How safe is AstraZeneca’s Covid jab? What are the side effects? And why do victims only have a 3-year cut-off – Daily Mail
By Emily Stearn, Health Reporter For Mailonline 11:39 08 May 2024, updated 14:58 08 May 2024
AstraZeneca's Covid vaccine once heralded as a 'triumph for science' is being withdrawn worldwide.
The jab, developed withOxford University, can no longer be used in the European Union after the company voluntarily pulled its 'marketing authorisation', coming into effect today.
Similar applications to withdraw the vaccine will be made in other countries which had previously approved it, including the UK. Around 50million doses were given in Britain.
While creditedwith saving more than 6million lives, the jab known as Vaxzevria has come under intense scrutiny in recent months over a rare but fatal side effect.
In February, thepharmaceutical titanadmitted in documents lodged with the High Court that it 'can, in very rare cases, cause thrombocytopenia syndrome (TTS)'.
So why has the jab now been withdrawn? Are you at risk if you had Vaxzevria? And what do you have to prove if you have been injured by the AstraZeneca vaccine?
Here, MailOnline explains everything you need to know.
Why has it been withdrawn?
Fifty-one families are currently pursuing legal action against AstraZeneca, arguing its 'defective' jab was to blame for their injuries and deaths of loved ones.
However, the Cambridge-based drug manufacturer denies the decision to withdraw the vaccine is related to the court case. Instead, it insists Vaxzevria is being removed from markets for commercial reasons.
The company said in court documents that the vaccine is reportedly no longer being manufactured or supplied, having been superseded by updated vaccines that tackle newer variants.
In a statement today, the company said:'According to independent estimates, over 6.5million lives were saved in the first year of use alone and over three billion doses were supplied globally.
January 2020: Oxford University scientists start working on a Covid vaccine after the World Health Organization declares the spread of the virus a 'Public Health Emergency of International Concern'
March 2020: Then Prime Minister Boris announced the first national lockdown. That same month, the Government invests 88million in the development of the Oxford vaccine
April 2020: Alongside AstraZeneca, scientists start the first clinical trials of their new vaccine. This involved 1,000 volunteers in the UK
July 2020: Results from phase two trials of AstraZeneca's jab are published
4 December 2020:Covid jab rollout begins with the Pfizer vaccine. Over-80s and care home workers are given priority
8 December 2020:Phase three trial results of theAstraZeneca's jab are published. These are what health officials will use to approve the jab for use in the UK
30 December 2020:AstraZeneca's jab is approved for emergency use
4 January 2021: FirstAstraZeneca doses start being dished out.Brian Pinker, 82, is the first person to receive the jab outside of clinical trials
8 January 2021: Frontline NHS staff start being offered vaccines
8 February 2021: Over-70s are called forward
14 February 2021: Roll-out opens up to Brits with underlying heath conditions, as well as the over-65s
28 February 2021: All over-60s are invited for jabs
11March 2021:European countries start suspending use of the AstraZeneca jab after death of a 60-year-old woman from a blood clot
17 March 2021: Over 50s start being offered Covid jabs in the UK
19 March 2021: Several European countriesreverse decision to suspendAstraZeneca jab after initialinvestigations find no link to reported blood clots
31 March 2021: People living with vulnerable adults are called forward to get a Covid vaccine in the UK, even if they are younger than eligible age groups
7 April 2021:UK restricts the use of the AstraZeneca vaccine to over-30s over a small but statistically significant risk of blood clots in younger people
30 April 2021: Over-40s are called forward for Covid jabs
7 May 2021: Restriction of the AstraZeneca vaccine is widened to include over-40s
August 2022: Government sources say they will not order anymore AstraZeneca Covid vaccines instead focuses on mRNA alternatives
March 2023: Dozens of patients and families launch legal action against AstraZeneca due to
April 2023: Widower of a BBC presenter Lisa Shaw who died after having the vaccine said he has 'no alternative' but to sue AstraZeneca
4 August 2023: Anish Tailor, whose wife Alpa died in March 2021 after receiving her first AstraZeneca dose, filed a product liability claim against AstraZeneca at London's High Court.His lawyer says he has nearly 50 other clients who will formally sue AstraZeneca in the coming months
17 August 2023: IT engineer Jamie Scott, who suffered a brain haemorrhage the day after his first AstraZeneca jab starts a legal case against the company. The law firm representing Mr Scott says it represents around 40 other individuals or bereaved families
'Our efforts have been recognised by governments around the world and are widely regarded as being a critical component of ending the global pandemic.
'As multiple, variant Covidvaccines have since been developed, there is a surplus of available updated vaccines.
'This has led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied.
'AstraZeneca has therefore taken the decision to initiate withdrawal of the marketing authorisations for Vaxzevria within Europe.'
What did the original trial data show about side effects?
Tens of thousands of volunteers, including ones in the UK and the US, willingly rolled up their sleeves to take part in original trials.
Heavily scrutinised data suggested two doses of the AstraZeneca jab offered about 70 per cent protection against becoming ill. This meant developing any symptoms, as opposed to being hospitalised.
Other studies calculated that a single dose reduced the likelihood of hospitalisation by up to 94 per cent.
Analysis of the phase 3 trial, the final hurdle typically needed to be cleared before any drug gets approved for widespread human use, noted no safety concerns.
Yet, like with all forms of medication, AstraZeneca's jab carried a range of potential side effects.
Officials knew about mild ones thanks to the massive trials, with recipients mostly complaining of routine issues like headaches.
And people who were subsequently vaccinated were warned about them ahead of getting any needle in their arm.
Common side effects, which health bosses say can affect more than 10 per cent of recipients, include fatigue, 'flu-like'symptoms, and pain in the arms or legs.
Stomach pain, a rash and excessive sweating were uncommon, strikes roughly one in 100 people who get vaccinated.
According to the pharmaceutical titan, rare (approximately one in 1,000) issues included facial drooping on one side.
It was only once the door was opened for millions more Brits to get the jab, as the UK did during the first few months of 2021, that another complication was spotted.
Officials noted a small, yet significant trend in cases of vaccine-induced immune thrombotic thrombocytopenia (VITT, or TTS)that allowed them to raise the alarm in the first week of April.
It causes blood clots to form in various parts of the body, including the brain, heart, lungs, kidneys, and the legs. It is an urgent medical emergency.
These blood clots, like any others, can be deadly depending on where they form or if they break up and travel to parts of the body like the brain.
Estimates suggest the risk of blood clots occurring from taking AstraZeneca's jab is in the region of one in 50,000.
Am I at risk now if I had the jab back in 2021?
Side effects from the AstraZeneca vaccine generally only occurred within the first four weeks of receiving it.
There is currently no evidence of a long-term risk from having had the jab, doctors insist.
As jabs are given as a single dose at a time, experts claim adverse effects generally only occur a short time after receiving the injection unlike with medication that people take for years.
Additionally, given the sheer quantity of people who received the AstraZeneca jab, some 50million in the UK and over 2.5billion globally, long-term effects would likely have been spotted by now, experts say.
How do you prove you have been injured by Vaxzevria?
The Vaccine Damage Payment Scheme,which has been around since the 70s, offers people, or their families, a tax-free sum of 120,000.
Established back in 1979, the policy covers covers an array of vaccines recommended by the Government, including measles, mumps and rubella and is meant to reassure people that, in the unlikely event something goes wrong, the state will provide support.
Under current rules however,strict eligibility criteria means those affected must either have been killed or be left 60 per cent disabled due to a vaccine.
This means a person theoretically judged to be only 59 per cent disabled will not get a penny.
The extent of a person's disability is based on an assessment by a doctor and can include both physicaldisablement, such as the loss of a limb, or mentaldisablement, such as a decline cognitive function.
It also means there is no escalation of the sum received.
So, for example, someone who is completely paralysed by a vaccine would receive the same 120,000 as someone who lost a leg.
Going blind or deaf counts as being 100 per cent disabled.
Brits can only make a claim for a child once they are two years old.Adults must apply within six years of having a vaccine.
What is the three year cut-off for compensation claims?
Government officials caution it can take at least six months to process a Vaccine Damage Payment claim. Covid vaccine specific claims 'will take longer'.
Under theConsumer Protection Act 1987, Brits also have a right to sue vaccine producers if a jabdefect has caused personal injury.
Lawyers representing 51 victims and families are currently undertaking such action against AstraZeneca,arguing the vaccine was 'a defective product' that was 'not as safe as consumers generally were reasonably entitled to expect'.
The pharmaceutical titan has strongly denied these claims.
You may have had a combined vaccination against a number of the diseases listed. For example, you might have been vaccinated against DTP (diphtheria, tetanus and pertussis) or MMR (measles, mumps and rubella).
You may also be able to get a payment if you're severely disabled because either:
Source: Gov.uk
Those injured or bereaved, however only have three yearsfrom the date of their injury or death in which to bring a claim.
Last month,Sarah Moore, a partner at law firm Leigh Day, who is representing alleged victims, told MailOnline the true toll of people injured may never be uncovered.
'The criteria for what constituted VITT was really only published and made available to the clinical community from the beginning of March (2021),' she said.
'We may never know if there were other injuries that could have been related to the vaccine before March 2021.
For the claims we are bringing, those injured or bereaved have three years from the date of their injury or the death in which to bring a claim so unfortunately in many cases that cut off has now been reached.'
How many Brits have been injured by the jab?
TTS is thought to be linked to at least 81 deaths in the UK, according to figures collated by UK drug watchdog, the MHRA.
Not all are proven, however. And not every family is seeking legal action.
No figures are provided for the number of people left disabled from AstraZeneca's Covid jab.
According to figures released by NHS Business Services Authority (NHSBSA) under freedom of information laws, the payment scheme has received more than 11,000 Covid vaccine claims as of April 2.
Of these, 168 claims for state-funded financial support have now been approved.
Fewer thanfive were Pfizer and Moderna, withthe remaining claims all AstraZeneca.
The successful claims cover those affected by VITT.
Others developedGuillain-Barre syndrome, anaphylaxis or suffered other blood clots.
More than 4,800 claims have been rejected, including 324 who were unsuccessful because they failed to meet the 60 per cent threshold.
'Althoughthe claims met the criteria for causation, the independent medical assessor recommended that the vaccine has not caused severe disablement,' the NHSBSA said.
When were officials first aware of the risk?
Health officials first identified cases of VITT linked to AstraZeneca's jab in Europe as early as March 2021, just over two months after the vaccine was first deployed in the UK.
However, it wasn't until April that year that evidence became clear enough that the jab started to be restricted.
Spooked officials first restricted the jab to only people over 30. They then narrowed this to only over-40s in May 2021.
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