Written Question · S5W-34191 · Session 5
How the Medicines and Healthcare products Regulatory Agency’s requirement for the Pfizer/BioNTech vaccine to be packed down and administere…
The question
To ask the Scottish Government how the Medicines and Healthcare products Regulatory Agency’s requirement for the Pfizer/BioNTech vaccine to be packed down and administered by the same legal entity will affect the (a) mass roll-out of the vaccine and (b) use of (i) mass vaccination centres, (ii) GP surgeries and (iii) mobile units to administer the vaccine in Scotland.
The answer
The Medicines and Healthcare Regulatory Authority (MHRA) require that the packing down of any vaccine under the exemption provided in section 10 of the 1968 Medicines Act is done by the same legal entity that is administering the vaccine.
This allows supplies of the vaccine to be packed down, if smaller quantities than the licensed pack of 195 vials (975 doses) are required, and sent to other hospital sites and additional premises, including NHS vaccination centres, mobile units and care homes within a Health Board area, where NHS nurses and other staff are administering the vaccine.
GP practices, which are separate legal entities, are directly receiving the vaccine, which supports their role in delivering the national vaccination programme.
Although the requirement causes some logistical issues, the single biggest limiting issue to this remains the supply of the vaccines.
This allows supplies of the vaccine to be packed down, if smaller quantities than the licensed pack of 195 vials (975 doses) are required, and sent to other hospital sites and additional premises, including NHS vaccination centres, mobile units and care homes within a Health Board area, where NHS nurses and other staff are administering the vaccine.
GP practices, which are separate legal entities, are directly receiving the vaccine, which supports their role in delivering the national vaccination programme.
Although the requirement causes some logistical issues, the single biggest limiting issue to this remains the supply of the vaccines.
In the Official Report
No contribution in the Official Report cites S5W-34191 by reference.