This post is by Peter Selley, – a doctor and RSV research trail blazer.
‘Tis the season to be jolly.
In the Northern hemisphere the dreadful RSV season is drawing to a close: man- and womankind can now relax.
But over the next few weeks “experts” in Europe and elsewhere will begin planning for the annual invasion by the deadly RSV virus for the 2024-25 season. In the UK tenders are already out for GSK, Pfizer and AstraZeneca to quote for supplying 6,300,000 doses of “vaccines”.
And what have you done?
Another year over
And a new one just begun
The near and the dear one
The old and the young
RSV is a winter virus that causes colds in people of all ages. It sometimes causes chest infections in children, especially those with underlying diseases, and is one of several viruses that can affect any youngsters over the age of 60 who have chronic conditions.
See previous posts:
- Yellow and Other Virus and Vaccine Perils
- A Shot in the Dark for Pregnant People
- Women, Pregnancy, and Clinical Trials
- Another Brick in the Wall
- Women and Children First: The RSV Iceberg
- Coming Clean on Neonatal Deaths
It is worth pointing out at the onset that none of the vaccine manufacturers have claimed that their vaccine saves lives.
When the vaccine season arrives on this side of the pond we have a chance to learn from the cock-eyed roll out of the RSV vaccines in the USA.
Supposedly outstanding efficacy results of clinical trials for the three products were all published in the summer of 2023.
- Pfizer’s Abrysvo for pregnant people and older adults,
- GSK’s Arexvy for older adults (but not pregnant people)
- Beyfortus, a monoclonal antibody, called a vaccine for babies.
All 3 were hastily licensed and approved with warped speed. With massive publicity all three products were let loose on the American public at the same time. There was a race to get Abrysvo into pregnant people ahead of the fall RSV season. The result was shortages in all products. Some pregnant women had to drive hundreds of miles to get their hands on the life-saving vaccine.
The vaccine could be obtained in some cases from doctors’ offices, and in some cases pharmacies but it was not always clear which would qualify for reimbursement. The predictable outcome was that some pregnant women got the GSK shots meant for the elderly. These GSK shots when given to pregnant women caused preterm births and neonatal deaths. Some babies even got shots licensed for adults only. There were reports of the RSV dry powder being reconstituted with the liquid in prefilled flu shot syringes.
Panic set in with health authorities instructing vaccinators to read and check the product label at least 3 times before injecting.
Things were less chaotic in France, Spain and Luxembourg, where Beyfortus – AstraZeneca/ Sanofi Pasteur’s monoclonal antibody – had a head start. Over the winter up to 90% of newborns in Spain, for instance, were given a Beyfortus injection by default, because there was nothing else, prior to discharge from maternity units. This was done even though it had never previously been given to babies so young. In the clinical trials the average age that babies were immunised was 2.6 months.
In France, pharmacologist Hélène Banoun has shared concerns that official data show that there has been an unusual excess of deaths in babies under 6 days of age since the product was introduced. At the moment it seems that Beyfortus has a foothold in Europe: it is difficult to see where maternal vaccination will fit in, unless it is significantly cheaper.
Vaccinate the World
A much-awaited industry-sponsored ReSViNET “Vaccinate the World” conference got underway in Mumbai on 13 February with RSV and its vaccines a major focus. There was also a major damage limitation exercise.
All the usual folk were there, including coordinator Louis Bont, Gates’s Keith Klugman, and Pfizer’s Iona Munjal. Eric Simões was there but didn’t have a speaking role. (Simões, you may remember, was in the unusual position of pushing Pfizer’s trial of their RSV vaccine in pregnant people while at the same time putting the brakes on GSK’s trial of an almost identical product when rather too many preterm births and neonatal deaths appeared on the horizon).
There were two ground rules. Do not mention the GSK problem, at least not outside of closed doors. Do not dwell on preterm births, especially in South Africa.
For Pfizer, Iona Munjal glossed over their preterm problem with a couple of slides:
So that’s good: the vaccine is “safe”. It seems that since the NEJM paper, the trial has produced a few more preterm births, again with twice as many in the vaccinated group.
Sad news for South Africa where preterm births are twice as likely in the vaccinated group. The Gates Foundation has already committed a $27.5 million grant to Pfizer to support the development of an affordable multidose vial for delivery of this RSV vaccine in lower-income countries, like South Africa.
Pfizer commits to providing patent-protected medicines in Africa
The difference a day makes
Can “24 little hours” make a difference? Perhaps not but there is reliable evidence that babies born preterm do not fare so well – According to the NHS “Certain people are also believed to be more at risk of ADHD, including people who were born prematurely (before the 37th week of pregnancy)”.
This chart shows various conditions which more frequently befall the prematurely born.
If you want to know how serious prematurity can be – this Casey Crump article may alert you.
WHO goes there?
The only subtle acknowledgment of “the problem” at ReSViNET came from Daniel Feikin of the the World Health Organization’s Department of Immunizations, Vaccines, and Biologicals. WHO/IVB is funded by a grant from the Bill and Melinda Gates Foundation for work on RSV immunization. Feikin showed this slide:
WHO/Gates are going to see whether Pfizer’s RSV vaccine Abrysvo is actually safe in Africa – after it has been licensed all over the world, and experimented on an estimated 16% of pregnant Americans in the four months up to 31 January last.
Is there any danger?
No, no, not really
Just lean on me
Takin’ time to treat your friendly neighbors honestly
I’ve just been fakin’ it (Feikin it)
Hot off Press – Two Years Later
In the last few days, the New England Journal of Misinformation has published the GSK report of their ill-fated commercial trial of RSFpreF3 in pregnant women. This is the infamous GRACE trial that ran into the preterm births and neonatal deaths problem. It terminated in February 2022. GSK’s investors and regulators were told why but the rest of us have been left in the dark. Until now? No not even now.
Results from 5328 women recruited worldwide (including one from the UK) were analysed looking for an explanation. Predictably, discussion of the role of breast feeding in modifying RSV disease in kids is, once again, evident by its absence.
The ghost writers obliquely and delicately refer anonymously to Abrysvo the Pfizer equivalent product.
“However, results of interim analyses of a phase 2b trial and a phase 3 trial of a maternal RSV vaccine that contained RSV F protein in a prefusion-stabilized conformation suggested that the risk of preterm birth was higher in the vaccine groups than in the placebo groups.”
This is the type of Misinformation at which the NEJM excels.
The main aim of the GRACE trial was to confirm find out whether their vaccine, when given to pregnant women, protected babies from RSV disease. Just 100 of the 8,000 words in this article are about efficacy. No deaths from RSV were reported in either group.
The efficacy in terms of preventing RSV disease in babies up to six months of age was between 65-69%, similar to the Pfizer figures although definitions are not identical in the two trials. This means 0.5% of children may have been spared a clear RSV infection. It takes heading toward 200 women to be vaccinated to reduce infections by one.
From the safety point of view, the headline message is:
Preterm birth occurred in 6.8% of the infants (237 of 3494) in the vaccine group and in 4.9% of those (86 of 1739) in the placebo group (relative risk, 1.37; 95% confidence interval [CI], 1.08 to 1.74; P = 0.01); neonatal death occurred in 0.4% (13 of 3494) and 0.2% (3 of 1739), respectively (relative risk, 2.16; 95% CI, 0.62 to 7.56; P = 0.23). Sadly, there were also 2.5 times as many deaths in children under one year of age in the vaccinated group (20/3494 vs 4/1739).
GSK’s trial report is supported by a NEJM advertorial which, true to form, also goes to great lengths to avoid any mention of Abrysvo – referred to here as “The (FDA approved) bivalent maternal RSV vaccine”.
The advertisers conclude:
“However, given the findings of the present trial and the modest imbalance in the incidence of preterm birth in the phase 3 trial of the bivalent vaccine, postmarketing surveillance of the bivalent vaccine is warranted.”
Big deal.
Isn’t it the truth that the whole RSV prevention policy has been botched? It calls into the question the regulators’ policy of Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review.
Effectively the FDA and Pfizer are belatedly conducting a massive Phase 4 trial across the United States, instead of a smaller, gradual, monitored introduction. Will Europe and Australia follow suit before safety and efficacy outcomes in real world settings have been analysed?
Brenda Baletti has written about the Grace Trial and NEJM here and gives some more detail on the advertisers.
Women of Africa Unite –
you have nothing to lose but your bioethical chains
As mentioned, the Gates Foundation is funding a WHO “Impact Study” of Pfizer’s maternal RSV shot in Africa. This is well advanced but still a closely guarded secret. Below is about all that the WHO wants to share at the moment about the Pfizer “Impact Study”.
How should the consent form be worded for the pregnant women in this trial? (Thumb prints are allowed to confirm full informed consent.)
How do you explain to these women that trials of two almost identical vaccines have shown an “imbalance” of preterm births in South Africa in vaccinated pregnant women?
And what about Pfizer’s efficacy results presented by the EMA (page 77) which showed South African babies in the placebo group had less RSV disease than those in the vaccinated group?
Why would any African Women wish to participate in this Impact Trial?
susanne says
‘Modest imbalance’ That’s a novel phrase Thumbs up and promotion to whoever coined that one Horrendous it can be used in a scientific report. , Why aren’t the African women activists? One who must have heard about it surely taking this on??
Can you open a copy of the article for those of us who have no access to the journal of misinformation? Which more importantly includes women in Africa ,It could maybe be circulated through to womens’ groups in UK and USA and other countries.
Dr. David Healy says
Will try to install the article but the key material is in the post – the Pfizer slide and other company slides are all you need to see and pass on. These were presented at a relatively closed meeting rather than published in journals the public could see
David
Dr. David Healy says
By the way – great idea to make this a woman’s issue but to date none of our RSV posts – on which Peter has led – have managed to engage women even though we have passed the message to obstetricians who these days are rarely male. Part of the problem is the charge to have these trials done in pregnancy and every pregnant woman get 7 vaccines is being led by women who also hold bioethical posts.
David
Dr. David Healy says
S
Anyone can download 2 free NEJM articles per month at
this includes supplementary files
https://store.nejm.org/signup/nejm/register/default?promo=ONFLNRC1
I don’t have free downloads left for a month
David
susanne says
D
Thanks
The New England Journal Of Medicine
WELCOME, SUSANNE
Thank you for creating your free NEJM Group account, and welcome. As a registered user, you’ve joined a dedicated group of readers who turn to the New England Journal of Medicine to gain a broader understanding of their areas of interest along with useful perspectives on the practice of medicine.
Let’s all join – it’s nice to share
tim says
Thanks. Signed up.
Searched for post SSRI sexual dysfunction without result.
I have however: “Joined a dedicated group of readers who turn to the NEJM to gain a broader understanding of their areas of interest along with useful perspectives on the practice of medicine”..
Two free NEJM articles per month is a valuable opportunity .
annie says
a doctor, and RSV research trail blazer, with thanks to Peter
Right from the Word Go, Peter Selley has been the ‘trailblazer’ from FDA initial submissions to his fact-finding blog today.
What is interesting, are also the comments below; if you read the full link you can fill in the gaps from Brenda Baletti
Brenda Baletti has written about the Grace Trial and NEJM here and gives some more detail on the advertisers.
GSK and Pfizer RSV Vaccines for Pregnant Women Increased Risk of Preterm Births — GSK Ended Its Trials, but FDA Approved Pfizer Shots
https://childrenshealthdefense.org/defender/rsv-vaccine-preterm-birth-risk-pregnant-women/
Dr. David Healy, a drug safety expert, told The Defender he didn’t think most people were aware of how serious premature birth is for both infants and mothers.
Healy said:
“It leads to having a shorter lifespan, hypertension, ischemic heart disease, types 1 and 2 diabetes, lipid disorders and chronic kidney disease. Any mother who does her research — and women who give birth do more research than any other group of people on the planet — is going to find this out and be very worried.”
Healy said in addition to the risks to the baby, “The vaccine also increases risks to the mother — there is an increased hypertension risk on [the GSK] and Pfizer’s identical vaccine [Abrysvo],” he said.
“Increased hypertension in pregnancy, especially preeclampsia, has long-term health consequences for the mother — rather like the preterm birth issues for her infant,” Healy added.
“The use of statistical significance here to discount the existence of a problem is statistically illiterate. There is a very clear increase in risk that should not be discounted in this manner,” Healy said.
He added:
“In the GSK trial, 1 in 54 vaccinated babies were likely to have a preterm birth compared with not being vaccinated and even in these small trials there were neonatal deaths linked to the vaccine.
“In contrast, there were no deaths linked to RSV. And we don’t have any indications that getting RSV as an infant has long-term health consequences — any problems there are more likely linked to another underlying condition the child had prior to the RSV.
“There might be a link to asthma but even this is dubious. The key point is 166 children have to be vaccinated to prevent one severe RSV infection.
“Let me put it like this — forget the 69% efficacy this vaccine has only 0.5% efficacy in absolute terms.”
Healy came to a different conclusion, noting that “Based on the Novovax trial, this trial and the Pfizer trial I think any woman who has an RSV vaccine is making a big mistake and has been badly advised.”
“But,” he said, “I think a lot of American women understand this and most are in no rush to get it.”
Bill & Melinda Gates Foundation Announces New Commitments for Vaccine Candidates With the Potential to Reduce Newborn and Infant Deaths in Lower-Income Countries
https://www.gatesfoundation.org/ideas/media-center/press-releases/2022/09/gates-foundation-announces-grants-to-reduce-infant-mortality
The Footprint
But not the the Fingerprint…
Peter Selley says
Thanks for the kind comments. I agree that women in all countries should not be kept in the dark about the facts.
I meant to point out that the NEJM “editorial” contains this gem that deserves to be preserved in the annals of medical misinformation reporting:
“The apparent difference in the incidence of preterm birth between the bivalent-vaccine and placebo groups was largely explained by results from a single country.”
Deciphered, this coded message means:
“The apparent difference in the incidence of preterm birth between Pfizer’s ABRYSVO and placebo groups was largely explained by results from SOUTH AFRICA.”
The two authors of the advertorial have a strong bureaucratic pedigree:
From 1997 to 2017, Denise J. Jamieson worked at the Centers for Disease Control and Prevention (CDC).
Sonja Rasmussen recently joined the University of Florida after 20 years at the CDC in Atlanta.
The article has all the hallmarks of having been ghostwritten; this may be a first for an editorial in a prestige journal.
Dr. David Healy says
Peter
The South Africa story deserves a post in its own right. This post is nearly it – as Susanne has picked up. But would be great if we could put together something that put South Africa sitting out there in plain sight so that no one had any excuse for turning a blind eye to a blunt reality.
It would be great to put the Advertorial out there in plain sight also – is this the first example of what may be a ghost written editorial in a prestigious journal? A moment as important as this also needs marking.
David
David
Peter Selley says
There has been a concerning development in that the influential Royal College of Paediatricians and Child Health (President Dr Camilla Kingdon) has just written an open letter to the government begging them to introduce RSV immunisation before the general election.
https://www.rcpch.ac.uk/news-events/news/over-2000-paediatricians-healthcare-professionals-call-government-introduce-game
[n.b. Spot the Sanofi plug for Beyfortus.]
“In their letter to the Chancellor of the Exchequer and Secretary of State for Health and Social Care, paediatricians and healthcare professionals are clear that by implementing this immunisation programme, the government would relieve pressure on NHS services this winter and reduce infant and child mortality.”
The reference to reducing child mortality is a lie. None of the trials show this, and even the drug companies don’t claim this.
“Rolling out an RSV vaccine to infants could result in 108 000 fewer GP consultations” but this will create an additional >600,000 vaccinations to/for either the mother or her baby. Game changing.
See my response in theBMJ.
https://www.bmj.com/content/384/bmj.q706/rapid-responses
Seasoned readers of this blog will doubtless be able to hazard a guess as to who might have “promoted” lobbying the government.
annie says
Peter,
At the top of this article from The Independent is this video.
‘Watch Live as UK health authorities hold briefing on the vaccination of children’
Chaired by Jonathan Van-Tam, with June Raine and Professor Lim
It is worth watching just to see how they didn’t know what they were doing then –
Plenty of plugs for JCVI in the mix.
Video starts at 9.30 mins
Children will be exposed to ‘dangerous’ winter virus if ministers fail to roll out vaccine, doctors warn
https://www.msn.com/en-gb/health/other/children-will-be-exposed-to-dangerous-winter-virus-if-ministers-fail-to-roll-out-vaccine-doctors-warn/ar-BB1kc6en
It comes after warnings were levied by the college in The Independent last year over “frustrating” delays from the government’s vaccine body, the Joint Committee on Immunisations and Vaccinations (JCVI) to recommend an RSV vaccine programme.
The JCVI has now recommended the programme and the RCPCH, alongside thousands of healthcare professionals, have urged the government to act.
National Health Executive
https://www.nationalhealthexecutive.com/articles/doctors-and-nurses-urge-government-roll-out-rsv-vaccine-programme
Previous research has also suggested that RSV in UK under fives costs £80m a year. The Joint Committee on Vaccination and Immunisation has advised the government to develop an RSV programme for infants and older adults.
On 2 May 2023, Van-Tam began work as a senior medical consultant to the Covid-19 vaccine maker Moderna
Dame June Raine, Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA), announces that she will be stepping down in the Autumn following five years in the role
Wei Shen Lim, a consultant respiratory physician at Nottingham University Hospitals NHS Trust and an honorary professor at the University of Nottingham, has had an extraordinary impact on health.
If The Independent thought putting up the video, alongside their RSV article, was a really good idea, think that they got that all wrong…
Dr. David Healy says
Whether they got it right or wrong depends on whose point of view you side with. Events like this are an incoming tide – the question is whether those of us who might have doubts are rather Canute like attempting to stop an incoming tide. If we’d any sense it might be better to be part of the grateful crowd cheering the Pope or Fuhrer mobile roll by.
D
Dr. David Healy says
Is there any reason to think they can’t fool most of the people most of the time
D
annie says
I thought Peter’s comment was great and his response to the BMJ.
Unless the Treasury and Jeremy, plead poverty, the pressure is on, and if Peter is right, puts people in danger.
For The Independent to drag up a rather ridiculous half-hour with June Raine looking like a lemon, and saying very little, and to use it as an argument for RSV struck me as such a false way to present RSV which is why I brought it to Peter’s attention.
If anyone takes the trouble to watch the video, pointing out the ‘fooling’ will seem evident, and, even provocative, in a time when ‘vaccines’ should be at their utmost scrutiny
Getting our feet wet, is par for the course; the hare-course…
‘Fooling most’ is the easy part of the ride…
susanne says
I think What Peter is flagging up here has all the hallmarks of the corruption and coercion during the Covid epidemic
Based on our modelling (One of the horrors involved in misinformation put out during Covid), the number of deaths of children aged up to five attributable to RSV is relatively small but still amounts to an estimated 33 per year in the UK
bit of history about Sanofi
Pharmaceuticals
Bristol-Myers, Sanofi fined $834m over Plavix warning label
PHARMACEUTICALSREGULATION
Bristol-Myers Squibb and Sanofi were reportedly ordered to pay more than $834m to the US state of Hawaii as the companies failed to warn non-white patients about health risks related to Plavix.
Plavix is an antiplatelet medication or blood thinner, intended to reduce the risk of heart disease and stroke in people at high risk.
Judge Dean Ochiai in the city of Honolulu concluded that the companies are involved in unfair business practices from 1998 to 2010, by failing to change the drug’s label to warn about the related risks.
Ochiai presided over the four-week non-jury trial, conducted over Zoom due to the Covid-19 pandemic, and ordered Bristol-Myers and Sanofi to pay a penalty of $417m each.
Office of the Hawaii Attorney General Clare Connors initially sued the companies in 2014.
Connors said: “Puts the pharmaceutical industry on notice that it will be held accountable for conduct that deceives the public and places profit above safety.”
The companies said in a joint statement that the decision was unsupported by the law and at odds with the evidence at trial, vowed to appeal, and said that their Plavix is safe and effective.
Hawaii alleged the companies violated state consumer protection laws by marketing Plavix with misleading information about its effect on people with East Asian and Pacific Island ancestry
According to the studies, around 14% of Chinese patients are incapable of properly metabolising the drug, compared to 4% Black communities and 2% white patients.
In 2010, the US Food and Drug Administration has granted a new Plavix warning label to reflect the advanced information.
Bristol-Myers, Sanofi fined $834m over Plavix warning label
PHARMACEUTICALSREGULATION
By NS Healthcare Staff Writer 16 Feb 2021
Bristol-Myers and Sanofi are currently fighting a similar lawsuit over Plavix in the US state of New Mexico.