Moderna faces suspension over Covid jab breaches
Moderna could face suspension from Britain's pharmaceutical trade body following a string of breaches of the regulatory code.
The Covid vaccine maker is due to be audited by the Prescription Medicines Code of Practice Authority (PMCPA) over 'unacceptable' practices that brought discredit upon the industry.
If found to be lacking adequate compliance systems, Moderna could ultimately be suspended or expelled from the Association of the British Pharmaceutical Industry (APBI).
It follows several code breaches, including representatives of the company offering children £1,500 and teddy bears to take part in Covid vaccine trials.
In a fresh ruling, which is expected to be published in the coming days, the company was also found to have misled regulators about when it first became aware of the financial incentives to children.
Moderna claimed it had taken action as soon as it was notified about the cash offer by the Health Research Agency in January 2024, but it has now emerged that senior executives were informed in August 2023 by the campaign group UsForThem, yet failed to take action.
Under the Medicines for Human Use (Clinical Trials) regulations, it is prohibited for incentives or financial inducements to be given to children or their parents.
The PMCPA ruled the company had shown a lack of transparency that was 'completely unacceptable' and brought discredit upon the industry.
A senior employee was also found to have co-authored three articles, including one with Nadhim Zahawi, the former vaccines minister, which promoted Moderna's Covid vaccine without disclosing he worked for the company. He also sent promotional tweets from a personal account without revealing his role.
The PMCPA said the article and tweets amounted to advertising the vaccine, and viewed the failure to inform readers of links to Moderna as unacceptable.
Molly Kingsley, the founder of UsForThem, said: 'Many of the previous judgments against Moderna have revealed how readily it put profit ahead of the health and safety of children.
'Now it has also laid bare just how little regard it has had for the regulatory system that was supposed to keep it honest.
'Never before has a company so new to the pharmaceutical industry been rebuked in this way.'
In two new rulings, Moderna was found to have made ten new breaches of the code. UsforThem said it was particularly worrying as they related to three senior executives at the company.
The PMCPA said that an audit was now necessary to look at whether Moderna's culture, governance and framework were operating effectively, and said the Appeal Board would then consider whether further sanctions were needed after auditors had reported back.
Suspension of expulsion
The Appeal Board can report a company to the APBI board, which can suspend or expel them from the APBI.
Suspension or expulsion would be a blow for Moderna, which only joined in 2023.
The APBI has taken the measure just nine times in the past 40 years.
The last company to be suspended was Novo Nordisk in 2023. The company manufactures the high-profile weight loss drugs Saxenda and Wegovy, and type 2 diabetes drug Ozempic. Its membership was restored in March.
In the past year, Moderna has been ordered to pay thousands for breaches of the regulations, including for using off-label data to promote its Spikevax vaccine at the European congress of clinical microbiology and infectious diseases in April 2022.
But critics argue the company's revenue is nearly £7 billion in 2023, so with such small sums it has no incentive to stick to the rules, while being suspended from the APBI only brings reputational damage.
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BBC News
27 minutes ago
- BBC News
'Life, amidst death, has to continue': Molly Jong-Fast on her new book and watching her mother fade away
BBC Special Correspondent Katty Kay chats with author Molly Jong-Fast about her memoir, How to Lose Your Mother, which tackles the life, legacy, and decline of her mother, Erica Jong. The death of a mother or father is one of the things we don't talk about much in modern life, maybe because it scares us. But it's a universal reality. Nearly all of us will go through it at some point. Molly Jong-Fast is a political commentator and writer for Vanity Fair who has just written a new memoir, How to Lose Your Mother. The book is Jong-Fast's account of her mother and feminist author Erica Jong's descent into dementia, which began the same year that Jong-Fast's husband, professor Matthew Adlai Greenfield, was diagnosed with a rare form of cancer. The book is an honest, emotional and at times funny account of how Jong-Fast got through that horrible time. Not only was she handling her mother's cognitive decline, Jong-Fast's stepfather was diagnosed with Parkinson's, the world was dealing with Covid and everyone in her orbit was under one roof, including an elderly dog with his own health problems. These are heavy topics, but we found moments of laughter, too, emblematic of Jong-Fast's style. In her memoir, the author explores lying to her children about their father's health, referring to a growth on his pancreas as a "mass", because, "a 'mass' could be anything – a group of people, a group of blood vessels, a group of cockapoos meeting in Central Park for a cockapoo meetup". I really enjoyed this conversation. Her lessons about handling loss and grief, facing the legacy of her mother's fame and the difficult decisions that come with ageing parents are things I think we can all learn from. Watch (or read) more of our discussion below. Below is an excerpt from our conversation, which has been edited for length and clarity. Katty Kay: When my mum died, I remember thinking that I've had training up the wazoo for everything in my life, but nobody's given me the guidebook for this. Nobody's said, as your parents get older, they're going to need their diapers changed or that you're going to need to think about the money – let alone anybody helping you with all of the emotions. I'm so glad you wrote this book to help people, but why is it that we've gotten to this position where something that almost everybody goes through, we're left kind of clueless when it comes to it? Molly Jong-Fast: I think there's a lot of shame about getting older. It's why I talk about being sober all the time; I want to destigmatise alcoholism and that's how I feel about this to a certain extent. People don't want to talk about it. People don't want to get older. It's really scary. It only goes one direction and you can't get off. You don't get to skip birthdays. It's just this endless march towards death and nobody knows what happens after you die. What I think was so interesting about this whole experience was that it gets you into this conversation of: Why are we here? What is the point of all of this? Why are we on this planet and what should we be trying to grab from this human experience before it's too late? KK: Having now gone through the last few years and written this book, do you feel like you have lessons to impart? MJF: Because I got sober at 19, I saw the incredible benefit of being able to look at my experience and show it to other people. I got that if you can go through something and share that experience with someone else, they can be helped by it. It's almost Jungian; there's a collective suffering that can be shared and lessened. The thing that I always try to say, especially with my kids, is to not feel bad about stuff. The rest of the world can make you feel bad, OK? But don't make yourself feel bad about things. The other thing I say to people is to just do the best you can. This is not going to look the way you want it to look. Maybe it will! And that's great, too. But just because things don't look the way you want them to doesn't mean it's not the way it's supposed to look. KK: I think some people looking at what you went through would think 'I couldn't bear that.' But you have lovely moments in the book where you write about taking the kids on spring break because it's spring break. And you have to buy groceries and you have to pick them up from college. And that life – amidst death – has to continue. MJF: There's this funny moment, I don't know if this made it into the book, but my husband and I had this thing where his father died and then, two weeks later, my stepfather's sister died – and we were at the same, very small funeral home in Connecticut. And the people who own the funeral home come up to us and they're like [makes a shocked face]. We saw that it was very dark – it was not a great year – but we saw the humour in it. I do think the wonderful thing – and I think you see this in much worse stories of people who are in camps or the stories of people who are in wars – is that your focus becomes very narrow and everything becomes a binary. You either can do this or you can do that. And there's something very clarifying about the binary, which I don't think is a bad thing. KK: You start in the book by saying you have this incredibly intense relationship with your mother and you're part of her and she's part of you. But it becomes pretty clear that the relationship is complicated and not as close as you had wanted it to be and that your mother had incredibly narcissistic tendencies when you were growing up. I think that, for so many people who go through this process, that makes what you have written even more important, because so many people don't have that loving, easy relationship with their parents, and when that moment comes they feel a terrible sense of guilt. MJF: I would guess that, on average, people have worse relationships with their parents than we think they do. Our generation is just going through this period with these parents who we're losing and there is a sense when I talk to these people that they feel guilty. They're sort of stuck and feeling bad. And I definitely felt guilty. I put this in the book, but my husband's shrink says, 'Sometimes, when you have narcissistic parents, you feel worse that it didn't work out.' KK: What did you feel guilty about when your mother started to get dementia and you made the decision to move her into a home? MJF: In my ideal world, my mother would not be an alcoholic and I would move her into my house and she'd be painting and writing poetry and maybe [be] a little dotty. But she'd live in my house. So, I felt very bad. It was not how I wanted it to go. But I also felt that my feeling bad was a useful thing for people to see. I'm not just doing this because I'm an exhibitionist. I'm doing it because I really do think that when you have a relationship that isn't what you want and then you suffer from it, you don't have to. And I'm saying, 'I did it and you don't have to,' is sort of the goal. –-
Daily Record
5 hours ago
- Daily Record
'Inspiring' hospital chaplain dies as tributes paid to 'passionate and compassionate' woman
Reverend Captain Katie Watson has been described as a "unique, inspiring, passionate and compassionate" person who had touched thousands of lives. A popular hospital chaplain died just a month after being discharged from an inpatient mental health ward where she had been "treading water" for months, an inquest heard. Reverend Captain Katie Watson has been described by her partner Dr Emily Watson as a "unique, inspiring, passionate and compassionate" person who had touched thousands of lives. Capt Watson, who was an ordained deacon, appeared in the Channel 4 documentary Geordie Hospital and through her work at the RVI and the Freeman Hospitals she had become a much-loved local figure before her death on September 20 last year. The show, which highlighted work at Newcastle's Royal Victoria Infirmary and Freeman Hospital during the later periods of the Covid-19 pandemic, featured her on the wards supporting colleagues and patients, along with welfare dogs Poppy Jingles and Fern. As reported by the Chronicle, acting senior coroner Karin Welsh heard at the inquest how Rev'd Capt Watson's mental health had worsened through 2023 and she had struggled with issues including suicidal ideation. Welsh ruled In her conclusion that Rev'd Capt Watson's death was suicide. In her remarks, however, the coroner added that Rev'd Capt Watson had been absent from work due to her mental health for a period in late 2022, and then again from October 2023 - this latter absence followed a colleague's death. She had also experienced an interpersonal issue at work which contributed to her stress. Welsh also referred to how Rev'd Capt Watson had not had a named psychologist for a seven week period during her time as an inpatient- but said it would be "conjecture" to draw any firm conclusions about the impact this would have had on her discharge from hospital - or when that might have been. Another issue saw details of a discharge letter shared with Rev'd Capt Watson via the NHS App, causing her distress as elements of her "formulation" had not be discussed with her. Welsh also said she could "understand the position that Katie was treading water" when on the ward, rather than making progress with regard to her recovery. She added that issues at work had "clearly caused Katie distress" but added: "In my view these issues were managed appropriately by the trust." The coroner paid tribute to Rev'd Capt Watson, saying: "As an army captain, but then Chaplain Katie had great empathy for those she was involved with at work, where she went above and beyond." She said that "underlying issues" appeared to have come to the fore - and added: "In short, although some elements of her care could have been done differently, it's my view this would not have altered the outcome for Katie. Therefore my conclusion must be one of suicide." Acting senior coroner Welsh added that those she worked with in pathology had spoken highly of Rev'd Capt Watson - and that she was described as "exceptionally helpful" in complex and difficult cases involving the deaths of children. Following the inquest, Dr Watson paid a moving tribute. She said: "Katie was a unique, inspiring, passionate and compassionate person who touched the lives of thousands of people. I am very grateful for the many hundreds of cards and messages I received when she died, and all the stories of how her ministry supported people at some of their darkest times. It is desperately sad that she wasn't able to see for herself how loved she was, and I am sorry that mental health services in their current condition were not able to help her. She is deeply missed by us all." Join the Daily Record WhatsApp community! Get the latest news sent straight to your messages by joining our WhatsApp community today. You'll receive daily updates on breaking news as well as the top headlines across Scotland. No one will be able to see who is signed up and no one can send messages except the Daily Record team. All you have to do is click here if you're on mobile, select 'Join Community' and you're in! If you're on a desktop, simply scan the QR code above with your phone and click 'Join Community'. We also treat our community members to special offers, promotions, and adverts from us and our partners. If you don't like our community, you can check out any time you like. To leave our community click on the name at the top of your screen and choose 'exit group'. If you're curious, you can read our Privacy Notice. The inquest earlier evidence both from the psychiatric consultants - employed by the Cumbria, Northumberland, Tyne and Wear NHS Trust - who were responsible for Rev'd Capt Watson's care in hospital and in the community. Newcastle Hospitals NHS Trust joint medical director Dr Michael Wright also gave evidence as to the issues experienced at work. Dr Wright said: "It's of immense concern to me and many others that a member of staff - one of our members of staff most valued by others - clearly at times did not feel that way. We have all reflected as to whether we did all we could to make her feel valued and [to show her] quite how important she was to our organisation. Procedures and processes were followed but does that mean there isn't anything we can learn from this? Absolutely not." He agreed that Revd Capt Watson was a "huge miss" and said work was ongoing to embed an NHS England "toolkit" designed to prevent NHS staff from dying due to suicide. The inquest had heard how her "exceptionally high standards" may have put herself under significant strain, while psychiatrists also referred to her experience of trauma during the worst of the Covid-19 pandemic. In court, Dr Watson queried why the trauma that her partner had experienced was not considered a greater factor in her diagnostic "formulation" while an inpatient - which instead focussed on "personality traits" and "emotionally unstable personality disorder". It was an element of this diagnosis was mentioned in a letter that one of Rev'd Capt Watson's consultants had not realised would be uploaded to her NHS App - and this caused her "significant distress" in the weeks prior to her death. However, Dr Faheem Ahmad said the opinion of staff at the inpatient ward during her months-long admission had been that Capt Watson's struggles were focussed around situations at her workplace and her "anger" at those. Dr Rachael Hall spoke in court to say she had not realised this would be the case and had made an urgent effort - accepted by Rev'd Capt Watson, to speak with her, explain the situation and continue their work together. Rev'd Capt Watson's death last autumn saw huge numbers of tributes - including from the senior Church of England Bishop of Newcastle and Northumberland. Right Reverend Dr Helen-Ann Hartley and the Right Reverend Mark Wroe. They said: "It is with a profound sense of sadness and grief that we received the news about Katie, and our first thoughts are with her partner Emily and their children and all who knew and loved Katie. "From her much valued work as a hospital chaplain, which reached beyond the bounds of the North East, to her many colleagues from her past career, and the sporting and running communities she was a part of, to all of us here in the Diocese of Newcastle, we mourn her death with a deep feeling of loss."
Wales Online
6 hours ago
- Wales Online
Company linked to Tory Peer Baroness Mone should pay back £121m for ‘faulty' PPE, High Court hears
Company linked to Tory Peer Baroness Mone should pay back £121m for 'faulty' PPE, High Court hears PPE Medpro is being sued for an alleged breach of contract over the supply of PPE during the Covid pandemic, with the Government claiming the gowns were unusable The company in court is linked to Baroness Mone (Image: PA Archive/PA Images ) A company linked to Tory peer Michelle Mone should pay back more than £121 million for breaching a Government contract for 25 million surgical gowns during the coronavirus pandemic, the High Court has heard. The Department of Health and Social Care (DHSC) is suing PPE Medpro for allegedly breaching a deal for the gowns, with lawyers for the Government telling the court they were "faulty" because they were not sterile. The company, a consortium led by Baroness Mone's husband, businessman Doug Barrowman, was awarded Government contracts by the former Conservative administration to supply PPE during the pandemic, after she recommended it to ministers. Any wrongdoing has been denied. For our free daily briefing on the biggest issues facing the nation, sign up to the Wales Matters newsletter here The Government is seeking to recover the costs of the contract, as well as the costs of transporting and storing the items, which amount to an additional £8,648,691. PPE Medpro said it "categorically denies" breaching the contract, and its lawyers claimed the company had been "singled out for unfair treatment". Opening the trial on Wednesday, Paul Stanley KC, for the DHSC, said: "This case is simply about whether 25 million surgical gowns provided by PPE Medpro were faulty. Article continues below "It is, in short, a technical case about detailed legal and industry standards that apply to sterile gowns." Mr Stanley said in written submissions the "initial contact with Medpro came through Baroness Mone", with discussions about the contract then going through one of the company's directors, Anthony Page. Baroness Mone remained "active throughout" the negotiations, Mr Stanley said, with the peer stating Mr Barrowman had "years of experience in manufacturing, procurement and management of supply chains". But he told the court Baroness Mone's communications were "not part of this case", which was "simply about compliance". He said: "The department does not allege anything improper happened, and we are not concerned with any profits made by anybody." In court documents from May this year, the DHSC said the gowns were delivered to the UK in 72 lots between August and October, 2020, with £121,999,219.20 paid to PPE Medpro between July and August that year. The department rejected the gowns in December, 2020, and told the company it would have to repay the money, but this has not happened and the gowns remain in storage, unable to be used. In written submissions for trial, Mr Stanley said 99.9999% of the gowns should have been sterile under the terms of the contract, equating to one in a million being unusable. The DHSC claims the contract also specified PPE Medpro had to sterilise the gowns using a "validated process", attested by CE marking, which indicates a product has met certain medical standards. He said "none of those things happened", with no validated sterilisation process being followed, and the gowns supplied with invalid CE marking. He continued that 140 gowns were later tested for sterility, with 103 failing. He said: "Whatever was done to sterilise the gowns had not achieved its purpose, because more than one in a million of them was contaminated when delivered. "On that basis, DHSC was entitled to reject the gowns, or is entitled to damages, which amount to the full price and storage costs." In his written submissions, Charles Samek KC, for PPE Medpro, said the "only plausible reason" for the gowns becoming contaminated was due to "the transport and storage conditions or events to which the gowns were subject", after they had been delivered to the DHSC. He added the testing did not happen until several months after the gowns were rejected, and the samples selected were not "representative of the whole population", meaning "no proper conclusions may be drawn". He said the DHSC's claim was "contrived and opportunistic" and PPE Medpro had been "made the 'fall guy' for a catalogue of failures and errors" by the department. He said: "It has perhaps been singled out because of the high profiles of those said to be associated with PPE Medpro, and/or because it is perceived to be a supplier with financial resources behind it. "In reality, an archetypal case of 'buyer's remorse', where DHSC simply seeks to get out of a bargain it wished it never entered into, left, as it is, with over £8 billion of purchased and unused PPE as a result of an untrammelled and uncontrolled buying spree with taxpayers' money." He also said there was a "delicious irony" that Baroness Mone was mentioned in the DHSC's written submissions, when she had "zero relevance to the contractual issues in this case". Neither Baroness Mone nor Mr Barrowman is due to give evidence in the trial, and did not attend the first day of the hearing on Wednesday. A PPE Medpro spokesperson said the company "categorically denies breaching its obligations" and will "robustly defend" the claim. Article continues below The trial before Mrs Justice Cockerill is due to last five weeks, with a judgment expected in writing at a later date.
