Video report by ITV Science Editor Tom Clarke
Under-30s in the UK will be offered Pfizer or Moderna vaccines rather than the Oxford/AstraZeneca vaccine due to concerns over a very rare risk of blood clots.
The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK said there were still huge benefits of the vaccine in preventing Covid-19, and has not concluded that the vaccine causes rare clots, although it says the link is getting firmer.
Due to a very small number of blood clots in younger people reported in the UK, those under the age of 30 will not be offered the AstraZeneca jab.
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 said there is a “reasonably plausible” link between the AstraZeneca jab and blood clots.
“The evidence has accrued not only in numbers and kinds of cases but the pattern of those cases," she told the briefing.
“So we feel it’s a much more solid basis in our regulatory world to put in the side effect into our product information and that tells us it is a reasonably plausible link.”
The briefing coincides with a review by the European Medicines Agency’s safety committee that concluded “unusual blood clots with low blood platelets should be listed as very rare side effects” of the AstraZeneca vaccine.
Professor Wei Shen, chairman of the JCVI, said the recommendation to prefer other vaccines to AstraZeneca for the under-30s was “out of the utmost caution” rather than because of “any serious safety concerns”.
The MHRA said that those who have had their first dose of the AstraZeneca vaccine should still get their second dose.
Political Correspondent Carl Dinnen examines the impact MHRA ruling will have on the UK's vaccine rollout
Only those who suffered a rare blood clot after the first dose should not get vaccinated.
Anyone with blood disorders that leave them at risk of clotting should discuss the benefits and risks of vaccination with their doctor before going for a jab.
ITV Science Editor Tom Clarke answers some questions about the AstraZeneca vaccine:
As far as any issues with other age groups are concerned, Deputy chief medical officer for England Professor Jonathan Van-Tam has said it would be “pretty absurd” to withhold the AstraZeneca vaccine from the over-40s.
He told the briefing: “The idea of withholding a vaccine where a potential harm, for example in the 40-49 group, is 0.5 harms per 100,000 people versus 51.5 intensive care admissions averted, and that’s not taking into account hospitalisations, long Covid and spreading to others, then the notion that you would clip the vaccine at that point is pretty absurd really.
“So it is very much an independent decision but I think it has been taken in an extremely rational way.”
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Up to March 31, the MHRA has received 79 reports of blood clots accompanied by low blood platelet count, all in people who had their first dose of the vaccine, out of millions of doses given. 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 other kinds of thrombosis in major veins.
Watch the briefing in full:
Sir Munir Pirmohamed, chairman of the Commission on Human Medicines, acknowledged that more work was needed to understand what was triggering the rare form of blood clots.
He told a press conference: “The early evidence is suggesting that there is an immune response which is occurring in relation to whatever the event is – it may be the vaccine or it may be a previous Covid infection, for example.
“But the way that immune response then targets the platelets – and why it targets the platelets in the very small number of individuals – we are not clear about and that further work is ongoing at the moment."
The Prime Minister said he doesn't see any reason to deviate from the roadmap out of lockdown:
Professor Van-Tam used a nautical analogy to describe the “course correction” in the vaccination programme. He said it was “quite normal” and “business as usual” for medics to alter their preferences on how to treat patients. “This is a massive beast that we are driving along at enormous pace with enormous success, this vaccine programme,” he said. “If you sail a massive liner across the Atlantic then it’s not really reasonable that you aren’t going to have to make at least one course correction during that voyage.”
At a meeting on Wednesday, experts from the World Health Organization examined the latest information from both the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
In an interim statement, the sub-committee said: “Based on current information, a causal relationship between the vaccine and the occurrence of blood clots with low platelets is considered plausible but is not confirmed.
“Specialised studies are needed to fully understand the potential relationship between vaccination and possible risk factors.”
The sub-committee added that while the blood clot incidents being assessed were “concerning”, they were “very rare”.