route of administration

As of September 2026, there are approximately 20 HepB paediatric vaccines with marketing authorisation that are manufactured directly by the authorisation holder. Several of them have only marketing authorisation in their country of origin.Go to footnote 1

Other HepB vaccines are authorised or commercialised under local brand names through technology-transfer, bulk-transfer, licensing, distribution or localisation arrangements.

Five of those vaccines are prequalified.Go to footnote 2 The vaccines are available from each manufacturer in single and 10-dose vials. All are available as liquid, ready-to-use formulations for intramuscular use. 

Detailed information on the different products can be found in the comparison table.Go to footnote 3

Sources
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