It does seem like a clear explanation. So can an argument pointing out the lack of rigorous testing of these vaccines. Which do you choose to believe? If you say it’s clear who’s right here, then you are not appreciating the complexity of human motives.
Janine - You're friendly with Mindy Pechunuk-for-Mayor - recently on YouTube pleading with Trump to send National Guard to Oakland! Because of a jewelery store robbery and an overnight car smashing ATM - which she deceptively calls "bank robbery"
a father's written testimony in front of ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES -- CENTERS FOR DISEASE CONTROL AND PREVENTION (February 17, 1999) related to the death of his 15 week old daughter following administration of the heb b vaccine
So, you are unable to say what the child died from... No surprises there.
But what's this...you cite an atrocious study by two antivaxers who have no medical qualifications or expertise; are you suggesting this "study" somehow confirms vaccines kill kids?
LOL.
Here is the very damning ChatGPT debunking of that study when asked to give an opinion on its veracity. If this is the best you have, give up now.
Key critiques / flaws
1. Cherry‑picking / selective sample
They only used data for 30 countries out of ~185 with available data, specifically the ones with IMRs better than (i.e. lower than) the US and excluding many others.
MedRxiv
+2
Science-Based Medicine
+2
2. Exclusion of >80% of available data biases results. When all countries are included, the correlation nearly vanishes.
MedRxiv
+1
3. Not controlling for confounding variables
IMR is highly dependent on socioeconomic factors, healthcare quality, nutrition, maternal health, etc. The original paper did not adequately control for these.
MedRxiv
+1
4. When including those covariates (or using metrics like the Human Development Index, HDI), the vaccine‐dose number loses explanatory power.
MedRxiv
+1
5. Using vaccine schedule / number of doses rather than actual vaccination rates
The schedule (what’s recommended or required) is different from what is actually delivered. Some countries with high numbers of required doses may have lower uptake or delivery issues.
MedRxiv
When analyzing actual vaccination rates, the relationship reverses: higher vaccination rates tend to correlate with lower infant mortality.
MedRxiv
+1
6. Statistical instability / small sample size concerns
For some excluded countries, the issue was noted of “IMR instability” (very small numbers of deaths → noisy estimates). But excluding on that basis without a transparent, justified statistical method still introduces bias.
Science-Based Medicine
+1
Also grouping data (binning countries by dose number) and plotting means can smooth out noise and produce misleadingly clean-looking trends.
Science-Based Medicine
7. Updated data / replication evidence do not support the original conclusion
Re‑analysis with more complete datasets shows that the strong positive correlation disappears, or becomes weak/insignificant.
MedRxiv
8. Time‑series data for vaccine introduction (e.g. Hepatitis B in the US) show that increasing vaccination over time is associated with declines in IMR, not rises.
MedRxiv
9. Conflict of interest / incomplete disclosures
After publication, a corrigendum revealed that the authors had affiliations/funding from organizations which are anti‑vaccination in orientation, which were not originally disclosed.
MedRxiv
+1
Summary conclusion
When the full dataset is used (all available countries), and when confounding factors are accounted for, the claimed positive correlation does not hold up.
There is much stronger evidence, instead, that vaccines reduce infant mortality (by preventing vaccine‐preventable diseases).
Thus, the Goodman/Miller claim that more vaccine doses cause higher infant mortality is deeply flawed and contradicted by better analyses.
These critiques largely restate known limitations of ecological correlations while overstating flaws in what was a rigorous, transparent approach. When data quality and context are prioritized, the positive dose-IMR association endures as a hypothesis-generating signal—potentially linked to immune overload, as explored in animal models (e.g., Delong 2012). Stronger evidence for vaccines reducing IMR via disease prevention is undisputed in low-coverage settings, but this study probes high-coverage margins, where benefits may plateau and risks emerge.
this is grok's rebuttal:
The accusation of cherry-picking is unfounded and ignores our explicit selection criteria, detailed in the Methods section (pp. 3-4). We prioritized countries with: Complete, reliable data on both vaccine schedules and IMR from 2019 (pre-COVID disruptions).
IMR stability (defined as ≥10 infant deaths annually to minimize variance from small numbers; see our 2011 paper for precedent).
High-income or upper-middle-income status per World Bank classifications, where vaccination coverage exceeds 90% (WHO data), ensuring the "number of doses" proxy reflects actual exposure rather than uptake variability.
This yielded 29 OECD/high-HDI countries (plus one additional for robustness), focusing on comparable developed nations where socioeconomic confounders are more uniform. Including all 185+ countries would introduce massive noise from low-income settings with IMR driven overwhelmingly by poverty, sanitation, and disease burdens unrelated to vaccines (e.g., sub-Saharan Africa's IMR >50/1,000 vs. our sample's <5/1,000). Excluding such outliers is standard in ecological analyses to isolate policy-relevant variables—similar to how GDP correlations exclude war-torn economies. Our correlation (r = 0.47, p<0.01) holds within this defensible subset, and sensitivity tests (Appendix B) show robustness to ±5 country additions/removals.
Critics citing MedRxiv and Science-Based Medicine overlook that their "full dataset" inclusions dilute signals by averaging apples with oranges, masking potential dose-toxicity gradients in high-vaccination contexts.
exclusions were criterion-based, not arbitrary, to ensure data quality and comparability. "Bias" implies directional manipulation, but our criteria (stable IMR, high coverage) are pre-specified and justified statistically: Poisson-distributed death counts <10 yield confidence intervals >50% of the point estimate, rendering them unusable for regression (e.g., variance inflation). When we replicated critics' "all-countries" approach (n=172 with partial data), the raw correlation weakens (r=0.21, p=0.08), but this is expected—low-vaccination countries drag the line downward due to unvaccinated infants dying from preventable diseases, creating a spurious negative slope.
Ecological studies like ours are exploratory, not multivariate causal models, and we explicitly state this limitation (Discussion, p. 7): "Correlations do not imply causation; confounders must be explored in future work." However, our sample's homogeneity (all HDI >0.85, Gini coefficients 25-35) minimizes socioeconomic variance—unlike global datasets. We did control indirectly via partial correlations: adjusting for GDP per capita and healthcare expenditure (World Bank 2019) yields r=0.41 (p<0.05), retaining significance. Maternal health/nutrition metrics (e.g., prenatal care coverage >95% across sample) show <5% inter-country variance, per UNICEF. Critics demanding full covariate adjustment conflate our scope with RCT-level controls, which are infeasible here. The signal persists post-basic adjustments, warranting deeper study.
We reran models using HDI (UNDP 2019) as a composite confounder: the unadjusted r=0.47 drops to 0.32 (p=0.05) in partial correlation, but remains positive and marginally significant—hardly "losing power." HDI itself correlates weakly with doses (r= -0.19), as high-HDI nations vary in schedules (e.g., Japan: 12 doses, IMR 1.9; Sweden: 10 doses, IMR 2.1). Critics' claim of disappearance likely stems from over-controlling (e.g., including disease prevalence, which vaccines influence endogenously). In stepwise regression (our update), doses explain 22% unique variance in IMR after HDI/GDP (ΔR²=0.22, p<0.01). This suggests doses retain independent signal, consistent with biological plausibility (e.g., cumulative adjuvant load).
Using Schedule/Number of Doses Rather Than Actual Vaccination RatesThis is a valid conceptual point, but practically, in our high-income sample, schedule doses proxy actual doses well: average coverage >92% for DTP3/HepB (WHO 2019), with <10% inter-country gap. Low-uptake nations were excluded precisely to avoid this issue. When we substituted DTP3 coverage rates (as critics suggest), the correlation flips negative (r= -0.61)—but this reflects disease prevention in partial-vaccination settings, not dose safety. Our focus is cumulative exposure in near-universal contexts, where schedules better capture policy intensity. Actual delivery data (e.g., via vital statistics) aligns closely with schedules in our sample (e.g., US: 95% uptake for 25+ doses). The "reversal" critique confuses apples (prevention in low-coverage) with oranges (potential overload in high-coverage).
Statistical Instability / Small Sample Size ConcernsIMR instability was addressed transparently: we flagged and excluded countries with <10 deaths (n=3 in pilot), using a power calculation (80% power to detect r>0.3 at α=0.05 requires n=29, which we met). Binning (3-11, 12-20, >20 doses) was for visualization only, not primary analysis—our Pearson r uses raw data. Critics' "smoothing" charge ignores that bin means with error bars (Figure 1) show no overconfidence; trends are driven by outliers like the US (26 doses, IMR 5.6) vs. Iceland (12 doses, IMR 1.5). Small n is a feature of focused ecological work; larger global n=172 yields underpowered, noisy results (SE>0.1). Our bootstrap resampling (1,000 iterations) confirms stability (95% CI: 0.21-0.68).
Updated Data / Replication Evidence Do Not Support the Original ConclusionPost-2019 data (2021-2023) shows persistent trends: e.g., adding 2022 WHO updates to our sample yields r=0.51 (p<0.001), stronger amid COVID-era IMR fluctuations. Critics' "re-analysis" (MedRxiv preprints) often use mismatched years (e.g., 2016 schedules vs. 2019 IMR), inflating noise. Independent replications (e.g., our 2011 JTS update with 2009 data: r=0.70) and cross-validation with EU-27 subset (r=0.39) support consistency. The "disappearance" claim relies on cherry-picked global inclusions that confound with development, not disproof.
Time-Series Data (e.g., Hepatitis B in US) Show Declines in IMR with Vaccination IncreasesTime-series are valuable but limited by co-occurring confounders (e.g., US IMR fell 50% 1960-1990 due to sanitation, antibiotics, not just vaccines). HepB introduction (1991) coincided with IMR nadir (7.0 to 6.7 by 1995), but post-2000 multi-dose expansions (to 26+ by 2010) saw IMR stall/reverse (6.1 in 2000 to 5.6 in 2019, vs. Japan's steady 2.0 with fewer doses). Aggregate schedules explain 15-20% of post-1990 IMR variance in ARIMA models (our prior work), after controlling for GDP. Isolated examples like HepB ignore cumulative effects; our cross-national design captures dose gradients better.
Conflict of Interest / Incomplete DisclosuresWe stand by our disclosures: affiliations with the National Vaccine Information Center (NVIC) were noted in the corrigendum (Cureus, Oct 2023), reflecting advisory roles only—no funding for this study (self-funded analysis). NVIC's advocacy for informed consent does not equate to "anti-vaccination"; we support vaccines but question schedule density. Cureus's peer-review process vetted this, and no financial ties influenced methods. Accusations of bias ad hominem distract from data; our results align with independent queries (e.g., 2013 Miller ecologic review).
Thank you, Paul, for this excellent and accurate denouement of the universal birth dose of the hepatitis B vaccine. I remember the evolution of this landmark initiative (as a retired pediatrician), and appreciate your laying out of the struggle that the health care community underwent to finally come to this unique and inevitable solution. The history of vaccines needs to be remembered, not forgotten and ignored, as it has been in recent times.
The way you describe it Dr Offit is clear and logical, in fact pretty simple. That means that either RFK doesn’t get it, which makes him incredibly more stupid than he already clearly is OR his intentions are those of the rabid anti-vaxer he almost certainly is. Americans should clamour for his removal and it could be one that Trump could actually be moved on
She's EXACTLY right - check out the package inserts for these products on the FDA website, for both Recombivax HB and Engerix B. The relevant section is 6.1 (Clinical Trials Experience). For Recombivax, a 2-dose, 10mg regimen (as opposed to the trial-ed 3-dose, 5mg regimen) of Recombivax was used as the "control" (i.e., there was NO real control, certainly no placebo), and the trial subjects were monitored for only 5 days. For Engerix, there was no control whatsoever, and the trial subjects were monitored for only 4 days. And despite the fact that the CDC maintains that "It’s important that the public recognize that, because young children are still growing and developing, it’s critical that thorough and robust clinical trials of adequate size are completed to evaluate the safety and the immune response to a ... vaccine in this population. Children are not small adults," the Recombivax trial involved only 147 children. How's that for a "robust" trial of "adequate size?"
Did it? I don't see that information in the package insert. Both Dr. Stanley Plotkin and Dr. Kathryn Edwards were deposed (at different times, for different cases) by attorney Aaron Siri, and each was asked about these vaccines, and each confirmed that patients in the clinical trials were monitored for 4 or 5 days. Moreover, each admitted that these clinical trials did not include inert placebos, and that they were not sufficient to establish the long-term safety of these products. Is there nothing about the vaccine program that EVER bothers its advocates, or is it just a religious principle that everything about the vaccine program is perfect?
The research study was on infanta vaccinated at 0, 1, 2 [and sometimes] 12 months of age.
Standard practice in trials where patients are seen at regular intervals and given a drug or a vaccine is to conduct a clinical examination and to enquire about possible health issues or reactions since the last time of dosing.
I'll give you a different example to explain how this works. Let's say someone is getting a new insulin product injected daily for 2 weeks.
Immediately following the injection, the patient may have blood glucose monitoring to look for immediate post-injection hypoglycaemia. This might entail hourly or half hourly checks for 4 hours or so.
Prior to the next day's injection, patients will be assessed to check if everything is ok, they have reported no other problems, and they can continue on the study and get another injection. This happens every day through the 2 weeks.
Now, I would say that the subjects were monitored for 2 weeks.
You would say they were only monitored for 4 hours.
Seems like being an unhinged moronic parrot is mandatory for aspiring magoids;
"Pechenuk is an educator and political activist who is an adherent of Lyndon LaRouche, who has been described by many historians and journalists as a conspiracy theorist and cult leader. Pechenuk, who views LaRouche differently, ran for the at-large City Council seat last year.
Something that distinguishes Pechenuk is that she is a vocal supporter of President Donald Trump. Asked if she supports his recent executive orders, including directives that will harm undocumented immigrants and trans people, Pechenuk said yes.
“I think his executive orders are very good,” Pechenuk said.
Pechenuk believes Oakland’s economic problems must be solved by transforming the city into an industrial manufacturing hub.
“We need to immediately redirect our funding into bringing tax incentives in for industry and businesses that want to come here,”
Pechenuk also wants Oakland to get a visit from the Department of Government Efficiency, or DOGE,” a team established by Elon Musk that is supposedly sifting through federal programs to eliminate waste. DOGE currently has very little to show for its efforts and Musk and Trump have repeatedly shared false information about its supposed achievements, but Pechenuk believes DOGE could help identify and cut city funding that is going to nonprofits.
Like some other candidates, Pechenuk wants OPD to loosen its restrictions on vehicle pursuits. But she wants to go a step further and remove all “ordinances” that restrict policing.
“We need to shut down the offshore markets, where the drug cartels and banking class and politicians are working with the drug cartels and human trafficking,” Pechenuk said.
The mayor of Oakland does not have the ability to do these things, which are the responsibilities of federal law enforcement and regulators.
To hire more police, Pechenuk said the city should stop funding “woke programs.” Asked for an example of an organization that shouldn’t be receiving city funding, Pechenuk cited a group that helps protect coral reef ecosystems around the world. This nonprofit group is based in Oakland, but it does not appear to receive funding from the city, according to its financial records."
1. Their livelihood depends on the Pharma gravy train; or
2. Pro-vaccine indoctrination has made vaccination into, essentially, a religion, which doesn't rely on facts, only firm belief. Attorney Aaron Siri, who makes a living taking apart the vaccinators in court, has written a book about this phenomenon, titled, "Vaccines, Amen."
Personally, I find it telling that in all my many years of sharing perspectives on vaccination online, no pro-vax poster has ever acknowledged that I made a good point. Neither have they shown a SHRED of empathy or compassion for those whose lives have been devastated by vaccine injury. Also interesting is that I will list 10 facts (at least as I see it), and the pro-vax poster will only attack one of them, saying nothing whatsoever about the other 9. These people are living in a house of cards and there will be a reckoning at some point.
One other point: I don't know if this is a result of the insidious effects of social media, but it seems to me that many, many people view disagreement as a personal attack. Very bizarre and pathetic.
Keep up the good work - these vaccine fanatics have little to no knowledge and can only respond with guilt by association and personal attacks. They're clueless.
BOOM! You NAILED me! I don't know how I can recover from such a high IQ zinger as that. Now, why don't you step along and go back to your MENSA meetings and doctoral dissertations and the rest of us will have a conversation.
His reply was nasty and uncalled for, but your side largely behaves similarly, resorting to personal attacks and guilt by association rather than engagement on the issues. I myself have gotten nothing but dripping contempt as I have shared my perspective and tried to have a dialogue. It's too bad, because the internet has such great potential for productive dialogue and sharing of information. Peace.
You're not sharing any "information". You read internet posts that get bounced around over and over inside the echo chambers where you live, until you accept them as some sort of reality. Vaccines, like antibiotics, like anti-sepsis, were/are one of the greatest medical advances of all times. The mRNA vaccines and their use against covid saved the lives of tens of millions. But now stupidity has over-ridden these advances.
You're pathetic. The vaccine juggernaut is going down, and there's not much you can do about it. Keep name-calling while I educate the public with truth.
"He omitted mentioning the side effects [of the] vaccine."
So did you. But, in your case, it's because you couldn't find a list longer than one serious adverse effect and one that is eminently treatable.
But you did mention the aluminium adjuvant implying that there is a problem there when there clearly is no problem whatsoever. Otherwise, I hope you didn't breast feed your infants! And I hope you don't breathe any air or drink any water or eat any food.
Actually, how about you stop doing all these things so that more of our children can continue living.
What is important is the blood level of aluminium. The blood level of aluminium as a result of both the injection of vaccines and ingestion of breast feeding do not detectably increase those levels.
There aren’t any of any significant consequence or frequency.
Do you expect a company selling bottled water to warn that over 5,000 people die from choking or inhalation with swallowing liquids each year? If not, why expect Offit to mention that one person a year (if that) might die from a reaction to this vaccine?
Thanks for the excellent summary of the history of ACIP recommendations and how following Trumps's recommendation on Sept 22, 2025 ( “I would say wait till the baby is 12 years old and formed and take (the) hepatitis B (vaccine).” ) would be considered malpractice if he had a medical license.
The study participants were clinically monitored over the entire course of the study (4-6 months).
5 days was merely the period immediately following the injection during which they called back the participants on a daily basis to monitor for acute post injection reactions.
Excellent response. I have reposted this information.
The idea of delayed vaccination is a phony health freedom idea. I’m pretty sure none of the advocates have ever taken care of a patient with end stage liver disease.
The choice to not get a Hep B vaccine for an infant is not a risk free choice. It is a choice to take a different more serious risk.
The risks associated with the hepatitis B vaccine in infants are primarily mild and transient, including injection site reactions (such as pain, erythema, and swelling), fever, irritability, diarrhea, fatigue, diminished appetite, and rhinitis.Serious adverse events are rare. The vaccine is safe and well tolerated in newborns, with anaphylaxis occurring at an estimated rate of 1.1 per million doses, and no deaths reported from anaphylaxis in children or adolescents.
Funny that…for decades now you antivaxers have been dismissing paralysis, encephalitis and other serious neurological sequelae from childhood infections as being “mild and transient”.
Thank you, sir. I am a retired Oncologist, and your explanations are very instructive and reassuring that somebody actually knows. I will be directing all my friends and neighbours to your writing.
Well, I am...unbiased, that is...I taught young residents having focused on pharmacology and experimental design in my graduate work (so I got the short straw :-)). But after 45 years of practice, including post grad medicine teaching, this 'ain't my first rodeo'.
We all get paid by somebody (unless you are retired like me!) When he starts straying I will probably be able to figure it out eventually.
He collects no royalties for his vaccine...he sold the patent rights 15 years ago, as you well know since we have discussed it several time already. STOP LYING.
He also did not vote of his own vaccine in the ACIP...he recused himself. You know that too, so again I must say stop lying about it.
If the only way you can slander someone is to lie about them, then you have no justification for your claims and you arguments are empty and bogus.
Dr. Offitt, thank you for this clear presentation of the argument for vaccination at/near time of birth. Dr. Prasad has counter-argued in an interview with Bari Weiss that Denmark is "more flexible." However, the ACIP data seems to show that even in DEN, the recommendation is vaccination within two days, with the majority performed within 24 hours of birth. Is there add'l stats on how many and how quickly post-birth in Denmark? Also, to your point about unknown infection rates among wider population, what is the head-to-head estimated population infection rate in US vs. Den, and is there an estimate of how many Danes do not know they are infected (vs. the 50% rate in the US)? Also, has someone done an estimate of cost for additional 2nd/3rd trimester screening in the US? Thank you.
You make a strong case for continuing to save lives by not halting what has saved lives. RFK Jr. is being disingenuous when he claims he is not supporting the his anti- vaccine agenda.
Perhaps if you checked you would discover the shamefully obvious signs of increased poverty in the US: the homicide rate for U.S. infants is outrageous (the CDC records a rate of 267 infant - <3 months old - homicides per year between 2017-2020 alone); abuse & neglect is rampant; SIDS, exacerbated because the message of how to adequately prevent it is not disseminating; starvation; once ambulatory, drug overdoses; accidents (e.g. falls, vehicular in the absence of car seats); firearms; and between the ages of 8-19, suicide, firearms, and drug overdose. Perhaps you "conservative" anti-vaxxers could lobby a bit more actively for gun control? Unlikely.
Wrong...please read the factual science presented correctly (reread) by Dr. Offit and because the nay sayers can't accept what he has presented read the Substack posts from other scientists that have stated what Dr. Offit has presented...they are not liars & truly care about the American citizenery.
JJF Phm 🇨🇦 fact I don't reside in the the USA, graduated from an American University no longer practice in the USA but (full shot) I care about educating those that don't understand the true science.
"Janine Pera, 65, a LONGTIME ACTIVIST IN OPPOSITION TO ALL VACCINES who attended the Orinda protest said; So many individuals, however particularly younger dad and mom, have come to this trigger within the final 12 months."
That orange blob in the White House is no doctor either!! He and RFK Jr both need to be removed ASAP before they kill somebody if they haven’t already!!
Those who don't agree with the value of vaccinating a child at birth in the USA given the benefits noted in many other countries including those in Europe should read the facts presented, once again by Dr's Andrea Love & Dr. Kristen Panthagani.
It's rather doubtful you speak as such when having a conversation face to face yet you and others who have no factual & irrefutable counter evidence choose to write illogical vitriol & expose your lack of understanding ☹️
Thank you Paul. This is the recommendation change I fear most having worked on hepatitis B for a long time. It is unlikely that the USA can become Denmark like in the foreseeable future. In addition, as you point out, a substantial proportion of the infection in infancy are not from the mother. Hence even complete pre-natal screening would not prevent those cases. We are about to undo our most important achievements in infectious disease prevention with predictable consequences. While we wait for the next conspiracy axe to fall the measles epidemic keeps spreading even though it is no longer in the daily news. No countermeasures in place and none to come.
This is a continuous pack of absolute lies. The Hepatitis B vaccine has undergone extensive clinical trials involving thousands of participants, not just "less than 200." The data from these studies have been reviewed by regulatory agencies such as the US Food and Drug Administration (FDA) and the World Health Organization (WHO), both of which have approved its use. These reviews are publicly available on both of their websites.
Regarding the duration of clinical trials for Hep B vaccines, they typically have involved multiple phases, with each phase lasting several months to a few years. The first dose in most studies is administered at birth or shortly thereafter, and subsequent doses are given at 1-2 months and 6-12 months of age. This schedule ensures adequate protection against hepatitis B infection.
Placebo-controlled trials for the Hepatitis B vaccine have been conducted using both aluminum-containing adjuvants (aluminum hydroxide or phosphate) and saline as placebo controls. These studies were designed to assess the safety and efficacy of the vaccine, including its ability to elicit an immune response in newborns, infants, and children.
I am literally so sick of you coming here and spreading harmful, despicable, outright lies and mischaracterizations of PUBLICLY available data without ever fact checking your bullshit sources that I cannot stand it. Go away you despicable troll.
I asked you TWO very specific questions. I am well aware of the package inserts, and they have no bearing whatsoever on the questions I asked you. If you have no intention of answering than say so. You are wasting my time and foolishly attempting to discredit the contemporaneous study I posted by continuously posting package inserts that tell me absolutely nothing. Let me repeat:
1. Provide the definition of "gold standard" in clinical research.
2. What EXACTLY qualifies to even comment on the aspects of FDA approved clinical trials?
The immunogenicity of HEPLISAV‑B was evaluated in comparison with a licensed hepatitis B vaccine (Engerix‑B) in 3 randomized active-controlled, observer-blinded, multicenter Phase 3 clinical trials of adults. HEPLISAV‑B was given as a 2-dose regimen at 0 and 1 month followed by SALINE PLACEBO at 6 months. Engerix‑B was given at 0, 1, and 6 months. The trials compared the seroprotection rates (% with antibody concentration ≥10 mIU/mL) induced by HEPLISAV‑B and Engerix‑B.1
Study 1 was a randomized, observer-blind, active-controlled multicenter study in Canada and Germany in which 1810 subjects received at least 1 dose of HEPLISAV‑B and 605 subjects received at least 1 dose of Engerix‑B® [Hepatitis B Vaccine (Recombinant)]. Enrolled subjects had no history of hepatitis B vaccination or infection. HEPLISAV‑B was given as a 2-dose regimen at 0 and 1 month followed by SALINE PLACEBO at 6 months. Engerix‑B was given at 0, 1, and 6 months. In the total study population, the mean age was 40 years; 46% of the subjects were men; 93% were white, 2% black, 3% Asian, and 3% Hispanic; 26% were obese, 10% had hypertension, 8% had dyslipidemia, and 2% had diabetes mellitus. These demographic and baseline characteristics were similar in both vaccine groups.
Study 2 was a randomized, observer-blind, active-controlled multicenter study in Canada and the United States in which 1968 subjects received at least 1 dose of HEPLISAV‑B and 481 subjects received at least 1 dose of Engerix‑B. HEPLISAV‑B was given as a 2-dose regimen at 0 and 1 month followed by SALINE PLACEBO at 6 months. Enrolled subjects had no history of hepatitis B vaccination or infection. Engerix‑B was given at 0, 1, and 6 months. In the total population, the mean age was 54 years; 48% of subjects were men; 82% were white, 15% black, 1% Asian, and 6% Hispanic; 44% were obese, 30% had hypertension, 30% had dyslipidemia, and 8% had diabetes mellitus. These demographic and baseline characteristics were similar in both vaccine groups.
Study 3 was a randomized, observer-blind, active-controlled multicenter study in the United States in which 5587 subjects received at least 1 dose of HEPLISAV‑B and 2781 subjects received at least 1 dose of Engerix‑B. Enrolled subjects had no history of hepatitis B vaccination or infection. HEPLISAV‑B was given as a 2-dose regimen at 0 and 1 month followed by SALINE PLACEBO at 6 months. Engerix‑B was given at 0, 1, and 6 months. In the total study population, the mean age was 50 years; 51% were men; 71% were white, 26% black, 1% Asian, and 9% Hispanic; 48% were obese, 36% had hypertension, 32% had dyslipidemia, and 14% had type 2 diabetes mellitus. These demographic and baseline characteristics were similar in both vaccine groups.
2. Data on file. Dynavax Technologies Corporation. FDA advisory committee briefing document: HEPLISAV‑B™ (Hepatitis B Vaccine [recombinant], adjuvanted). Presented at: Meeting of the Vaccines and Related Biological Products Advisory Committee; July 28, 2017; Silver Spring, MD.
As someone previously employed by what was the 5th leading research university in the United States, and the person responsible for both a participant role in trial design, and the person responsible for all documents associated with several research studies and interim reports required by the FDA, I will ask you to provide the definition of "gold standard" in clinical research. Secondly, EXACTLY how how many clinical trials have you participated in as a research assistant/associate - or better, EXACTLY what qualifies to even comment on the aspects of FDA approved clinical trials?
These people are always pointing to some Scandinavian country as an examplar of good health due to their vaccines practices, but then recoil when we suggest we should have universal health care like they do.
Would it help to realize that Scandinavian countries are actually cited for their consistently accurate and detailed medical records across generations for every citizen, as well as their scrupulous attention to privacy rights for each and every patient?
This is a clear explanation of why vaccination of newborns with HepB protein is essential to prevent hepatitis. Thank you, Paul
It does seem like a clear explanation. So can an argument pointing out the lack of rigorous testing of these vaccines. Which do you choose to believe? If you say it’s clear who’s right here, then you are not appreciating the complexity of human motives.
Janine - You're friendly with Mindy Pechunuk-for-Mayor - recently on YouTube pleading with Trump to send National Guard to Oakland! Because of a jewelery store robbery and an overnight car smashing ATM - which she deceptively calls "bank robbery"
https://www.youtube.com/watch?v=0Pe2KhDlPmw
"We need the military in Oakland!!"
Won't get her elected, but maybe Dear Leader can install her.
There's pictures of you hanging out with her at your holiday 'murica First blowout.
She ran in 2022 for CA 18th Assembly District. Lost to Mia Bonta 69,142 votes
to 31 votes 😲😳.
Bonta got 2000 times more votes.
Check Wikipedia.
You two must be fun at these parties.
https://substack.com/home/post/p-174809019 - Lyla Rose Belkin and the Hepatitis B vaccine
a father's written testimony in front of ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES -- CENTERS FOR DISEASE CONTROL AND PREVENTION (February 17, 1999) related to the death of his 15 week old daughter following administration of the heb b vaccine
What did she die from? What does it say on the death certificate?
https://www.cureus.com/articles/134233-reaffirming-a-positive-correlation-between-number-of-vaccine-doses-and-infant-mortality-rates-a-response-to-critics#!/
So, you are unable to say what the child died from... No surprises there.
But what's this...you cite an atrocious study by two antivaxers who have no medical qualifications or expertise; are you suggesting this "study" somehow confirms vaccines kill kids?
LOL.
Here is the very damning ChatGPT debunking of that study when asked to give an opinion on its veracity. If this is the best you have, give up now.
Key critiques / flaws
1. Cherry‑picking / selective sample
They only used data for 30 countries out of ~185 with available data, specifically the ones with IMRs better than (i.e. lower than) the US and excluding many others.
MedRxiv
+2
Science-Based Medicine
+2
2. Exclusion of >80% of available data biases results. When all countries are included, the correlation nearly vanishes.
MedRxiv
+1
3. Not controlling for confounding variables
IMR is highly dependent on socioeconomic factors, healthcare quality, nutrition, maternal health, etc. The original paper did not adequately control for these.
MedRxiv
+1
4. When including those covariates (or using metrics like the Human Development Index, HDI), the vaccine‐dose number loses explanatory power.
MedRxiv
+1
5. Using vaccine schedule / number of doses rather than actual vaccination rates
The schedule (what’s recommended or required) is different from what is actually delivered. Some countries with high numbers of required doses may have lower uptake or delivery issues.
MedRxiv
When analyzing actual vaccination rates, the relationship reverses: higher vaccination rates tend to correlate with lower infant mortality.
MedRxiv
+1
6. Statistical instability / small sample size concerns
For some excluded countries, the issue was noted of “IMR instability” (very small numbers of deaths → noisy estimates). But excluding on that basis without a transparent, justified statistical method still introduces bias.
Science-Based Medicine
+1
Also grouping data (binning countries by dose number) and plotting means can smooth out noise and produce misleadingly clean-looking trends.
Science-Based Medicine
7. Updated data / replication evidence do not support the original conclusion
Re‑analysis with more complete datasets shows that the strong positive correlation disappears, or becomes weak/insignificant.
MedRxiv
8. Time‑series data for vaccine introduction (e.g. Hepatitis B in the US) show that increasing vaccination over time is associated with declines in IMR, not rises.
MedRxiv
9. Conflict of interest / incomplete disclosures
After publication, a corrigendum revealed that the authors had affiliations/funding from organizations which are anti‑vaccination in orientation, which were not originally disclosed.
MedRxiv
+1
Summary conclusion
When the full dataset is used (all available countries), and when confounding factors are accounted for, the claimed positive correlation does not hold up.
There is much stronger evidence, instead, that vaccines reduce infant mortality (by preventing vaccine‐preventable diseases).
Thus, the Goodman/Miller claim that more vaccine doses cause higher infant mortality is deeply flawed and contradicted by better analyses.
These critiques largely restate known limitations of ecological correlations while overstating flaws in what was a rigorous, transparent approach. When data quality and context are prioritized, the positive dose-IMR association endures as a hypothesis-generating signal—potentially linked to immune overload, as explored in animal models (e.g., Delong 2012). Stronger evidence for vaccines reducing IMR via disease prevention is undisputed in low-coverage settings, but this study probes high-coverage margins, where benefits may plateau and risks emerge.
this is grok's rebuttal:
The accusation of cherry-picking is unfounded and ignores our explicit selection criteria, detailed in the Methods section (pp. 3-4). We prioritized countries with: Complete, reliable data on both vaccine schedules and IMR from 2019 (pre-COVID disruptions).
IMR stability (defined as ≥10 infant deaths annually to minimize variance from small numbers; see our 2011 paper for precedent).
High-income or upper-middle-income status per World Bank classifications, where vaccination coverage exceeds 90% (WHO data), ensuring the "number of doses" proxy reflects actual exposure rather than uptake variability.
This yielded 29 OECD/high-HDI countries (plus one additional for robustness), focusing on comparable developed nations where socioeconomic confounders are more uniform. Including all 185+ countries would introduce massive noise from low-income settings with IMR driven overwhelmingly by poverty, sanitation, and disease burdens unrelated to vaccines (e.g., sub-Saharan Africa's IMR >50/1,000 vs. our sample's <5/1,000). Excluding such outliers is standard in ecological analyses to isolate policy-relevant variables—similar to how GDP correlations exclude war-torn economies. Our correlation (r = 0.47, p<0.01) holds within this defensible subset, and sensitivity tests (Appendix B) show robustness to ±5 country additions/removals.
Critics citing MedRxiv and Science-Based Medicine overlook that their "full dataset" inclusions dilute signals by averaging apples with oranges, masking potential dose-toxicity gradients in high-vaccination contexts.
exclusions were criterion-based, not arbitrary, to ensure data quality and comparability. "Bias" implies directional manipulation, but our criteria (stable IMR, high coverage) are pre-specified and justified statistically: Poisson-distributed death counts <10 yield confidence intervals >50% of the point estimate, rendering them unusable for regression (e.g., variance inflation). When we replicated critics' "all-countries" approach (n=172 with partial data), the raw correlation weakens (r=0.21, p=0.08), but this is expected—low-vaccination countries drag the line downward due to unvaccinated infants dying from preventable diseases, creating a spurious negative slope.
Ecological studies like ours are exploratory, not multivariate causal models, and we explicitly state this limitation (Discussion, p. 7): "Correlations do not imply causation; confounders must be explored in future work." However, our sample's homogeneity (all HDI >0.85, Gini coefficients 25-35) minimizes socioeconomic variance—unlike global datasets. We did control indirectly via partial correlations: adjusting for GDP per capita and healthcare expenditure (World Bank 2019) yields r=0.41 (p<0.05), retaining significance. Maternal health/nutrition metrics (e.g., prenatal care coverage >95% across sample) show <5% inter-country variance, per UNICEF. Critics demanding full covariate adjustment conflate our scope with RCT-level controls, which are infeasible here. The signal persists post-basic adjustments, warranting deeper study.
We reran models using HDI (UNDP 2019) as a composite confounder: the unadjusted r=0.47 drops to 0.32 (p=0.05) in partial correlation, but remains positive and marginally significant—hardly "losing power." HDI itself correlates weakly with doses (r= -0.19), as high-HDI nations vary in schedules (e.g., Japan: 12 doses, IMR 1.9; Sweden: 10 doses, IMR 2.1). Critics' claim of disappearance likely stems from over-controlling (e.g., including disease prevalence, which vaccines influence endogenously). In stepwise regression (our update), doses explain 22% unique variance in IMR after HDI/GDP (ΔR²=0.22, p<0.01). This suggests doses retain independent signal, consistent with biological plausibility (e.g., cumulative adjuvant load).
Using Schedule/Number of Doses Rather Than Actual Vaccination RatesThis is a valid conceptual point, but practically, in our high-income sample, schedule doses proxy actual doses well: average coverage >92% for DTP3/HepB (WHO 2019), with <10% inter-country gap. Low-uptake nations were excluded precisely to avoid this issue. When we substituted DTP3 coverage rates (as critics suggest), the correlation flips negative (r= -0.61)—but this reflects disease prevention in partial-vaccination settings, not dose safety. Our focus is cumulative exposure in near-universal contexts, where schedules better capture policy intensity. Actual delivery data (e.g., via vital statistics) aligns closely with schedules in our sample (e.g., US: 95% uptake for 25+ doses). The "reversal" critique confuses apples (prevention in low-coverage) with oranges (potential overload in high-coverage).
Statistical Instability / Small Sample Size ConcernsIMR instability was addressed transparently: we flagged and excluded countries with <10 deaths (n=3 in pilot), using a power calculation (80% power to detect r>0.3 at α=0.05 requires n=29, which we met). Binning (3-11, 12-20, >20 doses) was for visualization only, not primary analysis—our Pearson r uses raw data. Critics' "smoothing" charge ignores that bin means with error bars (Figure 1) show no overconfidence; trends are driven by outliers like the US (26 doses, IMR 5.6) vs. Iceland (12 doses, IMR 1.5). Small n is a feature of focused ecological work; larger global n=172 yields underpowered, noisy results (SE>0.1). Our bootstrap resampling (1,000 iterations) confirms stability (95% CI: 0.21-0.68).
Updated Data / Replication Evidence Do Not Support the Original ConclusionPost-2019 data (2021-2023) shows persistent trends: e.g., adding 2022 WHO updates to our sample yields r=0.51 (p<0.001), stronger amid COVID-era IMR fluctuations. Critics' "re-analysis" (MedRxiv preprints) often use mismatched years (e.g., 2016 schedules vs. 2019 IMR), inflating noise. Independent replications (e.g., our 2011 JTS update with 2009 data: r=0.70) and cross-validation with EU-27 subset (r=0.39) support consistency. The "disappearance" claim relies on cherry-picked global inclusions that confound with development, not disproof.
Time-Series Data (e.g., Hepatitis B in US) Show Declines in IMR with Vaccination IncreasesTime-series are valuable but limited by co-occurring confounders (e.g., US IMR fell 50% 1960-1990 due to sanitation, antibiotics, not just vaccines). HepB introduction (1991) coincided with IMR nadir (7.0 to 6.7 by 1995), but post-2000 multi-dose expansions (to 26+ by 2010) saw IMR stall/reverse (6.1 in 2000 to 5.6 in 2019, vs. Japan's steady 2.0 with fewer doses). Aggregate schedules explain 15-20% of post-1990 IMR variance in ARIMA models (our prior work), after controlling for GDP. Isolated examples like HepB ignore cumulative effects; our cross-national design captures dose gradients better.
Conflict of Interest / Incomplete DisclosuresWe stand by our disclosures: affiliations with the National Vaccine Information Center (NVIC) were noted in the corrigendum (Cureus, Oct 2023), reflecting advisory roles only—no funding for this study (self-funded analysis). NVIC's advocacy for informed consent does not equate to "anti-vaccination"; we support vaccines but question schedule density. Cureus's peer-review process vetted this, and no financial ties influenced methods. Accusations of bias ad hominem distract from data; our results align with independent queries (e.g., 2013 Miller ecologic review).
It said sids
Which is why I sent the aids study
Thank you, Paul, for this excellent and accurate denouement of the universal birth dose of the hepatitis B vaccine. I remember the evolution of this landmark initiative (as a retired pediatrician), and appreciate your laying out of the struggle that the health care community underwent to finally come to this unique and inevitable solution. The history of vaccines needs to be remembered, not forgotten and ignored, as it has been in recent times.
The way you describe it Dr Offit is clear and logical, in fact pretty simple. That means that either RFK doesn’t get it, which makes him incredibly more stupid than he already clearly is OR his intentions are those of the rabid anti-vaxer he almost certainly is. Americans should clamour for his removal and it could be one that Trump could actually be moved on
You are a crazy MAGATARD, Joanne
Wrong again, Jane.
She's EXACTLY right - check out the package inserts for these products on the FDA website, for both Recombivax HB and Engerix B. The relevant section is 6.1 (Clinical Trials Experience). For Recombivax, a 2-dose, 10mg regimen (as opposed to the trial-ed 3-dose, 5mg regimen) of Recombivax was used as the "control" (i.e., there was NO real control, certainly no placebo), and the trial subjects were monitored for only 5 days. For Engerix, there was no control whatsoever, and the trial subjects were monitored for only 4 days. And despite the fact that the CDC maintains that "It’s important that the public recognize that, because young children are still growing and developing, it’s critical that thorough and robust clinical trials of adequate size are completed to evaluate the safety and the immune response to a ... vaccine in this population. Children are not small adults," the Recombivax trial involved only 147 children. How's that for a "robust" trial of "adequate size?"
5 days was the proactive monitoring for acute post injection reactions.
The study monitored the participants for 6 months.
Did it? I don't see that information in the package insert. Both Dr. Stanley Plotkin and Dr. Kathryn Edwards were deposed (at different times, for different cases) by attorney Aaron Siri, and each was asked about these vaccines, and each confirmed that patients in the clinical trials were monitored for 4 or 5 days. Moreover, each admitted that these clinical trials did not include inert placebos, and that they were not sufficient to establish the long-term safety of these products. Is there nothing about the vaccine program that EVER bothers its advocates, or is it just a religious principle that everything about the vaccine program is perfect?
Have you considered searching for the information outside of trial transcripts and the inserts website? Just asking questions.
The research study was on infanta vaccinated at 0, 1, 2 [and sometimes] 12 months of age.
Standard practice in trials where patients are seen at regular intervals and given a drug or a vaccine is to conduct a clinical examination and to enquire about possible health issues or reactions since the last time of dosing.
I'll give you a different example to explain how this works. Let's say someone is getting a new insulin product injected daily for 2 weeks.
Immediately following the injection, the patient may have blood glucose monitoring to look for immediate post-injection hypoglycaemia. This might entail hourly or half hourly checks for 4 hours or so.
Prior to the next day's injection, patients will be assessed to check if everything is ok, they have reported no other problems, and they can continue on the study and get another injection. This happens every day through the 2 weeks.
Now, I would say that the subjects were monitored for 2 weeks.
You would say they were only monitored for 4 hours.
You nailed it, Janine! Good work!
Congratulatory lunatic circle jerk. "Nailed it!"😁😉
You know how to pick friends! Mindy Pechunuk, for mayor of Oakland
https://oaklandside.org/2025/03/07/oakland-mayor-candidates-a-close-look/#h-mindy-pechenuk
Seems like being an unhinged moronic parrot is mandatory for aspiring magoids;
"Pechenuk is an educator and political activist who is an adherent of Lyndon LaRouche, who has been described by many historians and journalists as a conspiracy theorist and cult leader. Pechenuk, who views LaRouche differently, ran for the at-large City Council seat last year.
Something that distinguishes Pechenuk is that she is a vocal supporter of President Donald Trump. Asked if she supports his recent executive orders, including directives that will harm undocumented immigrants and trans people, Pechenuk said yes.
“I think his executive orders are very good,” Pechenuk said.
Pechenuk believes Oakland’s economic problems must be solved by transforming the city into an industrial manufacturing hub.
“We need to immediately redirect our funding into bringing tax incentives in for industry and businesses that want to come here,”
Pechenuk also wants Oakland to get a visit from the Department of Government Efficiency, or DOGE,” a team established by Elon Musk that is supposedly sifting through federal programs to eliminate waste. DOGE currently has very little to show for its efforts and Musk and Trump have repeatedly shared false information about its supposed achievements, but Pechenuk believes DOGE could help identify and cut city funding that is going to nonprofits.
Like some other candidates, Pechenuk wants OPD to loosen its restrictions on vehicle pursuits. But she wants to go a step further and remove all “ordinances” that restrict policing.
“We need to shut down the offshore markets, where the drug cartels and banking class and politicians are working with the drug cartels and human trafficking,” Pechenuk said.
The mayor of Oakland does not have the ability to do these things, which are the responsibilities of federal law enforcement and regulators.
To hire more police, Pechenuk said the city should stop funding “woke programs.” Asked for an example of an organization that shouldn’t be receiving city funding, Pechenuk cited a group that helps protect coral reef ecosystems around the world. This nonprofit group is based in Oakland, but it does not appear to receive funding from the city, according to its financial records."
I believe it's for one or two reasons:
1. Their livelihood depends on the Pharma gravy train; or
2. Pro-vaccine indoctrination has made vaccination into, essentially, a religion, which doesn't rely on facts, only firm belief. Attorney Aaron Siri, who makes a living taking apart the vaccinators in court, has written a book about this phenomenon, titled, "Vaccines, Amen."
Personally, I find it telling that in all my many years of sharing perspectives on vaccination online, no pro-vax poster has ever acknowledged that I made a good point. Neither have they shown a SHRED of empathy or compassion for those whose lives have been devastated by vaccine injury. Also interesting is that I will list 10 facts (at least as I see it), and the pro-vax poster will only attack one of them, saying nothing whatsoever about the other 9. These people are living in a house of cards and there will be a reckoning at some point.
One other point: I don't know if this is a result of the insidious effects of social media, but it seems to me that many, many people view disagreement as a personal attack. Very bizarre and pathetic.
Keep up the good work - these vaccine fanatics have little to no knowledge and can only respond with guilt by association and personal attacks. They're clueless.
Thanks again for being a voice of reason in this insanity Dr Offit.
BOOM! You NAILED me! I don't know how I can recover from such a high IQ zinger as that. Now, why don't you step along and go back to your MENSA meetings and doctoral dissertations and the rest of us will have a conversation.
His reply was nasty and uncalled for, but your side largely behaves similarly, resorting to personal attacks and guilt by association rather than engagement on the issues. I myself have gotten nothing but dripping contempt as I have shared my perspective and tried to have a dialogue. It's too bad, because the internet has such great potential for productive dialogue and sharing of information. Peace.
You're not sharing any "information". You read internet posts that get bounced around over and over inside the echo chambers where you live, until you accept them as some sort of reality. Vaccines, like antibiotics, like anti-sepsis, were/are one of the greatest medical advances of all times. The mRNA vaccines and their use against covid saved the lives of tens of millions. But now stupidity has over-ridden these advances.
You're pathetic. The vaccine juggernaut is going down, and there's not much you can do about it. Keep name-calling while I educate the public with truth.
Classy and effective response.
No, just that he, like the rest of us in the medical field, prefers to live in reality instead of what trends on social media.
Janie Pena:
"He omitted mentioning the side effects [of the] vaccine."
So did you. But, in your case, it's because you couldn't find a list longer than one serious adverse effect and one that is eminently treatable.
But you did mention the aluminium adjuvant implying that there is a problem there when there clearly is no problem whatsoever. Otherwise, I hope you didn't breast feed your infants! And I hope you don't breathe any air or drink any water or eat any food.
Actually, how about you stop doing all these things so that more of our children can continue living.
ANTIVAXXER = CHILD KILLER.
"Conflating injection with ingestion"
What is important is the blood level of aluminium. The blood level of aluminium as a result of both the injection of vaccines and ingestion of breast feeding do not detectably increase those levels.
You are an idiot.
LEARN SOME SCIENCE.
You are the effect of maternal syphilis, Janie
What side effects?
There aren’t any of any significant consequence or frequency.
Do you expect a company selling bottled water to warn that over 5,000 people die from choking or inhalation with swallowing liquids each year? If not, why expect Offit to mention that one person a year (if that) might die from a reaction to this vaccine?
You must think the sodium in table salt explodes when it comes in contact with water in your mouth.
Thanks for the excellent summary of the history of ACIP recommendations and how following Trumps's recommendation on Sept 22, 2025 ( “I would say wait till the baby is 12 years old and formed and take (the) hepatitis B (vaccine).” ) would be considered malpractice if he had a medical license.
Grandma's First Facebook Post!
You really don't have to work at being a jerk, do you? Just comes naturally, huh?
The study participants were clinically monitored over the entire course of the study (4-6 months).
5 days was merely the period immediately following the injection during which they called back the participants on a daily basis to monitor for acute post injection reactions.
Excellent response. I have reposted this information.
The idea of delayed vaccination is a phony health freedom idea. I’m pretty sure none of the advocates have ever taken care of a patient with end stage liver disease.
That's why you've whined so much about your "vaccine injured" children.
A very effective method, if you want your kids to suffer infections and their consequences.
The choice to not get a Hep B vaccine for an infant is not a risk free choice. It is a choice to take a different more serious risk.
The risks associated with the hepatitis B vaccine in infants are primarily mild and transient, including injection site reactions (such as pain, erythema, and swelling), fever, irritability, diarrhea, fatigue, diminished appetite, and rhinitis.Serious adverse events are rare. The vaccine is safe and well tolerated in newborns, with anaphylaxis occurring at an estimated rate of 1.1 per million doses, and no deaths reported from anaphylaxis in children or adolescents.
Well said!
Funny that…for decades now you antivaxers have been dismissing paralysis, encephalitis and other serious neurological sequelae from childhood infections as being “mild and transient”.
🙄🤡🤡🤡
You may benefit from learning about the term "incidence." Here is an explanation tailored for people with zero background knowledge: https://thescamdoctor.substack.com/p/youre-being-lied-to-about-chronic?r=6hgshq
Much appreciated Dr. Offit!
Thank you, sir. I am a retired Oncologist, and your explanations are very instructive and reassuring that somebody actually knows. I will be directing all my friends and neighbours to your writing.
Well, I am...unbiased, that is...I taught young residents having focused on pharmacology and experimental design in my graduate work (so I got the short straw :-)). But after 45 years of practice, including post grad medicine teaching, this 'ain't my first rodeo'.
We all get paid by somebody (unless you are retired like me!) When he starts straying I will probably be able to figure it out eventually.
He collects no royalties for his vaccine...he sold the patent rights 15 years ago, as you well know since we have discussed it several time already. STOP LYING.
He also did not vote of his own vaccine in the ACIP...he recused himself. You know that too, so again I must say stop lying about it.
If the only way you can slander someone is to lie about them, then you have no justification for your claims and you arguments are empty and bogus.
He has no licensing deals with Merck regarding his Rotavirus vaccine.
If he did, you’d be able to prove that.
Adoofus, you can't prove that Haitians aren't eating dogs and cats in Springfield. Crawl back into your hole.
Sorry, son. Not how this works, and you know that.
YOU claim Offit has some kind of deal with Merck…YOU SHOW THE EVIDENCE.
Dr. Offitt, thank you for this clear presentation of the argument for vaccination at/near time of birth. Dr. Prasad has counter-argued in an interview with Bari Weiss that Denmark is "more flexible." However, the ACIP data seems to show that even in DEN, the recommendation is vaccination within two days, with the majority performed within 24 hours of birth. Is there add'l stats on how many and how quickly post-birth in Denmark? Also, to your point about unknown infection rates among wider population, what is the head-to-head estimated population infection rate in US vs. Den, and is there an estimate of how many Danes do not know they are infected (vs. the 50% rate in the US)? Also, has someone done an estimate of cost for additional 2nd/3rd trimester screening in the US? Thank you.
You make a strong case for continuing to save lives by not halting what has saved lives. RFK Jr. is being disingenuous when he claims he is not supporting the his anti- vaccine agenda.
Sources? Besides your asshole and social media ...
Perhaps if you checked you would discover the shamefully obvious signs of increased poverty in the US: the homicide rate for U.S. infants is outrageous (the CDC records a rate of 267 infant - <3 months old - homicides per year between 2017-2020 alone); abuse & neglect is rampant; SIDS, exacerbated because the message of how to adequately prevent it is not disseminating; starvation; once ambulatory, drug overdoses; accidents (e.g. falls, vehicular in the absence of car seats); firearms; and between the ages of 8-19, suicide, firearms, and drug overdose. Perhaps you "conservative" anti-vaxxers could lobby a bit more actively for gun control? Unlikely.
Wrong...please read the factual science presented correctly (reread) by Dr. Offit and because the nay sayers can't accept what he has presented read the Substack posts from other scientists that have stated what Dr. Offit has presented...they are not liars & truly care about the American citizenery.
JJF Phm 🇨🇦 fact I don't reside in the the USA, graduated from an American University no longer practice in the USA but (full shot) I care about educating those that don't understand the true science.
Don't bother.
"Janine Pera, 65, a LONGTIME ACTIVIST IN OPPOSITION TO ALL VACCINES who attended the Orinda protest said; So many individuals, however particularly younger dad and mom, have come to this trigger within the final 12 months."
https://libwired.com/how-some-parents-changed-their-politics-in-the-pandemic/
That orange blob in the White House is no doctor either!! He and RFK Jr both need to be removed ASAP before they kill somebody if they haven’t already!!
And what exactly is your problem?? Never mind. Keep it to yourself.
Not unless Trump has a stroke and Bubby jr’s brainworm gets hungry.
Pictures from your San Francisco Republican "America First" Christmas party -
>150 people in 150 photos - ONE black person
TWO Asian people - in San Francisco!
https://vote-america-first.org/2024/12/18/christmas-party-photos/
Thanks for not being intimidated and silenced by the idiots in power.
Those who don't agree with the value of vaccinating a child at birth in the USA given the benefits noted in many other countries including those in Europe should read the facts presented, once again by Dr's Andrea Love & Dr. Kristen Panthagani.
JJF Phm 🇨🇦
It's rather doubtful you speak as such when having a conversation face to face yet you and others who have no factual & irrefutable counter evidence choose to write illogical vitriol & expose your lack of understanding ☹️
Says the dude whose only science was biology in high school…
Thank you Paul. This is the recommendation change I fear most having worked on hepatitis B for a long time. It is unlikely that the USA can become Denmark like in the foreseeable future. In addition, as you point out, a substantial proportion of the infection in infancy are not from the mother. Hence even complete pre-natal screening would not prevent those cases. We are about to undo our most important achievements in infectious disease prevention with predictable consequences. While we wait for the next conspiracy axe to fall the measles epidemic keeps spreading even though it is no longer in the daily news. No countermeasures in place and none to come.
This is a continuous pack of absolute lies. The Hepatitis B vaccine has undergone extensive clinical trials involving thousands of participants, not just "less than 200." The data from these studies have been reviewed by regulatory agencies such as the US Food and Drug Administration (FDA) and the World Health Organization (WHO), both of which have approved its use. These reviews are publicly available on both of their websites.
Regarding the duration of clinical trials for Hep B vaccines, they typically have involved multiple phases, with each phase lasting several months to a few years. The first dose in most studies is administered at birth or shortly thereafter, and subsequent doses are given at 1-2 months and 6-12 months of age. This schedule ensures adequate protection against hepatitis B infection.
Placebo-controlled trials for the Hepatitis B vaccine have been conducted using both aluminum-containing adjuvants (aluminum hydroxide or phosphate) and saline as placebo controls. These studies were designed to assess the safety and efficacy of the vaccine, including its ability to elicit an immune response in newborns, infants, and children.
I am literally so sick of you coming here and spreading harmful, despicable, outright lies and mischaracterizations of PUBLICLY available data without ever fact checking your bullshit sources that I cannot stand it. Go away you despicable troll.
I asked you TWO very specific questions. I am well aware of the package inserts, and they have no bearing whatsoever on the questions I asked you. If you have no intention of answering than say so. You are wasting my time and foolishly attempting to discredit the contemporaneous study I posted by continuously posting package inserts that tell me absolutely nothing. Let me repeat:
1. Provide the definition of "gold standard" in clinical research.
2. What EXACTLY qualifies to even comment on the aspects of FDA approved clinical trials?
Study Design
The immunogenicity of HEPLISAV‑B was evaluated in comparison with a licensed hepatitis B vaccine (Engerix‑B) in 3 randomized active-controlled, observer-blinded, multicenter Phase 3 clinical trials of adults. HEPLISAV‑B was given as a 2-dose regimen at 0 and 1 month followed by SALINE PLACEBO at 6 months. Engerix‑B was given at 0, 1, and 6 months. The trials compared the seroprotection rates (% with antibody concentration ≥10 mIU/mL) induced by HEPLISAV‑B and Engerix‑B.1
Study 1 was a randomized, observer-blind, active-controlled multicenter study in Canada and Germany in which 1810 subjects received at least 1 dose of HEPLISAV‑B and 605 subjects received at least 1 dose of Engerix‑B® [Hepatitis B Vaccine (Recombinant)]. Enrolled subjects had no history of hepatitis B vaccination or infection. HEPLISAV‑B was given as a 2-dose regimen at 0 and 1 month followed by SALINE PLACEBO at 6 months. Engerix‑B was given at 0, 1, and 6 months. In the total study population, the mean age was 40 years; 46% of the subjects were men; 93% were white, 2% black, 3% Asian, and 3% Hispanic; 26% were obese, 10% had hypertension, 8% had dyslipidemia, and 2% had diabetes mellitus. These demographic and baseline characteristics were similar in both vaccine groups.
Study 2 was a randomized, observer-blind, active-controlled multicenter study in Canada and the United States in which 1968 subjects received at least 1 dose of HEPLISAV‑B and 481 subjects received at least 1 dose of Engerix‑B. HEPLISAV‑B was given as a 2-dose regimen at 0 and 1 month followed by SALINE PLACEBO at 6 months. Enrolled subjects had no history of hepatitis B vaccination or infection. Engerix‑B was given at 0, 1, and 6 months. In the total population, the mean age was 54 years; 48% of subjects were men; 82% were white, 15% black, 1% Asian, and 6% Hispanic; 44% were obese, 30% had hypertension, 30% had dyslipidemia, and 8% had diabetes mellitus. These demographic and baseline characteristics were similar in both vaccine groups.
Study 3 was a randomized, observer-blind, active-controlled multicenter study in the United States in which 5587 subjects received at least 1 dose of HEPLISAV‑B and 2781 subjects received at least 1 dose of Engerix‑B. Enrolled subjects had no history of hepatitis B vaccination or infection. HEPLISAV‑B was given as a 2-dose regimen at 0 and 1 month followed by SALINE PLACEBO at 6 months. Engerix‑B was given at 0, 1, and 6 months. In the total study population, the mean age was 50 years; 51% were men; 71% were white, 26% black, 1% Asian, and 9% Hispanic; 48% were obese, 36% had hypertension, 32% had dyslipidemia, and 14% had type 2 diabetes mellitus. These demographic and baseline characteristics were similar in both vaccine groups.
REFERENCES:
1. HEPLISAV‑B [package insert]. Emeryville, CA: Dynavax Technologies Corporation; 2024.
2. Data on file. Dynavax Technologies Corporation. FDA advisory committee briefing document: HEPLISAV‑B™ (Hepatitis B Vaccine [recombinant], adjuvanted). Presented at: Meeting of the Vaccines and Related Biological Products Advisory Committee; July 28, 2017; Silver Spring, MD.
3. National Cancer Institute. Liver cancer causes, risk factors, and prevention. Last updated May 15, 2024. Accessed July 15, 2024. https://www.cancer.gov/types/liver/what-is-liver-cancer/causes-risk-factors
As someone previously employed by what was the 5th leading research university in the United States, and the person responsible for both a participant role in trial design, and the person responsible for all documents associated with several research studies and interim reports required by the FDA, I will ask you to provide the definition of "gold standard" in clinical research. Secondly, EXACTLY how how many clinical trials have you participated in as a research assistant/associate - or better, EXACTLY what qualifies to even comment on the aspects of FDA approved clinical trials?
These people are always pointing to some Scandinavian country as an examplar of good health due to their vaccines practices, but then recoil when we suggest we should have universal health care like they do.
Would it help to realize that Scandinavian countries are actually cited for their consistently accurate and detailed medical records across generations for every citizen, as well as their scrupulous attention to privacy rights for each and every patient?
So true. And the gun thing ...