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A serious lawsuit: "An experimental vaccine was given to hundreds of thousands babies in Israel"

Dr Yaffa Shir-RazA serious lawsuit: "An experimental vaccine was given to hundreds of thousands babies in Israel"

Dr. Yaffa Shir-Raz

Dr. Yaffa Shir-Raz (Ph.D., The University of Haifa, Israel) is a health and risk communication researcher, as well as a health journalist, and her interdisciplinary work in this field draws from both professions.  She is a researcher at the University of Haifa Health and Risk Communication Research Center, and a lecturer of health communication in the International Communication Program, Sammy Ofer School of Communication, IDC Herzliya, Israel.

An experimental, flawed, dangerous and harmful vaccine was given to newborns and infants in Israel, without informing their parents and without obtaining their informed consent. These serious allegations were raised last Wednesday in a lawsuit filed by Attorney Dr. Ahuva Ticho against the Israeli Ministry of Health and Scivac, the manufacturer of Sci-B-Vac. Between 2011 and 2015, Sci-B-Vac, a Hepatitis B vaccine made in Israel, was given, to 428,000 newborns and infants in Israel.

The lawsuit, for bodily injuries allegedly caused as a result of the vaccine, was filed on behalf of two children and their parents. At the same time, a motion for certification of a class action was filed against Scivac last Thursday, by attorneys David Or-Chen and Ahuva Ticho, in the amount of NIS 1,879,500,000. The class action alleges misrepresentation, loss of autonomy, exploiting distress and breach of duty to inform consumers. The motion for certification of a class action was filed on behalf of the two children and their parents.

According to an opinion that accompanies the statement of claim, by Prof. Avinoam Shofer, a pediatric neurologist, there is a reasonable basis to determine that Sci-B-Vac is the cause of the functional-developmental impairment in the two children for whom the lawsuit was filed, in the absence of any other known possible cause. With respect to plaintiff A, the statement of claim alleges that he suffers from Suffers from a severe seizures disease, epilepsy, and a developmental delay. He has multiple seizures, up to 40 a day. At the age of four, he does not speak yet, and apart from the word "father", he does not even make syllables, only sounds. As for plaintiff B, according to Prof. Shofer's opinion, his symptoms and test results indicate that he suffered from a vaccine-associated encephalitis, and today suffers from a developmental delay. 

The tip of the iceberg

The Sci-B-Vac story was exposed three years ago, on Ynet, an Israeli news website, following the Israeli Ministry of Health announcement of a recall of the Sci-B-Vac vaccine.

The recall was announced on July 29, 2015, and applied to all the batches distributed since1.1.2012. According to the recall notice, the reason for the recall, was "a technical failure in packaging". The notice emphasized that the recall was only conducted as a precautionary measure only and that there were no reports of concerns regarding the efficacy and safety of the vaccine. Two weeks later, in response to Ynet's investigation, the Ministry of Health issued a clarification notice, stating that the nature of the problem was "a concern about possible cracks in the vials, claimed to be the result of "a problem of a lack of synchronization at the rate of feeding the vials and labels into the machine." However, the later explanation did not reassure parents. In fact, the clarification notice may have increased parents' anxiety, especially given a recall announcement published online at the same time, by the Hong Kong Ministry of Health, where several hundred batches of the vaccine were sold. The latter announcement warned of a risk of infection and sepsis, and instructed the public to consult their healthcare professional, if in doubt or feeling unwell.

It was later revealed that the defect leading to the recall was only the tip of the iceberg. To date, Scivac has not received approval from any Western regulatory agency, such as the FDA or EMA. The company's documents show that the company's clinical studies, which the Israeli Ministry of Health relied upon to approve the vaccine and introduce it into the routine immunization schedule for infants, included only two phase III studies in neonates, with a scant number of participants.

The studies are a "trade secret"

Following the publication of the Ynet's report on the recall, Ynet and the Movement for Freedom of Information in Israel, and later on lawyers and parents whose children received the vaccine, submitted numerous requests under the Freedom of Information Act. They sought access to documents, protocols and company's clinical trials that would allow the public and clinicians to understand the basis for the vaccine's approval for marketing and its inclusion in routine immunization schedules for infants, as well as understanding the cause of the recall.

However, all Freedom of Information requests were refused. The Ministry of Health has repeatedly claimed that the clinical trials were "the manufacturer's trade secret" and that the protocols of committee discussions in which the vaccine was approved and included in the routine immunization schedule for infants " were not in the possession" of the Israeli Ministry of Health.

Scivac did not provide any answers either. In response to a request by Attorney Ticho, which was forwarded to Scivac's attorneys, Perl Cohen et al, it was claimed that "Sci-B-Vac marketed by our client was not defective. The reason for conducting the recall… was a specific failure in the vaccination package - which does not affect the efficacy and / or safety of the vaccine; and without any implications for those vaccinated in the past and / or in the future. Your request for information and documents is rejected. "

Over the past three years, in an attempt to find answers, dozens of documents that reveal additional details regarding the decisions to approve the vaccine and include it in the immunization schedule, and regarding the recall, were collected.

On what basis was the vaccine approved?

In the year 2000, the Sci-B-Vac vaccine was registered in Israel by the Ministry of Health. At that time, it was called Bio-Hep-B. The vaccine is based on the development of the Weizmann Institute, in cooperation with the Hadassah Medical Center and Bio-Technology General (BTG). The vaccine was later sold to SciGen, a Singaporean company.

According to the financial press, in 2014, 45% of Scivac's shares were sold to OPKO, a pharmaceutical company whose CEO and controlling shareholder, Philip Frost, was charged by the U.S. Securities and Exchange Commission, on September 7 2018, with participating in pump-and-dump schemes. In October 2015, about two months after the Sci-B-Vac recall, Scivac was merged with VBI Vaccines Inc.. Today, OPKO holds 10.4% of VBI.

The vaccine leaflet was approved in February 2009; and, in 2011, the vaccine was introduced into the routine immunization schedule for newborns and infants. At the time, GSK's Hepatitis B vaccine – Engerix B, had already been approved and had been used in Israel for years. Engerix B was approved by the FDA as early as 1989 and, in 1992, it was introduced into the infants' immunization schedule in Israel. Like Engerix B, Sci-B-Vac is given in three doses: immediately after birth, at the age of one month, and at the age of six months.

According to a protocol of the Advisory Committee on Infectious Diseases and Immunization, dated July 4, 2013, the Committee decided to divide the country in two: districts in which all infants were to receive Engerix B, and districts where all infants would receive Sci-B-Vac.

The lawsuit alleges that the decision to approve the vaccine and include it in the infant immunization schedule was made "without the approval of a recognized Western regulatory authority, such as the FDA or EMA" - a puzzling decision that contradicts the Ministry of Health's previously declared policy. In a Knesset, document on vaccinations for children, dated December 2000, Dr. Emilia Anis, the Director of the Epidemiology Division at the Israeli Ministry of Health, reported that "the field of immunization is under the close supervision of the Ministry of Health… The approval for every vaccine is given only after it has been widely used in the world".

The rationale behind this policy is that the international regulatory authorities have available resources, professional personnel, laboratories and equipment, control departments, procedures and budgets necessary for drug approval. In contrast, the statement of claim argues, the Israeli Ministry of Health does not have "the capabilities, skills, personnel, knowledge, experience and resources to examine and confirm the safety" of a new vaccine.

How many newborns were included in Phase 3 trials?

In a response to Ynet's investigative report, the Israeli Ministry of Health stated that "the State of Israel is a sovereign state and has an advanced drug registration system, at a level that is not inferior to large and well-respected health authorities, such as the FDA and the EMA, and therefore is able to examine and evaluate the data submitted to it".

Even if this were true, the question is why, in this particular case, when it came to immunizing neonates and infants – the most vulnerable population, the Ministry of Health found it appropriate to stray from its policy? This is particularly puzzling when a vaccine which did have both FDA and EMA approval and a recognized safety profile was available, and had been in use for years, in Israel and throughout the world.

Furthermore, the question arises whether the safety and efficacy studies were indeed carried out in accordance with the FDA and EMA standards. The lawsuit alleges that, the decision to introduce the vaccine into the routine immunization schedule for infants was made "without the defendant 2 (Scivac) conducting safety studies worthy of Phase III, in infants and newborns, prior to its approval and introduction for use, as opposed to what is required by its procedures".

Phase 3 is the crucial stage in clinical trials, designed to ensure the efficacy and safety of drugs and vaccines in a large number of patients. According to scientific sources attached to the statement of claim, "the FDA requires phase III studies involving thousands, if not tens of thousands of subjects". The Ministry of Health has argued in response to Ynet that "Phase III trials of the vaccine included more than 3,000 people. Of these, more than 1,000 were infants".

However, based on a May 1, 2015 official Scivac document, this claim seems to be incorrect. A table in the document, summarizes the main clinical studies carried out by the company. The table shows that four studies were defined by the company as Phase 3, of which only two were in newborns, totaling 276 newborns only.

"Comparisons of the data indicate that the scope of participants in the clinical trials conducted by Scivac is not the same at all, and in fact thousands of times smaller than the scope of GSK's trials for marketing approvals by the major authorities, for its Engerix vaccine," explains Dr. Dario Vertnik, an expert in analytical chemistry and a toxicological consultant, whose opinion accompanies the statement of claim.

In an effort to convince the public that the research infrastructure for approving the vaccine in newborns and infants was strong, the Israeli Ministry of Health published another table, "which includes the list of experiments carried out among infants and received from the company".

However, examining the numbers of the research protocols in the Ministry of Health table and comparing them to the company's own document, clearly shows that, apart from the two studies with 276 infants, the remaining studies were defined by the company itself as Phase 1-2 trials. Dr. Vertnik states that, in fact, all the studies presented in the two tables do not meet basic FDA and EMA requirements, nor meet the requirements of the Ministry of Health.

"The product is safe and effective in 300,000 Israeli babies"
In Dr. Veretnik's opinion, even the company itself has stated that it was not sure that its clinical trials would suffice to persuade the FDA to approve the vaccine for marketing: "Our research and clinical approaches may not lead to biologics that the FDA considers safe for humans and effective for the indicated uses we are studying".

In fact, the company has just recently begun Phase 3 trials on its vaccine, in order to market it in the US and in Europe, after receiving a green light from the FDA and the EMA in 2017. These are randomized, double-blinded and comparative trials, conducted in large number of medical centers (with about 4,764 participants).

Yet the company, which for years has been announcing its desire to obtain FDA and EMA approval, had another convincing card – that Sci-B-Vac has been approved by the Israeli Ministry of Health and given to hundreds of thousands of babies in Israel. In an interview with the Wall Street Analyzer, on June 23, 2017, VBI’s CEO, Jeff Baxter, said: "So the product was invented in Israel and has been used very successfully in over 300,000 individuals in Israeli hospitals, newborn children. In this group, in those 300,000, the vaccine was proven to be very safe and, most importantly, highly effective".

The statement, boasting hundreds of thousands of "patients" or infants who received the vaccine and in whom the "safety and efficacy were proven" is regularly highlighted in the company's publications. It should be noted that in some of the company's publications, including VBI's website, it is claimed that the vaccine was given to 500,000 patients. In a September 40, 2015 document, it states: "In Israel, where more than 500,000 persons have already been vaccinated with our vaccine, Sci-B-Vac™, is considered the standard of care. We have sold more than 1.5 million units in Israel". According to the data contained in the Ministry of Health's response to Ynet, on August 12, 2015, most of the doses were administered to children: "In total (since 2011 and up until the recall, at the end of July 2015), about 1,285,500 children-doses were issued".

How exactly has the safety and effectiveness of the vaccine been proven in the hundreds of thousands of Israeli babies who received it and how many babies did indeed receive it in Israel? These questions remain unanswered, in view of the contradictions in the publications and in light of the refusal by Ministry of Health and the company to disclose their documents.

Generic or "novel" vaccine?

In response to Ynet's inquiring why the company was not required to provide large-scale safety studies before the vaccine was approved, the Ministry of Health claimed that there was no need for them, since "this is a vaccine similar to the existing vaccine."

But is that in fact so? It seems that this claim is contradicted by the way in which the company itself presents the vaccine.

In an interview with the Wall Street Analyzer, on June 23, 2017, VBI’s CEO, Jeff Baxter, said: "I mean, I always summarize Sci-B-Vac as a diamond in a bucket of coal, i.e., it’s every biotech CEO’s dream to find a scientifically and clinically differentiated product, which is licensed in a highly regulated market and has the opportunity to be approved in North America and Northern Europe. And that’s exactly what we have with Sci-B-Vac, i.e., that it’s clinically and scientifically differentiated", said Baxter in another interview with the Wall Street Analyzer in April 2018.

Furthermore, in its studies, the company calls Sci-B-Vac an "a novel" vaccine, and presents it as a "third-generation vaccine". This is in contrast to hepatitis B second-generation vaccines, such as Engerix B.

According to the lawsuit, Sci-B-Vac "is a new vaccine, which is not an alternative and/or not a generic and/or not an improved vaccine, compared to Engerix" and is "substantially different by a number of technological-scientific parameters, each of which in itself increases the risk for contamination and/or morbidity".

First, Sci-B-Vac contains three surface-antigens compared with just one surface-antigen, contained in Engerix. Second, per Dr. Veretnik’s opinion, the company significantly reduced the amount of the antigenic material in the vaccine, that it is four times smaller than that included in Engerix, but according to Dr. Veretnik, "due to a serious design failure in the production of the vaccine", the amount of aluminum adjuvant was not reduced accordingly. As a result, "the ratio between the amount of adjuvant and the antigenic material in the Sci-B-Vac vaccine is four times greater than that of Engerix".

Because the aluminum adjuvant involves a risk for neurotoxicity, such a high ratio "has direct implications for the safety of the vaccine," Dr. Veretnik stated, adding that the manufacturer itself declared that the acquired immune defense in Sci-B-Vac was higher and achieved faster, following its injection. "This claim alone means that this is an innovative vaccine with a stronger effect on the immune system, so it had to be investigated extensively for safety, like any other new vaccine", an expert opinion, attached to the lawsuit stated. "This powerful effect may potentially put vaccinated people, especially newborns and infants, at high risk of injury".

Another difference is that, while Engerix is produced in yeasts, Sci-B-Vac is produced in mammalian cells, i.e. Chinese hamster ovary cells (CHO), and therefore is "prone to contamination". According to the expert’s opinion, the Israeli Ministry of Health was the first in the world to approve the use of a Hepatitis B vaccine produced in mammalian cells. "The use of mammalian cells in drugs and vaccines is considered problematic, because of their increased risk compared to plant cells, such as yeast cells. Animal cells are susceptible to many viruses, germs and genetic mutations that can be the source of contamination", Dr. Veretnik wrote. Because of these concerns, "American and European regulators require that pharmaceutical companies follow strict guidelines to ensure the safety of products produced from living tissue".

Moreover, the mere fact that the company is now conducting Phase 3 trials in order to get the FDA and the EMA's approval serves as clear evidence to the fact that Sci-B-Vac is not generic to Engerix or to any other hepatitis B vaccine. If the vaccine was really generic, the company would not have had to carry out phase 3 trials, and it would have been defined as an Abbreviated New Drug Application (ANDA). According to the FDA, "generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is performs in the same manner as the innovator drug". In contrast to the studies that led to the MOH approval in Israel, those Phase 3 trials currently carried out by VBI are IND (Investigational New Drug) studies, ie, studies conducted and submitted to the FDA in order to get its approval for a new drug – an innovator drug.

Technical failure in packaging?

The statement of claim and the motion for certification of a class action also reveal new details of the recall announced on July 29, 2015, and the nature of the recall. The recall announcement included a list with 27 batches to return, each includes 33,000 vials, and a total of 891,000 vials. In fact, according to the company's declaration, all the products sold since January 1, 2012 has been retrieved from the market; and the Ministry of Health has ordered a halt to the use of vials, Full and general until further notice.

As noted, the MOH recall announcement stated that the reason for the recall was "only a technical malfunction". Later on, the wording changed, and the ministry clarified that there was a fear of cracking in vials. From the company's defect reporting form (July 28, 2015), it turns out now that the essence of the defect was actually broken vials were found, with "partial or complete leakage of the vial content". In addition, according to an MOH conference call summary document regarding the defect (no date specified on the document) it was also reported by the company, that in the packaging process an empty vial and a wet cardboard box were found. According to the document, the company notified the Ministry of Health "of suspicion of contamination of vials and of a lower volume of liquid vials".

These findings, it was argued in the lawsuit, indicate fluid flow and damage to the sterility of the product, which causes "infection of the vaccine and risk and damage to vaccinated persons". From Dr Veretnik's opinion: "According to basic technological and professional logic, fluid loss proves that there is an opening in the packaging bottle through which material passes from the packaging to the outside, and vice versa. Each particle, including microbial particles of viruses, bacteria and chemicals can pass through the opening, penetrate the product and / or leave it. Since the product must be sterile, the immediate and clear conclusion is that the product is contaminated".

He said that the recall announcement was published late on Sunday, July 26, 2015, when the company reported to the Ministry of Health only on Tuesday, July 28, at 6:00 pm – "ie, a negligible range of two days after the company discovered Malfunction", and the Ministry of Health published the announcement to the public only on Wednesday at 14:10. "The arrest of the vaccine was therefore delayed 4 days after the case, during which the defective vaccine was given to thousands of newborns."

Second, the company and the Ministry of Health "made do with only a visual examination of the crack in the packaging, without imaging testing and without examining the presence of microbiological contamination in vials".

According to the MOH conference call summary document regarding the defect - to the MOH question, "Is there a fear that they will use a cracked wail?" The company replied that the nurse measures a 0.5 mL volume syringe and if the volume will be smaller than that, than this specific vial will not be used. "This answer is illogical and unreasonable, and demonstrates the superficiality of the investigation and the lack of necessary precautions to prevent giving a defective vaccine to babies", Dr. Veretnik wrote.

According to him, "In the process of controlling industrial production ... the volume of the product is tested in the laboratory ... Any deviation of 10% above or below the volume of the product listed on the label disqualifies the product for marketing and use. A deviation of 10% of the product volume of 0.5 mm means 0.05 ml - a quantity that would be difficult for a human eye to detect... The nurse, especially under the conditions of working with infants, should not be expected to notice a deficiency of 0.05 ml".
"The lawsuit constitutes a serious indictment against the Ministry of Health", says Plainfiff’s counsel, Dr. Ahuva Ticho, "The Ministry of Health failed in its role to protect public health. The Ministry of Health must answer to the public as to how it had approved and introduced vaccinations in babies, with a vaccine that has never been approved in any Western country and without proper trials in infants, and that it itself declares that it has more side effects".It (the Ministry) must explain why it hid from the parents that the vaccine was defective and dangerous, why it failed to warn them and physicians about the risk of contaminated vials and why it did not instruct them to come and have their children examined. Scivac must explain how it manufactured and marketed a vaccine for infants, without proper clinical studies."

"The vaccine was marketed with the deception of physicians and the public, without informing the parents that it was experimental and without their informed consent", says attorney Or-Chen. "By doing so, the company has turned newborns into 'guinea pigs'. Even when the vaccine was found to be defective, the company concealed it and did not act properly to correct it and inform the parents in time, thus endangering the babies and causing great anxiety among the parents."

The Ministry of Health said in response: "the Ministry of Health will study the lawsuit and will respond in court, as is customary. We note that this is a safe and effective vaccine that has prevented great morbidity in Israel."

Jeff Baxter, VBI’s CEO, issued the following statement: “We are always sorry to hear about any developmental complications in young children and about the difficulties experienced by their families. However, there is no evidence in the extensive clinical study experience and usage history of Sci-B-Vac® that such complications are a result of vaccination with Sci-B-Vac®. SciVac is still reviewing the content and nature of these claims, given they were filed so recently. That said, we take these claims and allegations very seriously and will respond and investigate accordingly. SciVac holds itself to the highest standards of integrity and compliance in its commitment to safely and effectively address public health unmet medical needs.”

The writer holds a Ph.D. in Health Communication from the University of Haifa, Israel, and is a health communication researcher. The Hebrew version of this article was published on Ynet, September 19, 2018.
https://www.ynet.co.il/articles/0,7340,L-5348495,00.html

 

 

Comments

Morag

Just too awful and horrific,ongoing repeated medical atrocities happening in local, national, and international zones.
An amalgamation of,
Edinburgh -Royal Mile- Burke and Hare
www.royal-mile.com>famous-scots>burke and hare
And
Plotkin's Vaccines 7th Edition -Elsevier Published June 2017 .
With, Root-and- Branch side-kick appendeges of ,
The behaviour change wheel . A new method for characterising and designing behaviour change interventions implementation science [Michie et al 2011]
Increasing vaccination - Putting Psycological Science into Action . Psychological Science in the Public Intrest . [ Brewer et al 2017]
Increasing the intent to receive a Pandemic influenza vaccination -Testing the impact of theory -based messages . Godino, Yardley,Marcu,Mobray, Beard,Michie, August 2016
Pray Big- Pray Hard- Pray Often ! That these medical atrocities and their appendages, get legally skelped as hard and sore as possible , straight into the middle of next week! .
Have they not got a species back-bone straight enough to share between the whole damn lot of them, for an icy- cold shiver to run up ?

Patrick

Check out all the contradictions in this insert. It basically states that they don't know anything about the measles V....how it works, if it is effective etc.... However they state that it is dangerous and it's a good idea to have life saving measures in place when administering the shot. https://www.fda.gov/media/75191/download?fbclid=IwAR0pAXzLC66NXvxdPR6j485P_2iyI0Mwdpw8Zc6NbE3akuLIqyKfChq5PVM

Rtp

Jenny, Len can read what we read.

The problem is that his desire to believe in vaccines is greater than any other desire.

So he has to pretend not to know what the word "restrict" means so he can continue his cognitive dissonance.

The thing is, even without these direct instructions, doctors would still often refuse to diagnose the condition if the patient is vaccinated. Doctors believe (genuinely but wrongly) that vaccines work - ie they think they reduce the *risk* of disease. Doctors also make their decisions on testing and diagnosing on the patient's presumed *risk* of having the disease. So, instructions or not, many kids with measles are being diagnosed with something else simply because of vaccine status.

If this wasn't true we would have to conclude either doctors don't believe vaccines work and/or doctors diagnoses are all arbitrary. Len won't agree with either of these but he'll still refuse to accept the necessary logical consequence - that is cognitive dissonance.

Along with the presence of sick people germs in doctor offices, this is the Achilles heel of the vaccine paradigm.

Hera

Hi All,
Len I would agree that "explicit" may or may not the right word, depending on your usage of it, but I also think RTP is right in that what he quotes is certainly suggested that vaccine status is taken into account before either diagnosis, or lab testing, apparently to prevent "false positives" ? What is up with that? And how are these "false positives" prevented in unvaccinated individuals?

On a related note, the CDC does seem to "explicitly" or you can use a different word if you prefer, "strongly suggest" perhaps? avoid testing vaccinated individuals for MMR titres. People who have had the measles get tested and the titres are used to prove they have the typical lifelong immunity, but , per the CDC somehow vaccinated people are it appears "strongly suggested " not to be tested for titre immunity.

https://www.cdc.gov/vaccines/vpd/mmr/hcp/recommendations.html
"After vaccination, it is also not necessary to test patients for antibodies to confirm immunity. "
Advice to not test the vaccinated is repeated again and again in multiple formats. How strange, don't you think , with an illness that the CDC is apparently really worried about?

Again, semantics and word use between us all may differ, but it seems very definite that testing to see if the MMR vaccine works is apparently against CDC guidelines.
Testing to check immunity in everyone else is fine, however...
Why would that be? and if multiple shots don't confer immunity in adults, as has been suggested, is that something we perhaps all need to know , if we actually are concerned about the illness?
Shouldn't vaccinated people with no immunity also be quarantined, denied an education in California and New York, etc , as well?
or is that the problem that they wish to avoid, in which case, it has never been about the spread of infection..

Jenny Allan

@Len Tukwilla
My previous post reported my elder daughter's measles like reaction to a monovalent live measles vaccine in 1968. As far as I am concerned the vaccine gave her a mild dose of the measles, which has apparently conferred lifelong immunity. Unfortunately this vaccine also caused an unacceptable number of adverse reactions in children and was withdrawn soon afterwards.

The following paper is an analytical analysis of a recent faster test for ascertaining specific measles strains in suspected measles cases. It's quite technical, but the authors make it absolutely plain vaccine derived measles, cases are not officially regarded in the same way as 'wild' measles cases, and are simply regarded as 'vaccine reactions'.
American Society for Microbiology
Rapid Identification of Measles Virus Vaccine Genotype by Real-Time PCR
https://jcm.asm.org/content/55/3/735

Extracts:-
"During measles outbreaks, it is important to be able to rapidly distinguish between measles cases and vaccine reactions to avoid unnecessary outbreak response measures such as case isolation and contact investigations."
"Importations of measles from areas of endemicity have caused frequent and sometimes large outbreaks (2–6) and a recent transitory suspension of the elimination status (7). An important component of the public health response to a measles outbreak is vaccination of unimmunized contacts (8). Since approximately 5% of recipients of measles virus-containing vaccine experience rash and fever which may be indistinguishable from measles (9), it is very important to identify vaccine reactions to avoid unnecessary isolation of the patient, as well as the need for contact tracing and other labor-intensive public health interventions."
" During the measles outbreak in California in 2015, a large number of suspected cases occurred in recent vaccinees (3). Of the 194 measles virus sequences obtained in the United States in 2015, 73 were identified as vaccine sequences ."

The references to 'unnecessary outbreak response measures ' and 'unnecessary isolation of the patient, as well as the need for contact tracing and other labor-intensive public health interventions.", make it perfectly clear vaccine derived measles does not justify the trouble and expense accorded to 'wild' measles. My measles vaccinated younger daughter had quite a nasty dose of measles when she was three years old, and I personally find this dismissive official attitude to vaccinated persons contracting measles unethical and potentially harmful. Measles is measles however derived.

This is plainly all about minimising expense and regaining WHO measles free status which ignores measles cases 'imported' from abroad. I think it is logical to assume doctors are probably being discouraged from even reporting measles cases in persons with full vaccination status.

Rtp

Len, can you please tell us all what exactly you think the word "restrict" means?

And what exactly do you think was meant by "Clinicians are reminded to consider the diagnosis of respiratory diphtheria in patients with membranous pharyngitis and who are not up-to-date with vaccination against diphtheria."?

Len Tukwilla

Rtp,

Nothing you’ve posted is an explicit instruction to not diagnose a patient with a VPD for which they’ve been vaccinated, and I’m not surprised.

Bill

Sounds like israel is engaging in population control through poor quality vaccines. Who is effected most by this latest vaccine related scandal? Mizrahis ( Jewish people indigenous to the Middle East and North Africa), Arabs (Palestinian), Ethiopians? We need to return to the "Green the Vaccine" movement the 'Anti vaxers" have gone crazy. Decades ago before mercury and aluminium contamination vaccines saved lives now they worsen things.

Rtp

Look at Len. He asked for something he never actually wanted and when he got it he acted obtuse. Color me shocked. A pro-vaxer who can't be honest.

Tell us Len, which one of those quotes didn't amount to doctors being encouraged/instructed not to diagnose the condition if the patient is vaccinated?

Jenny Allan

@David L "A small percentage of measles vaccine recipients experience rash and fever 10 to 14 days following vaccination. And from the World Health Organization: Rapid confirmation of measles vaccine reactions is essential."

Thank you David. I think it is logical to assume a live virus containing vaccine is capable of causing the disease vaccinated against. This is why immune compromised persons cannot be vaccinated with live vaccines.

UK 1968, and my elder daughter was vaccinated with a then 'new' measles vaccine. I was warned she might develop a rash, she did, and be fevered and fractious, she was. After about a week the rash cleared up. Now in her 50s, my daughter has never had any more measles problems. The measles vaccine was then very unpopular with family doctors, who complained it caused more proplems than the measles. The vaccine was withdrawn and replaced with a less effective version which my younger daughter got. She also caught thw wild measles when she was three.

There is evidence emerging of vaccinated persons catching measles in their 20s and 30s. It is imperative vaccinations for measles and mumps provide lifelong protection. It is obvious they are failing to do this.

David L

Unlike wildtype MeV, MeVV (Measles Vaccine) sequences are not submitted routinely to the WHO Measles Nucleotide Surveillance database for tracking. Research mentions MeVV strain RNA was detected in specimens from 11 children aged 18 to 45 months, more than 100 days (range: 101–784 days) following receipt of the most recent measles-containing vaccine and research shows to be capable of being infected with measles after vaccination and infecting others with it (secondary transmission) in a number of examples I've compiled here https://tgl.ink/60Bpty As one recent example, 61 samples tested between 1 January 2019 and 19 July 2019 in New Zealand detected the vaccine strain of the measles virus and were then subsequently identified as not being cases of measles and not included in measles outbreak reporting, only 41 reported cases in Canterbury were reported. The CDC also does not recommend measles antibody testing after MMR vaccination to verify the patient’s immune response to vaccination despite primary and secondary failure being a major contributor to outbreaks.
The CDC is aware of this as reported on their website: Genotyping is also the only way to distinguish whether a person has wild-type measles virus infection, or a rash caused by a recent measles vaccination. A small percentage of measles vaccine recipients experience rash and fever 10 to 14 days following vaccination. And from the World Health Organization: Rapid confirmation of measles vaccine reactions is essential. Sequence information allowed development of RT-PCR based assays for rapid confirmation of vaccines reactions. Rapid confirmation of vaccine reactions is an important part of laboratory surveillance in elimination settings. MeVA allows confirmation of MR, MMR vaccine reactions in 3-4 hours compared to 24-48 for sequencing.

Len Tukwilla

Still waiting for those explicit instructions...

Rtp

Here you go Len. Some more explicit than others but they all amount to the same thing - encouraging doctors to ignore the possibility of the condition if the patient is vaccinated:

"To minimize the problem of false positive laboratory results, it is important to restrict case investigation and laboratory tests to patients most likely to have measles (i.e., those who meet the clinical case definition, especially if they have risk factors for measles, such as being unvaccinated,[...]"

www.cdc.gov/vaccines/pubs/surv-manual/chpt07-measles.html

And here is the UK's National Health Service: "Following assessment, if a diagnosis of measles is considered likely, it is essential to notify the local Health Protection Unit (HPU)" and subsequently: "Measles is very unlikely in people who have been fully immunized", followed by “Consider a different cause if the patient is likely to have immunity” http://cks.nice.org.uk/measles#!diagnosissub

And this is for diphtheria: "Because diphtheria has occurred only rarely in the United States in recent years, many clinicians may not include diphtheria in their differential diagnoses. Clinicians are reminded to consider the diagnosis of respiratory diphtheria in patients with membranous pharyngitis and who are not up-to-date with vaccination against diphtheria."

http://www.cdc.gov/vaccines/pubs/surv-manual/chpt01-dip.html

And if you are still not sure. Here is an actual account of a parent of a child with pertussis who was refused a diagnosis by several doctors before they got one to even do a test. https://www.facebook.com/9NewsPerth/videos/1701725426506277/

Angus Files

Jeff Baxter, VBI’s CEO, issued the following statement: “We are always sorry to hear about..

Only sorry that someone is making them listen via the only channel the courts and even then its a rigged game.

Pharma For Prison

MMR RIP

Patrick

From the CDC: "Diagnosis

Your doctor can usually diagnose measles based on the disease's characteristic rash as well as a small, bluish-white spot on a bright red background — Koplik's spot — on the inside lining of the cheek. However, many doctors have never seen measles, and the rash can be confused with a number of other illnesses. If necessary, a blood test can confirm whether the rash is truly measles....
What to expect from your doctor

The doctor may ask that you come in before or after office hours to reduce the risk of exposing others to the measles. In addition, if the doctor believes that you or your child has the measles, he or she must report those findings to the local health department.

Your doctor is likely to ask you a number of questions, such as:

Have you or your child been vaccinated for the measles? If so, do you know when?
Have you traveled out of the country recently?
Does anyone else live in your household? If yes, have they been vaccinated for measles?"

Patrick

At 2 minutes the doctor mentions how one might think this kids rash is measles, BUT due to antibiotic usage that would not be considered. Sometimes they are diagnosed as having strep., sometimes Mono and sometimes they have both. One thing is for sure...kids are having a LOT of issues with their immune systems failing. The CDC DOES send out notice to all doctors at certain times to diagnose all rashes as measles....they did recently to fabricate a measles outbreak. : https://www.youtube.com/watch?v=p8SbaoeuSTo

Len Tukwilla

I'd like to see those "explicit instructions given to doctors not to diagnose measles (or other so-called VPDs) if the patient is vaccinated".

John Stone

Amused, Bored, Knowledgeable Person

Yes, it was a response to an NHS site - it did however cite US government acknowledgements of autism being caused by vaccination.

susan welch

A Bored/Amused person. Do you really think your inane comments, quoting government/media propaganda, cut any ice with those of us who witnessed regression in our perfectly progressing children/grandchildren immediately AFTER a round of multiple vaccines?

You really are on the wrong website.

Rtp

A bored person

What do you mean the measles outbreak "wasn't pretty"? What exactly did you personally observe (as opposed to what journalists, bureaucrats and doctors told you)? I am willing to bet you didn't observe anything at all of interest.

Come to think of it. Of all the beliefs you hold on this issue, why don't you declare which of them have been based on what you personally observed as opposed to what other people have assured you is true? I am willing to bet your (honest) answer is "absolutely nothing".

On the other hand, all of us can easily observe our beliefs to be true. We observed injuries immediately following vaccination (you have never witnessed a measles virus jump from someone to another and immediately cause injury or death). I personally can observe that the theory of contagion is overblown because I can easily observe people visiting doctor offices without dying - an implausible scenario if these diseases were so dangerous and contagious.

I can point to explicit instructions given to doctors not to diagnose measles (or other so-called VPDs) if the patient is vaccinated - so it is safe to conclude the government sourced stats are a lie and the so-called VPDs are just being renamed.

All of your beliefs are based on opinions. Feelings. Innuendo. Hearsay. Not a single direct observation and not a single logical (first principles argument).

Imagine that eh? You think that "science" is on your side. Well I'm sorry. But you have absolutely nothing. Just "that guy over there said so and he must be right because he calls himself a SCIENTIST!!!" And by the way, the fact that there are lots of "that guy" doesn't make it any more true.

By the way, why do you trust all government sourced statistics that support vaccination but completely ignore all government sourced statistics that tell us children are getting sicker? If we can't trust the ability of doctors back in 1900 to diagnose autism, why do you have complete unwavering faith in the same doctors' ability to diagnose smallpox or measles?

I will give you a hint: it is called "indoctrination". You even illustrated it yourself when you talked about your "experience" in Israel which we all know was just you falling for the media hysteria.

An Amused Person

John Stone, I was talking about it for context. One disease or another, an outbreak is still an outbreak. It also wasn't just hype, it was actually occurring but the media did exaggerate it. Your post is also about the United Kingdom's NHS as the title is literally just "Review of the United Kingdom National Health Service."
Barry, do you expect me to remember the name of the test of the top of my head? I don't think you could. For my family, we have not done genetic testing, but have got it diagnosed (I don't know how since I haven't bothered to ask). Also, I know this is more speculative evidence, but if you did put me in a conference, class, or whatever, I do get more easily distracted than the average person unless I find it truly interesting.

Barry

I have ADD, but that’s genetic and has been in my family since at least 1890

********

What test was used to diagnose your ADD?

What gene is responsible for the ADD in your family, and what test was used identify that gene?

How did you confirm that your ancestors also had that gene?

John Stone

Bored Person (previously posting as “Knowledgeable Person”)

When you say that vaccines do not cause autism what evidence are you citing? In a recent post I listed occasions on which US government officials acknowledged that vaccines cause autism albeit using circumlocutory language which you may or may not admire.

https://www.ageofautism.com/2019/08/review-of-the-united-kingdom-national-health-service-webpage-why-vaccination-is-safe-and-important-m.html

A recent Northern Ireland school census recorded that 3% of children now had an ASD diagnosis (up from 1.2% a decade ago) but it was not just additional marginal cases, >1.9% were Education Stage 5 and thus at a severe level of disablement. These figures are probably typical of our collapsing education system in the U.K. only more thoroughly compiled.

Almost certainly on your visit to Israel you did not personally encounter any cases of measles but just listened to the hype. Why are you going on about this in an article about a particularly harmful Hep B vaccine (which isn’t pretty)?

A Bored Person

I traveled to Israel during a measles outbreak (would go back again), and it wasn’t pretty. It could have been prevented by vaccine, yet it wasn’t (not going to blame anybody here). Now, people here obviously believe the disproven claim that vaccines cause autism. So, what about me? I have ADD, but that’s genetic and has been in my family since at least 1890. I have gotten all of my vaccines on schedule (unlike my sister, but her immune system functions at only 80% capacity) and people have never diagnosed me with autism when they could have. Everybody I know at my school of 1k kids takes vaccines, yet only one has autism.
This sparks an important question: why now? I think we all can agree that people have become more accepting of those with mental differences, including autism. Instead of being taken out of society, people with autism are being accommodated while being in society and while interacting with people. The amount of autistic people has increased linearly with the global population. Of course, I could use IQ scores internationally to back this up, but the IQ year is flawed.
If you have any questions, I should check this comment in about a day or so.
-A(n) [Insert Word] Person

expensive bologna

Dr Francisco Diaz-Mitoma, Chief Medical Officer, VBI Vaccines, will be prestenting
***Sci-B Results on Ph3 HepB Vaccine***
at the World Vaccine Congress, wasington DC Apr 6-9 2020

Lena Sun will be presenting Public Perceptions of Vaccines.
Gerberding the antivaxxer, Hotez and Offit will be there.
https://www.terrapinn.com/conference/world-vaccine-congress-washington/agenda.stm

Patrick

Boy, regarding va$$s they really love to use the phrase "safe and effective" like a cloak. They need to put their money where there mouth is. We need to see studies with inert placebos and healthy children following v's. The drug company's CEO even used it in their comment: "SciVac holds itself to the highest standards of integrity and compliance in its commitment to safely and effectively address public health unmet medical needs.” What a joke.

greyone

"this is a vaccine similar to the existing vaccine."
This concerned me about the Twenty first Century Cures Act, here in the US.
I believe there was a clause in the bill to allow this in the US.

Macbeth

Like Macbeth, Merck’s CEO and his army of pediatricians will never be able to wash the blood from their hands.

Gary Ogden

michael: Which makes it even worse, that it didn't even come up to the minimal standards the FDA uses. A trial with an enrollment of 276 in a phase 3, or even a phase 2 trial is utterly scientifically worthless. How dare they do this to infants. Hopefully this is a major scandal in Israel. My Israeli biologist friend told me that Israeli physicians have the lowest uptake of flu vaccine of any demographic group, so I suspect Israelis have a healthy skepticism of vaccine safety and efficacy, like a growing number of Americans.

michael

"without the approval of a recognized Western regulatory authority, such as the FDA or EMA"

Using the FDA to set the standard for safety, for regulatory diligence is an illusion.

Bob Moffit

After my beloved grandson "regressed" following vaccines .. now 20 years old … non-verbal .. with Elmo his favorite character .. requiring 24/7 careful supervision .. I blamed the vaccine industry for causing his autism. Now .. 20 years later .. I am beginning to change my mind on who deserves the greatest blame for what was done to him .. and the hundreds of thousands who regressed the same as he did.

No doubt in my mind that vaccines are the main CAUSE of 1 in 35 being diagnosed autistic today … but .. this "global" autism catastrophe could not have occurred .. let alone continue … had GOVERNMENT PUBLIC HEALH AGENCIES .. PROFESSIONAL MEDICAL BUREAUCRACIES … PROFESSIONAL MEDIA "HEALTH REPORTERS" … NOT CONSPIRED TO PROVIDE THE VACCINE INDUSTRY WITH COMPLETE LIABILITY PROTECTION FOR THEIR PRODUCT … THE ONLY PRODUCT .. VACCINES … THAT IS SO PROTECTED BY THOSE WHOSE RESPONSIBILITY IS TO PROTECT OUR MOST PRECIOUS RESOURCES .. OUR CHILDEN. THESE CAREER PROFESSIONAL BUREAUCRATS ARE AS GUILTY OF HARRMING TODAY'S GENERATION AS WELL AS GENERATIONS TO COME .. AND .. THESE MORALLY/ETHICALLY BANKRUPT CAREER INDIVIDUALS MUST BE HELD PERSONALLY ACCOUNTABLE FOR THEIR WILLING PARTICIPATION IN THIS GLOBAL HALOCAUST.

It is sickening to see these government officials, doctors, journalist speak LOUD AND CLEAR against the dangers of all kinds of products .. such as .. toxic toys or the latest clamor to ban vaping chemicals … while for DECADE AFTER DECADE .. WITH EVIDENCE OF DETERIORIATING HEALTH IN OUR CHILDREN ALL AROUND US .. 54% NOW DIAGNOSED WITH DEVELOPMENT PROBLEMS .. THEY HAVE CONSISTENTLY IGNORED AND REMAINED SILENT ON THAT DAMN ELEPHANT IN THE ROOM... WHILE THE VACCINE BAND OF HORRORS CONTINUES PLAYING ON AND ON … ON AND ON ..

They are all GUILTY in my opinion .. each one as responsible for what has happened to our children as the other …

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