PM: People of all ages can have full confidence in vaccines
The prime minister has been responding to the recommendation that under-30s in the UK should be offered an alternative to the Oxford-AstraZeneca jab.
Boris Johnson says: "We will follow today's updated advice, which should allow people of all ages to continue to have full confidence in vaccines, helping us save lives and cautiously return towards normality."
'We feel that there is a probable causal association' - EU official
Dr Sabine Straus, chair of the EMA’s Safety Committee, was asked at the briefing in Amsterdam to clarify if there was a “causal link” between the AstraZeneca vaccine and adverse events, given that an EMA press release had talked of a possible link.
“Sometimes our regulatory way of talking might be a little bit more complicated than it should be," Straus replied.
"What we have learned from the very detailed review of the cases is that there is a strong association with the AZ vaccine and the adverse events. And if we add something to [Section] 4.8, then that is a sign that we feel that there is a probable causal association between the occurrence of the events and the administration of the vaccine. That may be a language issue where we fail as regulators - ‘strongly associated’ is the word I would choose here."
She said the committee had carried out a detailed review of 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis in the EU drug safety database as of 22 March, 18 of which had been fatal.
She stressed that although most of the clotting cases had occurred in people under 60 years and in women, "due to different ways the vaccine in being use in different countries" her committee "did not conclude that age and gender were clear risk factors for these very rare side effects".
Straus said the review's findings would be added to the vaccine’s product information.
Another 45 deaths recorded in the UK
While the briefing was under way, the daily coronavirus statistics update for the UK was published.
A further 45 deaths have been recorded within 28 days of a positive Covid-19 test. It takes the total by this measure to 126,927.
And there were 2,763 new Covid cases reported.
Meanwhile, another 85,227 have had the first dose of a vaccine and 186,793 more people have received a second jab.
It means a total of 31,707,594 people have now had a first jab in the UK and 5,683,509 have had both doses.
At-a-glance: What did we learn from UK vaccine briefing?
The briefing from the UK medicines regulator, the MHRA, has just finished, as Prof Jonathan Van-Tam says the change in advice for the under-30s "is a course correction but nevertheless the UK vaccination programme is full speed ahead".
Here's a summary of the key points:
The benefits of the Oxford-AstraZeneca vaccine continue to outweigh the risks for the "vast majority of people", according to the MHRA
The risk of rare blood clots remains "extremely small", MHRA chief Dr June Raine said
She said "the evidence is firming up" but the MHRA's 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 JCVI has advised that under-30s with no underlying health conditions should be offered an alternative to the AstraZeneca vaccine where available
Those who have received their first dose of the AZ jab should continue to be offered a second dose of the same jab
Prof Van-Tam said the impact of the change on the timing of the UK's vaccine programme "should be zero or negligible"
Tom Whipple from the Times newspaper asks how the side effect might be triggered and if there are ways to mitigate it.
Sir Munir Primohamed says the early evidence suggests there is an immune response which is occurring to an event, such as the vaccine or a previous Covid infection.
He says understanding it might help with modifying a vaccine in the future which could prevent the side effect.
Primohamed says that there are several other viral vector vaccines, which use a similar method tot he AstraZeneca vaccine, but it is not clear if this is what is causing the issue.
Are women who have Oxford jab more at risk of blood clots than men?
Hannah Geissler from the Express asks if there are biological reasons why women might be at higher risks of blood clots than men.
Sir Munir Pirmohamed says of the 79 blood clot cases 51 were women and 28 were men.
"The numbers are quite small and it may reflect who is getting the vaccine because many of the healthcare workers for example are women.
"But if you look at the incidence rate according to the number of vaccines administered, there no difference between men and women," he says.
But scientists will continue to monitor any gender predilection to developing this side effect, he says.
Could 18-29s be offered the one-dose Janssen jab instead of AZ?
Nick McDermott asks about other vaccines available for the 18 to 29 year olds, who will now be offered an alternative to Oxford-AstraZeneca.
Prof Van-Tam says "in terms of the immediately available alternative we have the Pfizer vaccine".
He says we do expect to have Moderna from mid-April so "those will be the two for the next two weeks".
Van-Tam says it is common knowledge that the UK has placed orders with Janssen (also known as the Johnson & Johnson jab) but there is no certainty on the timing of the delivery.
"It could become available over the summer and is a one dose schedule," he says. "So it must be in the mix for solutions for vaccine requirement going forward."
What does 'the link is now firming up' mean?
Nick McDermott from the Sun newspaper asks about the earlier statement that "the link is now firming up" in relation to the Oxford-AstraZeneca jab and blood clots.
He asks whether this means it is more likely than not that there is a link between the Oxford jab and rare blood clots?
Dr Raine says: "We feel it is a much more solid basis in our regulatory world to put in the side effect into our product information.
"And that tells us that it is reasonably plausible link but there needs to be much more work of the scientific understanding of this new constellation of symptoms to give us the proof that you would expect and that work will go on at pace."
Why shouldn't middle-aged people be offered alternative jab?
Tom Moore from Sky News asks if the under-30s are being offered an alternative vaccine, why aren't middle-aged people too?
He also points out that some European countries and Canada have decided not go give the vaccine to under-55s - and asks the panel whether they are being too cautious?
Prof Wei Shen, chair of the JCVI, which advises ministers on vaccines, says every country has to make their own decision on what is best for their own population.
He says the JCVI took into account the UK's vaccine supply, the type of pandemic it is experiencing, and the current variants in circulation.
Jonathan Van-Tam adds that the idea of withholding a vaccine from the 40-49 age group would be "pretty absurd" in a high-exposure scenario - given the potential benefits.
He stresses the UK's vaccination programme should not be delayed because of this change in course.
EMA's AstraZeneca findings 'to have immediate impact' on EU rollout
As the UK briefing continues, health ministers from the European Union's 27 member states are set to discuss the findings of the Euopean Medicines Agency (EMA) on the risk of blood clots from the AstraZeneca jab.
According to a letter seen by Reuters news agency, the findings are expected to have an immediate impact on inoculation plans and will require a co-ordinated response.
"We expect this announcement will have a direct and immediate impact not only on our national vaccination plans, but also in our citizens' trust in vaccines against Covid-19," the letter says.
It comes after the EMA concluded the benefits of the AstraZeneca vaccine in preventing Covid-19 overall outweigh the risks of side effects (see our previous posts).
What about people in their early 30s?
Tom Clarke from ITV asks what advise the experts might give to a family member who is 31.
Dr Wei Shen says the vaccine programme should be "fair and transparent". "Everyone should know what the risk is before they come for their vaccination," he says.
He says someone in their early 30s will have to make their own decision on vaccination, but he would advise them to come forward "because of the risk from Covid-19 and the protection the vaccine offers".
Asked what it means for children, he says the JCVI has not made any decision about vaccines for those under 18, and clinical trials are still ongoing on that front.
Could this undermine vaccine confidence?
BBC medical editor Fergus Walsh asks if the panel is concerned that today's announcements could undermine vaccine confidence.
Prof Jonathan Van-Tam says: "Clearly this is a course change, we don't want it to result in a loss of vaccine confidence."
He says it remains vitally important that people called back for their second dose come back for it and all adults come for their vaccination when offered it.
Walsh asks how significant the risk of blood clots are in younger people compared to older people.
Professor Wei Shen says the offering of an alternative to the AstraZeneca jab to the 18 to 29-year-olds was "just on the side of safety rather than any particularly significant concern about the risk from the vaccine itself".
Van-Tam: Vaccines continue to be way out for UK
Jonathan Van-Tam reassures people that the NHS "will get the right vaccine to you in the right time according to the new JCVI
There might be "a slight delay" or "a slightly greater distance that some people might be asked to travel", but the NHS is "all over this", he tells the briefing.
He concludes by saying this is "a course change" based on newly emerging data but it "will be kept under very careful review".
"The benefits of vaccine accrue over a very long period of time," he adds, saying scientists are "fairly confident" this will be measured in months.
“Vaccines continue to be the way out for the UK, they
continue to be the way in which we can get our lives back to normal and our economy
opened up again the shortest time possible," he says.
Impact of change on UK vaccination programme 'negligible'
Jonathan Van-Tam says people should be "reassured" that experts are "all over this" and says it should not change the course of the vaccine rollout.
"This is a change in clinical advice for the under-30s, it will require some changes in the way the NHS operationalises the vaccine rollout programme," he tells the briefing.
But he says because of the supply situation with other vaccines the effect on the vacciantion programme should be "negligible".
"Changes in preferences for vaccines are business as usual," he adds.
"If you sail a massive liner across the Atlantic it is not really reasonable that you are not going to have to make one course correction over that time," he says.
People who have had Oxford jab should still take second dose - JCVI
Professor Wei Shen,
chairman of the Joint Committee Vaccination and Immunisation (JCVI), which advises the government on vaccines, says:
Information given to individuals who are being offered vaccination and information given to health professionals should be appropriately updated to reflect the JCVI and regulator MHRA findings
Those who have received their first dose of the Oxford-AstraZeneca vaccine should continue to be offered the second dose of the same vaccine
Adults 18-29 who do not have underlying health conditions should be offered an alternative Covid-19 vaccine in preference to the AstraZeneca vaccine where it is available
He says "we are not advising a stop to any vaccination for any individual in any age group".
The advice to swap the AZ for younger age groups was "really out of the utmost caution" rather than "any serious safety concerns", he says.
Van-Tam explains potential risks and benefits of the Oxford vaccine
England’s deputy chief medical officer Prof Jonathan Van-Tam now takes us through some data on the potential benefits and harms from Covid vaccines.
In a scenario of low exposure - where Covid rates are lower than the current rates in the UK - for those aged 20-29 the risk-benefit is "relatively finely balanced", he says.
However, in older age groups, the figures are "overwhelmingly in favour" of the vaccine, he adds.
In a medium risk scenario, where Covid rates are marginally higher than the current UK average, the "potential benefits start to stack up" but the serious harms remain static, he continues.
In a high exposure risk, comparable to the height of the second wave in the UK, even in the 20-29 age group, the potential benefits in terms of averting intensive care admissions is "very much higher" than the potential serious harms caused by the vaccine.
Prof Van-Tam says that this is why the UK's regulator has come to the conclusion it has.
Further advice issued for groups over Oxford jab
Sir Munir Pirmohamed, chairman of the Committee of Human Medicines, tells the briefing it has decided on the following advice:
Pregnant women should continue to discuss with their doctor whether the benefit of having the vaccine outweigh the risks
People with a history of blood disorders that increase the risk of blood clotting should only have the AstraZeneca jab where benefits outweigh potential risks
People who experienced clots after their first dose should not receive the second jab
He says the committee will continue monitoring the data so it can refine the advice
"It is important to remember that Covid-19 itself causes clotting and it causes lower platelets," he says.
The link between the vaccine and blood clots is getting firmer but an absolute link will need extensive scientific work, he says.
79 cases of rare blood clots reported after Oxford jab, says MHRA chief
Dr June Raine says the role of the medicines regulator, the MHRA, is to confirm that the vaccines are performing as expected, to identify any very rare side effects and to ensure the benefits outweigh the risks.
She says: "The public's safety is at the forefront of our minds."
She says that up to 31 March, 20m doses of the Oxford-AstraZeneca vaccine were given and 79 cases of rare blood clots were reported.
All 79 cases occured after the first dose and 19 people sadly died, Raine says.
Of the cases, 51 were women and 28 men aged 18 to 79 years old.
She said the risk of this kind of side effect was about four in one million to those who receive the vaccine.
"This is extremely rare and the balance of benefits and known risks of the vaccine is still very favourable for the vast number of people," she adds.
'Course correction' over rare side effects of AZ jab - Van-Tam
England’s deputy chief medical officer Prof Jonathan Van-Tam begins the briefing by saying the UK's vaccination programme has been "a most enormous success" but there is now the need for a "course correction".
June Raine, from the UK's medicines regulator, says more than 20 million doses of the AstraZeneca vaccine have been given in the UK and the jab is the best way to protect people from Covid-19 - but no effective vaccine is without risk.
While clinical trials allow us to assess relatively common
effects, rare side effects can only be identified when vaccines are used at scale, she adds.
She says "the evidence is firming up" but "more work is needed to establish beyond
all doubt" the vaccine has caused extremely rare blood clots.
No specific risk factors for clotting - EU official
Meanwhile, the European medicines regulator, the EMA, has been setting out the findings of its review into a link between the Oxford-AstraZeneca vaccine and rare blood clots.
The EMA's Emer
Cooke said that clots were seen in “all ages, and in men and women”, and there was no available evidence
of “specific risk factors such as age, gender, or previous medical history of
"Our safety committee... has confirmed that the benefits of the AstraZeneca vaccine in preventing Covid-19 overall outweigh the risks of side effects," she said.
"Covid-19 is a very serious disease with high hospitalisation and death rates and every day Covid is still causing thousands of deaths across the EU.
"This vaccine has proven to be highly effective - it prevents severe disease and hospitalisation, and it is saving lives."