With every national scandal you can trace the people who stood up first and said 'this is wrong'. Gareth Eve was one. When he lost his wife Lisa, who died due to complications from the AstraZeneca vaccine, he put himself in the firing line to tell her story.
He knew he had more chance than most of being listened to. Lisa Shaw, who was just 44, was a BBC journalist, a high profile and popular broadcaster on Radio Newcastle who was happy to receive the vaccine because, as Gareth puts it, 'it was the right and responsible thing to do'.
She paid with her life, and the minute a coroner recorded that the cause of her death was the vaccine, he knew he had to go public. Gareth, 44, spoke to this paper a year ago, movingly and eloquently explaining why families like his felt abandoned by the Government and treated as 'collateral damage'.
Then, he was explaining why he and other bereaved families had joined forces in a potentially ground-breaking legal class action against the pharmaceutical giant AstraZeneca.
It was a reluctant sort of legal action because at the start of the pandemic the Government desperate to roll out the Covid vaccine without delay had agreed an indemnity clause.
The exact details are not public, but it effectively meant that in the event of successful legal action against AstraZeneca over vaccine failings, the Government ('or more accurately, the taxpayer', says Gareth) would foot the bill.
'No one wanted to go to court,' he repeats today. 'But what option did we have? The Government has refused to help, or even acknowledge their role in our loved ones' deaths. We were on our own.'
Earlier this week came news of a significant victory for those families whose loved ones either died or suffered lasting health issues after having the vaccine.
It emerged that in court documents to the High Court, AstraZeneca admitted for the first time that 'in very rare cases' the vaccine can cause a type of blood clotting called TTS (thrombotic thrombocytopenia) the very condition that had killed Lisa.
Lisa Shaw with son Zach, who was just six when his mother died from blood clotting
Gareth Eve put himself in the firing line to tell Lisa's shocking story
Gareth Eve and BBC presenter Lisa on their wedding day
AstraZeneca, which is contesting the claims, also stated: '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 admission could open the door to multi-million-pound payouts for the families involved, many of whom have spent years being dismissed as anti-vaxxers, pilloried on social media for demanding answers and adequate compensation.
So is Gareth celebrating? Yes, but only 'for the others', he says not himself or his son Zach, who was just six when Lisa died.
The reason? Around six weeks ago, Gareth was told that he and 11 other families were being removed from the class action.
While others including one man who died on the same hospital ward as Lisa, in the same week, from exactly the same reaction to the vaccine could be in line for compensation payments if they win in court, he will not.
'It's because of a technicality, a loophole,' he says. 'I am devastated. I feel completely abandoned all over again. It actually takes me back to just after Lisa died when I was in that state of feeling utterly alone, thinking 'well, what now?'.' The background is complicated but, as it was explained to him, lawyers acting for the families were concerned when, in the course of legal proceedings, it emerged that after April 7, 2021, with the approval of the UK regulator, a warning about the risk of thrombotic complications was added by AstraZeneca and sent to healthcare professionals.
AstraZeneca say the benefits of vaccination outweigh the risks of extremely rare potential side-effects
Vikki Spit, from Cumbria, pictured with her partner Zion, who died in May 2021
Rock musician Zion died of from a blood clot after having the AstraZeneca Covid jab
There was no hoopla about it at the time. Gareth (and the legal team helping him) became aware of it only recently. 'The message from the Government at the time was still 'this is safe. It is your duty to have the vaccine'.
'And I'm pretty sure Lisa was not made aware of it either. The language was only for professionals the average lay person would not have understood it and it only went on documentation that would have gone to the vaccination centres.'
Yet the mere existence of this warning clearly caused concern with the legal team leading the class action.
'The way it was explained to me was that they felt it was better to remove those families where the vaccine had left the factory after that April 7 cut-off, because they felt that if it comes to court, AstraZeneca could use it against us.
'Lisa had her vaccine on April 29. It had left the factory on April 11. This meant a dozen of us were removed. The issue is that the insurers felt it was too much of a risk to include us. Had our names stayed on the class action and we lost in court, we would have been personally liable for those costs ourselves and they would run into hundreds of thousands of pounds. None of us can afford that.'
He understands the logic, and bears the lawyers no ill-will, but he still feels it is deeply unfair.
'We were all on this rollercoaster, all the families in the same position. Our loved ones died from the same vaccine. To start quibbling about dates and warnings is missing the point.
'We all know what those vaccination centres were like. No one on the ground got warnings! And even if it had been spelled out, there was no alternative. We were all told it was our duty. For this to now be used against us is well, it is wrong.'
The Mail has this week spoken to some of the other families involved in the class action, who were left bewildered by the development, many wondering if they too were going to be excluded.
'This is madness,' says Vikki Spit, from Cumbria, who lost her partner Zion in May 2021. 'We are gutted for Gareth and the others. We are such a tight group and it has left the rest of us wondering if they are going to find another loophole and we will lose more people.
'Gareth was one of the brave ones who dared to speak up, knowing that Lisa's status gave him more clout with the media. This has left us all really cynical and bitter. It's just another example of what we are up against.'
The cut-off date has thrown up anomalies that are hard to fathom, and also seem to make a mockery of Gareth's exclusion. For example, the late husband of another woman in the class action died on the same hospital ward as Lisa in the same week, from the same vaccine reaction, and was 'actually given the vaccine after Lisa', says Gareth.
'But because the vial containing his vaccine had left the factory before hers, his death can be included in the class action,' explains Gareth. 'It's nuts.'
The loophole could have massive consequences. If they reach court and win, the families involved will be entitled to compensation payments worth millions. Gareth will not receive a penny, unless he can fund a separate court action.
'It's not just about the money, though,' he says. 'What we've been fighting for and I will continue to fight for, even if I'm not part of the class action is for someone, the Government or AstraZeneca, to step up and take responsibility.'
What a legal and moral mess this is, and a world away from the huge fanfare that accompanied the rollout of the vaccine in 2020. Developed by scientists at the University of Oxford, it has been credited with saving more than a million lives. Fifty million doses were administered in 2021, and co-developer Dame Sarah Gilbert was given a standing ovation at Wimbledon that year.
And yet as far back as February 2021 problems with the AstraZeneca vaccine had been identified, leading France and Germany to switch to other vaccines.
Various caveats in the UK were introduced with official advice changing first to say it should not be offered to the under-30s, then the under-40s. By the autumn of 2021, its use was being quietly shelved. Figures from the Medicines and Healthcare products Regulatory Agency (MHRA) show 81 deaths appear to have been linked to the adverse reaction from the vaccine that caused blood clotting. Hundreds more have been left with lasting disabilities.
In a statement, AstraZeneca said: 'Our sympathy goes out to anyone who has lost loved ones or reported health problems. Patient safety is our highest priority, and regulatory authorities have clear and stringent standards to ensure the safe use of all medicines, including vaccines.
'From the body of evidence in clinical trials and real-world data, the AstraZeneca-Oxford vaccine has continuously been shown to have an acceptable safety profile and regulators around the world consistently state that the benefits of vaccination outweigh the risks of extremely rare potential side-effects.'
How affected families should be supported, though, is at the heart of this complex issue. The Government insists there is financial support available, under the Vaccine Damage Payment Scheme. But this was not designed for Covid-related situations (it was launched in 1979). Payments are limited to 120,000 per claim (a figure set in 2007, and paltry even when you consider loss of earnings alone) and applications must prove severe disablement.
Vikki Spit was the first recipient of this payment in respect to Covid vaccine deaths, but tells us she had to 'fight for a year for it'.
'And even though Zion had died, I had to fight to convince them he had suffered 60 per cent disability. It's not fit for purpose.'
Each family has its own tragedy, but there are striking parallels. Zion, previously fit and healthy, died at 48 after developing headaches following the vaccine.
Gareth's tragedy unfolded in the same way. Lisa started to suffer headaches just a week after having the vaccine 'so she could hug her mum'. On May 16, while having tests in hospital, she started to suffer speech difficulties, struggling to say the word 'goggles' when she and Gareth were discussing Zach's swimming lessons.
A rare bleed on the brain was identified, and Lisa 'the healthiest, bubbliest, loveliest person you could meet,' says Gareth spent the last five days of her life on a ventilator.
Gareth was the one who had to tell their son his mum had died. 'It was the hardest thing I have ever had to do.' He still maintains that speaking up was the right course of action, even though it has brought great distress.
'Nobody wanted to know at the beginning because it went against the narrative,' he recalls, remembering how he would try to tell Lisa's story on TV only to be shut down or for viewers to be reminded that vaccines were 'safe'. He recalls being made to feel like a 'crackpot or conspiracy theorist'. 'At the time if you questioned anything about the vaccine, you were accused of being an anti-vaxxer and unpatriotic.'
Conversely, he was also attacked by the anti-vax lobby for daring to have a vaccine (albeit the Pfizer one) even after Lisa died. 'My crime was wanting to take my son on holiday after his mum died, and to do that I needed to be vaccinated. This issue is one of those ones where you have to take a side. I don't want to be on a side. I just want acknowledgement of the facts.'
His fight, certainly before the class action, was lonely, and carried out while he was almost destroyed by grief. He admits he considered suicide in the early, raw days after losing Lisa, 'but could not, because of Zach'.
'He absolutely does remember Lisa. I just don't know how much is from pictures or what the family have told him.'
He says family, particularly Lisa's sisters, have pitched in but the strain of single parenthood is evident. 'I still don't know how I've done,' he shrugs. 'It hasn't been easy. Even daft things like decorating the house Lisa would do that all. I still find myself looking at a cushion and thinking 'do I like this? Would Lisa like it?'.'
Throughout, he continued to fight for some official recognition of the 'sacrifice' his family had made. The families who lost loved ones have long thought of themselves as akin to war veterans, accepting of their fate of being sent to the front but expecting that their families would be looked after if they never came home.
Gareth wrote to three successive prime ministers pleading for help. 'No one wanted to know. I actually have a letter from Rishi Sunak saying he was too busy to see me, but he'd pass me on to the health minister. No word from her either. I'm sure everyone wishes we would go away.'
Trapped between what they call the 'twin Goliaths' of the Government and AstraZeneca, a company worth 185billion, the families increasingly seem like pawns in a bigger game.
'To this day, I can't understand why we have to fight,' says Gareth. 'AstraZeneca have been lauded for saving the world, and maybe rightly so, but ever since their profits have gone through the roof and their people have been rewarded with damehoods, knighthoods and the like. Why do they want to fight us the little people in court?
'There is no debate about how our loved ones died the Government has admitted as much by the payments, even if derisory, from the payment scheme.
'Successive coroners have ruled that the vaccine caused the deaths. Now AstraZeneca have admitted that the vaccine caused the condition that killed Lisa.
'Surely they or the Government, or both would want to support us and say 'we asked you to do your duty, and you did, and now we will support you'.'
From here, his fight seems over. 'I can't afford to take either the Government or AstraZeneca to court on my own,' he says.
And there is salt in the wounds. In cases like his, any legal action must be instigated within three years of injury in this case, the date of the vaccination. Lisa received her vaccination three years ago this week, making this time of year, with anniversaries on the horizon, even more painful.
Were you or a loved one diagnosed with a serious health condition as a result of the Astra-Zeneca vaccine? Or was it even cited as a cause of death of a loved one? Contact us to tell your story at femailreaders@dailymail.co.uk
By Luke Andrews Senior Health Reporter For Dailymail.Com 16:19 02 May 2024, updated 16:45 02 May 2024
The mother of a toddler with measles has revealed how she thought he would 'die in my arms' after the little one fell sick with the extremely infectious disease.
Jessica Colleti, from Chicago, said her son Vincent, three, developeda fiery, red, rash on his face in early March that rapidly spread 'all the way down his body'.
Within days of feeling sick, he had a 'super empty' and vacant look in his eyes and almost completely stopped moving and speaking.
'I honestly thought he was going to die in my arms,' she said. 'I just kept telling him that "mommy's getting help, and you're going to be okay".'
'I didn't think that [this] would happen to us. I never would have thought he would come back positive for measles'.
Vincent is one of around 130 Americans struck with measles this year, amid warnings that falling vaccination rates and surging immigration is leaving America's children more vulnerable to the disease than ever before.
The family, who say their 10-month-old also got sick, do not know where Vincent caught the virus, but they live in the same city as the Pilsen migrant center that is thought to be the source of Chicago's outbreak.
Ms Coletti said she rushed her son to hospital on Monday after a neighbor who was a nurse checked him over, where doctors quickly confirmed the infection.
He spent a night in the ER and received fluids, before being discharged with medications as doctors with Ms Coletti told to bring him back if he worsened.
At home, he battled a fever of 105F (40C) for five days before finally recovering from the infection.
Vincent had received his first dose of the vaccine against measles, his mother said, but hadn't yet got the second because he was too young. He is said to be up to date on all other vaccines.
The CDC says infants should receive their first dose of the measles vaccine at the age of 12 to 15 months, and their second dose between the ages of four to six years.
Studies show the first dose is 93 percent effective against the virus while the second is 97 percent effective.
Vaccinated people can still get sick, doctors say, but they have a much milder infection because they already have immunity.
The mother was worried for her young daughter Vanna who was too young to receive any vaccinations against the disease at the time Vincent was diagnosed.
'I know for our specific case, for my son, I have never seen him sicker,' she told WGN Chicago.
'I had never been more worried, or scared, or tired. From fighting fevers for five days and just trying to figure out how to get him better... I felt like I could not get him better.'
In Chicago, many migrants have been packed into buildings in the Pilsen neighborhood for shelter which have been completely overrun after more than 25,000 migrants arrived in the city over the past 16 months, including 2,400 who were housed at the shelters.
A total of 31 measles cases have already been diagnosed at the shelter, while officials also say some residents have tested positive for tuberculosis.
The surge in migrants comes as Chicago continues to pride itself as a 'sanctuary city', or a location where people can ask for aid from city services without revealing their immigration status. Officials also do not ask residents about whether they are legally entitled to be in the US.
Ms Coletti said workers at the city's health department had tried to trace her son's infection to the Pilsen migrant center, but had been unsuccessful.
'We weren't by the 12 cases [at the migrant center at the time],' she told WGNTV, 'and they still can't link us to the 12 cases'.
She added: 'I was shocked, honestly, I didn't think that that would happen to us.'
Experts say it is possible for people to catch the disease in many locations because it is one of the most infectious known to man.
Coverage has dropped a further two percent between the 2019-2021 school year to the 2022-2023 school year.
Dr Claudia Hoyen, a pediatrician at UH Rainbow Babies and Children's Hospital in Cleveland, Ohio, toldCNN: 'Measles is so terribly contagious. You could be in line at a grocery store with somebody who had measles and catch it and would never know, because the measles virus hangs out in the air for so long.'
Measles infections are more dangerous for children younger than five years old because they are less likely to be vaccinated and have immature immune systems.
Complications the disease can cause include pneumonia and encephalitis or swelling of the brain with the CDC saying up to every three in 1,000 children who are infected die from the disease.
In the current US outbreak, nearly half of patients 46 percent, or 57 individuals have been under five years old.
This group has also recorded the highest hospitalization rate, with 65 percent or 37 individuals hospitalized.
For comparison, among those aged 20 years or older there have been 40 cases detected or 32 percent of the total and 53 percent, or 21 individuals, have been hospitalized.
She said: 'He seems much better. He's sitting next to me. He has chocolate on his face, but he is much better.
'I never would have thought we would come back positive for measles, and now I'm just scared and concerned for my 10-month-old.'
Vanna appeared sickly in mid-March, shortly after Vincent's diagnosis, and had tested positive for Covid and adenovirus.
Both Ms Coletti and her husband have been tested and found to have antibodies against measles.
But the whole family had to quarantine for 21 days to minimize the risk of them spreading the disease to others.
They also had to provide a list of where they had been and who they had been in contact with for tracing purposes to avoid any other cases.
As millions of migrants race to come to America under Joe Biden's policies, experts have warned that overcrowded shelters and low vaccination rates in other countries could leave the US vulnerable to outbreaks.
They've said asylum seekers could be bringing infectious illnesses across the southern border and 'open border' policies are leading to drug-resistant diseases.
And city leaders have said migrants are arriving to their areas in 'disturbing' and 'very very unhealthy' conditions.
Migrants themselves have said illnesses are rampant in shelters because of overcrowding and unsanitary conditions.
Chicago's newest outbreak adds to the growing list across the country, which has seen clusters of tuberculosis, chicken pox and an unidentified illness that killed a five-year-old boy in December.
By Morgan Phillips, Congress Reporter On Capitol Hill For Dailymail.Com 17:35 02 May 2024, updated 18:16 02 May 2024
Judiciary Chair Jim Jordan released fresh details about the close collaboration between the Biden White House and Amazon to deplatform books they deemed 'sensitive' - as White House officials insisted they never 'coerced' private companies.
On March 2, 2021, White House advisor Andrew Slavitt reached out to Amazon. 'Who can we talk to about the high levels of propaganda and misinformation or disinformation at the White House?'
Amazon initially resisted White House pressure to restrict anti-vaccine material.
'We will not be doing a manual intervention today,' one email between Amazon executives read. 'The team/PR feels very strongly that it is too visible, and will further compound the Harry/Sally narrative (which is getting the Fox News treatment today apparently), and won't fix the problem long-term because of customer behavior associates.'
And ahead of a March 9, 2021 meeting between the White House and Amazon officials, a 'pre-brief' email to Amazon employees emphasized a 'top talking point': 'Is the admin asking us to remove books, or are they more concerned about search results/order or both?'
But the very day of the meeting Amazon immediately adopted a 'do not promote' category for anti-vaccine books listed on its website.
'The impetus for this request is criticism from the Biden administration about sensitive books we're giving prominent placement to, and should be handled urgently,' an Amazon official wrote in an email to other staffers.
In another internal email, an Amazon official expresses urgency in making the changes to shadow-ban anti-vaccine content 'due to criticism from the Biden people.'
'The next 4 months of vaccine response/adoption are going to be critical,' the official writes.
They suggested removing the books from sale entirely, because 'search data shows customers who buy this content are looking for specific books and using high intent queries, which means customers will likely continue to consume this content in spite of our warnings.'
By March 12, Amazon wanted to take further steps to crack down on anti-vaccine books because they were'feeling pressure from the White House Taskforce.'
Amazon wasn't alone in bending to the Biden administration's wishes to deplatform content that could sow doubt about the Covid-19 vaccines - Twitter, now X, and Facebook felt the heat too.
Jordan went after Slavitt andRob Flaherty, a key White House communications staffer, in a censorship hearing on Wednesday.
Jordan showcased emails between the White House and Facebook, including one in which Flaherty allegedly wrote,'My bias is to kick people off the platform.'
'The White House is telling a social media platform one of the biggest ones in the world you should kick people off your platform if they're saying things we don't like,' Jordan said.
Flaherty and Slavitt denied that they had been coercive.
'There were no threats, and there were no consequences,' Flaherty said.
'We had no intention in coercing any social media companies into taking any action,' Slavitt said. 'We never received any indication that our dialogue ever was interpreted that way. I want to be clear that they made their own decisions.'
The Judiciary Committee shared a 98-page interim report of the 'censorship-industrial complex,' which detailed the tens of thousands of emails betweenBiden officials and Facebook, YouTube and Amazon, claiming the White House had infringed on free speech.
Flaherty insisted private companies were the 'ultimate decisionmakers,' but'that does not mean that communication staff cannot ask or even implore those companies to address misinformation on their platforms.'
A court ruled last July that the White House could not communicate with private companies about deplatforming content, but that ruling was blocked. Still, the White House has scaled back its outreach to tech companies.
But the FBI has resumed sharing intelligence about foreign influence campaigns with those companies.
'What are they up to now that's going to restrict speech and keep important information from the American people?' Jordan questioned.
Rep. Dan Goldman, R-N.Y., suggested Republicans wanted to cease communications with tech companies so that Russia could help Donald Trump get elected.
'They want to chill the government from actually interacting with private companies as we come upon an election in November of 2024,' he said.
'If that can't happen, then Donald Trump and these Republicans benefit because Russia will help them,' Goldman said. 'That is why we are here, and that is why this is bogus.'
A thread of documents shared by Jordan last year showed Facebook had caved to pressure from the White House to remove posts that questioned the vaccine.
It began with an email from April 2021 to Zuckerberg and COO Sheryl Sandberg.
It stated: 'We are facing continued pressure from external stakeholders, including the [Biden] White House' to remove posts.
An additional April 2021 email from Facebook's president for global affairs Nick Clegg to his team said that Biden advisor Slavitt was 'outraged . . . that [Facebook] did not remove' a particular post.'
The post had to do with the COVID-19 vaccines that the White House wanted labeled as 'misinformation' and removed off the social media platform.
Clegg responded to the White House saying that removing that content would 'represent a significant incursion into traditional boundaries of free expression in the US.'
According to additional emails, Facebook sought to 'repair' its relationship with the Biden administration.
'Given what is at stake here, it would also be a good idea if we could regroup and take stock of where we are in our relations with the [White House], and our internal methods too,' Clegg wrote in another email.
HYDERABAD: After AstraZenecas admitted in a UK court that its Covid-19 vaccine caused a rare side-effect Thrombosis with Thrombocytopenia Syndrome (TTS), Hyderabad-based vaccine maker Bharat Biotech on Thursday stressed on the safety of its indigenous vaccine Covaxin to allay public concerns over Covid vaccines. AstraZenecas vaccine Vaxzevria, which it developed in collaboration with Oxford University, was manufactured under the Covishield brandname in India by Pune-based Serum Institute of India (SII). Bharat Biotech developed the inactivated whole virion vaccine Covaxin. Both of them were the most widely administered vaccines under Indias Covid-19 vaccine immunisation drive.
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A new vaccine strategy could spell the end of yearly flu shots, by targeting part of the virus that is much less prone to mutations. So far, its worked well in mice and ferrets could we soon be looking at a human equivalent?
Seasonal flu is responsible for roughly half a million deaths every year. It can be a very serious disease, and spreads easily between people, so vaccines that prime our immune system to recognize proteins on the viruss surface are our best possible defense.
Unfortunately, the flu virus also has an irritating habit of mutating. A lot. That means we have to constantly update the vaccine to try and keep up. Each year, scientists study the trends from previous flu seasons and tailor the vaccine to the strains of virus they think will be most prevalent.
It's not a perfect system, and some years flu vaccines are better than others, but it does save lives.
The two major surface proteins on an influenza virus are called hemagglutinin and neuraminidase. The different types of these proteins give each strain a shorthand name you may have heard of H5N1 or H1N1. The H, sometimes abbreviated to HA, is what were most interested in.
On the virus particle, there's five to 10 times more hemagglutinin than neuraminidase, said associate professor of molecular genetics and microbiology Nicholas Heaton in a statement. If we took your blood to see if [you are] likely to be protected from a strain of flu, we'd be measuring what your antibodies do to hemagglutinin as the best metric of what's likely to happen to you.
The strongest correlates of protection have to do with hemagglutinin-directed immunity.
A number of groups have gone through and experimentally mutagenized the whole hemagglutinin and asked which areas can change and still allow the hemagglutinin to function? And the answer is, you can't really change the stalk and expect it to continue to function, Heaton said.
The head of the hemagglutinin protein is constantly changing as the virus is locked in an arms race with the human immune system. Heaton and the team came up with a way to get the immune system to shift its focus to a new target instead: the stalk.
The team generated some 80,000 different variants of hemagglutinin, each with small changes in one section at the top of the head. They mixed a vaccine cocktail of these variants and injected it into mice and ferrets. We dont see ferrets cropping up in the lab all that often, but theyre a very good model organism for the study of influenza.
Because the hemagglutinin heads being presented to the immune system via the vaccine were all different, whereas the stalks were consistent, this altered the balance of antibodies being generated by the immune system.
Antibodies against the stalk of the protein work differently than those against the head. By creating a vaccine that generates both types of antibodies, Heaton and the team hoped to give the immune system a better chance even if the seasonal strains selected for the vaccine werent quite right, or in case a whole new pandemic strain should come along.
Essentially, the paper says, Yes, we can accomplish that, said Heaton.
Well, they were pretty impressive. In some of the mouse experiments, 100 percent of the animals avoided illness or death when given a dose of flu that should have been fatal. Across the ferret experiments, the animals given the new vaccine had less severe illness than those given an old-style shot.
However, its a little early to get excited. If you want up-to-date protection, youre going to be scheduling in that annual shot for a good few years yet.
One of the important caveats the authors note in their paper is that the animals they used had no pre-existing immunity to flu. This is not the case for pretty much every human who is not a newborn baby, so it will be important to find out how this approach works in people with a history of previous vaccine or illness.
They also only used one specific type of hemagglutinin, and as we know there are many others out there. More work is needed to completely tease apart the mechanism by which the vaccine prevented serious disease in the animals, and the scientists are also keen to find out whether it can work with fewer than 80,000 different variants.
Ferrets and flu go back a long way it's thanks to them that we first discovered the virus in 1933.
All of these questions will hopefully be answered in future studies, and human trials would of course be needed before you could rock up to Walgreens and get your universal flu shot. The results form part of a five-year project these things are marathons, not sprints.
We might have allowed ourselves to forget, just for a second, what flu can do while our attention was necessarily focused on COVID-19. But with H5N1 avian flu making concerning moves, and this years annual season already underway in the Southern Hemisphere, its good to think that the universal vaccine weve been hoping for is a step closer to fruition.
The study is published in Science Translational Medicine.
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Study design and procedure
We conducted a prospective, observational mixed-methods pilot study from May 2021-September 2022 in seven GP practices across two urban London boroughs. The study was designed as a pilot to test processes and approaches which may inform a future large-scale study or trial. The overall objectives were to measure routine vaccination coverage among migrants presenting to UK primary care and establish and test new referral pathways for catch-up vaccination. The study procedure was as follows: following recruitment, participants were asked about their vaccination history (including for routine childhood immunisations including MMR, Td/IPV, and other vaccines including tuberculosis/bacille Calmette-Guerin vaccine (TB/BCG) and HPV), which was coded into their electronic patient record and the study database. In the absence of a written vaccination card or record documenting a completed vaccine course, or if patients said they had not had a vaccine or were unsure, patients were referred for catch-up vaccination for each eligible vaccine (following the UK algorithm for vaccinating individuals with uncertain or incomplete immunisation status [21]) and invited to attend an appointment(s) with their practice nurse. Eligible catch-up vaccines were MMR, Td/IPV, HPV (aged 1125 years) and MenACWY (aged 1025 years). Practice nurses followed the UK algorithm to administer missing vaccine doses, boosters, and courses and recorded the data into the patients electronic record and the study database. A standardised data collection tool was designed to facilitate the collection of data, which then prompted referrals for catch-up vaccination (see Data collection and referral pathway for catch-up vaccination).
PICOTS criteria for the study are shown in Table 1. In addition to collecting quantitative data from migrant patients, we explored the views of practice staff on catch-up vaccination and current guidance, including barriers to implementation, suggestions, and areas for improvement and support, through focus group discussions (FGDs), which were carried out in August 2022. During the study, we also decided to conduct an in-depth interview with two staff members to explore examples of good practice from the most successful (in terms of recruitment and uptake) participating practice. We carried out in-depth interviews with a diverse range of recently arrived (10 years) migrants to explore views and concerns around catch-up vaccination after arrival in the UK. The study tool, recruitment, and data collection pathways are shown in Fig. 1. The reporting of this study follows the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines [22].
This study received ethics approval from the NHS Health Research Authority Yorkshire and HumberSouth Yorkshire Research Ethics Committee (20/YH/0342) on 18 December 2020. The qualitative in-depth interview study with migrants received ethics approval from the St Georges, University of London Research Ethics Committee (REC reference: 2020.0058). Migrants with lived experience of the UK immigration and healthcare systems were involved in the design of this study through our National Institute for Health and Care Research (NIHR)-funded Patient and Public Involvement and Engagement (PPIE) Project Advisory Board and were compensated for their time and contributions.
The study was conducted with support from the NHS North Central London Research Network (NoCLoR) and the North Thames Clinical Research Network (CRN). GP practices in areas with a high proportion of migrant residents were purposively invited to join the study. We aimed to recruit up to 10 GP practices across two boroughs (Barnet and Tower Hamlets) in North and East London (referred to henceforth as sites 1 and 2), with a target sample size of 100 participants. Boroughs were selected for their high proportion of migrant residents (estimated to be approximately half, according to 2021 Census data [23]). Both rank in the top 50% of most deprived local authorities in England, based on the English indices of deprivation 2019 [24], although Tower Hamlets ranks as significantly more deprived than Barnet. In practice, seven GP practices were recruited, with six across site 1 and one practice belonging to site 2.
Patients registered at participating practices were eligible for the study if they were (a) aged 16 years or older, (b) born outside of the UK (our migrant definition excluded those born in North America, Australia, New Zealand, or Western Europe, as defined by the UN maximal definition of Western Europe [25]), and (c) capable of giving informed consent. Recruitment procedures differed between the two sites (see Fig. 2).
Figure showing standardised data collection tool (left) and referral pathways implemented in study sites 1 and 2 (right). VPDs, vaccine-preventable diseases; PN, practice nurse; HCA, healthcare assistant; CRN, clinical research network
We held site initiation visits with all practice sites, inviting GPs, practice managers, healthcare assistants (HCAs), and nurses involved in immunisation. Alongside delivering training on the current UK primary care catch-up vaccination guidelines [21] and the referral pathway to implement upon identifying under-vaccinated patients, these visits covered the study processes and procedures, approaches to identifying the study population and recruiting participants, and use of the standardised data collection tool.
At site 1 (n=6 GP practices), clinical practice staff were originally going to recruit and consent patients. However, the recruitment pathway was modified as clinical staff were under intense pressure from the COVID-19 pandemic, so the CRN led the recruitment and consenting process. Practice nurses and HCAs first identified patients who met the eligibility criteria, filtering patient records by ethnicity or notes on migrant status (where recorded) to identify those potentially eligible and sent an SMS/text message with a link to the study website, from which patients could download the study documents (participant information sheet [PIS], consent form, and leaflets about catch-up vaccination and HPV vaccination, all available in the six dominant local languages, which were Arabic, Farsi, Pashtu, Romanian, Urdu, English). A researcher at the CRN (DF) then followed up with patients by a telephone call enquiring whether they would like to join the study and to take informed consent. Practice nurses also mentioned the study opportunistically to patients during routine appointments, who would then be referred to the CRN researcher (DF) for consent. At site 2 (n=1 GP practice), the practice nurses HCAs invited and consented participants to the study opportunistically during routine appointments, as per the original recruitment pathway. Participants were given hard copies of the study documents and given the opportunity to ask questions and decide whether they wanted to participate. We gave practice and CRN staff a copy of a form detailing the names of common childhood vaccines in multiple languages, to support taking vaccine history during appointments (see Supplementary files). Telephone interpreters (via Language Line) were available on request at both sites during recruitment and data collection.
We developed a standardised data collection tool using Microsoft Excel, which was used to collect specific sociodemographic information (such as country of birth, which is not routinely recorded in patient records), immunisation history, and monitoring and uptake data when patients were referred for catch-up vaccination (Fig. 2). We documented participants rates of under-vaccination for MMR, Td/IPV, and other key vaccines in the UK routine immunisation schedule, history of VPDs, and uptake rates of MMR, Td/IPV, MenACWY, and HPV vaccines following referral to the practice nurse for catch-up vaccination. We also explored sociodemographic factors associated with under-vaccination in the study population. Immunisation history was based on self-reporting or vaccination records (via the primary care computer system or hand-held vaccination cards) where available.
Data collection and referral pathways and procedures differed between sites and are outlined in Fig. 2. In site 1, the CRN researcher collected core data via telephone call with the participant, which were recorded in the patients electronic medical record and on the password-protected study database. The CRN researcher determined the participants need for catch-up vaccinations based on the study training and the UK catch-up vaccination guidelines [21] and, if accepted by the participant, contacted the practice nurse (at the practice where the patient was registered) to arrange an appointment. Once the CRN staff had facilitated an appointment for first doses, they then left practice nurses to follow-up patients for subsequent doses as per routine care. Subsequent catch-up vaccination doses (uptake data) were recorded by practice staff in the patients medical record at the time of administration and these data were later extracted by the CRN researcher (see Data management, follow-up, and statistical analysis). In site 2, the practice nurse collected core data (recorded in the patients medical record) during face-to-face appointments, administered first doses where vaccine stocks allowed, and booked patients for any necessary follow-up appointments for catch-up vaccinations and subsequent doses. Anonymised study data (core, monitoring and uptake data) were extracted from electronic patient records by the practice manager at site 2 and securely transferred to the CRN researcher, who added them to the aggregate study database.
We aimed to follow-up patients for a minimum of 6 months at both sites to allow for all doses (Td/IPV is 3 doses, with a 4-week gap in between each; Fig. 1). At the end of follow-up, the CRN researcher securely extracted monitoring and outcomes data from participants electronic medical records and updated the aggregate study database. A de-identified, anonymised version was then transferred securely to the study team at St Georges for data cleaning and analysis.
Data cleaning and analyses were done using STATA 12. All tests were two-tailed and p values less than 0.05 were regarded as significant. We used descriptive statistics to describe the sociodemographic characteristics, vaccination history, VPD history, and catch-up vaccine uptake of participants. We summarised continuous data with mean and standard deviation (SD) and described categorical responses using the frequency and percentage. Comparisons between categorical variables were calculated using Pearsons chi-squared test, and comparisons between continuous variables were calculated using unpaired t-tests.
Bivariable and multivariable logistic regression analyses were chosen to model the relationship between a binary outcome and predictor variables and were used to look for factors associated with being un-vaccinated (received zero doses) or under-vaccinated (received at least 1 dose, but not full schedule) for key vaccines at the time of study enrolment. Outcomes included un-vaccinated for MMR vaccine, un-vaccinated for Td/IPV vaccine, un-vaccinated for MMR vaccine and Td/IPV vaccine, unvaccinated for any poliocombined or single vaccines, unvaccinated for any measlescombined or single vaccines, and under-vaccinated for MMR vaccine or Td/IPV vaccine. Explanatory variables were age, sex, birth region, region lived prior to the UK, years in the UK, and study site (migration reason and occupation were only recorded in site 1 and were therefore not included in the regression analyses). Multivariable models were built in a forward, stepwise fashion. Age, sex, and birth region were adjusted for in each multivariable model; certain variables were removed from the final model to reduce collinearity.
Our qualitative component included FGDs and an in-depth interview conducted with practice staff from participating practices and in-depth interviews conducted with recently arrived migrants. Topic guides were developed by the research team. The interviews with migrants were done remotely (either over the phone or through video call) across 17 months. Migrant participants were recruited using purposive and snowball sampling, with the aim of recruiting participants from a broad range of nationalities, migration statuses, and age groups. Adverts for the study and participant information sheets were circulated to 20 UK-based migrant support groups (mostly based in South London and chosen for their locality around St Georges, University of London) and on social media. Those who expressed an interest in taking part were contacted by telephone, and the study was explained to them with interpreters available on request. Translated participant information sheets were circulated, and written informed consent was obtained from all participants prior to carrying out an interview (methods reported in full elsewhere [26]). We did three FGDs which were scheduled to take place at the end of routine practice meetings conducted on Microsoft Teams (most convenient for participants). Participants were practice nurses, HCAs, and practice managers (roles involved in vaccination delivery/scheduling) from the participating practices. An in-depth interview was conducted with two staff from site 2 (due to timing, these staff had not participated in FGDs). For the FGDs, all staff received information about the study and how their data would be used in advance, which was reiterated at the start of the meeting, and staff were able to make an informed decision about their participation. Participants were asked to imply consent by remaining on the call, which was considered appropriate because the topic was low risk, not audio recorded, and anonymised summary feedback (broad views) was collected. All participants received a PIS and provided written informed consent prior to participating. Both the FGD and staff interviews followed a semi-structured topic guide, which explored participants experiences of implementing the study, current barriers and challenges to delivering catch-up vaccinations, and suggestions for improving the tool, referral pathways, and engaging migrant patients/promoting catch-up vaccination among these groups. Broad views and selected short-hand quotations (non-attributable) were collected during FGDs in the form of hand-written and typed notes (by SH and LPG). The staff interview was conducted by AFC with two staff participants in a private room, audio-recorded and transcribed verbatim by a professional transcription service.
Qualitative data were analysed deductively using a flexible and rapid thematic analysis and evaluation approach [27]. Notes from the FGDs which were reflected on and discussed afterwards by AFC, SH and LPG, and AFC then independently coded and grouped the findings into broad barrier and facilitator concepts using a matrix method (by hand and in Microsoft Excel). The data in the matrix were corroborated and discussed again by the three researchers, to ensure rigour and coding reliability. The same approach was used to analyse the transcript of the key informant interview. Migrant interviews were analysed using the thematic framework approach in NVivo 12. Triangulation occurred when the qualitative and quantitative data were combined but also by the interaction between the three researchers during data collection and analysis and through the contributions of their own perceptions, beliefs, and academic disciplines to the collection and interpretation of data.
Erskine Palmer / CDC
The benefits of vaccinating vulnerable preterm infants in the neonatal intensive care unit (NICU) against diarrhea-causing rotavirus outweigh the risks, according to a USstudy being presented this weekend at the Pediatric Academic Societies (PAS) 2024 Meeting in Toronto.
The finding that rotavirus vaccination doesn't cause significant hospital outbreaks is important because many NICUs don't give the vaccine because of fears of viral transmission (the vaccine contains a weakened form of rotavirus), and some babies are too old to receive it after NICU release, researchers from the Children's Hospital of Philadelphia (CHOP) said in a PAS news release.
The researchers assessed the risk of vaccinated infants spreading highly contagious rotavirus to unvaccinated babies in NICUs that administer the vaccine. They analyzed 3,448 weekly stool samples from 774 newborns from January 2021 to January 2022.
Less than 1% of unvaccinated infants exposed to vaccinated babies contracted rotavirus, and their symptoms resolved after 2 weeks.
US Readies Vaccines for Potential Spread of Bird Flu Among Humans
Amid concerns over a strain of bird flu circulating in dairy cows potentially spreading to humans, US federal health officials have announced readiness to deploy vaccines should the need arise, according to NBC News. Although there's currently no evidence of person-to-person transmission, preparations are underway given the virus' prevalence in dairy herds across several states. Vaccine candidates are already available, with plans to ship hundreds of thousands of doses within weeks if the situation escalates.
Walmart to Close Health Centers Amid Retail Health Challenges
Walmart's decision to close its Walmart Health centers in 5 states, along with its virtual care services, reflects the significant challenges retail players face in disrupting primary care, according to Fierce Healthcare. The closure of all 51 health centers underscores issues related to sustainability, profitability, and operational costs. This move has marked a dramatic shift from the retailer's earlier plans to expand its health care footprint, aligning with similar struggles faced by other retailers like Walgreens as they scale back their primary care clinic chains.
Arizona Lawmakers Repeal Civil WarEra Abortion Ban Amid Political Fallout
Arizona lawmakers voted to repeal the state's long-standing Civil Warera abortion ban, according to Politico. The repeal preserves access to abortion for millions of women and marks a significant shift from previous efforts to uphold the 1864 ban. Democrats had been leveraging the ban to rally support ahead of the November election, but Republicans, fearful of electoral consequences, ultimately joined Democrats in passing the repeal.
