Longer fridge Pfizer storage could be imminent as MHRA prioritising review

Exclusive The MHRA is assessing an extension of the storage time for the Pfizer vaccine at fridge temperature as a ‘priority’, Pulse has learned.

It comes as the European Medicines Agency (EMA) has authorised an update to the vaccine’s approved storage conditions at +2-8C from five days to a month.

The additional flexibility follows an assessment of further stability data submitted by the manufacturer.

MHRA chief executive Dr June Raine told Pulse the medicines watchdog has ‘also received an application from Pfizer for an update to the storage conditions for their Covid-19 vaccine’ and is making assessment ‘a priority’.

She said: ‘It is normal practice for new products to undergo updates to aspects of their conditions for use and as with any update, this will need our assessment and approval before the new conditions for supply are approved in the UK. 

‘We will continue to make this a priority.’

The EMA announced on Monday that it had approved more flexible storage conditions for the Pfizer vaccine – extending the storage period of unopened thawed vials in a +2-8C fridge from five days to 31.

It said: ‘The change was approved following assessment of additional stability study data submitted to EMA by the marketing authorisation holder. 

‘Increased flexibility in the storage and handling of the vaccine is expected to have a significant impact on planning and logistics of vaccine roll-out in EU Member States.’

The change will be reflected in the vaccine’s labelling as well as ‘publicly available information’, the EMA said.

The Pfizer/BioNTech 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.

Currently, undiluted vials of the Pfizer vaccine can be stored for up to five days at +2-8C in a fridge or up to two hours at temperatures of up to 25C prior to use, according to the patient group direction for its administration. It can be stored frozen at around -70C for six months.

But practices were told in December that they must administer batches of 975 doses within 3.5 days rather than five due to having to factor in delivery time.

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 that the Moderna vaccine, which is also more volatile than AZ, is not being prioritised for use in general practice at the moment.