20th Sep 2024 19:08
(Alliance News) - AstraZeneca PLC on Friday announced that its influenza vaccine FluMist has been approved for self-administration in the US.
The Cambridge, England-based biopharmaceutical company said the nasal spray is the only influenza vaccine approved for self-administration at home.
AstraZeneca said FluMist can be self-administered by adults aged 49 and under, or administered by a caregiver to children aged two to 17 years.
The US Food & Drug Administration's approval "was based on a comprehensive submission, which included results from a usability study demonstrating that individuals over 18 years of age could self-administer or administer FluMist to eligible individuals two to 49 years of age".
Astra said the FDA-required studies "showed that 100% of intended users administered a full dose.
"In addition, data show that efficacy, immunogenicity and adverse events with self-administration of FluMist are similar to that seen with HCP-administered vaccination."
FluMist will continue to be available in offices and pharmacies for administration by healthcare professionals, Astra said.
It "was originally approved in the US in 2003 and since then almost 200 million doses have been distributed around the world", the firm added.
"The approval of FluMist for self-administration is an important step forward in making vaccines more accessible to fight the high annual burden of influenza," said Vaccines & Immune Therapies Executive Vice President Iskra Reic.
"For more than 20 years, FluMist has been the only nasal spray flu vaccine licensed in the US and now it is also the only vaccine to help individuals, families and communities access an influenza vaccine conveniently through self- and caregiver administration outside of traditional healthcare settings."
Shares in AstraZeneca closed 1.0% lower at 11,780.00 pence on Friday in London.
By Emma Curzon, Alliance News reporter
Comments and questions to [email protected]
Copyright 2024 Alliance News Ltd. All Rights Reserved.