Frederik Schaltz-Buchholzer
@fsbuchholzer.bsky.social
MD PhD, Assistant Professor at Bandim Health Project
@SyddanskUni
Vaccine trials & epi.
Father of 2, polyglot.
WhatsApp (+45) 42702170
✉️ frederik@bandim.org
https://x.com/FSBuchholzer
@SyddanskUni
Vaccine trials & epi.
Father of 2, polyglot.
WhatsApp (+45) 42702170
✉️ frederik@bandim.org
https://x.com/FSBuchholzer
I encourage you to research the protocol for the study and then provide your comments to the study design:
www.bandim.org/protocol-for...
www.bandim.org/protocol-for...
Protocol for the trial: The broader health effects of Hepatitis B vaccination at birth: An investigator-initiated randomized controlled trial in Guinea-Bissau – Bandim Health Project
We are pleased to share the protocol for the upcoming trial, which will compare the currently recommended neonatal vaccine schedule of BCG + OPV vaccines to the future policy of BCG + OPV + HBV0, in r...
www.bandim.org
January 21, 2026 at 4:31 PM
I encourage you to research the protocol for the study and then provide your comments to the study design:
www.bandim.org/protocol-for...
www.bandim.org/protocol-for...
We do not have the authority to change the vaccination programme in Guinea-Bissau and decide that everyone should receive Hep. B.
So if the study was not to move forward, 0 newborns would receive the vaccine.
So if the study was not to move forward, 0 newborns would receive the vaccine.
January 21, 2026 at 4:29 PM
We do not have the authority to change the vaccination programme in Guinea-Bissau and decide that everyone should receive Hep. B.
So if the study was not to move forward, 0 newborns would receive the vaccine.
So if the study was not to move forward, 0 newborns would receive the vaccine.
We will evaluate the overall health effects of hepatitis B vaccination, which has never been done before. The two trial arms are:
BCG + OPV (current policy)
BCG + OPV + HepB
The trial will expand access to BCG and OPV with half of the participants receiving HepB, the other half standard vaccines.
BCG + OPV (current policy)
BCG + OPV + HepB
The trial will expand access to BCG and OPV with half of the participants receiving HepB, the other half standard vaccines.
January 21, 2026 at 4:28 PM
We will evaluate the overall health effects of hepatitis B vaccination, which has never been done before. The two trial arms are:
BCG + OPV (current policy)
BCG + OPV + HepB
The trial will expand access to BCG and OPV with half of the participants receiving HepB, the other half standard vaccines.
BCG + OPV (current policy)
BCG + OPV + HepB
The trial will expand access to BCG and OPV with half of the participants receiving HepB, the other half standard vaccines.
Rachael, how many of the 14000 babies in the hep B birth dose study would get a birth dose if there were no study?
January 17, 2026 at 3:42 PM
Rachael, how many of the 14000 babies in the hep B birth dose study would get a birth dose if there were no study?
It seems that you have misunderstood the design of the study. I don't blame you, because misinformation about it has been rampant.
January 16, 2026 at 9:42 PM
It seems that you have misunderstood the design of the study. I don't blame you, because misinformation about it has been rampant.
If the trial should be cancelled, it would mean that at least 7,500 less newborns would get the Hepatitis B vaccine. Would that make you happy?
Fortunately, it has not been cancelled.
Fortunately, it has not been cancelled.
January 16, 2026 at 9:41 PM
If the trial should be cancelled, it would mean that at least 7,500 less newborns would get the Hepatitis B vaccine. Would that make you happy?
Fortunately, it has not been cancelled.
Fortunately, it has not been cancelled.
The trial in question will investigate whether adding HBV0 to the current policy of BCG and OPV at birth in Guinea-Bissau is associated with non-specific effects (positive, none, or detrimental).
Since few African countries have implemented HBV0, this is a very relevant study question.
Since few African countries have implemented HBV0, this is a very relevant study question.
January 13, 2026 at 4:11 PM
The trial in question will investigate whether adding HBV0 to the current policy of BCG and OPV at birth in Guinea-Bissau is associated with non-specific effects (positive, none, or detrimental).
Since few African countries have implemented HBV0, this is a very relevant study question.
Since few African countries have implemented HBV0, this is a very relevant study question.
You can read more in this meta-analysis of the available data: pubmed.ncbi.nlm.nih.gov/27737834/
Association of BCG, DTP, and measles containing vaccines with childhood mortality: systematic review - PubMed
Evidence suggests that receipt of BCG and MCV reduce overall mortality by more than would be expected through their effects on the diseases they prevent, and receipt of DTP may be associated with an increase in all cause mortality. Although efforts should be made to ensure that all children are imm …
pubmed.ncbi.nlm.nih.gov
January 6, 2026 at 10:33 AM
You can read more in this meta-analysis of the available data: pubmed.ncbi.nlm.nih.gov/27737834/
I wouldn't go that far, but we should investigate why especially female mortality is increased after DTP vaccination, & we could reduce the negative non-specific effects by given a live vaccine shortly after.
You can read more here:
pubmed.ncbi.nlm.nih.gov/32645296/
pubmed.ncbi.nlm.nih.gov/32185398/
You can read more here:
pubmed.ncbi.nlm.nih.gov/32645296/
pubmed.ncbi.nlm.nih.gov/32185398/
Vaccinology: time to change the paradigm? - PubMed
The existing vaccine paradigm assumes that vaccines only protect against the target infection, that effective vaccines reduce mortality corresponding to the target infection's share of total mortality, and that the effects of vaccines are similar for males and females. However, epidemiological vacci …
pubmed.ncbi.nlm.nih.gov
December 26, 2025 at 10:49 PM
I wouldn't go that far, but we should investigate why especially female mortality is increased after DTP vaccination, & we could reduce the negative non-specific effects by given a live vaccine shortly after.
You can read more here:
pubmed.ncbi.nlm.nih.gov/32645296/
pubmed.ncbi.nlm.nih.gov/32185398/
You can read more here:
pubmed.ncbi.nlm.nih.gov/32645296/
pubmed.ncbi.nlm.nih.gov/32185398/
Not surprised at all that you had zero arguments for why that paper is garbage.
I'll block you now.
I'll block you now.
December 26, 2025 at 10:47 PM
Not surprised at all that you had zero arguments for why that paper is garbage.
I'll block you now.
I'll block you now.
You clearly havent read the paper, or any of our papers. I am not surprised.
December 26, 2025 at 10:46 PM
You clearly havent read the paper, or any of our papers. I am not surprised.
The findings have been replicated many times. The dataset is unique because it stems from the introduction of DTP in Guinea-Bissau, something that of course only happened once.
December 25, 2025 at 9:00 PM
The findings have been replicated many times. The dataset is unique because it stems from the introduction of DTP in Guinea-Bissau, something that of course only happened once.
Well enlighten us then. Why is this and all other DTP studies (there are many) garbage? Which bias can, within the same dataset, have some vaccines (like MV and BCG) associated with reduced all-cause mortality, and DTP associated with increased mortality? pubmed.ncbi.nlm.nih.gov/11110734/
Routine vaccinations and child survival: follow up study in Guinea-Bissau, West Africa - PubMed
These trends are unlikely to be explained exclusively by selection biases since different vaccines were associated with opposite tendencies. Measles and BCG vaccines may have beneficial effects in addition to protection against measles and tuberculosis.
pubmed.ncbi.nlm.nih.gov
December 25, 2025 at 8:56 PM
Well enlighten us then. Why is this and all other DTP studies (there are many) garbage? Which bias can, within the same dataset, have some vaccines (like MV and BCG) associated with reduced all-cause mortality, and DTP associated with increased mortality? pubmed.ncbi.nlm.nih.gov/11110734/
If you read my post and analyse how events have actually unfolded, do give me a breakdown of the positives and negatives following his nomination?
For the positive, removing unnecessary dyes from food and removing an unnecessary universal hepatitis B shot (reserving it for those in need), was good.
For the positive, removing unnecessary dyes from food and removing an unnecessary universal hepatitis B shot (reserving it for those in need), was good.
December 22, 2025 at 11:20 PM
If you read my post and analyse how events have actually unfolded, do give me a breakdown of the positives and negatives following his nomination?
For the positive, removing unnecessary dyes from food and removing an unnecessary universal hepatitis B shot (reserving it for those in need), was good.
For the positive, removing unnecessary dyes from food and removing an unnecessary universal hepatitis B shot (reserving it for those in need), was good.
It is published in a good journal, and includes a completely unique dataset. Reproduces the result of many other DTP studies showing the same (negative) effect on all-cause mortality. But all of that is of course garbage to you because you don't like the conclusions.
December 22, 2025 at 11:18 PM
It is published in a good journal, and includes a completely unique dataset. Reproduces the result of many other DTP studies showing the same (negative) effect on all-cause mortality. But all of that is of course garbage to you because you don't like the conclusions.
In a Danish trial, BCG did not have NSEs, except if the mother had received BCG. pubmed.ncbi.nlm.nih.gov/27443836/
In a Ugandan trial, normal birth weight infants were randomized to BCG at birth or at 6 weeks, with BCG at birth associated with fewer infections.
www.thelancet.com/journals/lan...
In a Ugandan trial, normal birth weight infants were randomized to BCG at birth or at 6 weeks, with BCG at birth associated with fewer infections.
www.thelancet.com/journals/lan...
BCG-induced non-specific effects on heterologous infectious disease in Ugandan neonates: an investigator-blind randomised controlled trial
BCG vaccination protects against non-tuberculous infectious disease during the neonatal
period, in addition to having tuberculosis-specific effects. Prioritisation of BCG
on the first day of life in h...
www.thelancet.com
November 18, 2025 at 10:07 PM
In a Danish trial, BCG did not have NSEs, except if the mother had received BCG. pubmed.ncbi.nlm.nih.gov/27443836/
In a Ugandan trial, normal birth weight infants were randomized to BCG at birth or at 6 weeks, with BCG at birth associated with fewer infections.
www.thelancet.com/journals/lan...
In a Ugandan trial, normal birth weight infants were randomized to BCG at birth or at 6 weeks, with BCG at birth associated with fewer infections.
www.thelancet.com/journals/lan...
If it is simply specific, then why is measles vaccination associated with reduced all-cause mortality when there is no measles? Why do measles survivors have lower mortality risk? Why does measles vaccination only have NSEs when provided in the presence of maternally-derived antibody?
November 18, 2025 at 10:02 PM
If it is simply specific, then why is measles vaccination associated with reduced all-cause mortality when there is no measles? Why do measles survivors have lower mortality risk? Why does measles vaccination only have NSEs when provided in the presence of maternally-derived antibody?
If this is just inflammation, shouldn't there be examples of other pro-inflammatory substances that has been shown to greatly reduce mortality in frail newborns like these?
Also, if this is just a temporary inflammatory effect, then why does infants with a BCG scar have lower long-term mortality?
Also, if this is just a temporary inflammatory effect, then why does infants with a BCG scar have lower long-term mortality?
November 18, 2025 at 10:00 PM
If this is just inflammation, shouldn't there be examples of other pro-inflammatory substances that has been shown to greatly reduce mortality in frail newborns like these?
Also, if this is just a temporary inflammatory effect, then why does infants with a BCG scar have lower long-term mortality?
Also, if this is just a temporary inflammatory effect, then why does infants with a BCG scar have lower long-term mortality?
I honestly don't recall having had a brawl with you. I remember being surprised to have been blocked by you.
Enlighten me, what was it about?
Enlighten me, what was it about?
November 18, 2025 at 9:56 PM
I honestly don't recall having had a brawl with you. I remember being surprised to have been blocked by you.
Enlighten me, what was it about?
Enlighten me, what was it about?
You can read about non-specific effects of vaccines here:
pubmed.ncbi.nlm.nih.gov/32645296/
I understand that we disagree in regard to what appropriate controls are in this context.
pubmed.ncbi.nlm.nih.gov/32645296/
I understand that we disagree in regard to what appropriate controls are in this context.
Vaccinology: time to change the paradigm? - PubMed
The existing vaccine paradigm assumes that vaccines only protect against the target infection, that effective vaccines reduce mortality corresponding to the target infection's share of total mortality, and that the effects of vaccines are similar for males and females. However, epidemiological vacci …
pubmed.ncbi.nlm.nih.gov
November 17, 2025 at 8:49 AM
You can read about non-specific effects of vaccines here:
pubmed.ncbi.nlm.nih.gov/32645296/
I understand that we disagree in regard to what appropriate controls are in this context.
pubmed.ncbi.nlm.nih.gov/32645296/
I understand that we disagree in regard to what appropriate controls are in this context.
The BLOW2 trial is not small, featurng more than 5,000 neonates and >500 events, it is the largest trial of BCG done in decades. The GB low birth weight trials are not as large, but also not small.
The reason why such groups are investigated is because vaccination is often delayed for them.
The reason why such groups are investigated is because vaccination is often delayed for them.
November 17, 2025 at 8:47 AM
The BLOW2 trial is not small, featurng more than 5,000 neonates and >500 events, it is the largest trial of BCG done in decades. The GB low birth weight trials are not as large, but also not small.
The reason why such groups are investigated is because vaccination is often delayed for them.
The reason why such groups are investigated is because vaccination is often delayed for them.
I am not sure what this comes from? Why so confrontative? I just came here for a scientific discussion about the BLOW2 trial.
But you are more than welcome to block if you are not interested in sharing scientific ideas about non-specific effects of vaccines.
But you are more than welcome to block if you are not interested in sharing scientific ideas about non-specific effects of vaccines.
November 17, 2025 at 8:46 AM
I am not sure what this comes from? Why so confrontative? I just came here for a scientific discussion about the BLOW2 trial.
But you are more than welcome to block if you are not interested in sharing scientific ideas about non-specific effects of vaccines.
But you are more than welcome to block if you are not interested in sharing scientific ideas about non-specific effects of vaccines.
We investigated this 5 years ago & found that BCG induces G-CSF within hours of administration in both mice & humans, resulting in emergency granulopoiesis and a spike of neutrophils from the bone marrow, which in a murine sepsis model was protective against death.
pubmed.ncbi.nlm.nih.gov/32376769/
pubmed.ncbi.nlm.nih.gov/32376769/
BCG vaccination-induced emergency granulopoiesis provides rapid protection from neonatal sepsis - PubMed
Death from sepsis in the neonatal period remains a serious threat for millions. Within 3 days of administration, bacille Calmette-Guérin (BCG) vaccination can reduce mortality from neonatal sepsis in human newborns, but the underlying mechanism for this rapid protection is unknown. We found that BCG …
pubmed.ncbi.nlm.nih.gov
November 17, 2025 at 8:41 AM
We investigated this 5 years ago & found that BCG induces G-CSF within hours of administration in both mice & humans, resulting in emergency granulopoiesis and a spike of neutrophils from the bone marrow, which in a murine sepsis model was protective against death.
pubmed.ncbi.nlm.nih.gov/32376769/
pubmed.ncbi.nlm.nih.gov/32376769/
I don't really see why you would want to have a vaccination/inflammation control, if the purpose is to test whether BCG has non-specific effects.
Is it because you would like to see if you can substitute BCG for something else? If yes, what for?
If anything, there should be 3 arms then, I'd say.
Is it because you would like to see if you can substitute BCG for something else? If yes, what for?
If anything, there should be 3 arms then, I'd say.
November 17, 2025 at 8:32 AM
I don't really see why you would want to have a vaccination/inflammation control, if the purpose is to test whether BCG has non-specific effects.
Is it because you would like to see if you can substitute BCG for something else? If yes, what for?
If anything, there should be 3 arms then, I'd say.
Is it because you would like to see if you can substitute BCG for something else? If yes, what for?
If anything, there should be 3 arms then, I'd say.
The BLOW2 trial reproduces findings of non-specific effects of BCG-Danish from Guinea-Bissau (pubmed.ncbi.nlm.nih.gov/29579158/) and Uganda (pubmed.ncbi.nlm.nih.gov/33609457/).
I find double-blind, in the context of neonatal mortality, to be unnecessary and potentially unethical.
I find double-blind, in the context of neonatal mortality, to be unnecessary and potentially unethical.
Early BCG-Denmark and Neonatal Mortality Among Infants Weighing <2500 g: A Randomized Controlled Trial - PubMed
NCT00625482.
pubmed.ncbi.nlm.nih.gov
November 17, 2025 at 8:30 AM
The BLOW2 trial reproduces findings of non-specific effects of BCG-Danish from Guinea-Bissau (pubmed.ncbi.nlm.nih.gov/29579158/) and Uganda (pubmed.ncbi.nlm.nih.gov/33609457/).
I find double-blind, in the context of neonatal mortality, to be unnecessary and potentially unethical.
I find double-blind, in the context of neonatal mortality, to be unnecessary and potentially unethical.