Infectious virus in exhaled breath of symptomatic seasonal influenza cases from a college community

Jing Yan, Michael Grantham, Jovan Pantelic, P. Jacob Bueno de Mesquita, Barbara Albert, Fengjie Liu, Sheryl Ehrman, Donald K. Milton and EMIT Consortium

PNAS 2018; published ahead of print January 18, 2018, https://doi.org/10.1073/pnas.1716561115

Edited by Peter Palese, Icahn School of Medicine at Mount Sinai, New York, NY, and approved December 15, 2017 (received for review September 19, 2017)

 

Article Figures & SI Authors & Info  PDF

Significance

Lack of human data on influenza virus aerosol shedding fuels debate over the importance of airborne transmission. We provide overwhelming evidence that humans generate infectious aerosols and quantitative data to improve mathematical models of transmission and public health interventions. We show that sneezing is rare and not important for—and that coughing is not required for—influenza virus aerosolization. Our findings, that upper and lower airway infection are independent and that fine-particle exhaled aerosols reflect infection in the lung, opened a pathway for a deeper understanding of the human biology of influenza infection and transmission. Our observation of an association between repeated vaccination and increased viral aerosol generation demonstrated the power of our method, but needs confirmation.

(emphasis mine)

Go here for plain language story- Flu Vaccine Increases Your Risk of Infecting Others by 6-Fold, Study Suggests

“Evidence suggests that DTP vaccine may kill more children from other causes than it saves from diphtheria, tetanus or pertussis.”

04-30-2013guineabissau

A nurse gives a measles vaccination to a child in Guinea-Bissau. Photo: UNICEF/Roger Lemoyne

greenmedinfo.com

Study: DTP Vaccine Associated With 212% Increased Infant Mortality Risk

Posted on: Wednesday, March 15th 2017 at 12:15 pm Written By: Jefferey Jaxen

Study: DTP Vaccine Associated With Increased Infant Mortality.

A study from West Africa’s Guinea-Bissau discovered that all-cause infant mortality more than doubled after the introduction of the DTP vaccination.

(Follow the above link to read more.)

Here is the study referred to in Jeffrey Jaxen’s article.

The Introduction of Diphtheria-Tetanus-Pertussis and Oral Polio Vaccine
Among Young Infants in an Urban African Community: A
Natural Experiment
Available online 1 February 2017Abstract

Background
We examined the introduction of diphtheria-tetanus-pertussis (DTP) and oral polio vaccine (OPV) in an urban community in Guinea-Bissau in the early 1980s.

What I consider to be the important points….

  • In this natural experiment vaccinated children had 5-fold higher mortality than not-yet-DTP-vaccinated children. DTP-only vaccinations were associated with higher mortality than DTP + OPV vaccinations. Hence, DTP may be associated with a negative effect on child survival.
  • Except for the measles vaccines, surprisingly few studies examined the introduction of vaccines and their impact on child survival.
  • DTP was associated with 5-fold higher mortality than being unvacci-
    nated. No prospective study has shown beneficial survival effects of
    DTP. Unfortunately, DTP is the most widely used vaccine, and the pro-
    portion who receives DTP3 is used globally as an indicator of the perfor-
    mance of national vaccination programs.
  • All currently available evidence suggests that DTP vaccine may kill more children from other causes than it saves from diphtheria, tetanus or pertussis. Though a vaccine protects children against the target disease it may simultaneously increase susceptibility to unrelated infections.

Smallpox in the USA

 

Was smallpox eliminated in the USA by vaccines?

(emphasis mine)

The CDC on smallpox vaccination (USA) in the early 20th century.

Smallpox. Smallpox is the only disease that has been eradicated. During 1900-1904, an average of 48,164 cases and 1528 deaths caused by both the severe (variola major) and milder (variola minor) forms of smallpox were reported each year in the United States (1). The pattern in the decline of smallpox was sporadic. Outbreaks of variola major occurred periodically in the first quarter of the 1900s and then ceased abruptly in 1929. Outbreaks of variola minor declined in the 1940s, and the last case in the United States was reported in 1949.

Source – Achievements in Public Health, 1900-1999 Impact of Vaccines Universally Recommended for Children — United States, 1990-1998

Plotkin and Orenstein on smallpox vaccination (USA)in the early 20th century.

However, antivaccinationist sentiment and antipathy toward compulsory measures prevailed in many states, most of which passed no legislation or prohibited compulsory vaccination. Reported cases of smallpox declined from 102,791 in 1921 to 30,151 in 1931, and between 1932 and 1939, 5000 to 15,000 cases were reported annually, with 23 to 52 deaths. During the following decade, reported cases steadily diminished, the last occurring in 1949. This progress occurred in the absence of any nationally coordinated smallpox control effort, and little is known about the extent of vaccination immunity in the country during the 1940s or about the epidemiology of smallpox. However, improved smallpox control, and eventually its elimination, is attributed by Leak (see below) to the wider availability of better refrigeration and, consequently, better preservation of the vaccine. Routine vaccination continued in the United States until 1971 as a protection in case smallpox was imported and was enforced in most states by compelling vaccination as a requirement for school entry.

Vaccines. 3rd edition. Editors – S.A. Plotkin and W.A. Orenstein. Published 1999.

J.P. Leak, Surgeon Public Health Rep. 1927 Jan 28; 42(4): 221–282.

Who are Plotkin and Orenstein?

Stanley Plotkin 

Dr. Stanley Plotkin has such a storied vaccine development career that one might say he wrote the book on vaccines. In fact, he did and his book “Vaccines”, now in its 6th edition, is the standard medical reference. Dr. Plotkin’s background reads like a roadmap of 20th century infectious disease—polio, rubella, rotavirus, rabies, and varicella (chicken pox). His career has been spent on the development of these vaccines and he now advises and influences clinical practice, academia, vaccine policy, as well as industry.

Walter Orenstein

Dr. Orenstein worked for 26 years in the Immunization Program at the Centers for Disease Control and Prevention. From 1988-2004, he was the Director of the United States Immunization Program. Dr Orenstein is a Professor of Medicine, Epidemiology, Global Health, and Pediatrics, as well as Associate Director of the Emory Vaccine Center and Director of the Emory Program on Vaccine Policy and Development

The Eradication of Polio

A well written and researched article. Definitely worth a read.

Polio. We can’t just all stop vaccinating, because, well… polio. Right? This is the undying retort of everyone who questions the anti-vaccine stance. I get it. No one wants polio to “come back”. Not even the anti-vaxxers. But, was it ever truly eradicated? I know, I sound nuts. Let’s back up. In the 50s, prior to the introduction […]

via The Eradication of Polio. — a evidence-based, heartfelt blog.

The science of Smallpox vaccination

All Hail the CDC, the ‘science’ of smallpox vaccination clearly explained.

(Emphasis mine)

Vaccinia (Smallpox) Vaccine

Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2001

Vaccine Efficacy

Neutralizing antibodies induced by vaccinia vaccine are genus-specific and cross-protective for other Orthopoxviruses (e.g., monkeypox, cowpox, and variola viruses) (16–18). Although the efficacy of vaccinia vaccine has never been measured precisely during controlled trials, epidemiologic studies demonstrate that an increased level of protection against smallpox persists for 10 years (19,20). Antibody levels after revaccination can remain high longer, conferring a greater period of immunity than occurs after primary vaccination alone (3,19). Administration of vaccinia vaccine within the first days after initial exposure to smallpox virus can reduce symptoms or prevent smallpox disease (2–4).

Although the level of antibody that protects against smallpox infection is unknown, after percutaneous administration of a standard dose of vaccinia vaccine, >95% of primary vaccinees (i.e., persons receiving their first dose of vaccine) will experience neutralizing or hemagglutination inhibition antibody at a titer of >1:10 (21). Neutralizing antibody titers of >1:10 persist among 75% of persons for 10 years after receiving second doses and The level of antibody required for protection against vaccinia virus infection is unknown also. However, when lack of local skin response to revaccination with an appropriately administered and potent vaccine dose is used as an indication of immunity, <10% of persons with neutralizing titers of >1:10 exhibit a primary-type response at revaccination, compared with >30% of persons with titers although it can also indicate unsuccessful vaccination because of improper administration or less potent vaccine.

https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5010a1.htm

Vital Statistics graphs

All graphs sourced from –

VITAL STATISTICS RATES IN THE UNITED STATES

1940-1960

By Robert  D.  Grove,  Ph.  D.and Alice  M.    Hetzel

U.S.  DEPARTMENT OF  HEALTH, EDUCATION, AND WELFARE PUBLIC HEALTH SERVICE

Washington,   D.C.   1968

National   Center  for Health  Statistics

http://www.cdc.gov/nchs/data/vsus/vsrates1940_60.pdf

Note – Graphs show death rates for diseases, preceded by the approximate date when vaccination for disease was widely instituted.

Diphtheria

Immunization for Diphtheria was incorporated with tetanus toxoid and pertussis vaccine and became routinely used in the 1940s.

Reference:  http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/dip.pdf

vital statistics diptheria mortality

CDC on TB vaccination

Tuberculosis

BCG vaccination is not recommended as a routine strategy for TB control,

References: http://www.cdc.gov/mmwr/preview/mmwrhtml/00041047.htm

TB Vaccine (BCG)

Bacille Calmette-Guérin (BCG) is a vaccine for tuberculosis (TB) disease. This vaccine is not widely used in the United States, but it is often given to infants and small children in other countries where TB is common. BCG does not always protect people from getting TB. (emphasis mine)

References: http://www.cdc.gov/tb/topic/vaccines/

vital statistics TB mortality

Typhoid

Immun Infekt. 1983 Jan;11(1):16-22.

[Typhoid vaccination yesterday and today].

Abstract

Despite the early attempts to produce resistance against typhoid fever with parenteral vaccination by Pfeiffer and Kolle in 1896, and with oral vaccines by Carroll in 1904, it was not until the 1950s when typhoid vaccine efficacy was prospectively evaluated in both well-controlled field trials and human volunteer studies. Among the parenteral whole cell preparations the acetone-inactivated and heat-phenol-killed vaccines, respectively, demonstrating an efficacy of 60-90% for 3-5 years, have received most attention. Oral killed typhoid vaccines have enjoyed popularity for many years, but their effectiveness has never been proven under statistically and epidemiologically controlled conditions

Reference: http://www.ncbi.nlm.nih.gov/pubmed/6341210

vital statistics typhoid fever

Measles

Measles vaccine introduced 1963

Achievements in Public Health, 1900-1999 Impact of Vaccines Universally Recommended for Children — United States, 1990-1998

Reference: http://www.cdc.gov/mmwr/preview/mmwrhtml/00056803.htm

Note – Measles vaccines were introduced in 1963 but coverage was low until the 1970’s.

1966-1970 Measles vaccine coverage among 1- to 4-year-old children did not exceed 63% for any year.

Reference: http://jid.oxfordjournals.org/content/189/Supplement_1/S17.long

vital statistics measles mortality

Dysentery

No vaccine available

Note- decline parallels that of other infectious diseases, suggesting that other factors were responsible for fall in death rates.

vital statistics dysentry all forms

Cocooning to protect infants from pertussis

Recent studies on cocooning to protect infants from pertussis

Evaluation of the impact of a pertussis cocooning program on infant pertussis infection.

Healy CM, Rench MA, Wootton SH, Castagnini LA. 2015

Postpartum immunization and cocooning did not reduce pertussis illness in infants ≤6 months of age. Efforts should be directed toward increasing tetanus, diphtheria and acellular pertussis immunization during pregnancy, combined with cocooning, to reduce life-threatening young infant pertussis.


Impact of maternal postpartum tetanus and diphtheria toxoids and acellular pertussis immunization on infant pertussis infection. 

Castagnini LA, Healy CM, Rench MA, Wootton SH, Munoz FM, Baker CJ. 2012

It was disappointing—but not surprising, given the likelihood of contact with other pertussis-infected individuals—that we were unable to demonstrate any
impact of this program on the occurrence of pertussis in infants.


Acellular pertussis vaccines protect against disease but fail to prevent infection and transmission in a nonhuman primate model

Jason M. Warfel, Lindsey I. Zimmerman, and Tod J. Merkel 2013

Consistent with these findings, seroepidemiological studies have concluded that B. pertussis circulation is still high in countries with excellent aP uptake (27, 50), and a cross-sectional study showed that postpartum aP vaccination of mothers did not reduce pertussis illness in young infants (51). These data suggest that cocooning is unlikely to be an effective strategy to reduce the burden of pertussis in infants.


The impact of parental postpartum pertussis vaccination on infection in infants: A population-based study of cocooning in Western Australia.

Carcione D, Regan AK Tracey L Mak DB, Gibbs R, Dowse GK, Bulsara M, Effler PV. 2015

There was no difference in the incidence of pertussis among infants whose parents were both vaccinated postpartum compared to those with unvaccinated parents


Cost-benefit of the introduction of new strategies for vaccination against pertussis in Spain: cocooning and pregnant vaccination strategies. 

Fernández-Cano MI, Armadans Gil L, Campins Martí M 2015

The number of parents needed to vaccinate with the cocoon strategy to prevent 1 pertussis hospitalization would be 4752 and to prevent 1 death, more than 900,000. With VPW, 1331 pregnant women would have to be vaccinated to prevent 1 hospitalization and 200,000 to prevent 1 death. The benefit-to-cost ratio was 0.04 for cocooning and 0.15 for VPW.


Finding the ‘who’ in whooping cough: vaccinated siblings are important pertussis sources in infants 6 months of age and under. 2014
Bertilone C, Wallace T, Selvey LA.

At its peak, siblings were the most important sources of pertussis in infants 6 months and younger, particularly fully vaccinated children aged 2 and 3 years. Waning immunity before the booster at 4 years may leave this age group susceptible to infection. Even if cocooning programs could achieve full vaccination coverage of parents and ensure all siblings were fully vaccinated according to national schedules, waning immunity in siblings could provide a means for ongoing transmission to infants.

Tell me again how vaccines are the sole cause of the decline in Measles?

vital statistics measles mortality

Graph source – VITAL STATISTICS RATES IN THE UNITED STATES 1940-1960

Note the steep decline in death rates from the measles from 1900 to 1960. The measles vaccine was introduced in the USA in 1963.  – Achievements in Public Health, 1900-1999 Impact of Vaccines Universally Recommended for Children — United States, 1990-1998

Measles case fatality decreased from 21 deaths/1000 reported cases in 1911–1912 to 1 death/1000 in 1953–1962. This improvement in survival of people infected with measles virus presumably resulted from improved nutrition and medical care, especially the availability of newly discovered antibiotics to treat many of the bacterial complications of measles. – Evolution of Measles Elimination Strategies
in the United States

Was the measles considered a dangerous disease in the pre-vaccine era? 

Measles was a routine childhood ailment back in 1967, described here by the longest serving director of the CDC, David J. Sencer in Epidemiologic basis for eradication of measles in 1967 .

The clinical disease is a characteristic syndrome of notable constancy and only moderate severity. Complications are infrequent, and, with adequate medical care, fatality is rare. Susceptibility to the disease after the waning of maternal immunity is universal; immunity following recovery is solid and lifelong in duration.

Alexander Langmuir was the founder of the Epidemic Intelligence Service in the USA. In 1962 he wrote about measles in The Importance of Measles as a Health Problem

This self-limiting infection of short duration, moderate severity, and low fatality has maintained a remarkably stable biological balance over the centuries.

 The decline in mortality demonstrates the  degree to  which we have adapted to this balance and have learned to live with this parasite. Thus, in the United States measles is a disease whose importance is  not to be measured by total days disability or number of deaths, but rather by human values and by the fact that tools are becoming available which promise effective control and early eradication.

To those who ask me, “Why do you wish to  eradicate  measles?,”  I  reply with the same answer that Hillary used when asked why he wished to climb Mt. Everest.  He said, “Because it is there.” To this may be added, “and it can be done.

Decline in Measles death case ratio began in 1930’s.

The annual number of measles deaths in the United States fluctuated between 2000 and 10,000, and the death-to-case ratio (DCR; the number of reported  deaths  per  1000  reported  cases)  generally ex-ceeded  10  (figure  1).  The  number  of  deaths  and the DCR began to decline significantly in the 1930s, most probably as a result of treatments for secondary infections   [1–4],   improved   nutrition   [5],   and   reduced crowding [6].

Acute Measles Mortality in the United States, 1987–2002

(All emphasis throughout is mine)

 

 

 

Marc Girard M.D., M.Sc. on the science of vaccination

 

 

(please note this page has been updated on 2nd August 2017 due to incorrect information)

Marc Girard, MSc, MD – Biography
After a first training leading to a MSc in mathematics (partial differential equations), Marc Girard became a MD in parallel of his research on mathematical modelling. He works on drugs mainly as a consultant for pharmaceutical firms, and also practices as a psychotherapist of Freudian obedience.
Besides a number of scientific papers (about 90, most of them in peer-reviewed journals), he published also in literary criticism, esp. about Flaubert, Balzac, Zola as well as the Grimm’s tales. His experience as a drug specialist goes from the early phases of development (I, II and III) to late post-marketing, with a long standing interest in safety (monitoring of clinical trials, pharmacovigilance, pharmacoepidemiology): as early as in 1984, he was the first French author to publish a criticism on the methods used to assess the causality of drugs adverse reactions. He also has a long practice of co-operation with regulatory departments as well as marketing teams, including the redaction of a number of expert reports and medical writing (papers, brochures, proceedings). He was also a medical expert witness and has been commissioned by French Judges in a number of judicial litigations involving drugs (growth hormone, appetite suppressants, cerivastatine, vaccines…); in France, his papers published in judicial journals (about drug causality, defective products and medical expertise) have been appreciated by a number of lawyers and magistrates, and he is currently in charge of a seminar on drugs and medical expertise in two Faculties of law (Versailles & Chambéry). He is also regularly invited to comment on the ethics of drug development.

 

 Here are some of his comments and papers regarding vaccines.

extract from Editorial – Being or not being an “activist”, that is the question

In effect, if this is so easy for amateurs to get involved in vaccine controversies, this is because as a whole, the development, assessment and administration of these agents is a shame for the medical world: the weaknesses, contradictions, dissimulations and even lies of most vaccine leaders or governmental “experts” are so gross that they cannot escape the attention even of non medically-trained persons.

 

 

Marc Girard’s comment on “Safety of vaccines used for routine immunization of U.S. children: a systematic review.”

“By the distance between what it demonstrates and what it claims, this paper (as well as the preceding IOM report this one is supposed to update) illustrates that the issue of vaccines safety is still a matter of serious concern for anyone endowed with a minimum of expertise in drug safety or pharmacoepidemiology.”

 

On VAERS safety data-

“Another illustration of the same bias: when reassuring, VAERS data are unchallenged, whereas the shortcomings of the system are immediately pointed out each time they may suggest a safety problem…”

On Iatrogenic risk

“Yet, experience of drug assessment suggests that below frequencies of, at best, 1-2% of exposed patients, clinical trials fail to identify drug side-effects with a minimum of reliability (the statistical power of postmarketing surveillance being even lower by far). In a country like the USA, this detection threshold is consistent with a shadow area on iatrogenic risk of about 40,000-80,000 persons per vaccine for each vaccinated class of age: it should be obvious that risk-taking of such a size is simply disproportionate to the potential benefits of reducing the morbidity of trivial diseases (even taking into account the natural tendency of vaccine promoters to exaggerate the efficacy of immunizations…). The stubborn obfuscation of this evident arithmetical imbalance by health professionals or governmental agencies suggests that there is something rotten in the kingdom of immunization…”

Safety of vaccines used for routine immunization of U.S. children: a systematic review.

Maglione MA. Pediatrics. 2014. (bottom of page)

Summary of points raised –

Methodological consistency and biases questioned.

Immunization against trivial diseases.

Conflict of interests

Methodological defects concerned with safety assessments in general

Underreporting of adverse events

VAERS data

Clinical trials and post marketing surveillance unreliable.

Iatrogenic risk of immunizations

 

2005 Letter to Dr Jong-wook Lee Director General – World Health Organization

Auto-immune risks of hepatitis B vaccination: a clue to biological plausibility

On Hep B-

It is blatant that in the promotion of the hepatitis B vaccination, the WHO has never been more than a screen for an undue commercial promotion, in particular via the Viral Hepatitis Prevention Board (VHPB), created, sponsored and infiltrated by the manufacturers (Scrip no. 2288, p. 22). In Sept 1998, while the dreadful hazards of the campaign had been given media coverage in France, the VHPB met an panel of “experts”, the reassuring conclusions of which were extensively announced as reflecting the WHO’s position: yet some of the participants in this panel had no more “expertise” than that of being employees of the manufacturers, and the vested interests of the rest did not receive any attention.

 

 

On Adverse events following vaccination-

Vaccine. 2013 Oct 17;31(44):5041-6. doi: 10.1016/j.vaccine.2013.08.087. Epub 2013 Sep 8.

Assessment of causality of individual adverse events following immunization (AEFI): a WHO tool for global use.

On lack of expertise-

“As a drug specialist with a more than 30-year experience in safety, I was often missioned as a medical expert witness in criminal or civil inquiries on vaccine litigations, where I repeatedly pointed out the worrying lack of knowledge of most vaccine experts regarding the basic scientific and regulatory requirements normally applicable to pharmaceutical products – esp. as far as adverse reactions were concerned: this represents a tragic shortcoming for such preventive drugs, targeted towards people in perfect health with the problematic aim of protecting them against diseases the occurrence of which in a severe form is often an unlikely event, and for which therefore the risk of side-effects should not go beyond extremely narrow limits… Amongst many others examples, this paper by Tozzi et al. is an impressive illustration of this lack of expertise a far as drug safety is concerned.”

On algorithms-

“To come now to the assessment of causality of individual adverse reactions, the first remark is that the methodological inspiration of Tozzi et al. is regrettably obsolete. The use of algorithms has been almost completely abandoned by most regulatory bodies, for one reason which was pointed out more than 25 years ago …that use of algorithms is a tool for clinical decisions …whereas assessing causality in drug toxicity is a process of knowledge, and not of decision.”

On ingenuity –

After all and as the authors confess with an astonishing ingenuousness, the main point is it not, to “maintain public confidence in immunization programs”?

Med Hypotheses. 2006;66(1):84-6. Epub 2005 Sep 19.

On Multiple Sclerosis-

“….thus, if one focus on the late significant symptoms, this very long time lag is almost always interpreted as speaking against a vaccine role whereas, when considering the whole of symptoms sequence from its very beginning (i.e. from the time of quite discrete symptoms just after injection), it is on the contrary highly suggestive of a vaccine causality. I have never seen this crucial problem properly taken into account in any database, so that most investigations about the time between vaccination and the onset of MS symptoms are essentially misleading.”

Vaccines and the risk of multiple sclerosis and other central nervous system demyelinating diseases. Langer-Gould A.JAMA Neurol. 2014

 

On Hepatitis B Vaccine-

“In spite of a huge number of reports of severe hazards after injection of hepatitis B vaccine (HBV), the issue is regularly raised that no mechanism is available for the development of central demyelinating disorders such as multiple sclerosis (MS). A number of convergent facts, however, suggests that the manufacturing process could introduce HBV polymerase as a contaminant, and then trigger an auto-immune process against myelin in some vaccinated subjects.”

Multiple sclerosis and hepatitis B vaccination: adding the credibility of molecular biology to an unusual level of clinical and epidemiological evidence.

Full text

 

Links for Marc Girard and risks of Hep B vaccine.

Why medical journals must make researchers share data from clinical trials

From the Conversation July 6 2015

BMJ Acting Head of Research and Associate Professor of Neurology at Harvard Medical School

This month a new BMJ policy on sharing data from clinical trials takes effect. From July 1 2015, the authors of all clinical trials published by the journal must agree to make individual patient data from the trial available to other researchers upon reasonable request. Among major medical journals, only PLOS also requires data sharing as a condition of publication.

An additional benefit of wider sharing of data from clinical trials is that it might help restore trust in the clinical research enterprise. At present, according to the Center for Information and Study on Clinical Research Participation: “Public sentiment toward the clinical research enterprise is at an all time low … more than 70% of Americans believe that drug companies put profits ahead of patient needs.”

It is important to counter cynicism about medical research. If patients and doctors lack confidence in medical evidence, what hope is there for evidence-based medicine? If the evidence on which guidelines and recommendations are based is not trusted, how likely is it that doctors will apply therapies or act in other ways that are consistent with the best evidence?

read the rest of the article here