Bioneedles are biodegradable, needle shaped mini-implants that can be pre-filled with vaccines or other high potency medicines. Pain free delivery takes place through the skin at high speed using a handheld Bioneedle delivery device. After subcutaneous or intramuscular delivery, the Bioneedle dissolves within minutes and releases the vaccine. Vaccines formulated in Bioneedles become thermostable, eliminating the need for cold chain transport and storage.

Bioneedle, the science

Vaccine pre-filled Bioneedles have been tested for thermostability and efficacy for 4 commonly used vaccines: Tetanus toxoid, Hepatitis B, Influenza and IPV (Inactivated Polio Vaccine). In addition, an experimental Tuberculosis vaccine has been tested for efficacy. Empty Bioneedles have passed safety and tolerability evaluations in a clinical trial setting in healthy volunteers in Germany. All trials have been published in peer reviewed scientific journals.

  • Tetanus toxoid prefilled Bioneedles
  • Hepatitis B prefilled Bioneeldes
  • Influenza prefilled Bioneedles
  • Inactivated Polio Vaccine prefilled Bioneedles
  • Bioneedles prefilled with an experimental vaccine against Tuberculosis
  • Clinical trial phase 1 of non loaded Bioneedles in volunteers

Currently, Bioneedle Drug Delivery is preparing for running preclinical and clinical trials with COVID-19 vaccine pre-filled Bioneedles.

Bioneedle and vaccination logistics

The current COVID-19 pandemic and the global roll out of vaccines clearly brings to light the flaws and hurdles in the traditional Syringe-Needle-Vaccine-Refrigerator (SNVR) system:  cooled or even deep-frozen transport and storage requirements (cold chain), large storage and transportation volumes, complex and time-consuming vaccination process, shortage of glass vials, shortage of needles, shortage of freezers. In addition, there are hidden disadvantages, such as needle stick injuries, reuse of syringes and needles (cross contamination), and biohazardous waste disposal.

Bioneedle affects all the links in this vaccination chain -from manufacturing and packaging, through transport, storage and distribution, to vaccinating people, and finally to waste disposal- and brings significant advantages thanks to its unique features:

  • Vaccine pre-filled Bioneedles are the final dosage form, guaranteeing dose integrity and saving up to 25% of vaccine.
  • Vaccines pre-filled in Bioneedles become thermostable, eliminating the need to maintain cold chain during transport and storage.
  • Bioneedles are extremely small, there are no vials or other intermediate container systems or complex, insulated packaging requirements, leading to storage and transportation volumes of a factor 160 smaller.
  • Vaccination is simple and fast and requires only 1 action.  No medical background is required, a simple training is sufficient to get a health worker ready for doing up to 1,000 vaccinations per hour.
  • Vaccination with Bioneedles is safe and pain-free. There is no risk of needle stick injuries, no re-use of syringes and needles, and therefore no risk of cross contamination. Bioneedle injections are completely painless.
  • Bioneedles bring a high level of sustainability and environmental friendliness. There is no contaminated biohazardous sharps waste, and there are no vials, syringes, safety boxes, cartons, outer packages and insulation material to be disposed.

These unique features combined make vaccinations with Bioneedle easier, faster, safer, less prone to mistakes, more sustainable and environment friendly, and cheaper.