CPhI Online

Preparing for mass vaccination

11 Jan 2021

Needle free systems offer compelling advantages for mass vaccination - could this be a potential platform for COVID19 vaccination programmes?

The global effort to develop COVID 19 vaccines has delivered its first product approvals. Significant investment is being made by governments and non-profit sources to build adequate capacity for the delivery and administration of these vaccines at national and global scale (1). With potentially hundreds of millions of doses to be administered annually, it is important to challenge the incumbent delivery technology of needle and syringe and think carefully about whether investment should be made to open the way for needle-free delivery of COVID-19 vaccines.

The low cost and ready availability of hypodermic syringes makes them immediately attractive, but the cost burden of needlestick injuries cannot be ignored. The annual cost of treating needlestick injury in hospital workers alone is as high as $591m in the US, $302m in Japan and $900k in the UK (2) . These represent developed countries with the highest levels of training and resource. COVID 19 is a global pandemic, therefore the cost burden of needlestick is likely to be far higher.

Needle-free injection eliminates this risk and, when designed appropriately, enables safe, targeted and reproducible dermal delivery. Furthermore, needle-free delivery is independent of viscosity and hence independent of the flow characteristics of a vaccine. With so many candidate vaccines still in development, it is important to consider whether a subset of vaccines should be developed and approved for needle-free delivery.

Current status of COVID-19 vaccine developments

In the latest update to their excellent COVID-19 vaccine tracker (3), the Regulatory Affairs Professionals Society shows 6 vaccines as being authorised/approved:

• BNT162b2 (mRNA-based vaccine) from Pfizer, BioNTech and Fosun Pharma has approval in UK, Bahrain, Canada and US

• Coronavac (Inactivated vaccine [with adjuvant]) from Sinovac has approval in China

• Sputnik V (non-replicating viral vector) from Gamaleya Research Institute has approval in Russia

• BBIBP-CorV (Inactivated vaccine) from Beijing Institute of Biological Products has approval in China and UAE.

• EpiVacCorona (Peptide vaccine) from Federal Budgetary Research Institution State Research Centre of Virology and Biotechnology has approval in Russia.

• An unnamed inactivated vaccine from Wuhan Institute of Biological Products has approval in China.

A further 46 vaccines are listed as being in development with 6 vaccines at Phase 3, 3 at Phase 2/3, 2 at Phase 2, 8 at Phase 1/2, 13 at phase 1 and 14 at pre-clinical.

Delivery platforms for vaccine administration

Many people will have experienced annual influenza vaccinations being administered by intramuscular injection (generally used for adults) or by nasal delivery (generally used for children). These are the most common methods of vaccine administration and a review of COVID 19 vaccine trials on ClinicalTrials.gov shows that, for a sample of 17 studies, the following administration methods were cited:

– Intramuscular injection (9 studies)

– Intradermal injection (2 studies)

– Sub-cutaneous injection (2 studies)

– Electroporation via the Cellectra 2000 (1 Study [INO-4800])

– IV Infusions (1 study)

– Not cited (2 studies)

It is clear that parenteral delivery by hypodermic syringe remains the administration method of choice. Although the convenience and cost advantages of hypodermic syringes are undeniable, we believe that a needle-free delivery has key role to play in the global, mass vaccination against COVID-19.

The case for needle-free injection

When appropriately configured, needle-free injection offers compelling advantages over hypodermic syringe delivery as a platform for mass vaccination. These advantages include a) dose-sparing through intradermal efficiencies b) reliable intradermal delivery, c) elimination of needlestick and re-use d) insensitivity to vaccine flow characteristics and e) attractive healthcare economics.

Based on work by Team Consulting, it is feasible to develop mass vaccination needle-free injectors where the cost of re-use is limited to a pre-filled single shot vaccine cartridge. One concept involves vaccines being dispensed from the low volume single-shot, non-reusable capsule using a robust, high duty cycle, multi-use actuator device.

Governments, international agencies and technology companies continue to invest significant sums of money into vaccine development programmes and associated delivery systems. With sufficient coordination across stakeholders, a reliable, needle-free, dose efficient vaccine delivery system is a very viable concept that offers compelling potential advantages for mass vaccination programmes.

By Andy Fry and Stephen Blatcher

Andy Fry - Founder of Team Consulting

Andy has played a leading role in developing Team’s drug delivery business, both in development of client and partner relationships and in technology development. He has helped both multi-national and startup companies identify develop the right parenteral delivery system for their drugs.

Steve Blatcher - Head of Early Stage MedTech at Team Consulting

Steve joined our commercial team in 2019 to help expand our work in the MedTech space. With a particular focus on high risk devices, his strategic business skills and background in engineering and biotechnology gives him an aptitude for both managing technical projects and developing business opportunities.

References:

[1] Industry Builds Fill/Finish Capacity for Pandemic Response” PharmaTech.com, July 15, 2020

[2] Estimating the national cost burden of in-hospital needlestick injuries among healthcare workers in Japan” PLoS One 2019, 14(11) pp 1-21

[3] “COVID-19 vaccine tracker”, 14 December 2020, Regulatory Focus, https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker

 

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