Open access article
The Royal Pharmaceutical Society has made this article free to access in order to help healthcare professionals stay informed about an issue of national importance.
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The Pfizer-BioNTech COVID-19 vaccine can now be stored at normal fridge temperatures for up to 31 days, following updated advice from the Medicines and Healthcare products Regulatory Agency (MHRA).
The mRNA vaccine must be stored at ultra low temperatures until use and previously had to be administered within five days of being removed from the freezer.
However, in guidance published on 20 May 2021, the MHRA said it had conducted a detailed review of additional stability data submitted to the regulator by Pfizer and agreed to extend the length of time the thawed vaccine can be stored at fridge temperatures of 2–8°C.
These changes are expected to make storage easier and administration possible for a wider range of health facilities, the regulator said.
NHS England previously said on 5 May 2021 that community pharmacy–led vaccination sites would soon be administering the Pfizer/BioNTech COVID-19 vaccine as well as the Oxford/AstraZeneca vaccine, as part of NHS England’s effort to increase vaccinating capacity.
Following the MHRA’s announcement, a letter from NHS England to all vaccination sites stated that the responsible NHS hospital chief pharmacist, clinical commissioning group (CCG) lead pharmacist or superintendent pharmacist “should engage with healthcare professionals operating on site now to make them aware of this development and ensure that the implications for vaccine supplies already in their possession are carefully understood”.
The letter, sent on 20 May 2021, added that, despite the changes to the storage, no other conditions of authorisation relevant to the handling of the vaccine itself had changed and that the vaccine remained “inherently fragile”.
“It must be treated with care and in particular, it is important that any transportation and preparation of the vaccine always takes place within the permitted parameters and in accordance with the Standard Operating Procedures developed by the NHS Specialist Pharmacy Service.”
Ewan Maule, head of medicines optimisation at Sunderland CCG, said that the previous storage conditions for the Pfizer/BioNTech vaccine presented “significant operational challenges”.
“Matching up the number of patients with the number of doses in order to prevent wastage but being able to fulfil appointments [was] extremely challenging,” he said.
“As we have moved through the age groups, rates of [‘did not attends’] have increased, making the above even more difficult. This has resulted in significant administrative burden in managing backup lists and short notice appointment availability.”
Maule said that the short shelf life of the defrosted vaccine had also caused increased requests for ‘mutual aid’ — the transfer of a vaccine from one organisation providing NHS COVID-19 vaccination services to another.
“This takes significant resource and planning, which distracts from both vaccine programme service delivery as well as business as usual post-COVID-19 recovery,” he said.
“We know that we will be vaccinating continuously throughout the summer and next winter, as a result of both the booster campaign and the need to control the Indian variant, which will rise as lockdown eases, so the greater flexibility this will offer in operational management [is] very welcome.”