Vaccination against COVID-19: feedback on the reconstitution of doses of Comirnaty® vaccine

28 September 2021

C. Biasolo1, M-A. Gratelle1, C. Bédoucha1, Jean-Pierre Pereira2, R. Dulin1, M. Gayral1, A-C. Marion1
(1) : Pharmacy of the Libourne Hospital Center
(2) : IT services department

On January 7, 2021, the vaccination campaign against SARS-COV2 began at the Hospital Center following the availability on French territory of the Comirnaty® vaccine. Its reconstitution modalities and its packaging in multidose vials raised the issue of dose management and their preparation. At the request of COPIL vaccination, the pharmacy got involved in the reconstitution with a dedicated circuit. The objective is to secure and streamline the circuit for the doses to be administered of the vaccine.

Material and methods
The reconstitution of the doses is centralized in the pharmacy, in the preparatory, under a laminar flow hood. The production activity requires 2 people: one dedicated to reconstitution (hospital pharmacy technician or nurse from the vaccination center), and one in double check, labeling and dispensing (pharmacist, internal or external in pharmacy).
To facilitate management, a computer platform for programming and monitoring stocks has been created. Production starts at 8:00 a.m. The first patients are called at 9:20 a.m. and the last at 5:30 p.m. Preparation ends at 1:00 p.m., in line with the 6-hour stability of the Comirnaty® vaccines. The syringes are transported by logistics, in a container guaranteeing storage <25 ° C and protection of the doses.

A double check is carried out on the volume of dilution then, for each dose of vaccine, the volume sampled. Labeling is affixed to each dose, indicating the name of the vaccine, the date and time of reconstitution, the batch number, the shelf life, and the method of storage. The syringes are packaged in plastic bags, identical to those used for chemotherapy. The doses are produced in series. The evaluation of the number of doses is carried out over 6 months: from January to June. Per vial, 6.85 doses have been carried out since the start-up. A total of 31,000 doses were reconstituted, i.e. 72 doses per hour.

Figure 1: Evolution of the number of doses during the vaccination campaign

The production hours are in accordance with the activity of the vaccination center so that it operates continuously. The IT platform enables reliable patient planning : at the vaccination center and in hospital. It also allows the consumption of doses to be monitored in real time, thus optimizing production. The main difficulty is managing the last doses of the day. With the involvement of the various professionals, the dose loss rate is ≤0.025%.
The centralization of production and the circuit implemented ensure quality and safety for the patient. With the involvement of the PUI, hospital pharmacists play a leading role in the SARS-COV2 vaccine campaign.

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