FDA Approves Hiberix As Hib Booster Dose

The FDA has approved Hiberix, a Haemophilus influenzae Type b (Hib) vaccine, as a booster dose for children 15 months through 4 years old. Hiberix is manufactured by GlaxoSmithKline (GSK).

According to FDA, Hiberix is safe and effective for use as a booster dose in certain children in the US, based on data from seven clinical studies conducted in Europe, Latin America and Canada that involved more than 1,000 children.

As part of the approval, GSK will conduct a post-market study in the US to evaluate the safety and immunogenicity of primary and booster vaccination with Hiberix, as compared to a Hib vaccine already licensed in the US.

Additionally, the study is intended to confirm the clinical benefit of booster immunization with Hiberix in accordance with the accelerated approval regulations, and to provide additional data on Hiberix for young infants.

Karen Midthun, acting director of center for biologics evaluation and research at FDA, said: “The FDA approved Hiberix under the agency’s accelerated approval pathway. This approval will provide an additional safe and effective vaccine to help ensure that there is an adequate Hib vaccine supply during necessary catch-up vaccinations.”