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FDA approves 0.5 mL Fluzone for young children
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The FDA approved the 0.5 mL dose of Fluzone, a quadrivalent influenza vaccine, for use in children aged between 6 and 35 months. The manufacturer said in a press release that this dose will be available for the 2019-2020 influenzas season, alongside the 0.25-mL dose option.
“For a number of reasons — especially in pediatric and family medicine offices — it is much simpler to have one vaccine in the fridge for all your patients,” Monica Mercer, MD, director of scientific and medical affairs for Sanofi Pasteur, told Infectious Diseases in Children.
Results of a phase 4 study that included approximately 2,000 children demonstrated that one or two 0.5-mL doses had a comparable safety profile compared with one or two 0.25-mL doses of Fluzone. No safety concerns were observed during the study, and researchers described the immune response as “robust.”
Mercer said that the CDC’s Advisory Committee on Immunization Practices suggests patients aged younger than 9 years who have not previously been vaccinated against influenza should receive two doses of the immunization.
“Because Fluzone has four strains, it gives as much coverage as one could hope for,” Mercer said. “We encourage that everyone gets fully vaccinated. If children are provided the vaccine according to recommendations, they are getting the best protection available. We are hopeful that if children are vaccinated and vaccinated appropriately with the right number of doses for the season, they will have the best possible protection against influenza.” – by Katherine Bortz
Disclosure: Mercer is an employee of Sanofi Pasteur.