Can H1N1 vaccines be used outside of the Food and Drug Administration (FDA)-approved age indications?
Whenever possible, vaccines should be administered in accordance with FDA labeling. Vaccines approved for an age group have undergone required testing for that age group. There are no known safety concerns with use of inactivated vaccines in appropriate doses outside their labeled age indications. Data on vaccine effectiveness when used outside of labeled age indications are limited. Live, attenuated intranasal flu vaccine should not be used outside the approved age indications (2-49 years) and inactivated vaccine should not be given to infants younger than six months. However, clinicians may use inactivated H1N1 vaccines for persons aged six months and older outside their labeled age range if a vaccine licensed for use in a particular age group is not available and the need to provide vaccination is urgent. For instance, some H1N1 vaccines (for example, the CSL product licensed for people 18 years and older and the Novartis product licensed for children and adults four years and older
