A tragedy begets more tragedy. Wisdom is needed.

 If I were writing 100 years ago the title of this story would be "Repent"

A worthless piece of pseudo-research on physicians spreading misinformation online was carried out by 2 young women with BS degrees and supervised by an MD, PhD professor at the University of Massachusetts. It wound up in a top journal (JAMA Network) on August 15—but no one seems to know how it could have possibly gotten there. And the ‘study’ claims there was no outside funding. So who paid for it?

I was quoted last week in The Defender about this article.

https://childrenshealthdefense.org/defender/jama-doctors-covid-misinformation/

The JAMA paper has actually garnered quite a bit of press. The methodology seems to be random (“mixed methods study” is what the authors call it). The 2 young first authors trolled social media to collect a list of 52 doctors who provided alternative COVID narratives, and misinformation was DEFINED by any disagreement with the CDC.

I am writing about this because there is an extraordinary, tragic and infuriating backstory to this article that I was not aware of until now.

Design, Setting, and Participants  Using US Centers for Disease Control and Prevention guidelines for the prevention and treatment of COVID-19 infection during the study window to define misinformation, structured searches of high-use social media platforms (Twitter, Facebook, Instagram, Parler, and YouTube) and news sources (The New York Times, National Public Radio) were conducted to identify COVID-19 misinformation communicated by US-based physicians between January 2021 and December 2022. Physicians’ state of licensure and medical specialty were identified. The number of followers for each physician on 4 major platforms was extracted to estimate reach and qualitative content analysis of the messages was performed…

Results  The propagation of COVID-19 misinformation was attributed to 52 physicians in 28 different specialties across all regions of the country. General misinformation categories included vaccines, medication, masks, and other (ie, conspiracy theories).

Conclusions and Relevance  In this mixed-methods study of US physician propagation of COVID-19 misinformation on social media, results suggest widespread, inaccurate, and potentially harmful assertions made by physicians across the country who represented a range of subspecialties. Further research is needed to assess the extent of the potential harms associated with physician propagation of misinformation, the motivations for these behaviors, and potential legal and professional recourse to improve accountability for misinformation propagation.

The only way the medical boards can justify punishing doctors like me, Pierre Kory, Peter McCullough, Paul Marik, Sherri Tenpenny, Paul Thomas etc. etc. etc. is by saying we HARMED someone. This article is attempting to buttress those false assertions and does its best to call for laws against misinformation and more punishments for doctors who stray from the CDC’s fairytales.

MedPropaganda Today wrote a piece supporting the JAMA article, of course. Its editor-in-chief was the chief “expert” witness against me before the Maine medical board.

Read the Robertson quote at the bottom: “The most common theme in the different posts was discouraging people from getting the COVID-19 vaccine.” This ties into my surprise ending. We were trying to save peoples’ lives and health by warning about the COVID vaccines. Yes, we were, and proud of it. Wish we had saved a lot more.

Some media were actually able to distinguish trash when they saw it. Surprisingly, Bloomberg dissed the JAMA paper, acknowledging that the CDC had been wrong about any number of things regarding COVID. It even admitted there could be honest scientific disagreement, something the JAMA paper’s authors never heard of.

Why in heaven’s name, in August of 2023, when most people have learned so much about the lack of benefit of masks, vaccines, lock-downs, “approved” drugs, etc., is this archaic paper coming out now, with its easily disputed claims about what constitutes misinformation?

Corresponding Author: Sarah L. Goff, MD, PhD, Department of Health Promotion and Policy, School of Public Health and Health Sciences, University of Massachusetts, 715 N Pleasant St, Amherst, MA 01002 (sgoff@umass.edu).

Author Contributions: Dr Goff had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Mss Sule and DaCosta are considered co–first authors.

Concept and design: Sule, Gilson, Goff.

Funding/Support: The study was funded via internal support by the University of Massachusetts (Dr Goff).

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Disclaimer: The views expressed here are those of the authors and do not represent the official policy or position of the US Department of Veteran Affairs or the US government.

Note that the above is contradictory. Professor Goff is responsible for concept and design, also for funding, and yet it says the funder had no role in the design and conduct of the study. And if the study was self-funded by Dr. Goff and U Mass, why add a disclaimer about the US government and the VA? Something is not right.

The conclusions of the JAMA paper are as nasty as expected:

Discussion

This study was the first, to our knowledge, to identify the types of COVID-19 misinformation propagated by US physicians on social media and the platforms they used, as well as characterize the physicians who spread the misinformation. The content of misinformation physicians spread was similar to the misinformation spread by others; this study contributes new information about the range of specialties and regions of the country the physicians represented. The widely varying number of followers on social media for each physician suggested that the impact of any individual physician’s social media postings also may vary.

Some of the physicians identified belonged to organizations that have been propagating medical misinformation for decades,¹⁰ but these organizations became more vocal and visible in the context of the pandemic’s public health crisis, political divisiveness, and social isolation. Understanding the motivation for misinformation propagation is beyond the scope of this study, but it has become an increasingly profitable industry within and outside of medicine. For example, America’s Frontline Doctors implemented a telemedicine service that charged $90 per consult, primarily to prescribe hydroxychloroquine and ivermectin for COVID-19 to patients across the country, profiting at least $15 million from the endeavor.²⁹ Twitter’s elimination of safeguards against misinformation³⁰ and the absence of federal laws regulating medical misinformation on social media platforms suggest that misinformation about COVID-19 and other medical misinformation is likely to persist and may increase. Deregulation of COVID-19 misinformation on social media platforms may have far-reaching implications because consumers may struggle to evaluate the accuracy of the assertions made.³¹

National physicians’ organizations, such as the American Medical Association, have called for disciplinary action for physicians propagating COVID-19 misinformation,³² but stopping physicians from propagating COVID-19 misinformation outside of the patient encounter may be challenging.³³ Although professional speech may be regulated by courts³⁴ and the FDA has been called on to address medical misinformation,¹⁶ few physicians appear to have faced disciplinary action. Factors such as licensing boards’ lack of resources available to dedicate toward monitoring the internet³⁵ and state government officials’ challenges to medical boards’ authority to discipline physicians propagating misinformation³⁶ may limit action.

Scientific evidence depends on a body of accumulated research to inform practice and guidelines and the evidence depends on the best quality research available at any given time. A recent Cochrane Review has been misinterpreted to have definitively shown that wearing masks does not reduce transmission of respiratory viruses and has been used to support assertions that masks definitively “do not work.”³⁷ Although the Federal Bureau of Investigation and Department of Energy presented a theory to Congress that the COVID-19 virus was the result of a laboratory leak,³⁸ scientific evidence and a more recent report from the Office of the Director of National Intelligence demonstrate lack of evidence for a laboratory leak and favor a zoonotic origin of the virus.^39,40 These recent challenges to prior understandings illuminate the importance of transparency and reproducibility of the process by which conclusions are drawn…

Conclusions

Results of this mixed-methods study of the propagation of COVID-19 misinformation by US physicians on social media suggest that physician-propagated misinformation has reached many people during the pandemic and that physicians from a range of specialties and geographic regions have contributed to the “infodemic.” High-quality, ethical health care depends on inviolable trust between health care professionals, their patients, and society. Understanding the degree to which the misinformation about vaccines, medications, masks, and conspiracy theories spread by physicians on social media influences behaviors that put patients at risk for preventable harm, such as illness or death, will help to guide actions to regulate content or discipline physicians who participate in misinformation propagation related to COVID-19 or other conditions. A coordinated response by federal and state governments and the profession that takes free speech carefully into account is needed.

After Pierre Kory told me that he was one of the 52 doctors identified in this ‘study’ I went back and read all the excerpted doctor comments and found that I too was one of the identified 'misinformationists.' I wonder who really paid the cost of the study, which included the creation of the bad doctor list? Professor Goff? UMass? The USG? The VA? I wonder who the list of us got circulated to.

_______________________________

Dr. Goff made a terrible mistake. It was a lot more horrible than producing this silly article. She made an understandable error of judgement two years ago, and it had the most awful result possible. It killed her only child.

I have written about this story previously, but from a different perspective. Dr. Sarah L. Goff vaccinated her only child for COVID, a beautiful daughter attending Amherst High School, and that child suffered a sudden death at a high school track meet last year.

Not only that, but her daughter had an autopsy, and the cause of death was lymphohistiocytic myocarditis. Certainly the preponderance of evidence—a 99% probability, is that this was a vaccine death due to a COVID vaccine. Everyone must know this, yet Dr. Goff pretends otherwise.

And so instead of warning other parents about the dangers of COVID vaccines, Dr. Goff has funded a “study” to encourage the authorities to hunt down doctors like me for warning other parents not to do what she did.

It must be horrible to know your minor lapse in judgement led to your child’s death. I know Polly Tommey, my colleague at CHD-TV, has a very hard time living with her decision (resulting in an autistic son) and feels called to warn others constantly.

Dr. Goff, however, has chosen the opposite path, to strike out against those of us spreading the warning. Her paper mentions the motivations of us, suggesting it is profit. Really? When it leads to loss of career? How about some honesty, doctor?

She feels free to talk about my motivations (incorrectly) so I feel entitled to talk about hers.

Dr. Sarah L. Goff uses a number of defense mechanisms, which have allowed her to keep her guilt at bay. I think I understand it, but her method of attacking the truth tellers is so harmful, especially when new COVID vaccines are to roll out next month, and could even be mandated for children, that she must be called out. I have much to say to her:

Dr. Goff, stop trying to shoot the messengers who could have saved your daughter, if you had not been deaf to our entreaties. You are using some or all of the following Freudian defense mechanisms to deal with your grief, pain and guilt: denial, repression, projection, displacement, rationalization, sublimation and reaction formation. Get yourself the help you need. You did not mean to hurt her, it was not your fault, it was a tragic accident. You have suffered enough. You can let it go. Get the help you need to do so.

You don’t need to encourage anyone else to be harmed, now that you know the possible consequences. Stop now. I hope God helps you.

[She is not alone. Drs. Peter Hotez and Paul Offit are said to have autistic children, likely as a result of vaccine injuries. They too strike out in exactly the same ways to control their own pain and guilt, as the most aggressive vaccine pushers in the US. Let’s hope they all wake up soon.]

How the current version of the WHO's Pandemic Treaty (aka Bureau Text) encourages rather than prevents pandemics

Weapons of Mass Destruction: Chem Bio

Traditionally, Weapons of Mass Destruction (WMD) were Chemical, Biological, Radiologic and Nuclear (CBRN).

The people of the world don’t want them used on us—they are cheap ways to kill and maim lots of people at once. And so international treaties were created to try to prevent their development (sometimes) and use. First was the Geneva Protocol of 1925, banning the use of biological and chemical weapons in war. The US and many nations signed it, but it took 50 years for the US to ratify it, so we believed we were not bound by it.

The US used chemical weapons subsequently. The US probably used biological weapons in the Korean War, and perhaps in Vietnam, which experienced an odd outbreak of plague during the war. The use of napalm, white phosphorus, agent orange (with its dioxin excipient causing massive numbers of birth defects and other tragedies) and possibly other chemical weapons led to much pushback, especially since we had signed the Geneva Protocol and we were supposed to be a civilized nation.

In 1968, a young Seymour Hersh wrote a book about the US chemical and biological warfare program. In 1969 Congressman Richard D. McCarthy wrote the book “Ultimate Folly” about the US production and use of chemical and biological weapons. Prof. Matthew Meselson’s review of the book noted,

Our operation, "Flying Ranch Hand, " has sprayed anti-plant chemi-

cals over an area almost the size of the state of Massachusetts, over

10 per cent of it cropland. "Ranch Hand" no longer has much to do with

the official justification of preventing ambush. Rather, it has become

a kind of environmental warfare, devastating vast tracts of forest in

order to facilitate our aerial reconnaisance. Our use of "super tear

gas" (it is also a powerful lung irritant) has escalated from the originally

announced purpose of saving lives in "riot control-like situations" to the

full-scale combat use of gas artillery shells, gas rockets and gas bombs

to enhance the killing power of conventional high explosive and flame

weapons. Fourteen million pounds have been used thus far, enough

to cover all of Vietnam with a field effective concentration. Many

nations, including some of our own allies have expressed the opinion

that this kind of gas warfare violates the Geneva Protocol, a view

shared by McCarthy.

A Biological Weapons Convention

Amid great pushback over US conduct in Vietnam, in November 1969 President Nixon announced to the world we were going to end the US biowarfare program (but not the chemical program). In February 1970 Nixon announced we would also get rid of our toxin weapons (snake, snail, frog, fish, bacterial and fungal toxins that could be used for assassinations, etc.). Furthermore, Nixon said the US would initiate an international treaty to prevent the use of these weapons ever again. And we did: the 1972 Convention on the prohibition of the development, production and stockpiling of bacteriological (biological) and toxin weapons and on their destruction, or Biological Weapons Convention (BWC) for short, which entered into force in 1975.

The BWC established conferences to be held every 5 years to strengthen the Convention. The expectation was that these would add a method to call for ‘challenge inspections’ to prevent cheating and would add sanctions (punishments) if nations did not comply with the treaty. However, the US has consistently blocked the addition of protocols that would have an impact on cheating. By now, everyone knows that cheating occurs and is likely widespread.

A leak in an anthrax production facility in Sverdlovsk, USSR in 1979 caused the deaths of about 60 people. A clear BWC violation. US experiments with anthrax production during the Clinton administration, detailed by Judith Miller et al. in the 2001 book Germs were also thought by experts to have transgressed the BWC.

In 1997 a Chemical Weapons Convention came into force. It took over 20 years, but all official stocks of chemical weapons have been destroyed by the USA and by Russia and the other 193 member nation signatories.

Pandemics or Biological Warfare?

So here we are. It is 2023 and the WHO Director0General has declared 2 pandemics (the current terminology is ‘Public Health Emergency of International Concern’) over the past 3 and a half years: COVID-19 and monkeypox, which was renamed MPOX to “avoid stigma.” I am sure the monkeys were relieved by the name change.

I have previously (in my substack) described why I believe both SARS-CoV-2 and MPOX were bioengineered pathogens that came from labs. I do not know if they leaked or were deliberately released, but I am leaning toward deliberately released for both of them, based on where they appeared, how they spread, and in particular the official responses to each—neither of which was explained accurately to the public, and yet we never changed course, even when the lack of efficacy with masks, social distancing, EUA drugs and vaccines had become clear.

Vaccines: the Chicken or the Egg?

Both the monkeypox vaccines (there are two, Jynneos and ACAM2000) are known to cause myocarditis, as do the two COVID-19 mRNA vaccines and the Novavax vaccine. The Novavax vaccine was first associated with myocarditis during its clinical trial in Australia. I have written about all this previously on substack.

How frequently does myocarditis occur after these vaccines? If you use elevated cardiac enzymes as your marker, ACAM2000 caused this in one in thirty people receiving it for the first time. If you use other measures like abnormal cardiac MRI or echo, according to the CDC it occurs in one in 175 vaccinees. We do not know the number for Jynneos, but there was some degree of elevation of cardiac enzymes in 10% and 18% of recipients in two small prelicensure studies. My guess for the mRNA vaccines is that they are somewhere in this range. I don’t know about Novavax’ vaccine.

Why would our governments push 5 separate vaccines all known to cause myocarditis on young males who have been at extremely low risk from COVID, and who simply get a few pimples for 1-4 weeks from monkeypox unless they are immunocompromised? It’s an important question. It does not make medical sense. Especially when the vaccine probably does not work—Jynneos didn’t on the monkeys in whom it was tested. And CDC has clammed up about the 2,000 Congolese healthcare workers on whom CDC tested it for efficacy and safety in 2017. (I have detailed this too in earlier substacks.)

The health authorities could have just been ignorant—that could explain the first 8 months of the COVID vaccines’ rollout. But once they figured out, and even announced in August 2021 that the vaccines did not prevent catching COVID or transmitting it, why did they still push it on low risk populations who were clearly at greater risk from a vaccine side effect?

Once this is acknowledged, you realize that maybe the vaccines were not made for the pandemic, and instead the pandemic was made to roll out the vaccines. I’m not sure. But I’m suspicious. And the fact that multiple countries contracted for 10 doses per person makes me even more suspicious—for a vaccines whose safety and efficacy had not been established. WHY would you want ten doses apiece? Three maybe. But ten?

Furthermore, you don’t need a vaccine passport aka digital ID aka justification to convert to all-electronic money unless you are giving out regular boosters. Were the vaccines conceived of as the pathway to getting our vaccinations, health records, official documents and financial transactions all online—as Ukraine has already done?

A Pandemic Treaty and Amendments: Brought to you by the same people who mismanaged the past 3 years, to save us from themselves?

The same US government and western governments that imposed draconian measures on their citizens to force us to be vaccinated and take dangerous, expensive, experimental drugs and withheld the good drugs, decided in 2021 we needed a pandemic treaty to prevent and ameliorate future pandemics or biological warfare events... so we would not suffer as we did with the COVID pandemic.

Except COVID was a disaster due to its mismanagement (or should I say dismanagement or malmanagement?) by our nations’ rulers, their bosses and the WHO. Hundreds of millions of our fellow human being were slammed into extreme poverty—by nations following guidelines issued by the WHO, whose main job it was to protect exactly those people. Tens of millions died from starvation as a result. Yet the WHO blathers on about equity, diversity and solidarity—having itself caused the worst (manmade) food crisis in our lifetimes. Have you heard any apology or explanation?

How can anyone with a brain believe the public health officials who messed up COVID so badly want to spare us from another medical and economic disaster, after they imposed the last one on us? And the fact that no governments or health officials will admit their mistakes — especially how they made it nearly impossible to obtain the cheap and safe drugs that effectively treat COVID — why would we let them plan anything, let alone an international treaty that will bind our governments to obey the WHO’s dictates? How thoughtful of these officials to want to spend a king’s ransom of our money to prevent the next government-caused disaster.

We are fed up with secret vaccine contracts, waivers of liability for junk medical products, and spikes in sudden deaths and chronic disabilities. No more secret negotiations. Please shove your pandemic planning where the sun…

The Gain of Function farce

Obviously, the best way to spare us from another pandemic is to immediately stop funding “Gain of Function”* research, and get rid of what has already been funded and created. Let all the nations make big bonfires and burn up their evil creations at the same time, while allowing other nations to inspect their biological facilities and records.

But the WHO in its Bureau Text of the draft Pandemic Treaty has a plan that is the exact opposite of this. In the WHO’s world, which almost all nations’ rulers have bought into, all the governments will share any and all viruses and bacteria they come up with that have “pandemic potential” — share them with all the other governments. They are supposed to sequence them and then put the sequence online. No kidding. Then the WHO and all the Faucis of the world would gain access to every Frankenstein virus, at once. Presumably a bunch of hackers would also gain access to the sequences. Does this make you feel more secure?

The WHO Treaty draft incentivizes Gain Of Function research

At least this plan makes clear whose side everyone is on. Fauci, Tedros and their ilk at the WHO, and those managing biodefense and biomedical research for nation states are on one side, the side that gains access to even more biological weapons, and the rest of us are on the other, at their mercy.

This crazy plan used to be called proliferation of weapons of mass destruction—and it is almost certainly illegal. But it is their plan. Governments will all share the weapons. And they are to put a lot more money into biolabs, and especially into genomic sequencing. Presumably so they can make even better weapons, and maybe they will even get around to cures or antidotes. But who will get the cures? It wasn’t us during the COVID-19 pandemic. Here is where you can read the current Treaty draft:

https://apps.who.int/gb/inb/pdf_files/inb5/A_INB5_6-en.pdf

Pages 10 and 11:

What else is in the Treaty? Gain of Function research (designed to make pathogens more transmissible or more virulent) is explicitly incentivized. Administrative hurdles to it must be minimized, while unintended consequences (pandemics) should be prevented: (page 14)

Vaccines will be rolled out speedily under future testing protocols

Just in case you thought the COVID vaccines took too long to be rolled out, the WHO has plans to shorten testing. There will be new clinical trial platforms. Nations must increase clinical trial capacity. (Might that mean mandating people to be human subjects in out-of-the-way Africa, for example?). And there will be new “mechanisms to facilitate the rapid interpretation of data from clinical trials” as well as “strategies for managing liability risks.” (page 14)

Manufacturer and government liability will be “managed”

Nations are supposed to use existing models as a reference for compensation of injuries due to pandemic vaccines. Of course, most countries do not have vaccine injury compensation schemes, and when they do the benefits are usually minimal. The US government scheme for injuries due to COVID pandemic products (the Countermeasures Injury Compensation Program or CICP) has compensated 4 (yes, FOUR) people as of July 1, 2023. All pandemic EUA drugs and vaccines fall into this program (monoclonal antibodies, early remdesivir, paxlovid, molnupiravir, some ventilators and all COVID vaccines). There have been nearly 12,000 claims made to the CICP related to a COVID product. Slightly over 1,000 have been adjudicated while 10,886 are pending review. Twenty claims were deemed eligible and are waiting to see whether they can collect. A total of 983 people, or 98% had their claims denied. About 90% of all claimants filed for a vaccine injury.

The treaty draft also demands weakening the regulation of medical drugs and vaccines during emergencies under the rubric of Regulatory Strengthening. As announced in the UK last week, where ‘trusted partner’ approvals will be used to speed licensure, this is moving toward a single regulatory agency approval or authorization, to be immediately adopted by other nations (p 25)

Why would any developed country sign up for this? Is this what we the people want?

The WHO did sweeten the pot, however. Remember how the need to respect “human rights, dignity, and freedom of persons” was removed in the WHO’s draft IHR Amendments that are being negotiated? Well, WHO apparently did not like us pointing that out—so the old human rights language that was removed from the International Health Regulations draft has been added to this newest version of the Treaty.

There is much more I could say about problems with this draft of the Treaty, but I will save them for another time.

Please share this brief analysis of the WHO’s Pandemic Treaty. We must EXIT the WHO.

*Gain of Function is a euphemism for biological warfare reserch or germ warfare research. It is so foolhardy that it was banned in the US for SARS coronaviruses and avian flu viruses from 2014-2017 due to public outcry by scientists. Then in 2017 Fauci and Collins lifted the moratorium, claimed they were putting safeguards in place, which were just a handwaving exercise, and off we were to the races: creating new bioweapons. Fauci and Collins had the nerve to publish their opinion that the risk was ‘worth it.’

*Please make them stop the insanity of using nearly all newborns as guinea pigs.* CDC's ACIP today voted unanimously to give a monoclonal antibody to newborns on day 1-7 of life to prevent RSV.

 

MORE babies DIED who were TREATED than were in the control group. Same story as Pfizer's initial COVID shot trial. This will almost certainly kill many babies.

I previously revealed a published CDC paper from 2021 that showed only 25 babies up to one year of age die from RSV yearly in the entire US, averaged over 12 years. This is death certificate data, which CDC collects. It is considered THE GOLD STANDARD.

4 million babies are born yearly in the US. 20,000 die in their first year. RSV kills 0.125% of them. It is way down the list of top causes of death.

https://www.cdc.gov/nchs/products/databriefs/db427.htm#section_5



RSV almost never causes chronic problems, except perhaps asthma. Or maybe children with an asthma tendency are also more susceptible to severe RSV.

RSV does hospitalize a lot of US infants. It frightens parents and causes a lot of work for doctors. And so this group of pediatricians on CDC’s advisory committee went gaga over this new product, which is supposed to be 70-80% effective at preventing severe RSV disease.

Now let’s step back.

1. What is a monoclonal antibody? In this case, it is a genetically engineered antibody produced in hamster ovary cells. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761328s000lbl.pdf

   

2. What are potential risks? According to the label, the only risks specified are rashes and anaphylaxis. This is a very uninformative label. Hardly worth the paper it is printed on.

   



Here is what the Cleveland Clinic says about risks from other monoclonal antibodies:

https://my.clevelandclinic.org/health/treatments/22246-monoclonal-antibodies



1. Has any monoclonal antibody product been given on a mass scale to children ever? No

2. Has one ever been approved for newborns? Absolutely not.

3. Is it safe? The label waffles around the issue of safety. The hardest evidence for safety would be if fewer babies died overall in the group who received the RSV monoclonal than in the placebo group that got nothing. But in this case, the FDA briefer said there was an ‘imbalance’ of deaths in the two groups. The members knew what that meant, but I am sure the briefer hoped the audience did not. FDA ‘judged’ [i.e., guessed] that the excess deaths were not due to the monoclonal antibody. But how would FDA know that? You find out what the side effects are by doing clinical trials. And the label does not provide any details about side effects. It can be difficult to tell in a newborn. And the manufacturer and FDA appear to use that as a benefit, requiring less safety evaluation. The label does not inform us of the causes of deaths. This is extremely worrisome.

4. Will it work in the real world? There is already resistance in RSV strains to this product, and so as it gets used, the resistant strains will outperform the susceptible ones, and the RSV ecology is likely to change…meaning its use will likely not last very long.

   

5. Is this a drug or a vaccine? CDC is playing fast and loose with the definition of vaccine again, calling it a vaccine when convenient and a drug when that is more convenient. In order to get it onto the childhood vaccine schedule it becomes a vaccine—giving the manufacturer a waiver of liability. But it must be coded for reimbursement as a drug. It will be covered by the Affordable Care Act insurance program as a vaccine. But if there is an adverse event when it is used alone, the adverse event report will be filed in the drugs system (FAERS) belonging to FDA. If it is administered along with vaccines, the adverse event report will be sent to VAERS, belonging jointly to FDA and CDC.

6. What about interactions with other vaccines or drugs used at the same time? We have no idea, but just go ahead and mix and match ad lib, per FDA and CDC.

   

7. How much does it cost? Price to the CDC is $395 pp for 0-8 month olds, and $495 to other buyers. Price for 8-19 month olds is double that.

8. It will be recommended for virtually all babies, except those born in April, due to the way its supposed 5 months of efficacy is intended to overlap with the RSV fall-winter seasons.