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MHRA ‘reviewing AstraZeneca vaccine use in under-30s’


second dose


The medicines regulator is considering restrictions on the use of the Oxford/AstraZeneca Covid vaccine in patients under 30, it has been reported.

It comes as the European Medicines Agency (EMA) is also conducting an ‘ongoing review’ of the link between blood clots and the vaccine.

Channel 4 News yesterday claimed that the MHRA is being ‘urged’ to ‘pause or restrict’ the use of the vaccine amid the concerns.

It reported: ‘Two senior sources [have told this programme] that while the data is still unclear, there are growing arguments to justify offering younger people – below the age of 30 at the very least – a different vaccine.’

The MHRA and JCVI are ‘urgently scrutinising’ whether young women in particular could be at greater risk of a ‘potentially fatal blood clot’ than of death from Covid after receiving the vaccine, it added.

Both risks remain ‘very small’ and senior sources emphasise their ‘support’ for the vaccine and ‘anguish’ that any restrictions could damage public confidence in it, the programme stressed.

However, the medicines regulator told The Guardian that no decision has yet been made on whether rollout should be restricted to older cohorts.

MHRA chief executive Dr June Raine said: ‘Our thorough and detailed review is ongoing into reports of very rare and specific types of blood clots with low platelets following the Covid-19 vaccine AstraZeneca. 

‘No decision has yet been made on any regulatory action.’

Meanwhile, the EMA last week said it is continuing to review cases of ‘very rare’ and ‘unusual’ blood clots associated with low blood platelets (thrombocytopenia).

It said: ‘At present, the review has not identified any specific risk factors, such as age, gender or a previous medical history of clotting disorders, for these very rare events. 

‘A causal link with the vaccine is not proven, but is possible and further analysis is continuing.’

The EMA is expected to issue an updated recommendation to its member countries this week, it added.

Earlier this month, an EMA safety review of the vaccine concluded that it ‘likely reduces’ the risk of blood clots overall.

However, the watchdog said at the time that it would continue to monitor thrombosis events as ‘some concerns’ remained about younger patients, especially women.

Thirteen European countries had suspended use of the Oxford/AstraZeneca vaccine whilst the EMA review was ongoing.

The MHRA previously said patients with a headache lasting more than four days after their Covid vaccination should ‘seek medical attention’ as a precautionary measure to rule out thrombosis.

It urged patients to continue to turn up for their AstraZeneca Covid vaccination, however, GPs told Pulse that many patients had already been put off by the news of the European suspensions and were turning down the jab or not turning up at all.

Meanwhile, AstraZeneca’s phase-3 trial for the US market concluded that the vaccine presents ‘no increased risk’ of blood clots.

READERS' COMMENTS [1]

Subhash Chandra Bhatt 6 April, 2021 4:32 pm

We need firm guidance from mhra now . We need to give vaccines on daily basis .
What do we do if they refuse? Offer Pfizer ?