Coming Clean on Neonatal Deaths

This post by Peter Selley needs reading in conjunction with Uterine Roulette, Lonesome Heroines and Silent Health.  It is about our rights to information rather than about vaccines per se. There is an industry playbook here put in place with SSRI drugs over 30 years ago that needs recognizing and tackling.

GSK (GlaxoSmithKline) are dragging their feet about being transparent with the data from their pivotal phase 3 Respiratory Syncytial Virus (RSV) vaccine trial in pregnant women, terminated on safety grounds in February 2022.

See also:

• 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

This commercial development, codenamed GRACE, was designed to assess an RSVpreF3 vaccine given in pregnancy to prevent RSV chest infections in babies. It was stopped when an excess of preterm births and neonatal deaths became apparent.

These tragedies must have been “significant” to the women and their families, but, by all standards, the risk was also “statistically significant”.

Stopping a commercial exercise like this was the right thing to do. What was and is wrong is not explaining fully what happened. Rumours of a pre-term births issue were circulating in the investment community as early as March 2022.

Pfizer definitely knew by October; not surprisingly as Eric Simões (see below), lead author of Pfizer’s Phase 2 trial and in charge of their Phase 3 trial, was on the Data Safety Monitoring Board that warned GSK to stop.

The rest of the world had to wait until Freedom of Information requests in November confirmed the danger – a danger that GSK and the wider vaccine community desperately, it seems, wanted kept under wraps.  Pre-term births have not been the only problem, there were neonatal deaths as well.  And we still don’t have any of the details that might help make sense of this.

The RSVpreF3 vaccine had only been tested in pregnant rats and rabbits – animals whose pregnancies last for one month or less. The only monitoring of the animals’ pregnancies was daily weighing.

There were no Phase 1 intensive safety studies in pregnant women.

In November 2022 I asked medical.information@gsk.com for further information and was told “We are still investigating”.

GSK in Phases

Let’s go back to 2020 when the preliminary Phase 2 trial of this product in pregnant women started.

The trial design recognised the risk of preterm births – so much so that a safety “trigger” was set. But it required about a quarter of births to occur before 37 weeks’ gestation before the trigger would be activated. There was no safety trigger for pre-eclampsia.

This small study showed a slight excess of preterm births in the vaccinated group, but the warning signs were there for disruption to maternal metabolism.

Blood pressure-related problems were reported as an Adverse Event of Special Interest (AESI) more frequently in the two vaccinated groups, compared to the placebo group (far right column).

However the study concluded that RSVPreF3 maternal vaccination had an “acceptable safety risk profile”, and waxed lyrical about the massive increase in RSV antibody titres in the babies’ blood samples.

Phase 3

5,330 women were enrolled in this placebo-controlled trial of the vaccine given between 24 and 34 weeks of pregnancy. The only information we have comes from a conference presentation.

GSK’s Ilse Dieussaert (above) drew the short straw and had to present some sketchy findings – See Ilse’s Presentation – about the “Safety Signal” of preterm births at the ReSViNET “Vaccinate the World” congress in Lisbon in February 2023.

Ilse’s presentation was ghost-written by Iona Sima of Akkodis Belgium. She describes an “imbalance” in the proportions of preterm births and neonatal deaths, which is a delicate term to describe the statistically significant danger – in the vaccine group.

This presentation contains the only commercially sensitive information that has been allowed out from this commercial exercise. There is a formal acknowledgment of the problem in GSK’s brief RSVPreF3 OA Sponsor Briefing Document (section 6) for the FDA Hearing that approved the same vaccine for use in people over the age of 60. .

Since then there has been complete radio silence from all RSV researchers about this trial.

Come in Geeta

Dr Geeta K Swamy was the only named author on Ilse’s Lisbon presentation who was not a GSK employee.

Geeta (R) was chair of the INDEPENDENT Data Safety Monitoring Board (DSMB) that made GSK stop their trial. Dr Eric Simões (L), of course, was a member of the same DSMB but also an “author” of the Pfizer RSV Vaccine trial publications. He also ran clinical trials giving AstraZeneca’s nirsevimab (RSV antibody) to newborn babies.

I am at a loss to understand how Geeta could claim to be INDEPENDENT of GSK when she has been employed by them as a clinical trials investigator for other products.

She confesses to being chair of Independent Data Monitoring Committees for GSK (RSV vaccine) and Pfizer (Group B Strep vaccine), Member DSMB National Cancer Institute (HPV vaccine), Member Immunization Expert Group at the American College of Obstetrics and Gynecology. Investigator for clinical trials sponsored by Novavax, GlaxoSmithKline, Regeneron, Pfizer, NIH, and US Centers for Disease Control & Prevention.

The RSV Club is close knit. Almost all the researchers in this field are sponsored by all the vaccine manufacturers and do the peer-review for each other’s articles. Senior members of the club are flown around the world to conferences by Pharma who pay them to sit on DSMBs for their colleagues’ trials.

The report of the GSK Phase 3 trial in older adults of the adjuvanted RSVpreF3 vaccine, ghostwritten by Natalie Denef, of Modis, was published in the NEJM in February 2023. But the outcomes of the pregnant women’s trial, which started and finished before the Older Adult trial remain unpublished.

A Pre-Eclampsia Hypothesis

Let’s go back to part of Ilse’s presentation, which tries to explain the preterm births.

GSK best suggestion is that “additional vaccines” hinting at Covid vaccines might be associated with the excess preterm births particularly in lower income countries.  Difficult to know what to make of the Covid vaccine hint – given the abandonment of the Pfizer trial – but perhaps better the Covid vaccine than the Flu or TDAP vaccines – see Uterine Roulette.

This would fit in with what may be a new hypothesis that the preterm births are linked to pre-eclampsia triggered by “inflammation” and the more vaccine shots you have the more inflammation you get – see Uterine Roulette.  To gauge what is happening women who have nothing to do with GSK or the RSV industry need the data from this study.

Note added the day after posting

The termination of Pfizer’s Maternal Covid Vaccine Trial in October 2021, after less than 400 or a projected 4000 women were recruited, is shrouded in mystery.  See Uterine Roulette.  The story put around by Pfizer it seems and promoted by bioethicists who favor empowering women by getting them involved in trials is that by then pretty well everyone had been been vaccinated and it was difficult to recruit.

In early November, Icon who were running the trial on behalf of BioNTech (A Pfizo who is not barking) contacted all research centres telling them that in early August 2021, following discussions with FDA, a revised protocol for the trials included myocarditis and pericarditis as Adverse Events of Special Interest. This with other factors meant that a decision was taken to termination recruitment in late October.

Amazing GRACE?

We still know nothing about maternal safety in terms of preeclampsia/gestational hypertension in the mothers, yet alone about efficacy in the babies in GSK’s RSV GRACE venture.

Now is the time for organisations like ReSViNET, BMGF, and PROMISE, to bite the bullet and discuss the premature births and neonatal deaths issue, and insist that GSK publish the results. The problem is not going to “go away”.

GSK said that neonatal deaths were to be expected in premature babies and had no other cause. There is something inherently wrong about these deaths being dusted under the carpet.

“An in-depth qualitative review of the clinical information available for each neonatal death concluded that the events leading to neonatal death (e.g., very low or low birth weight, sepsis, necrotizing colitis, pneumonia, respiratory distress syndrome, hypoxic-ischemic injury) are commonly observed in preterm-born infants, particularly those who are extremely and very preterm”

That is a whitewash. The suggestion that stopping the trial was all that had to be done to put things right is just not right.

If that number of deaths (13/3496 vs 3/1739 – RR 2.16) had occurred in a trial in a developed country, there would have been an outrage.

Until such time as another patho-physiological explanation is found the assumption must be that vaccination in pregnancy is always dangerous. It is not acceptable to say the cause is having the vaccine in a poorer country.

The charismatic Dr Louis Bont who runs ReSViNET must have something to say about the GSK problem, which is also seen in the Pfizer trials, and the implication for low and middle income countries where infants take the RSV toll.  Given he is surrounded by just as many Bont Girls, surely he is no less intrepid than 007 in getting to grips with things that need solving.

ContraConcePTION

The Utrecht Medical Centre has recently announced ConcePTION, with which Louis has links.  This aims to set up a registry to make medicines safer for pregnant and breastfeeding women. It is generously sponsored by EFPIA – the European Pharmaceutical Industry.

They use the language of empowerment to good effect but despite asking, ConcePTION has not clarified whether they include maternal vaccines in their remit. Surely they must. But they need to think outside the box and do more than focus on drugs in breast milk as currently billed. In the light of the GSK RSV exercises here and the closely related Pfizer exercises outlined in Uterine Roulette, what about looking closely at placental function and histology?

Pre-eclampsia is a 2,500 year old mystery. Isn’t it time we worked out what is going on?