THE UK’S MEDICINES regulator has recommended halting the rollout of the Oxford/AstraZeneca Covid-19 vaccine to people aged under-30.
The Medicines and Healthcare products Regulatory Agency (MHRA) said there were still huge benefits of the vaccine in preventing Covid-19 and serious disease.
However, due to a very small number of blood clots in younger people, those under the age of 30 will be offered Pfizer or Moderna instead.
England’s deputy chief medical officer Professor Jonathan Van-Tam said the changes being proposed to the vaccination rollout were a “course correction”.
Dr June Raine, chief executive of the MHRA told a briefing the clots were “extremely rare” and the benefits of the jab were clear.
She added: “The evidence is firming up and our review has concluded that while it’s a strong possibility, more work is needed to establish beyond all doubt that the vaccine has caused these side effects.”
The recommendation is broadly in line with thinking in Europe. This afternoon a review by the European Medicines Agency’s safety committee concluded that “unusual blood clots with low blood platelets should be listed as very rare side effects” of the Oxford/AstraZeneca vaccine.
Emer Cooke, executive director of EMA, said its review “confirmed that the benefits of the AstraZeneca vaccine in preventing Covid-19 overall outweigh the risk of side effects,” adding: “Vaccination is extremely important in helping us in the fight against Covid-19.”
Up to 31 March, the UK’s MHRA received 79 reports of blood clots accompanied by low blood platelet count, all in people who had their first dose of the vaccine.
Of these 79, a total of 19 people have died, although it has not been established what the cause was in every case.
The 79 cases occurred in 51 women and 28 men, aged from 18 to 79.
Of the 19 who died, three were under the age of 30, the MHRA said.
Some 14 cases of the 19 were cerebral venous sinus thrombosis (CVST), a specific type of clot that prevents blood from draining from the brain.
The other five cases were thrombosis.
The MHRA has concluded that the balance of risk for the vaccine is “very favourable for older people” but more finely balanced for younger groups.
UK Prime Minister Boris Johnson said the government believes the Oxford/AstraZeneca vaccine is “safe”, telling reporters on a visit to Cornwall: “But the crucial thing for everybody is to listen to what the scientists, the medical experts have to say later on today.”
More than 20 million doses of the AstraZeneca vaccine have now been given in the UK, saving an estimated 6,000 lives.
With reporting by Céimin Burke
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