Aptar Announces CE marking for LuerVax® and Accompanying Spray Divider, Strengthening Support for Vaccine Developers

Aptar Pharma, part of AptarGroup, Inc. (NYSE:ATR), a global leader in drug delivery, dosing and protection technologies, and consumer product dispensing, today announced that its LuerVax^® intranasal delivery device and accompanying Spray Divider have been CE marked under the EU Medical Device Regulation (MDR), indicating that they meet the European general safety and performance requirements for medical devices. This milestone expands Aptar Pharma’s support for customers developing innovative intranasal vaccine products.

LuerVax^® is an intranasal delivery device for administration of vaccines by a healthcare professional, when connected to a compatible LuerLock syringe. The optional Spray Divider is designed to enable the delivery of two sequential sprays, one per nostril. This gives vaccine developers access to a CE-marked intranasal delivery platform, to support development activities from early clinical studies through commercialization.

The CE marking demonstrates Aptar Pharma's continued commitment to delivering high-quality, compliant device solutions designed to help customers throughout vaccine development.

“Achieving CE marking for both LuerVax^® and the Spray Divider is an important step in strengthening our support of vaccine developers worldwide,” said Alex Theodorakis, President, Aptar Pharma Prescription. “Customers are increasingly seeking established device platforms that can support regulatory pathways and enable efficient clinical and commercial development. This CE marking reinforces Aptar's commitment to being a trusted partner throughout the vaccine development journey.”

Supporting Customers from Clinical Development to Commercialization

LuerVax^® and Spray Divider provide a flexible and reliable intranasal delivery platform intended to support a broad range of vaccine development programs.

Spray Divider is available in two sizes, 200 µL and 500 µL, for use with the corresponding LuerLock syringe, designed to enable the prepared syringe volume to be delivered as two sequential sprays, one per nostril.

Beyond access to a CE-marked intranasal delivery platform, customers can leverage Aptar Pharma's expertise in drug delivery, vaccine technologies, regulatory support, industrialization and manufacturing. This integrated approach helps vaccine developers navigate development activities from early clinical studies through commercialization while benefiting from a single partner that can support key stages of the development journey.

 Advancing Intranasal Vaccine Delivery

As interest in non-invasive vaccine administration continues to grow, intranasal delivery offers the potential to improve patient acceptance and ease of administration while supporting innovative immunization strategies. With the CE marking of LuerVax^® and the Spray Divider, Aptar is well positioned to help customers capitalize on these opportunities through delivery technologies and development expertise.

"This achievement reflects Aptar's ongoing investment in innovative delivery solutions that address the evolving needs of vaccine developers," said Nektaria Karavas, Global Business Development Director - Vaccines and Antivirals, Aptar Pharma. "Our goal is to provide customers with the delivery technologies, expertise and regulatory support to bring the next generation of vaccines to market." 

Regulatory Information 

LuerVax^® is a Class I non-sterile, single use medical device under MDR intended for use by healthcare professionals, validated with compatible LuerLock syringe.The Spray Divider is an optional component intended to be used with LuerVax^® and the corresponding LuerLock syringe Refer to the Instructions for Use for the full intended use, warnings and precautions. LuerVax^® is a registered trademark of AptarGroup, Inc. or its affiliates.

Read full press release.