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.
Dr. June Raine, chief executive of the MHRA, told a press conference: “While it’s a strong possibility, more work is needed to establish beyond all doubt that the vaccine has caused these side effects.”
It said those aged between 18-29 should be offered an alternative vaccine – either the Pfizer-BioNTech or the Moderna shots.
It comes moments 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.
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 shot, but that no specific risk factors had been identified based on current evidence.
The MRHA has said it identified 30 cases of rare blood clot events out of 18.1 million doses of the shot administered up to and including March 24.
The news means the rollout of the vaccination program could be slowed significantly as more than a fifth of the UK’s vaccine supply is tied up in the Oxford/AstraZeneca injection.
The government has secured a total of 457 million doses, of which 100 million 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 20 million 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.”
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