Can 2009 H1N1 vaccines be used outside the age range approved by the FDA?
Off-label use of a vaccine is not recommended. Vaccines approved for an age group will have undergone the required testing for that age group. Data on vaccine effectiveness for influenza vaccine use outside of labeled age indications are limited. If off-label use of a vaccine does occur inadvertently, providers should report such an event to VAERS. It is also not known at this time whether a provider who administers 2009 H1N1 vaccine in an off-label manner will still be covered under the Prep Act and therefore will be open to liability.
