The MHRA has authorised the Pfizer/BioNTech vaccine being stored for up to 31 days at normal fridge temperatures, following a review.
Previously, unopened thawed vials of the vaccine could only be kept at +2-8C in the fridge for five days – but this is now extended to a month.
In an MHRA announcement yesterday evening confirming the extension it said the ‘more flexible storage conditions’ mean the vaccine ‘can be used in a wider range of healthcare settings, giving patients greater access to the Pfizer vaccine’.
NHS England said the change will give vaccination sites more time to use the vaccine, minimise wasted stock and make it ‘easier’ to both align vaccine clinics with deliveries and plan pop-up vaccination services.
Vaccine sites will receive new expiry labels from 24 May onwards to reflect the 31-day storage period, according to a new temporary standard operating procedure (SOP) from the NHS Specialist Pharmacy Service, which added that sites should ‘destroy’ five-day thaw labels after that point.
In the interim, existing vaccine stock that has already been assigned a five-day label can be re-labelled using an indelible pen if ‘operationally necessary’, it added.
Earlier this week, the MHRA told Pulse it was assessing the possibility of the change as ‘priority’, after the European Medicines Agency (EMA) approved longer fridge storage times for the vaccine on the same basis.
The MHRA said it approved the change following a ‘detailed review of additional stability data submitted to the regulator by Pfizer’.
MHRA chief executive Dr June Raine said: ‘We are pleased to confirm that, having rigorously assessed the additional data submitted to us by the company, we have now approved more flexible storage conditions for the Pfizer/BioNTech vaccine.
‘Now that the jab can be stored at normal fridge temperatures for up to 31 days, it can be used in a wider range of healthcare settings, giving patients greater access to the Pfizer vaccine.’
A letter from NHS England sent to GPs and and all Covid vaccination sites said: ‘This is a welcome move which brings additional flexibility to our vaccination programme.
‘Vaccination administration sites will now have a longer period of time over which to use this vaccine, supporting efforts to open up booking slots, minimise waste and ensure that cohort penetration is achieved. It will become easier to align vaccine clinics with the delivery and availability of this vaccine.’
It added: ‘Planning for “roving” or “pop-up” vaccination services will also be made easier by this amendment.’
However, it stressed that no other conditions of authorisation for the Pfizer vaccine in terms of its handling have changed, and that the vaccine must continue to be treated ‘with care’ and in line with guidance.
It added: ‘It remains important that vaccination administration sites continue to vaccinate all patients within eligible cohorts at pace, ensuring that residual on-site stock holdings remain low at all times.’
The Pfizer Covid vaccine was the first to be authorised for use in the UK but was initially only rolled out in hospitals due to logistical challenges with its storage and handling.
The news comes as it was announced this month that practices should offer patients under 40 an alternative to the AstraZeneca vaccine amid blood clot fears.
GP vaccination sites were told they could order extra Pfizer doses to meet the guidance.
Meanwhile, the BMA has said the Moderna vaccine, which is also more volatile than AZ, is not being prioritised for use in general practice at the moment.