Aptar Pharma has 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 health care professional, when connected to a compatible LuerLock syringe. The optional Spray Divider is designed to enable the delivery of 2 sequential sprays, 1 per nostril. This gives vaccine developers access to a CE-marked intranasal delivery platform, to support development activities from early clinical studies through commercialisation.

Alex Theodorakis, President, Aptar Pharma Prescription, said, “Achieving CE marking for both LuerVax and the Spray Divider is an important step in strengthening our support of vaccine developers worldwide. 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.”

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 2 sizes, 200 µL and 500 µL, for use with the corresponding LuerLock syringe, designed to enable the prepared syringe volume to be delivered as 2 sequential sprays, 1 per nostril.

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

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 immunisation strategies. With the CE marking of LuerVax and the Spray Divider, Aptar is well positioned to help customers capitalise on these opportunities through delivery technologies and development expertise.

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

LuerVax is a Class 1 non-sterile, single use medical device under MDR intended for use by health care professionals, validated with compatible LuerLock syringe. The Spray Divider is an optional component intended to be used with LuerVax and the corresponding LuerLock syringe.