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Semi-automatic COVID-19 vaccine preparation for upscaling of vaccination
European Statement
Production and Compounding
Author(s)
Denise van der Nat, Anouk Lindemans, Laurens van Rijn, Wilfred Weijers, Elisabeth Ruijgrok
Why was it done?
COVID-19 is an ongoing worldwide pandemic which causes millions of deaths. To reduce COVID-19 mortality and morbidity, vaccines are developed. However, preparing COVID-19 vaccines before administration is a time consuming process. To accelerate this process and increase efficacy for health care workers, the Vaxtractor was designed in January 2021. We aimed to examine the quality of COVID-19 vaccines prepared with the Vaxtractor.
What was done?
Development and testing of a device (Vaxtractor) for semi-automatic large-scale preparation of COVID-19 vaccines.
How was it done?
With the Vaxtractor, the desired volume of vaccine is drawn up automatically in syringes from two vials of vaccine simultaneously. A sterility test, measurement of accuracy and uniformity of dosage units tests were performed in September and October 2021. For the sterility test, 22 syringes were filled with 0.5 ml Tryptic Soy Broth and these were incubated at 25°C for seven days followed by a seven day incubation period at 30°C. For the accuracy and uniformity of dosage units test, 60 syringes were filled with vaccine. Subsequently, the filled and emptied syringes were weighed. Furthermore, a time analysis was performed on manually and semi-automatically prepared COVID-19 vaccines.
What has been achieved?
The sterility test showed no visual sign of growth of micro-organisms. Furthermore, the weight of 60 prepared Spikevax® vaccines deviated less than 5% compared to the average weight of the vaccines. Also, the observed volume per vaccine deviated less than 5% compared to the declared volume. Besides that, preparing COVID-19 vaccines with the Vaxtractor was about three times faster compared to manually prepared vaccines and reduced the risk of needlestick injuries.
What next?
The Vaxtractor can be used to safely prepare Spikevax® vaccines. In the next months we will assess the quality of preparing Comirnaty® vaccines with the Vaxtractor. If these results are positive, the device can be implemented at large scale at the in- and out-of-hospital setting. This will contribute to effective upscaling of COVID-19 vaccination.