WHAT ARE THE SYMPTOMS OF THE RARE BLOOD CLOTS LINKED TO THE JAB?
Health officials say anyone who has one or more of the below symptoms for longer than four days after vaccination should seek urgent medical advice.
- Shortness of breath
- Chest pain
- Swollen leg
- Persistent stomach pain
- Severe headache
- Blurred vision
- Skin bruising beyond the site of injection
Britons under 40 should be offered an alternative to the Oxford/AstraZeneca Covid vaccine due to its link to rare blood clots, health officials announced today.
Advisers made the recommendation after more adults suffered the potentially-fatal clotting disorder in the past week.
They said the absolute risk of the clots is still ‘extremely small’, affecting around one in 100,000 people given the British-made jab.
So far regulators have spotted major blood clots in 242 people, of whom 49 died. But they are occurring more in younger adults, with a rate of around one in 60,000 under-40s.
Experts said the infection rate in the UK is now so low that the risk of the rare clots outweigh that of Covid in younger adults, who often only suffer mild illness. They will be offered the Pfizer or Moderna vaccines instead, so long as there is enough supply and it won’t delay the rollout.
Anyone, no matter what age, who has been given their first dose of the AstraZeneca jab and didn’t suffer the complication is being urged to come forward for their second.
England’s deputy chief medical officer Professor Jonathan Van-Tam claimed the change would not affect the Government’s target to vaccinate all adults by July 31.
‘Our vaccine supply schedule will support the change without limiting the speed and scale of the vaccine roll-out,’ he told a televised Downing Street press conference.
‘I do expect that we are still on target to offer a first dose to all adults by the end of July.’
It was previously recommended on April 7 that those under 30 with no underlying health conditions should be offered an alternative to AstraZeneca.
Britons under 40 will be offered an alternative to the Oxford/AstraZeneca Covid vaccine due to its link to rare blood clots, health officials announced today. Announcing the update today, England’s deputy medical officer Professor Jonathan Van-Tam said there were enough jabs on order to vaccinate everyone by the Government’s July 31 target
Professor Lim Wei Shen, head of the JCVI, said the decision was only able to be made because the UK’s Covid situation is stable
Data show that the risk/benefit balance of the AstraZeneca vaccine for people in their 20s and 30s who have almost no chance of catching coronavirus may not be in favour of getting the jab, so officials have decided to encourage people to get a different vaccine not linked to blood clots. As the risk of catching coronavirus increases (shown in the graphics below) the benefits of the jab start to outweigh its risks again (Graphics by the Winton Centre for Risk and Evidence Communication at Cambridge University)
The latest figures from the Medicines and Healthcare products Regulatory Agency (MHRA) show there have been 10.5 cases of blood clots combined with low platelet counts per million doses.
But in those between age 30 and 39, the risk is higher at 17.4 per million.
There have been 242 cases of the rare clotting disorder following the Oxford jab up to April 28, with more than 28million doses now administered.
WHY HAS THE DECISION BEEN MADE AND WILL IT AFFECT THOSE ALREADY GIVEN ONE DOSE?
The JCVI, which advises UK health departments on immunisation, has said there is an ‘extremely small risk’ of people suffering blood clots after having the AstraZeneca jab.
But they added that the risk of serious illness with Covid-19 also drops for younger people as infection rates fall across the country.
Professor Wei Shen Lim, Covid-19 chairman for JCVI, said: ‘We have continued to assess the benefit/risk balance of Covid-19 vaccines in light of UK infection rates and the latest information from the MHRA on the extremely rare event of blood clots and low platelet counts following vaccination.
‘As Covid-19 rates continue to come under control, we are advising that adults aged 18 to 39 years with no underlying health conditions are offered an alternative to the Oxford/AstraZeneca vaccine, if available and if it does not cause delays in having the vaccine.’
– How many people have been affected?
Up to April 28, the MHRA had received 242 reports of blood clots accompanied by low blood platelet count in the UK, all in people who had had the AstraZeneca jab, out of around 28.5 million doses given.
These clots occurred in 141 women and 100 men aged from 18 to 93, and the overall case death rate was 20 per cent, with 49 deaths.
Six cases have been reported after a second dose of the vaccine.
A particular type of brain blood clot – cerebral venous sinus thrombosis (CVST) – was reported in 93 cases (with an average age of 47), and 149 had other major thromboembolic events (average age 55) accompanied by low blood platelet count.
The MHRA said the overall incidence of blood clots with low platelets after a first dose is put at 10.5 per million doses, and about one in a million for a second dose.
For those aged 40 to 49 the incidence is 10.1 per million doses, and 17.4 per million for those aged 30 to 39.
Overall, the death rate per million doses is 2.1, but is 4.5 for those aged 30 to 39.
– What about those who are waiting for their second dose of the AstraZeneca jab?
Health experts have said those who have had a first dose of AstraZeneca and not suffered a clot should have a second dose of the same jab, irrespective of their age.
The MHRA said that, as a precautionary measure, anyone who has a severe headache which is not relieved with painkillers or is getting worse, should seek prompt medical attention at any point from around four days to four weeks after vaccination.
Other side-effects that may need medical attention include a headache that feels worse when a person lies down or bends over, a headache that is unusual and occurs with blurred vision, feeling or being sick, problems speaking, weakness, drowsiness or seizures, a rash that looks like small bruises or bleeding under the skin, and shortness of breath, chest pain, leg swelling or persistent abdominal pain.
-What other vaccines are available?
Apart from AstraZeneca, the UK is also using two other vaccines – Pfizer/BioNTech and Moderna.
The UK has an in-principle agreement for 60 million doses of the Valneva jab, with an option to acquire a further 130 million doses from 2022-2025.
The country has also ordered 30 million doses of a coronavirus vaccine developed by Johnson & Johnson, which has been shown to be 66% effective in preventing coronavirus infection.
Both the Valneva and Johnson & Johnson jabs will need regulatory approval for use in the UK, once data from later-stage trials become available.
Six out of 5.9million people who received a second injection developed the rare combination, a rate of around one in a million.
A total of 49 patients have died after getting the vaccine, giving it an overall fatality rate of 2.1 per million, rising to 4.5 per million in under-40s.
In a televised press conference announcing the move, MHRA chief Dr June Raine said the benefits of the vaccine clearly outweighed the risks for elderly adults but the ratio was ‘more finely balanced’ for younger people.
The Joint Committee on Vaccination and Immunisation (JCVI) has been analysing the data and drafted its recommendation earlier this week.
Professor Lim Wei Shen, head of the JCVI, said the decision was only able to be made because the UK’s Covid situation is stable.
He said good control of infections, plenty supplies of vaccines and high level of vaccine uptake meant the cautious recommendation could be made.
If any of these three things were to go awry then the decision could be reversed, he added.
The clots have so far occurred in 141 women and 100 men aged from 18 to 93, and the overall case death rate is 20 per cent.
They appear to be more common in younger adults and slightly more common in women.
A particular type of brain blood clot – cerebral venous sinus thrombosis (CVST) – was reported in 93 cases with an average age of 47.
The 149 had a rare combination of blood clots and low platelet counts, with an average age of 55.
The MHRA and JCVI have both said that the benefits of the AstraZeneca vaccine continue to ‘outweigh the risks for the vast majority of adults’.
The MHRA is responsible for patient safety and the authorisation of medicines in the UK.
The JCVI advises the Government on how vaccines should be used in a public immunisation programme.
Experts have also assessed the risks from any third wave of Covid in the UK and concluded that that wave is likely to be smaller than previously anticipated.
Asked about the risk of vaccine hesitancy in light of the new AstraZeneca guidance, Professor Van-Tam told the briefing: ‘All of the opinion polls I read very clearly show that the British public has very, very high confidence in the vaccine programme in the UK.
‘[They] can already see what it is doing in terms of changing our future, and the data get better and stronger in terms of the layers of protection, not just the aversion of deaths, serious infections, but now the prevention of transmission on top for young adults.’
MHRA chief executive Dr June Raine said: ‘Public safety is always at the forefront of our minds and we take every report seriously.
‘Our position remains that the benefits of the Covid-19 vaccine AstraZeneca against Covid-19, with its associated risk of hospitalisation and death, continues to outweigh the risks for the vast majority of people.
‘The balance of benefits and risks is very favourable for older people but is more finely balanced for younger people and we advise that this evolving evidence should be taken into account when considering the use of the vaccine, as JVCI has done.’
According to Public Health England (PHE), the vaccine programme is estimated to have prevented more than 10,000 deaths in England alone by the end of March.
A Government spokesperson said: ‘The Oxford/AstraZeneca vaccine is safe, effective and has already saved thousands of lives in the UK and around the world.
‘As the MHRA – the UK’s independent regulator – and the Joint Committee on Vaccination and Immunisation have said, the benefits of the vaccine far outweigh the risks for the vast majority of adults.
‘The government will follow today’s updated advice, which sets out that, as a precaution, it is preferable for people under the age of 40 with no underlying health conditions to be offered an alternative vaccine where possible once they are eligible, and only if doing so does not cause a substantial delay in accessing a vaccination.
‘More than 50 million vaccines overall have already been administered, and our current vaccine supply and rate of infection means we are able to take this precautionary step while remaining on track to achieve our target of offering a vaccine to all adults by the end of July.’
The UK has enough supplies on order to vaccinate the entire population many times over
It came as an expert source said they anticipate approval of the Johnson & Johnson vaccine in the UK shortly.
The Medicines and Healthcare products Regulatory Agency (MHRA) is currently appraising the jab and the review is said to be at an advanced stage.
Separately, yesterday’s daily death toll from Covid was 13, bringing the UK total to 127,583. Some 81 deaths have been reported in seven days – down 48 per cent. A further 2,613 people have tested positive for Covid, taking the tally to 4,428,553.
The weekly total is down 10 per cent. Cases have fallen across all regions except the North West.
The Indian strain of Covid is likely to be declared a ‘variant of concern’ after more than 40 clusters were reportedly found across England.
Advisers could U-turn on guidance if cases begin to take off again
Today’s decision to restrict the AstraZeneca in under-40s could be reversed if the UK suffers a third Covid wave, a top Government scientific adviser said.
Professor Anthony Harnden, deputy chairman of the JCVI, said the advisory panel was ‘not frightened’ to make bold decisions.
He said there were enough other jabs on order – including Pfizer, Moderna and the imminent Johnson and Johnson vaccines – to stick to the change in guidance, even if there is a resurgence of the virus.
But if there are any kinks in the supply chain or if there is greater demand for more doses in the UK, perhaps in the face of a new variant, then the AstraZeneca jab could be recommended for everyone again.
Responding to a question from MailOnline at a press conference today, Professor Harnden said what made the JCVI unique was that it was ‘not frightened of making bold and quick decisions’.
He added: ‘Certainly, if the epidemiology or vaccine supply changes we may well steer in a slightly different direction.
‘Speed will be priority, if there’s enough supply we’d stick to that [restricting AZ in under-40s]… This is all about speed of vaccination.’
Professor Harnden admitted that repeatedly changing the guidance around vaccination could lead to a breakdown of public confidence.
He said: ‘We’re very cognisant of the fact any changes can lead to lack of confidence and a rise in vaccine hesitancy, so we don’t want to make too many changes.’