smallpox and monkey pox vaccine information

 Like the previous posts, this is my taking notes about a clinical problem that I want to learn about, so exuse the lack of well written essay.

when 911 happened, a lot of people were worried that terrorists would get hold of smallpox from rogue scientists, so they did restart the vaccination program.

I am old enough to remember when we all got this, and we had people who developed generalized vaccinia which can be rarely fatal.

So what happened in 2001?

JAMA:

Subjects US service members and DoD civilian workers eligible for smallpox vaccination. Main Outcome Measures Numbers of vaccinations and rates of vaccination exemptions, symptoms, and adverse events. Data were collected via reports to headquarters and rigorous surveillance for sentinel events. Results In 5.5 months, the DoD administered 450 293 smallpox vaccinations (70.5% primary vaccinees and 29.5% revaccinees). In 2 settings, 0.5% and 3.0% of vaccine recipients needed short-term sick leave. Most adverse events occurred at rates below historical rates. One case of encephalitis and 37 cases of acute myopericarditis developed after vaccination; all cases recovered. Among 19 461 worker-months of clinical contact, there were no cases of transmission of vaccinia from worker to patient, no cases of eczema vaccinatum or progressive vaccinia, and no attributed deaths.

of course that was in low risk people, so in a general population it would be higher (immune problems from HIV or cancer predispose to generalized vaccinia)

I could be wrong (will have to check it later) But they were using the old 1931 vaccine, but I seem to remember they were using a newer vaccine for high risk first responders, a vaccine that had fewer generalized vaccinia side effects but it was stopped because it caused myocarditis, and after a few months the realized Saddam wasn't going to spread smallpox to the USA.

so anyway, fast forward and voila, monkey pox. Something that is not very infectious but no one wants to discuss the activity in homosexual gatherings that was spreading this to the US and Europe. So these gatherings were not shut down, but the affluent white gay community spread the word to each other about the disease and the need for the vaccine. Alas, the the average non affluent bisexuals in the minority communities warned that they were at risk, so most of the deaths were in minorities.

So anyway, the present Smallpox vaccine is JYNNEOS vaccine, approved in 2019 for both smallpox and monkey pox.

Smallpox/monkeypox vaccine (JYNNEOS™) can help protect against smallpox, monkeypox, and other diseases caused by orthopoxviruses, including vaccinia virus...

Some people continue to be at risk of exposure to the virus that causes smallpox, including people who work in emergency preparedness and some laboratory workers.,,..

Smallpox/monkeypox vaccine (JYNNEOS™) is made using weakened live vaccinia virus and cannot cause smallpox, monkeypox, or any other infectious disease. JYNNEOS™ is approved by the Food and Drug Administration (FDA) for prevention of smallpox and monkeypox disease in adults 18 years or older at high risk for smallpox or monkeypox infection...

more here.

there are scattered reports out there about it's efficiency, and if you get two doses it does give good protection, so you can ignore that the basic public health shut down of places where high risk behavior goes on was never done.

here is the report of how well it worked to stop monkeypox:

apparantly there was a lot more MPox out there than I knew about: But maybe it was because it was a localized disease, in certain states and in high risk groups

During May 12, 2022–May 18, 2023, a total of 5,765 persons with mpox and 250 (4.3%) mpox-associated hospitalizations were reported among California residents

Overall, 233 (5.0%) Monkeypox virus infections occurred in persons who received 1 JYNNEOS dose, 79 (1.7%) in those who received 2 doses, 457 (9.9%) in persons who received PEP,¶ and 3,845 (83.4%) in unvaccinated persons. A total of 250 (5.4%) mpox patients were hospitalized, including four (1.6%) who received 1 JYNNEOS dose, one (0.4%) who received 2 doses, 12 (4.8%) who received PEP, and 233 (93.2%) who were unvaccinated. Compared with unvaccinated mpox patients, the odds of hospitalization among persons with mpox who received 1 dose, 2 doses, and PEP were 0.27, 0.20, and 0.42, respectively (Table 2).

PEP means pre exposure vaccination

and they gave out a lot of vaccines:

Approximately 300,000 doses of the JYNNEOS vaccine have been administered to California residents since May 26, 2022.** During this time, an estimated 64% of California’s at-risk population†† received 1 dose and 40% received 2 doses (10). Messaging to persons at higher risk for Monkeypox virus infection and persons with HIV infection should encourage completion of the 2-dose JYNNEOS vaccination series to limit virus transmission and mitigate disease severity.

Vaccine controversies

 Dr C discusses how the US CDC is telling everyone, even toddlers, get the new booster. And points out the side effects are more common than the risk of the disease, which is why the UK only recommends boosters for those over 65.

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In other news, the court case against officials who approved of the Dengue Vaccine might finally come to court Manila Standard article.

Science magazine lamented that these people were charged back in 2019...

full background in the Wikipedia page (although it is controversial of course so might not be accurate).

SciAmerica has another article discussing the scandal.

follow the money? The price tag was huge for a cash strapped country. And although dengue is a major problem, other diseases kill more people.

At three billion pisos ($57.5 million) for procurement alone, the Dengvaxia campaign would cost more than the entire national vaccination program for 2015, which covered pneumonia, tuberculosis, polio, diphtheria, tetanus, pertussis, measles, mumps and rubella. It would reach less than 1 percent of the country’s approximately 105 million residents. And although dengue was reported to kill an average of 750 people annually in the Philippines, it was not even among the top 10 causes of mortality. Among infectious diseases, pneumonia and tuberculosis took a far heavier toll.

the increased mortality was pointed out to the DOH, but if you read down in the article, note that the WHO pooh poohed the problem<P>

In retrospect, it did not surprise Dans and Dans that the authorities chose to ignore their concerns. “It was either believe us or believe the WHO,” says Antonio Dans. “If I were them, I’d believe the WHO. I mean, who were we? We were just teachers in a small medical school.” Filipino authorities were apparently so confident about Dengvaxia’s safety that they did not oblige Sanofi Pasteur to submit results from so-called pharmacovigilance trials that would usually test the safety of a new drug or vaccine in local conditions.

The induction of a new pharmaceutical product into the national program typically took three to five years, says Anthony Leachon, a former president of the Philippine College of Physicians, but the dengue vaccination program began right away, in April 2016.

it wasn't until late in 2017 that the drug company admitted that there was a problem.

The dengue saga also raises difficult questions about how pharmaceutical companies and regulators should proceed in the context of evolving scientific knowledge and imperfect vaccines. Is it ethical to endanger a minority in the interest of protecting a majority, as the WHO’s September 2018 advisory on Dengvaxia implies? Who should be making these difficult decisions: global bodies of experts, national health authorities, fully informed parents and doctors, or some combination of these? And who should be held accountable when things go wrong?

medical ethics

 

Downs syndrome and the human ity of unborn children.

Doctors routinely advise moms expecting a baby with Downs syndrome to abort the child: often they insist that the child will never grow up, never be able to care for himself, or read or write. ,

in reality, the IQ is usually 40 points lower than the parents, so this is not always true.

So I am seeing Netflix had a series about adults with Down's syndrome facing dating, adulthood, etc.

this mother of a Down's syndrome baby is a bit sceptical of the series for ignoring that alas they are overestimating the challenges for these people, and the challenges that their parents face.

and few realize the medical problems that these children face: in the past, most died because of immune system problems, but now live thanks to antibiotics. But they also have an increased chance of developing leukemia, hypothyroidism, and develop Alzheimers at an early age.

thanks (/s) to abortion, it is rare to see a child with Down's syndrome in the USA, but we have one here who is an altar boy in our Catholic church, and one young woman who used to beg all the time and was living with family was moved to a home when her parent died.

when I was in medical school they were not sure what caused the problem: Until a doctor Jreome LeJeune discovered it was due to an extra chromosome.

his realization that his discovery might not benefit these children, but be a way to destroy their lives, horrified him. Indeed, as this film review notes:The meteoric rise of this young French scientist will be be stopped in a flash in 1969. While receiving the William Allen Award in San Francisco, the highest award in genetics, he delivered a speech defending the human dignity of the embryo, causing an earthquake in the scientific sphere. A few months before, he realized that his discovery would be used against his convictions, by opening the door to abortion of embryos with genetic abnormalities

since then, of course, not only is screening and aborting imperfect children become the norm, but now there are experiments with fetal part, using fetal tissue to make stem cells for vaccines, and manipulating embryos: all of which do not see an unborn child as a person recognized and love by God, but just a bunch of cells to be manipulated for the good of mankind ( or actually out of scientific curiosity by amoral scientists). It says a lot about stem cells that it was a non Christian Japanese scientist who started worrying about destroying life in these experiments, so he found a way to use adult stem cells to do the same thing.

Ethics? No. Because bioethics is merely a way to justify what they want to do.

well, anyway, Vaticanista reporter Magister notes that LeJeune warned John Paul II and the Vatican about the implications of his discovery: but that in more recent years, although Pope Francis does mention the problems, it is no longer a priority.

I mean, hey who cares if damaged children are killed in the womb, or aborted baby parts are sold, or if fetal tissue from children killed in early gestation is used to make or test vaccines, or if assisted reproduction not only ignores the philosophical implications of a child as a fruit of love, but also results in hundreds of thousands of frozen embryos who will never be given a chance of life, not to mention outsourcing babies for the affluent: some are volunteers, but most of these are third world poor women who will carry them to term for the affluent first world moms who are either infertile or can't be bothered to do this.

Magister includes his talk in\warning of this:

(From “Jérôme Lejeune. The freedom of the scientist,” pp. 386-393)

the cutting edge back then was IFV, where embryos are made outside the womb and replanted into a woman who is infertile and wants a baby. Babies are good, aren't they? But no one wants to see the problem: It makes the embryo a commodity to be discarded if imperfect or not needed, and it destroys the idea that a child is a product of love making: and this is at a time when the pill already made having children an enemy of sexual freedom.

A number of journalists continue to ask Jérôme about the instruction, and his replies include the following [...]: “Cardinal Ratzinger, with ‘Donum vitae,’ is telling men the moral truth in an attempt to protect them from a formidable abuse of technology capable of leading to a total collapse of conduct. Reread Huxley’s Brave New World, reread Goethe and the second Faust and you will see the immense need for the appeal of ‘Donum vitae’.” “You who are for the family will be laughed at. The specter of science, apparently gagged by an outdated morality, will wave against you the tyrannical flag of relentless experimentation. Bishops, have no fear. You have the words of life.”

Magister \notes that although the present Pope Francis does condemn these things, he does so quietly and it is not his priority.

xeno transplantation

 The Inquirer has an article about China growing organs in pigs.

you can go and read the entire article, which sounds more like propaganda than science and if you look beyond the headlines, it is a very preliminary experiment.

Chinese scientists made a world record for growing the first-ever humanized kidneys in pigs. In other words, they have figured out how to create organs in pigs, potentially helping those who need transplants.

We could use this method to produce vital body parts instead of waiting for donors. Still, the project requires further research and development for real-life applications.The experts admitted their experiment has several flaws, but it may pave the way for better healthcare.

This is a very preliminary experiment, and the article goes into the details.

But should you worry?

yes. Because an organ grown in a pig will pick up pig viruses, and the person getting the organ will be exposed to these viruses. And it will increase the chance of the viruses mutating to a fully human version that could kill people.

Am I being paranoid? Well, read this article in the New England journal of Medicine

except of course it is behind a paywall. Sigh

a similar article on the Wiley library site from 2018: and they deny that any of these viruses could affect humans so no problem

Swine herpesviruses including porcine cytomegalovirus (PCMV) and porcine lymphotropic herpesvirus (PLHV) are largely species-specific and do not, generally, infect human cells. Human cellular receptors exist for porcine endogenous retrovirus (PERV), which infects certain human-derived cell lines in vitro. PERV-inactivated pigs have been produced recently. Human infection due to PERV has not been described. A screening paradigm can be applied to exclude potential human pathogens from “designated pathogen free” breeding colonies.

The available data suggest that risks of xenotransplant-associated recipient infection are manageable and that clinical trials can be performed safely. Possible infectious risks of xenotransplantation to the community at large are undefined but merit consideration.

this article is from a vet journal

Porcine endogenous retroviruses (PERVs) are integrated in the genome of all pigs, and some of them are able to infect human cells. Therefore, PERVs pose a risk for xenotransplantation, the transplantation of pig cells, tissues, or organ to humans in order to alleviate the shortage of human donor organs. Up to 2021, a huge body of knowledge about PERVs has been accumulated regarding their biology, including replication, recombination, origin, host range, and immunosuppressive properties. Until now, no PERV transmission has been observed in clinical trials transplanting pig islet cells into diabetic humans, in preclinical trials transplanting pig cells and organs into nonhuman primates with remarkable long survival times of the transplant, and in infection experiments with several animal species. Nevertheless, in order to prevent virus transmission to the recipient, numerous strategies have been developed, including selection of PERV-C-free animals, RNA interference, antiviral drugs, vaccination, and genome editing. Furthermore, at present there are no more experimental approaches to evaluate the full risk until we move to the clinic.

MIT Tech review notes that a pig heart recipient did get infected:The gene-edited pig heart given to a dying patient was infected with a pig virus The first transplant of a genetically-modified pig heart into a human may have ended prematurely because of a well-known—and avoidable—risk.

The presence of the pig virus and the desperate efforts to defeat it were described by Griffith during a webinar streamed online by the American Society of Transplantation on April 20. The issue is now a subject of wide discussion among specialists, who think the infection was a potential contributor to Bennett’s death and a possible reason why the heart did not last longer.

but they deny it spread to the patient (it destroyed the heart but not the patient)

the real problem is mutation of a virus.

PBS FrontlineIt is known that infectious viruses, including the Epstein-Barr virus and cytomegalovirus, can be transmitted during allotransplants -- transplants involving individuals in the same species. Therefore, many worry that animal-to-human cell, tissue or organ transplants may make it easier for viruses to cross the species barrier.

and they list a few.

but maybe the worst ethical experiment is this report: They put pig organs into "brain dead" patients.

Ah but were they brain dead, or merely in a deep coma?

destroying Prepfar by political types

 link

the holier than thou types are trying to destroy it for some reason, which would let the Biden's push their agenda with all that lovely money.

We share the report’s concern over the Biden administration’s new guidance and are hopeful that they will, like all prior administrations, resist destroying the careful compromises of 2002. Those compromises include such important guidelines that conservatives fought for, such as the ABC (Abstinence first, Be Faithful and then Contraception when needed) approach to prevention efforts.

While we sympathize with some of the concerns raised by our fellow conservatives, without a clean authorization, there will be no reauthorization. That means the administration will have a free hand to do what it wants with the money appropriated. The right solution is to do what the Trump administration did with fanfare, pass a clean extension and leave the compromises in place for now.

 We share the report’s concern over the Biden administration’s new guidance and are hopeful that they will, like all prior administrations, resist destroying the careful compromises of 2002.

Those compromises include such important guidelines that conservatives fought for, such as the ABC (Abstinence first, Be Faithful and then Contraception when needed) approach to prevention efforts.

While we sympathize with some of the concerns raised by our fellow conservatives, without a clean authorization, there will be no reauthorization.

That means the administration will have a free hand to do what it wants with the money appropriated. The right solution is to do what the Trump administration did with fanfare, pass a clean extension and leave the compromises in place for now.

the coverup is in the open but don't expect anyone to point fingers.

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notice the information was denied because they hated Trump for pointing to China for being the source of the virus.

Thank you for dying (and lowering the federal budget)

 It's not just those bioethicists who are pointing out that if you kill the sick it saves money.

Apparently a lot of old folks with chronic illness died of covid, so surprise surprise they won't have to spend so much on Medicare.

The origina NYTimes article  is behind a paywall, but theFiscal Times site discusses it.

they start by saying it was those budgetary cuts to hospitals etc from Medicare

Something strange has been happening with Medicare, The New York Times reports: “Instead of growing and growing, as it always had before, spending per Medicare beneficiary has nearly leveled off over more than a decade.” If Medicare’s spending per beneficiary had continued along the trajectory it had been on two decades ago, the program’s spending from 2011 until now would be some $3.9 trillion higher and deficits would have been more than a quarter larger, according to an analysis by The Upshot, part of the Times site.

“Without a doubt, this is the most important thing that has happened to the federal budget in the last 20 years,” David Cutler, a professor of health policy and medicine at Harvard, told the Times. Cutler helped the Obama White House develop the Affordable Care Act, which appears to be one reason for the shifting trendline.

The Trend downward started in 2010...

But AnnAlthouse's blog notes something else in the NYTimes article:

"Medicare may even wind up saving money because of Covid-19 — because the older Americans who died from the disease tended to have other illnesses that would have been expensive to treat if they had survived...."

that graph is not total spending but per capita spending.

one comment noted that 2010 was the start of Obamacare, but would this impact Medicare?

another commenter noted:

Yahoo Finance article from August 2021: COVID-19 didn't hurt Social Security or Medicare as much as experts feared, report finds Money quote from the article: "On the other side, a senior administration official described increased deaths from the pandemic as helping the program's bottom line. It had a "small effect in the other direction" compared to the drop in revenue from fewer workers paying into the system. The sad result of the hundreds of thousands of additional deaths meant that fewer older Americans were available to receive Social Security and Medicare benefits."

another comment noted the decision to put covid patients into nursing homes might have had something to do with this, as do DNR orders/living wills

economics is not my strong point but I might point out that the budget cuts stopped a lot of defensive mediicne and excess testing so we didn't get sued.

But I have been living in the Philippines for 18 years so am not up to date with all this.

are drug regulators for hire asks Dr C

 

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  Bmj article here

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]From FDA to MHRA: are drug regulators for hire? BMJ 2022; 377

 

 

(Published 29 June 2022)

 

Patients and doctors expect drug regulators to provide an unbiased, rigorous assessment of investigational medicines before they hit the market. But do they have sufficient independence from the companies they

are meant to regulate? Maryanne Demasi investigates Over the past decades, regulatory agencies have seen large proportions of their budgets funded by the industry they are sworn to regulate. In 1992, the US Congress passed the Prescription Drug User Fee Act (PDUFA), allowing industry to fund the US Food and Drug Administration (FDA) directly through “user fees” intended to support the cost of swiftly reviewing drug applications. With the act, the FDA moved from a fully taxpayer funded entity to one supplemented by industry money. Net PDUFA fees collected have increased 30 fold—from around $29m in 1993 to $884m in 2016.1 In Europe, industry fees funded 20% of the new EU-wide regulator, the European Medicines Agency (EMA), in 1995. By 2010 that had risen to 75%; today it is 89%.2 In 2005 in the UK, the House of Commons’ health committee evaluated the influence of the drug industry on health policy, including the Medicines and Healthcare Products Regulatory Agency (MHRA).3 The committee was concerned that industry funding could lead the agency to “lose sight of the need to protect and promote public health above all else as it seeks to win fee income from the companies.” But nearly two decades on, little has changed, and industry funding of drug regulators has become the international norm.

note this article is one year old.