Category: Vaccine

New Delhi: The Telegraphs report that the maker of the AstraZeneca vaccine, which was sold in India as Covishield, has admitted to an adverse event called Thrombosis with Thrombocytopenia Syndrome or TTS in very rare cases has led to deluge of social media posts and a growing sense of paranoia among people.

TTS is a spectrum that involves blot clots along with a low platelet count in the body, which at times can cause serious injury or even death.

While there had been reported cases of deaths and serious adverse effects following the administration of the vaccine, all drug regulators and scientific bodies have categorised them as extremely rare occurrences. All of them have said there are risks, but the benefits of the vaccine, including saving lives, have outweighed the risks.

The Wire breaks down the risk v/s benefits scenario for those who took Covishield in India.

How rare is rare?

One of the keywords that was reported to have been used by AstraZeneca, in terms of adverse events occurring, was rare something that most of the commentary is now missing.

But how rare is it? By looking at the data from the UK and the European Union, the Global Advisory Committee on Vaccine Safety assessed that the risk was low. The committee consists of independent vaccine and other domain experts. It advises the World Health Organisation on vaccine safety.

[The] data from the UK suggest the risk is approximately 4 cases per million adults who receive the vaccine, while the rate is estimated to be approximately 1 per 100, 000 in the European Union (EU), it said back in 2021. It was in late 2020 and early 2021 that the Covid-19 vaccination drive picked up globally.

There are several other studies that looked into the rate of TTS caused by the AstraZeneca vaccine. One such study looked at the AstraZeneca Global Safety Database in 2022. They found the rate of this adverse event to be 7.5 per million vaccinated persons, while yet another meta-analysis, which studied two mRNA vaccines and the AstraZeneca vaccine, found the rate of severe adverse reactions with the latter as two per million vaccinated in 2020.

For how long does one run the risk of developing clots?

An Australian assessment says the serious adverse events may develop within four to 42 days of administration of the vaccine. The TTS can develop within a short stretch of duration, and not years after the vaccination. Hence any TTS event, or clotting, cant occur with Covishield/Astrazeneca vaccine unless one has taken it in the immediate past.

This time period may also stretch to 3-6 months, Jacob John, an infectious diseases expert with Christian Medical College (CMC) Vellore, told The Wire.

The vaccine cant cause an epigenetic effect. It is not something that it has altered your genes, he explained, and so cant lead to the development of clots years down the line.

Is this new information?

Another claim that is doing the rounds is that this is the first time we have come to know that TTS could take place in rare instances due to the vaccine. While it may be the first time the information has reached such a wide audience, scientific papers had spoken of the issue back in 2021.

Moreover, the company too had put in the public domain something called a package insert while rolling out the vaccine for use. That package insert, shared on the AstraZeneca website, mentions the occurrence of clotting as a rare event.

However, what did not happen was adequate publicising of this information. Neither governments around the world, including Indias, nor the company itself, made meaningful efforts to let the risks be known on a large scale. Therefore, people are now raising questions regarding the transparency of governments and vaccine companies even if such adverse events were rare.

How does the rare clotting happen?

The British Heart Foundation says the exact pathway is still being studied.

Satyajit Rath, a noted immunologist who has also been associated with Institute of Immunology in India, says it may be due to an inadvertent event. Apart from making the antibodies against the Covid-19 virus, the autoantibodies against a protein found in blood called platelet-4 also got developed in some rare cases, he explained.

This, in turn, seems to be contributing to triggering a cascade of platelet clumping, and, therefore, the clots, Rath said.

He added that why it happens in the case of some people even though rare and not in others, is yet to be understood clearly.

Heart attack because of Covid-19

There are ample studies, like this long-term research, now, on Long Covid a spectrum of diseases that many have developed even after patients have recovered from the initial infection. Heart attacks are the most common among them. The British Heart Foundation says the clots were far more common after a Covid-19 infection than after the vaccine.

This large-scale study looked into the records of 10.17million vaccinated and 10.39million unvaccinated people in the UK, Spain and Estonia. The researched concluded:

[The] COVID-19 vaccination reduced the risk of post-COVID-19 cardiac and thromboembolic outcomes. These effects were more pronounced for acute COVID-19 outcomes, consistent with known reductions in disease severity; following breakthrough [or reinfection] versus unvaccinated SARS-CoV-2 [virus causing Covid-19] infection.

Another study by a group of scientists from Oxford University published in 2021 compared the possibility of thrombocytopenia after Covid-19 infection, and after the administration of the AstraZeneca vaccine.

They concluded that there was an increased risk of thrombocytopenia (low platelet count) and venous thromboembolism (clotting in veins) in short time intervals after the administration of the first dose of the vaccine.

But they also wrote that these risks were much higher if one got the Covid-19 disease, as compared to the vaccine.

Importantly, the risks of these outcomes after vaccination were much lower than those associated with SARS-CoV-2 infection in the same population, they wrote.

Countries suspended/stopped use of AstraZeneca vaccine for young populations

More than a dozen countries, especially in Europe, suspended the use of the AstraZeneca vaccine for an interim period after reports of clotting surfaced in 2021. However, many of them resumed using it a month or so later.

The governments in the UK and Australia have maintained that younger people, especially those below 50, should not take the AstraZeneca vaccine. They recommended alternative vaccines for this age group; Australia recommended Pfizers mRNA vaccine for the younger cohort.

Should India have altered its strategy too? The answer heavily rested on the fact that the Indian government did not allow the import of Pfizer or Moderna vaccines. Therefore, it had limited the options for itself, should a change in strategy have been required.

Moreover, the Indian government had hardly initiated any study, like the other governments, to understand the adverse effects of the vaccine on the younger population after its rollout.

In order to make a good determination of Covid risk versus vaccine risk to an individual, it would be necessary to have really robust evidence for local transmission situations and clinical risk profiles, Rath said.

Even though the Astrazeneca vaccine-associated adverse effects were rare, Rath questioned whether India had collected reliable background information as the basis for any potential decision to halt vaccine use in a specific set of the population.

Lack of adverse events monitoring system in India

One of the reasons that a paranoia of sorts has taken over people after the reports of AstraZenecas admission is the lack of a proper monitoring mechanism for the side effects of Covid-19 vaccines, or Adverse Effects Following Immunisation (AEFI), in India.

Till date, there is no public platform that the Indian government has built where one can easily look into the data regarding this. As against this, many governments around the world have been transparent.

A case in point is this website of the UKs drug regulator, Medicines and Healthcare products Regulatory Agency (MHRA).

On this website one can look for the number of adverse reactions caused by each of the three available vaccines in the country two mRNA vaccines of Pfizer and Moderna, and Novovax. Not only have they put in the public domain how many adverse events occurred, they have also put a summary of how many events were reported and studied to be finally characterised as adverse events.

The USs Vaccine Adverse Events Reporting System (VAERS) gives anyone the opportunity to download data for the vaccines side effects.

The public availability of this information is one point. Another worrisome point in India, as far as Covid-19 vaccines are concerned, is how one should report if an adverse event has occurred.

The Ministry of Health and Family Welfare in India created a toll free number for this. But there were no efforts made to widely circulate that number definitely much less than the efforts taken to convince people to take vaccines.

There have been reports how registering an AEFI event caused due to Covid-19 vaccination has been an uphill task in India. On the other hand, the MHRA has an easy-to-use yellow card reporting website for this.

There have been 180 reported deaths in India following Covid-19 vaccination, but experts dont rule out some sort of an undercounting here

Our regulator really needs to learn regarding creating an efficient AEFI reporting system, CMCs John said. There have been no post-approval real-life long-term studies in India done by the government to understand how the vaccines performed.

If such a system [of monitoring] isnt created, then it is bound to hit the trust of the people in Science. Worse, should an epidemic occur again, how are people going to trust [the vaccines], John asked.

Other vaccines causing side effects

A panic has now set in among common people. They are questioning why this unsafe vaccine was rolled out in India. However, there has been no vaccine against any virus in history which was shown to have 100% safe. Rare side effects have been associated even with those jabs which have been in use for decades now.

The oral polio vaccine can, in rare instances, lead to vaccine-induced poliomyelitis disease, Rath explained. He cited another example of the BCG vaccine which, in rare instances, can cause severe inflammation and abscess formation.

It is then not entirely unsurprising and perhaps not a cause for widespread panic that the Covid-19 vaccine too can lead to rare adverse events.

Go here to read the rest:

Report on Rare Adverse Side Effects of Covishield Causes Panic. But Should It? - The Wire

A healthcare worker readies a COVID-19 vaccine for administration at a public healthcare centre in Navi Mumbai, Maharashtra.

Concerns over the Covishield vaccine's potential side effects have sparked debates once again, amidst the ongoing backdrop of the coronavirus pandemic. Let's delve into the intricacies of this controversy and decipher whether there's genuine cause for alarm.

Following his vaccination with the AstraZeneca COVID-19 vaccine, Jamie Scott's life took a tumultuous turn. He grappled with a brain clot and severe bleeding, leaving him with permanent brain damage. This rare condition, labelled Thrombosis with Thrombocytopenia Syndrome (TTS), poses a significant threat due to its potential to cause dangerously low blood clot and platelet levels. Jamie's plight, accompanied by memory loss, impaired vision, and cognitive decline, prompted him to seek legal recourse against the pharmaceutical giant in 2023.

Jamie's legal team contends that AstraZeneca downplayed the potential risks associated with their vaccines. Disturbingly, reports suggest that over 50 vaccinated individuals suffered similar adverse effects, some tragically resulting in fatalities or severe injuries. Despite vehement denials from the pharmaceutical company, subsequent legal proceedings unveiled a startling admission: AstraZeneca acknowledged the vaccine's rare propensity to cause TTS, although the exact mechanism remains elusive.

In essence, not quite. While scientific links between the AstraZeneca vaccine and vaccine-induced immune TTS have been established, such occurrences are exceedingly rare merely a handful of reported cases amidst millions of administered doses. The World Health Organization has, in fact, reaffirmed the vaccine's safety and efficacy for individuals aged 18 and above. Moreover, it's essential to recognise that contracting COVID-19 itself elevates the risk of blood clots and other complications, whereas vaccination offers protection.

Furthermore, the telltale signs of TTS ranging from headaches to leg swelling typically manifest within 1-6 weeks post-vaccination. Considering that most individuals received their Covishield jabs a couple of years ago, there's little reason for immediate panic.

While there's no definitive evidence favouring one vaccine over another, each comes with its own set of potential side effects. Covaxin, for instance, boasts higher efficacy rates and robust research data among Indian subjects. Nevertheless, it's noteworthy that several countries have suspended the AstraZeneca vaccine's administration due to clotting concerns in specific age groups.

Ultimately, these vaccines have been instrumental in saving countless lives, underscoring the importance of continued vaccination efforts. As we navigate through these uncertain times, it's crucial to heed the guidance of health authorities and make informed decisions for the collective well-being.

**

For weather, science, space, and COVID-19 updates on the go, download The Weather Channel App (on Android and iOS store). It's free!

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As AstraZeneca Admits to New Side Effects, Should People With Covishield Vaccines Worry? - The Weather Channel

Urinary tract infections are among the most common bacterial infections. They can be painful, require antibiotic treatments, and recur in 20%-30% of cases. With the risk for the emergence or increase of resistance to antibiotics, it is important to search for potential therapeutic alternatives to treat or prevent urinary tract infections.

The MV140 vaccine is produced by the Spanish pharmaceutical company Immunotek. MV140, known as Uromune, consists of a suspension of whole heat-inactivated bacteria in glycerol, sodium chloride, an artificial pineapple flavor, and water. It includes equal percentages of strains from four bacterial species (V121 Escherichia coli, V113 Klebsiella pneumoniae, V125 Enterococcus faecalis, and V127 Proteus vulgaris). MV140 is administered sublingually by spraying two 100-L doses daily for 3 months.

The vaccine is in phase 2-3 of development. It is available under special access programs outside of marketing authorization in 26 countries, including Spain, Portugal, the United Kingdom, Lithuania, the Netherlands, Sweden, Norway, Australia, New Zealand, and Chile. Recently, MV140 was approved in Mexico and the Dominican Republic and submitted to Health Canada for registration.

A randomized study published in 2022 showed the vaccine's efficacy in preventing urinary tract infections over 9 months. In total, 240 women with a urinary tract infection received MV140 for either 3 or 6 months or a placebo for 6 months. The primary outcome was the number of urinary tract infection episodes during the 9-month study period after vaccination.

In this pivotal study, MV140 administration for 3 and 6 months was associated with a significant reduction in the median number of urinary tract infection episodes, from 3.0 to 0.0 compared with the placebo during the 9-month efficacy period. The median time to the first urinary tract infection after 3 months of treatment was 275.0 days in the MV140 groups compared with 48.0 days in the placebo group.

On April 6 at the 2024 congress of The European Association of Urology, urologists from the Royal Berkshire NHS Foundation Trust presented the results of a study evaluating the MV140 vaccine spray for long-term prevention of bacterial urinary tract infections.

This was a prospective cohort study involving 89 participants (72 women and 17 men) older than 18 years with recurrent urinary tract infections who received a course of MV140 for 3 months. Participants had no urinary tract infection when offered the vaccine and had no other urinary abnormalities (such as tumors, stones, or kidney infections).

Postvaccination follow-up was conducted over a 9-year period, during which researchers analyzed the data from the electronic health records of their initial cohort. They queried participants about the occurrence of urinary tract infections since receiving the vaccine and about potential related side effects. Thus, the results were self-reported.

In this cohort, 48 participants (59%) reported having no infections during the 9-year follow-up. In the cohort of 89 participants, the average period without infection was 54.7 months (4.5 years; 56.7 months for women and 44.3 months for men). No vaccine-related side effects were observed.

The study's limitations included the small number of participants and the collection of self-reported data. Furthermore, all cases were simple urinary tract infections without complications.

The authors concluded that "9 years after first receiving the sublingual spray MV140 vaccine, 54% of participants remained free from urinary tract infection." For them, "this vaccine is safe in the long-term, and our participants reported fewer urinary tract infections and, if any, they were less severe."

Vaccination could thus be an alternative to antibiotic treatments and could help combat the emergence of antibiotic resistance. The full study results should be published by the end of 2024.

Other studies are planned to evaluate the efficacy and safety of the MV140 vaccine in older patients residing in long-term care homes, in children suffering from acute urinary tract infections, and in adults suffering from complicated acute urinary tract infections (for example, patients with a catheter or with a neurogenic bladder).

This story was translated fromJIM, which is part of the Medscape Professional Network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

Read more:

Vaccine Against Urinary Tract Infections in Development - Medscape

Gareth Eve needed no reminder that his wife had died too young, but the process of clearing her wardrobe provided one anyway.

'It was all wrong,' he says. 'I remembered my dad doing it when my grandad died, but then they were sorting out an old man's suits and cardigans and walking sticks the sort of things you should be dealing with in this situation.

'You aren't supposed to be faced with bright bikinis, yellow high heels, dresses that still have the labels on them and Kylie Minogue T-shirts.'

Lisa Shaw, an award-winning radio presenter on Radio Newcastle, was just 44 when she died in May 2021. Until she was admitted to hospital she had been fit, healthy and fizzing with the sort of energy her job on the morning show required.

Her devastated colleagues had to announce her death on air, but it was down to Gareth, now 43, to tell their six-year-old son Zach that his 'mam' wasn't coming home. 'I told him the morning after Lisa died. It was the hardest thing I've ever had to do.

Lisa Shaw, an award-winning radio presenter, died aged 44 in May 2021 after having the jab

Lisa pictured with her husband Gareth Eve and their son Zach

'He climbed into our bed for a cuddle and I said the doctors had tried everything they could but they couldn't make her better again. He cried, but you don't know how much kids understand.

'I'm not religious, but I told him Lisa was in Heaven, which was a perfect place where she'd see Grandad again, and Sally my dad's dog.'

Zach is now eight, still too young to have the full facts of his mother's death explained to him, but there is no question what killed her. In August 2021, Newcastle Coroner Karen Dilks recorded that Lisa had died 'due to complications of an AstraZeneca Covid vaccination'.

'That word AstraZeneca is on her death certificate,' points out Gareth.

Lisa had been vaccinated on April 29, but started developing headaches a week later. On May 13, she was admitted to hospital where Gareth, reeling, was handed a print-out explaining what 'vaccine-induced thrombotic thrombocytopenia' was.

It's a rare condition ('but not rare enough that they didn't have a print-out,' he says) leading to clots on the brain.

At first doctors were confident they could treat it, but on May 16,

Lisa started to have speech problems. 'We were having a conversation about Zach's swimming lessons and she couldn't get out the word "goggles".'

It was discovered she had suffered a bleed on the brain, and was rushed to surgery where part of her skull was removed to ease the pressure. She never recovered and spent the last five days of her life on a ventilator, as her family gathered in shock.

'I held her hand. It was all just a haze. Apart from the bandages, you wouldn't have been able to tell there was anything wrong.

'She looked as if she was sleeping. She looked as she always looked perfect.'

A devastating tragedy for one family, of course. But the questions raised by Lisa's death have much wider implications.

And so, Gareth took a step which is the equivalent of lobbing a hand grenade into the vaccine debate. He launched legal action against pharmaceutical giant AstraZeneca, joining forces with another 75 families who have also lost loved-ones, or seen them severely disabled after having the vaccine.

Lawyers say the payouts, should the action be successful, could reach seven-figure sums.

Who will foot the bill? Not Astra- Zeneca. Under a legal indemnity that the Government gave the company early in the pandemic (because of the need to roll out the vaccine fast), the UK taxpayer will have to pay any compensation awarded. Gareth finds this astonishing. 'The idea that a drug company can be immune from any legal responsibility is staggering, but even if they are, what about moral responsibility?'

Her death certificate says she 'died due to complications of an AstraZeneca Covid vaccination'

At his home in County Durham, Gareth insists this action is not about money ('because no amount will ever bring Lisa back') but about truth and justice.

'I have been trying to get answers from AstraZeneca, and from the Government, since Lisa died. I have contacted my MP who didn't really want to know.

'I have asked questions of three prime ministers now, including Boris Johnson who was in charge at the time, and I've been ignored, brushed off.

'I think I'm an embarrassment to the authorities because Lisa's death was inconvenient for them. It challenges their narrative that the vaccine was safe, and that any risk was so rare we shouldn't even talk about it.'

Today, he is at pains to point out that he is absolutely not an antivaxxer. He went on to have two more doses even after his wife died (although he had the less-contentious Pfizer jab for them, and has long advocated people being able to have an informed choice).

'I'm not anti-vaccine. I'm anti bulls***,' he says. 'I just want answers. After Lisa died, I was contacted by a woman whose husband died from exactly the same thing.

'He was treated in the same hospital, by the same doctors, and ended up in the same high-dependency unit. What are the chances of that, with a condition that is supposed to be this rare?'

The Oxford-AstraZeneca vaccine was, of course, the first Covid jab approved for use in the UK in December 2020, with the Government ordering 100 million doses for its vaccination programme.

A study by the University of Oxford, published in August 2021, estimated that for every ten million people vaccinated with Astra- Zeneca, there were 66 extra cases of blood clots in the veins and seven extra cases of a rare type of blood clot in the brain.

The authorities continue to stress its effectiveness, although it is worth noting that the vaccine is no longer used in the UK. In August 2022, it was announced there were no plans to order further Astra- Zeneca vaccines for the UK.

At the time, the Department of Health and Social Care (DHSC) said the decision was down to a recommendation by the Joint Committee on Vaccination and Immunisation (JCVI), that mRNA vaccines such as the Pfizer or Moderna jabs should primarily be used for boosters rather than viral vector vaccines such as AstraZeneca.

A JCVI spokesman said: 'The results of the Cov-Boost trial conducted during the summer of 2021 provided good evidence that mRNA vaccines are the most effective option for the UK's booster programme.'

This week, a spokesman for the DHSC said: 'More than 144 million Covid vaccines have been given in England, which has helped the country to live with Covid and saved thousands of lives.

'All vaccines being used in the UK have undergone robust clinical trials and have met the Medicines and Healthcare products Regulatory Agency's (MHRA)

strict standards of safety, effectiveness and quality.'

At the time of the vaccine rollout, Lisa was thrilled to get the call for her jab.

'She wanted to hug her mum again,' Gareth recalls. 'But she also thought it was the right thing to do, the responsible thing. She'd seen some friends and one of them had decided not to have the vaccine, which she couldn't believe.'

Lisa was an intelligent and informed woman she had studied journalism at university but only after she died did Gareth start questioning some of the conversations they had had about the vaccine.

Lisa had been vaccinated on April 29 but started developing headaches a week later. On May 13, she was admitted to hospital

Something that torments him today is that, in March 2021 just weeks before they were called for their vaccines the AstraZeneca vaccine was mired in controversy. Other European countries, including France and Germany, had stopped using it over concerns about blood clots. No alarm bells rang. There was no sense of hesitation in their home.

'We watched it on the news and I remember having a conversation with Lisa about it, and us concluding that it was all about Brexit the Germans were annoyed with Britain for leaving the EU, so they weren't going to have a Britishmade vaccine.

'But now, I want to know what those countries saw in the reports that made them pull back on AstraZeneca.

'Did Boris see those reports too and know that people were going to die? Was my wife collateral damage?'

These are difficult questions but legitimate ones for any grieving widower to ask. Gareth's frustrations are that, in asking them, he has been made to feel as if he has stepped out of line.

At the peak of the pandemic, you could argue that it was in the public interest not to fuel fears about vaccines. Now? Gareth says the pendulum has swung too far in that direction.

'I went on TV shortly after Lisa died, but I'd love the opportunity to speak to the likes of Lorraine Kelly or Holly Willoughby without them rushing to point out the "alternative view... the safe and effective stats". There is no debate about this. My wife died!

'But people like me have been made to feel that we are crackpots or conspiracy theorists. It's a dirty secret. If you question it, you are accused of being an anti-vaxxer, or almost of being unpatriotic in some way.

'But we aren't crackpots. We are husbands and wives and families who just want answers. Taking legal action now seems to be the only way of getting them.'

He argues that the lack of public discourse 'actually fuels the crackpots, because if you have a void there, then it will be filled with nonsense'. He has no patience, either, for the argument that in unprecedented times, difficult decisions were and are necessary for the greater public good.

'How dare they tell me that,' he says. 'Because the decision I had to make was whether to let my six-year-old son come to his mother's funeral.'

His grief is still raw. He tells me that he still sleeps with Lisa's T-shirt under the pillow, still wishes it was him who had died after having the vaccine, rather than Lisa.

'Zach would have been better having his mam,' he says. 'At that age, children need their mums more than their dads. There is nothing that can take the place of a mammy hug.'

He and Lisa got together in 2011, while both were working for the same radio station. She was one of the star presenters; he worked upstairs, on the advertising side. He admired her from afar, then one day sneaked down 'and said the printer on our floor was broken, which was a lie'.

He could not believe that someone like Lisa 'so bubbly, positive, vibrant' would be interested in him, but she was.

Gareth pictured at his home in Newcastle

Zach arrived in 2015; in 2018 they got married. 'Life was perfect. She was perfect. She turned my life around,' he says. 'I suffer from anxiety, and just having Lisa there made everything better.

'I always say that she knew me better than I knew myself. She gave me the instruction manual for life. My problem is that she took it with her.'

The realisation that Lisa was seriously ill did not happen until quite late. She tried 'all the usual things' when she started to develop headaches a week after her vaccine. When over-the-counter medicines didn't work, she consulted her GP, and ended up having blood tests which flagged a serious issue.

'It was about her platelets being low. They sent an ambulance in the middle of the night, but even then there was no panic about it. She was up and dressed. She walked to the ambulance. Her sister had come to look after Zach and she didn't even hug her. It didn't occur to any of us that she wouldn't come home again.'

Even as things became desperate, he was perhaps in denial.

'It just didn't seem possible. I remember after she had the surgery, they were saying that if she did pull through, she might not be the same. There could be brain damage. I said, "We will deal with it, whatever".'

The whole country was in shock at Lisa's death, and the reasons for it which were widely reported.

Memories are muddy now though, and Gareth says he constantly feels the need to 'prove' in some way that she died from the vaccine. 'I feel I have to whip out the death certificate or quote the coroner.'

He contemplated suicide the Christmas after Lisa died. What stopped him? Zach, of course.

'I saw a therapist who said she had treated children who had lost a parent, and they had gone on to have happy lives, but she'd also treated children who had lost a parent, then a second one to suicide. They never recovered.'

He is hard on himself, and it cannot be easy coping with single parenthood amid such grief, but Zach seems to be thriving. There is a close-knit wider family, including Lisa's three sisters, two of whom live close by.

How, as a society, should we support families like this, who have found themselves in a dreadful predicament through no fault of their own? There is official recognition for families who have been affected by the vaccine.

Those who have suffered ill health are entitled to financial support under the Government-run Vaccine Damage Payment Scheme. But this was not designed for Covid-related situations (it was launched in 1979) and payments are limitedow req to 120,000 per claim and applications must prove severe disablement.

Gareth told his son that Lisa was in heaven 'which was a perfect place where she'd see Grandad again, and Sally - my dad's dog'

Gareth was incredulous when he got the application forms. 'There was no option to say your lovedone had died. It was all about proving they were disabled.

'I had to amend my form. Even then it took over a year for them to pay out.'

The sense of injustice among all the families in this class action is strong. Some talk of feeling like war veterans who were sent to the front line, did what was required of them by their country, and have now been abandoned.

Last week, the British Medical Journal reported that, in response to a Freedom of Information request, NHS Business Services (which operates the Vaccine Damage Payment Scheme) revealed that it had received 4,017 claims relating to Covid vaccines. Of those, 334 were for a death.

Gareth's solicitor, Sarah Moore, a partner in the Hausfeld law firm, one of two bringing this action, stresses that a legal action was a last resort. 'The Vaccine Damage Payment Scheme is not working. It fails to provide those who have been bereaved or seriously injured by vaccination with adequate financial support, and of course it only pays out where 60 per cent disablement can be proven.'

An AstraZeneca spokesman said the company could not comment about ongoing legal matters, but stressed that 'patient safety is our highest priority and regulatory authorities have clear and stringent standards to ensure the safe use of all medicines, including vaccines.'

They added: 'Regulators around the world state that the benefits of vaccination outweigh the risks of extremely rare potential side-effects.'

Whatever the outcome, this will be a difficult one to explain to a little boy who has lost his mum.

Rare complication? 'It wasn't rare in our house, was it?' says Gareth.

Original post:

Gareth's wife died from the AstraZeneca vaccine. This is her story - Daily Mail

The chief scientist of China's COVID vaccine project was kicked from the National People's Congress.

Yang Xiaoming, 62, is accused of"serious discipline and law violations," a phrase alluding to corruption.

Yang led the team that developed the Sinopharm vaccine, and was China's top researcher in its vaccine project.

The chief researcher of China's first general-use COVID vaccine was ousted last week from the country's highest organ of power.

Yang Xiaoming, 62, was booted on April 23 from the National People's Congress "due to serious discipline and law violations," state media reported this weekend.

The phrase typically means a person is under investigation for corruption in China.

That means Yang, the chairman of Sinopharm's vaccine subsidiary China National Biotec Group, is no longer one of the nearly 3,000 congressional deputies who make decisions on major national issues.

A congressional report on his dismissal said he served on the Ethnic Affairs Committee.

Yang is a medical researcher who led the Sinopharm team that developed the BBIBP-CorV vaccine, a COVID-19 shot that was the nation's first approved for general use.

Known colloquially as the Sinopharm vaccine, the shot was one of the most widely administered COVID-19 shots in China, with an efficacy of 79% against hospitalization.

Apart from developing the Sinopharm shot, Yang was also the head of China's vaccine project under the 863 program, or Beijing's push to make the country more independent by developing homegrown advanced technologies.

Yang's dismissal has gone viral on Weibo, China's version of X, with thousands of posts questioning the circumstances behind his removal from deputy status. It received around 180 million views and, for several hours, was the platform's hottest topic on Sunday.

The discussion soon morphed into wild speculation that the reason behind his dismissal may have been related to the Sinopharm vaccine, though there has been no evidence to indicate as such.

"The father of the Sinopharm vaccine violated regulations and laws, but it doesn't mean there are problems with the vaccines he developed and produced," wrote "Dr Chen," a popular medical blogger. "Let's wait before panicking."

The announcement about Yang comes amid China's sweeping crackdown on corruption in its healthcare sector, with investigations launched against hundreds of hospital deans and secretaries.

It's been the heaviest disciplinary campaign ever enforced on China's healthcare industry, plagued for years by thousands of commercial bribery cases between pharmaceutical suppliers and healthcare providers.

In August, the anti-corruption campaign caused pharmaceutical A-share stocks in China to fall so sharply that it wiped out an estimated $27 billion market value within one day.

Read the original article on Business Insider

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China is gunning for the chief scientist of its COVID vaccine project, accusing him of 'serious discipline and law violations' - Yahoo! Voices

A lump in your throat, along with ear pain or a change in voice, could mean the unthinkable: cancer. Dr. Seerat Poonia, a head and neck surgeon at Swedish, is learning that throat cancers linked to human papillomavirus, or HPV, are preventable.

"HPV-related throat cancer is one of the fastest growing cancers that we see, [increasing] about four to five-fold in the last 10 years."

Poonia is used to hearing about HPV related to cervical cancer, "We've found that the same strains that cause cervical cancer, are the same ones that cause HPV-related throat cancer."

Poonia treats anything from skin cancer to cancers of the mouth caused by smoking. Around 46 million Americans use tobacco products and about 62% of U.S. adults drink alcohol.

Poonia says that to avoid head and neck cancers that come about from tobacco or alcohol, she tells patients to abstain from that. With HPV-related throat cancer, "we have a prevention tool. We have a vaccine, which is essentially, cancer prevention."

More and more Poonia sees HPV-related throat cancer in men more than women, although she sees it in a wide range of people.

The vaccine is available for everyone, "Anyone from the age of nine to 45 should be considering the vaccine."

There is good news, "Cancer in the throat can be very easily treated. Ninety-five percent of patients who have cancer of any stage will survive."

Jaimie Dodge produces original content for CBS News Colorado's 24-hour streaming channel and writes about health, politics and crime in Colorado.

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HPV-linked throat cancers may have vaccine prevention, Colorado doctors learn more about head and neck cancers - CBS Colardo

Global pharmaceutical giant AstraZeneca has said that its AZD1222 vaccine against Covid-19, which was made under licence in India as Covishield, could cause low platelet counts and formation of blood clots in very rare cases.

AstraZeneca has accepted a link between the vaccine and Thrombosis with Thrombocytopenia Syndrome (TTS), a medical condition characterised by abnormally low levels of platelets and the formation of blood clots.

AstraZenecas vaccine formula was licensed to Pune-based vaccine maker Serum Institute of India (SII) during the coronavirus pandemic for the manufacture of Covishield. More than 175 crore doses of Covishield have been administered in India.

What has led AstraZeneca to make this submission? What is known about the vaccines and TTS? And should Indians who received Covishield shots be worried?

What exactly has AstraZeneca said?

AstraZeneca spoke about TTS in court documents following a suit brought against the company in the United Kingdom. The pharmaceutical giant is being sued over health claims related to the vaccine that it developed in collaboration with the University of Oxford amid the Covid-19 pandemic in 2020.

The UK-based media organisation The Telegraph reported recently that a case was lodged last year by Jamie Scott, a father of two, who was left with a permanent brain injury after developing a blood clot and a bleed on the brain that has prevented him from working after he received the vaccine in April 2021.

The report said that in all, fifty-one cases have been lodged in the High Court (in the UK), with victims and grieving relatives seeking damages estimated to be worth up to 100 million.

In court documents from February, AstraZeneca denied that TTS is caused by the vaccine at a generic level. However, it admitted to the possibility of TTS as a result of its vaccination in very rare cases.

A range of symptoms are associated with TTS, including breathlessness, pain in the chest or limbs, pinhead-size red spots or bruising of the skin in an area beyond the injection site, headaches, numbness in body parts, etc. TTS could mean a restriction in the flow of blood due to clotting.

The website of Johns Hopkins Medicine says, Thrombosis can block the blood flow in both veins and arteries. Complications depend on where the thrombosis is located. The most serious problems include stroke, heart attack, and serious breathing problems.

Why have these concerns surfaced now, four years after the outbreak?

These concerns have in fact, been reported earlier. But this is the first time that AstraZeneca has confirmed the link between TTS and its vaccines.

Before the Covid-19 vaccines were rolled out in India, the Indian government had issued a fact sheet in January 2021, in which it specifically said that Covishield (the Indian variant of AstraZenecas vaccine) should be given with caution to individuals with thrombocytopenia, that is, a condition of low platelet counts. Covishield and Covaxin were the two Covid vaccines given to Indians.

Then, in March 2021, the European countries France, Germany, Italy, Netherlands, Denmark, Norway, Iceland, Austria, Estonia, Bulgaria, Romania, Estonia, Lithuania, Luxembourg, and Latvia temporarily paused the use of the AstraZeneca vaccine after a few cases of blood clotting were reported.

The following month, the World Health Organisation (WHO) said TTS was being reported in some cases after vaccinations with Covishield and Vaxzevria (which was the other trade name for AstraZenecas vaccine).

However, the WHO had added, Based on latest available data, the risk of TTS with Vaxzevria and Covishield vaccines appears to be very low. Data from the UK suggest the risk is approximately four cases per million adults (1 case per 250,000) who receive the vaccine, while the rate is estimated to be approximately 1 per 100,000 in the European Union (EU).

The Indian government said in May 2021 that 26 potential thromboembolic events, or formation of clots in blood vessels, had been reported since Covishield began to be administered.

India started administering the vaccines on January 16, 2021, and considering the total number of doses that had been administered until then, the number of potential thromboembolic events worked out to 0.61 cases per million doses, or a percentage of 0.000061.

According to more recent data, the governments committee on Adverse Events Following Immunization (AEFI) said at least 36 cases of TTS have been vetted and confirmed to have been caused due to Covishield. The committees last report, which was made public in June last year, showed that of these cases 18 deaths were reported. Almost all of these TTS cases pertain to 2021 ,which was the first year of Covid-19 vaccination in the country.

The Union Health Ministry had termed this possibility as minuscule, and said that Covishield continues to have a definite positive benefit-risk profile with tremendous potential to prevent infections and reduce deaths due to Covid-19.

In the case of Covaxin, which was Indias indigenous vaccine manufactured by Bharat Biotech, it said no potential thromboembolic events had been reported.

The Ministry had added that scientific literature suggests this risk (of blood clotting) is almost 70% less in persons of South and Southeast Asian descent in comparison to those from European descent.

In 2023, the WHO incorporated vaccine-induced immune thrombotic thrombocytopenia (VITT) into its classification of TTS.

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Covishield could cause blood clots in very rare cases, manufacturer AstraZeneca has said. What does this mean? - The Indian Express

TTS is classified into 2 tiers by theCDC.

AstraZeneca, a British pharmaceutical giant, has admitted that its Covid-19 vaccine can result ina rare side effectknown as Thrombosis with Thrombocytopenia Syndrome (TTS).This acknowledgement follows a lawsuit filed against the company, alleging serious harm and deaths linked to the vaccine.

According to court documents, Covishield, a vaccine developed by AstraZeneca and Oxford University and manufactured by the Serum Institute of India, can, in rare instances, lead to this condition. This vaccine was extensively administered throughout India during the Covid-19 pandemic.

Thrombosis with Thrombocytopenia Syndrome (TTS) is a rare condition in which blood clots form in unusual places in the body, and the number of platelets in the blood drops. Platelets are small cells that help blood to clot, so having too few of them can be dangerous.

The condition was observed in people who received adenoviral vector COVID-19 vaccines, such as Vaxzevria, Covishield (AstraZeneca) and the Johnson & Johnson/Janssen COVID-19 vaccine. TTS seems to occur because the body's immune system reacts to the vaccine by making antibodies that attack a protein involved in blood clotting.

TTS is classified into 2 tiers by theCDC.

Symptoms of TTS can include severe headaches, stomach pain, swelling in the legs, trouble breathing, and problems with thinking or seizures. If someone shows these signs after getting a vaccine, they should see a doctor right away.

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What Is TTS, A Rare Condition Caused By AstraZeneca's Covishield Vaccine - NDTV

AstraZeneca (AZ), UK's pharmaceutical giant, has admitted its Covid vaccine, sold under the brand name of Covishield in India, in 'very rare cases' can cause a blood clot-related side effect, according to court papers being quoted in the UK media. According to media reports, the admission was made in a legal document submitted to the High Court in London in February for a group action being brought by 51 claimants. (Also read: AstraZeneca admits in court that its Covid vaccine can cause rare side-effect TTS, what is it?)

The pharmaceutical company has admitted that the vaccine developed with the University of Oxford to protect against Covid-19 may cause Thrombosis with Thrombocytopenia Syndrome (TTS).

It is admitted that the AZ vaccine can, in very rare cases, cause TTS. The causal mechanism is not known. Further, TTS can also occur in the absence of the AZ vaccine (or any vaccine). Causation in any individual case will be a matter for expert evidence, The Daily Telegraph quoted the legal document as stating.

"Vaccine induced thrombosis with thrombocytopenia syndrome (TTS) is an extreme immunological reaction that occurs after Covid-19 immunization. Initially thought to be associated with viral-vector-based vaccines like Johnson & Johnson/Janssen and AstraZeneca-Oxford, it was found that the side effect may also be seen with covishield vaccine. The immunological reaction leads to the activation of platelets and the coagulation system and can cause venous or arterial thrombosis and in certain circumstances can lead to secondary haemorrhage," says Dr Viswesvaran B, Consultant Interventional Pulmonology and Sleep Medicine, Yashoda Hospitals Hyderabad.

"The finding of Thrombosis with Thrombocytopenia Syndrome (TTS), an unusual but notable adverse event that may be linked to the Covishield vaccine, has opened a new chapter about Covid-19 vaccination. As a cardiologist today, I try to understand the intricacies of cardiovascular health, which necessitates accurate and thorough investigation of this issue. My objective is to clarify the foundations of TTS, its clinical implications, and the vital role that vigilant monitoring plays in the vaccination landscape," says Dr Vanita Arora, Senior Consultant Cardiac Electrophysiologist & Interventional Cardiologist at Apollo Hospital, Delhi.

Dr. Viswesvaran says incidence of TTS among vaccine recipients appears to be higher even amongst younger individuals and recipients of a first dose and can manifest as clotting at unusual sites and sometimes with haemorrhage. "Persistent and progressively worsening headache in addition to focal neurological symptoms like visual disturbances are described as early red flags for suspecting VITT in patients," adds the expert.

Elaborating on the symptoms Dr Vishwesvaran says, "majority of these patients develop thrombosis in the lower extremities and lungs but can also develop clots at unusual sites including blood vessels supplying gut like splenic, portal or mesenteric, adrenal, cerebral, and even ophthalmic veins."

"We have been noticing that a lot of people are coming with complications of covid per se and also complications of vaccination also particularly covishield. Numerous case reports and also cases we have seen in our institute, that a lot of patients developed strokes and cardiac complications like arrhythmias and cardiac arrest and failures and also diabetes. One of these complications is thrombosis with thrombocytopenia syndrome which states that people develop blood clots in blood vessels of vital organs which is also associated with low platelet counts. Symptoms are like severe headache, stroke, abdominal pain, swelling of legs and severe breathlessness," says Dr Gopi Krishna Yedlapati, Sr. Consultant Interventional Pulmonologist & Clinical Director, Yashoda Hospitals Hyderabad.

Dr Vanita Arora says from a clinical standpoint, it is very challenging to diagnose TTS and necessitates a high level of suspicion and acute clinical judgement, particularly in those who have received the Covishield vaccine.

"Patients may experience a broad spectrum of symptoms, ranging from severe headaches and particular neurological deficits to more subtle indications of thrombotic episodes. The co-occurrence of thrombosis and thrombocytopenia, however, is what sets TTS apart and emphasises the diagnostic conundrum that medical practitioners face. Differential diagnosis must account for a wide range of thrombotic and thrombocytopenic disorders. This necessitates a comprehensive evaluation and careful application of diagnostic modalities, including imaging tests, laboratory analyses, and haematological assessments," she says.

"When treating patients with TTS, cardiologists need to carefully consider the dangers of thrombosis and bleeding issues. In order to lessen the burden of thrombosis, anticoagulation is still necessary, but only after a thorough assessment of each patient's particular risk profile and supporting documentation. To learn more about the effects of adjuvant drugs including intravenous immunoglobulins, platelet transfusion, and corticosteroids on the immune response connected to the pathophysiology of TTS, more research is required. The development of a cohesive treatment plan tailored to the requirements and clinical trajectory of TTS patients requires interdisciplinary collaboration between cardiologists, haematologists, neurologists, and other allied health specialists," says Dr Arora.

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Understanding Covishield's rare side effect: What is Thrombosis with Thrombocytopenia Syndrome? Know symptoms, treatment - Hindustan Times

According to a report by The Telegraph, AstraZeneca, the company behind the Covishield vaccine, has acknowledged in court documents for the first time that the vaccine may lead to a rare side effect. It said, It is admitted that the AZ vaccine can, in very rare cases, cause TTS. The causal mechanism is not known. This marks a notable reversal that could lead to a multi-million pound legal payout.

According to the report, the company is being sued in a class action over claims that its vaccine can cause a health issue called Thrombosis with Thrombocytopenia Syndrome (TTS). This condition leads to blood clots forming in the body and a decrease in the number of platelets in the blood. Covishield, developed by AstraZeneca and Oxford University, was widely used during the COVID-19 pandemic, including in India where it was produced by the Serum Institute.

Dr Jagadish J Hiremath, a public health intellectual, elaborates, Thrombosis with Thrombocytopenia Syndrome (TTS) is a rare condition characterised by the formation of blood clots (thrombosis) in blood vessels and a low number of blood platelets (thrombocytopenia). It has been observed as an extremely rare adverse effect associated with certain COVID-19 vaccines, notably those that use adenovirus vectors, like the AstraZeneca vaccine (Covishield).

The exact mechanism by which TTS occurs following vaccination with Covishield isnt fully understood. However, he adds, it is hypothesised that the vaccine may trigger an immune response that leads to platelet activation and the formation of blood clots, which is similar to autoimmune heparin-induced thrombocytopenia.

This differs from non-vaccine related thrombosis where factors such as surgery, smoking, or obesity might trigger thrombosis without the immune-mediated platelet activation seen in TTS, he says.

While TTS is exceedingly rare, according to Dr Hiremath, certain factors might predispose individuals to this condition, such as age, gender (more common in younger women), and possibly genetic factors.

Health providers are encouraged to monitor for symptoms of TTS, especially in individuals more at risk, to manage and treat the condition promptly.

He informs, TTS typically presents symptoms like severe headache, blurred vision, chest pain, leg swelling, persistent abdominal pain, and shortness of breath appearing within a few weeks after vaccination.

Early detection and treatment are crucial for recovery, thus both healthcare providers and patients are advised to be vigilant for these symptoms.

AstraZenecas acknowledgment of the link between Covishield and TTS may prompt enhanced safety monitoring and regulatory oversight for vaccines, Dr Hiremath believes.

This development, he says, might affect public trust in vaccines, emphasising the need for transparent communication and robust vaccine surveillance systems to maintain public confidence in vaccination programs worldwide.

Indians need to be aware but not necessarily alarmed about this report, he assures.

Given the rarity of TTS, the benefits of the Covishield vaccine in preventing COVID-19, with its potentially severe outcomes, generally outweigh the risks of this rare side effect, he explains.

Continuous monitoring and prompt medical attention for symptoms are recommended strategies for managing the risk.

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First uploaded on: 30-04-2024 at 12:31 IST

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AstraZeneca admits its Covishield vaccine can cause a rare side effect: Learn more about this condition - The Indian Express