Under-30s will be offered an alternative to the AstraZeneca Covid vaccine while experts review a possible link to rare blood clots.
People aged 18 to 29 in the UK will be offered the Pfizer, Moderna or another jab where available, scientists revealed in a major press conference today.
But if the AstraZeneca vaccine is the only one available in their area, people will still be offered that jab – regardless of their age.
The AstraZeneca jab rollout is not being halted in the UK. The Medicines and Healthcare products Regulatory Agency (MHRA) insisted benefits of the jab still outweigh the risks – and ministers and scientists urged Brits to continue getting vaccinated.
It came as Europe’s medicines regulator officially branded blood clots a rare side-effect of the AstraZeneca vaccine – but said the benefits of vaccination still outweigh the risks.
England’s Deputy Chief Medical Officer Jonathan Van-Tam admitted it was “a course correction” but said: “This is a massive beast we are driving along at enormous pace with enormous success, this vaccine programme.
“If you sail an enormous 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”.
UK vaccine authority chief Prof Wei Shen Lim insisted the change was being made “out of the utmost caution, rather than because we have any serious safety concerns”.
The MHRA unveiled new advice after 79 cases of rare blood clots were reported out of more than 20million doses of the AstraZeneca jab – with 19 deaths.
That is up from 30 cases and seven deaths out of 18.1million doses a week ago.
Of the 19 deaths, 14 involved cerebral venous sinus thrombosis (CVST), a type of clot that prevents blood from draining from the brain.
All 79 cases happened after the first dose, in 51 women and 21 men aged 18 to 79 – a risk of about one in 250,000 people who receive the jab. Three of the 19 were under 30.
While the benefits outweigh the risks in older adults, because they are far more likely than younger people to die of Covid, the MHRA has been probing whether the balance of risk could be different in younger adults.
MHRA chief executive Dr June Raine said there was “evolving evidence” that blood clots were a “potential side effect” in “an extremely small number of people”.
She said: “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.”
She said there will be a public information campaign for anyone who has symptoms four or more days after vaccination to seek medical attention promptly. Those symptoms are:
- A new severe or persistent headache
- Blurred vision
- Shortness of breath
- Leg swelling
- Chest pain
- Persistent abdominal pain
- Pinpoint spots beyond the injection site
- Unusual bruising.
Dr Raine insisted “the risk of this rare side effect remains extremely small”, adding: “Based on the current evidence, the benefits of the AstraZeneca vaccine against Covid-19… continues to outweigh the risks for the vast majority of people.”
But she accepted: “The balance of benefits and risks is very favourable for older people but it is more finely balanced for the younger people.”
The Joint Committee for Vaccination and Immunisation (JCVI) announced the new “clinical preference” for under-30s in a press conference at the Department of Health.
Boris Johnson made clear he would accept the change to official guidance – but insisted it would not delay the roadmap out of England’s lockdown.
During a visit to Cornwall, the Prime Minister told broadcasters: “I don’t think anything that I have seen leads me to suppose that we will have to change the road map or deviate from the road map in any way.”
Prof Van-Tam said there might be small delays to people’s jabs or they could be asked to travel further. But he added: “Because of our supply situation in relation to alternative vaccines, the effect on the timing of our overall programme should be zero or negligible.
“That of course is contingent upon getting the supplies we expect to get of the alternative vaccines.”
Mr Johnson insisted the Government believes the AstraZeneca vaccine is “safe”, saying: “It’s pretty clear that the decline in the number of deaths, the decline in the number of hospitalisations is being fuelled, is being assisted, the steepness of that decline is being helped by the roll-out of the vaccines.
“So it’s very important for everybody to continue to get your second jab when you’re asked to come forward for your turn.”
Officials stressed the change in guidance was not unlike new approaches to the annual flu vaccine as side-effects emerge.
But today’s press conference comes after growing unease about a possible link between the AstraZeneca jab – of which the UK has ordered 100million doses – and extremely rare blood clots.
Last night a trial of the Oxford/AstraZeneca vaccine in children was paused while regulators investigate, out of “exceptional caution”.
The European Medicines Agency today officially listed blood clots as a rare side-effect of the AstraZeneca jab.
A review by the EMA’s safety committee concluded “unusual blood clots with low blood platelets should be listed as very rare side effects”.
But the EMA declared the benefits still outweighed the risks – with Covid-19 still killing thousands of people per day.
Chair of the EMA’s vaccine evaluation team Marco Cavaleri told Italian media ahead of the 3pm update: “In my opinion, we can now say it, it is clear that there is an association (of the brain blood clots) with the vaccine. However, we still do not know what causes this reaction.”
Germany, France, the Netherlands, Sweden and Canada have restricted the use of the AstraZeneca vaccine in younger people, while Denmark and Norway have paused administering it.
But several European countries – such as Greece, Italy and Portugal – have been using the vaccine without such restrictions.
At the previous update last Thursday, the UK had recorded 30 cases of blood clots with low platelet counts out of 18.1million AstraZeneca doses up to March 24.
Of those 22 were cerebral venous sinus thrombosis (CVST), a type of clot that prevents blood from draining from the brain. Seven people out of the 30 have died.
MHRA officials were investigating whether young people had a greater risk of a complication from the vaccine than of dying of Covid-19 itself.
JCVI member Prof Adam Finn told the BBC: “We see thrombosis, including thrombosis in the cerebral veins, all the time.
“But we don’t normally see them in association with a low platelet count – which is a small blood cell which is involved in blood clotting.
“And so that makes them stand out and makes us think that this is something a little bit different and out of the norm.”
He added: “What we urgently need to understand, if this is a causal thing, is whether that risk-benefit ratio stands up when you get down to younger ages.”
It comes after reports the MHRA had considered restricting the jab in under-30s and offering them a different vaccine.
There had been fears that could slow down the vaccine rollout – with more than a fifth of the UK’s jab orders, 100million, coming from AstraZeneca.
If the vaccine timetable was knocked off-course that could have delayed the roadmap to ease England’s lockdown, including indoor socialising from May 17.
Ahead of the press conference, government sources would not say whether the July 31 deadline to offer all adults a first dose was still on track.
The alternative Moderna jab is being rolled out in Wales and is due in England within days – but sources warn quantities will be very small at first, and the UK has only ordered 17million doses compared to 100million of AstraZeneca.
Today’s press briefing at the Department of Health was led by England’s Deputy Chief Medical Officer Prof Jonathan Van-Tam.
He was joined by MHRA chief executive Dr June Raine, JCVI chairman Prof Wei Shen Lim and Prof Sir Munir Pirmohamed, chairman of the Commission on Human Medicines.
Prof Finn of the JCVI earlier insisted it was vital to keep the vaccine programme going in order to keep the roadmap on track – after SAGE experts warned of a third wave this summer.
He told the BBC: ”As time goes forward, we will have much more flexibility about who can be offered what.
“On the other hand, we do need to keep the programme going if the plan to open things up and allow things to get back to normal is to proceed without another wave of the pandemic coming through.”
He urged people being offered the vaccine at the moment to take it, saying the “risk-benefit is very strongly in favour of receiving the vaccine”.
GP Dr Ellie Cannon, told the BBC the rate for the worrying type of blood clot was around one in 2.5 million people.
She said that, in contrast, among 2.5 million 40-year-olds with Covid “we would expect around 2,000 deaths”, adding the risk of a clot was “incredibly rare”.
SAGE advisor Prof Calum Semple said he was personally ”not worried one little bit”, telling LBC radio: “I’ll take (it) myself, I’m 53, my risk of death from Covid is about one in 13,000, for me it’s a no-brainer, I need to have the vaccine.
“This vaccine is safe. What do I mean by safe? You can look right, look left, look right again, cross a road, it’s safe to cross because you don’t see any cars (but) you can trip, you can stumble.
“Nothing is risk-free, but is the vaccine safe? I would say yes.”
Former MHRA chief Professor Sir Kent Woods also told LBC radio: “Covid itself – the infection itself – is known to be associated with a substantial increased risk of blood clots of various kinds.
“At a time when the population has got lots of Covid going around, it’s very difficult to know what the actual background rate of these clotting events is without the vaccine.
“We can say, I think, that if there is a connection, it’s a very, very rare one.”
But Dr Maggie Wearmouth, a member of the JCVI, told the Daily Telegraph that “perhaps slowing things down” with the rollout “until we’re absolutely certain” might be wise.
Speaking in a personal capacity, she said: “The issue is about safety and public confidence. We don’t want to cover anything up that we feel that the public should be knowing.
“We’re not here to blindly follow targets or due dates. We will do what is necessary.”