The Oxford/AstraZeneca vaccine should only be given to people over the age of 30, the UK’s medicines regulator has recommended.
The Medicines and Healthcare Products Regulatory Agency (MHRA) announced the decision on Wednesday, amid reports of very rare incidences of blood clotting.
But chief executive of the MHRA Dr June Raine told a press conference: “While [the link is] a strong possibility, more work is needed to establish beyond all doubt that the vaccine has caused these side effects.”
The body has said it identified 79 cases of rare blood clot events after the first dose out of 18.1m doses of the jab administered up to and including March 31.
Of the 51 women and 28 men affected, 19 died. The risk is equivalent to four people in one million.
The MHRA has said those aged between 18 and 29 should be offered an alternative vaccine – either the Pfizer or the Moderna jabs.
It comes after a review by the European Medicines Agency’s (EMA) safety committee concluded that “unusual blood clots with low blood platelets should be listed as very rare side effects” of the vaccine – but that the benefits of the vaccine still significantly outweighed the risks.
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The EMA’s executive director Emer Cooke said: “The EMA’s expert committee on the safety of medicines (PRAC) has confirmed that the benefits of the AstraZeneca vaccine in preventing Covid-19 overall outweigh the risks of side effects.”
She added: “A plausible explanation for these rare side events is an immune response to the vaccine.”
The EMA said most of the cases of blood clots reported have occurred in women under 60 within two weeks of vaccination with the AstraZeneca jab, but that no specific risk factors had been identified based on current evidence.
The news means the rollout of the vaccination programme could be slowed significantly as more than a fifth of the UK’s vaccine supply is tied up in the Oxford/AstraZeneca jab.
The government has secured a total of 457m doses, of which 100m are from AstraZeneca.
Despite this, the government has recommitted to its pledge to offer all adults a Covid-19 vaccination by summer and the Moderna vaccine is expected to be rolled out around the third week of April.
Speaking earlier on Tuesday, vaccines minister Nadhim Zahawi told BBC Breakfast: “The regulators absolutely look at, very closely, any adverse incidents through the yellow card system.
“And June Raine, who is the chief executive of the MHRA, our independent regulator, said last night that if you get the invite for the vaccine to take that invitation and get the vaccine and get protected.
“At the same time, they are looking at these very rare instances of blood clotting. To put it in perspective, we have done almost 20m vaccinations using the Oxford/AstraZeneca vaccine.
“Both vaccines [Pfizer and AstraZeneca] have saved something like 6,300 lives between December and the end of February, so it’s important to continue to follow what the clinicians, the scientists, the regulators tell us. And we will absolutely do exactly as they say.”