Fifteen year follow up of trial of BCG vaccines in the south India for tuberculosis prevention. Tuberculosis Research Center 1999, Indian J Med Res

The largest double blind randomized controlled trial that was carried out in Chingleput district of south India to evaluate the protective effect of BCG against bacillary forms of pulmonary tuberculosis. 281,161 persons were vaccinated with BCG or placebo by random allocation. Two strains of BCG were used, the French and Danish, with a high dose (0.1 mg/0.1 ml) and a low dose (0.01 mg/0.1 ml) in each strain. The entire population was followed up for 15 years.
BCG offered no overall protection in adults and a low level of overall protection (27%) in children, although there was no statistical significance.
In the first years after the trial start, the vaccinated contracted tuberculosis more often than the unvaccinated. Then, in the period of 5-12 years after the vaccination, the unvaccinated contracted tuberculosis with higher incidence. After 12 years, tuberculosis occurred with higher incidence in the vaccinated again. The same effect was seen in another BCG study in India. In the first 3 years, the vaccinated fell ill more often, and in the period of 3-9 years after vaccination the tuberculosis incidence rate in vaccinated became lower than in unvaccinated. In a British study, on the contrary, in the first 12 years the vaccinated contracted tuberculosis with lower incidence rate, and after 12 years the incidence rate went higher than in unvaccinated. Infants under one month of age were not tested in this study. [1]


Clinical spectrum of tuberculosis in BCG vaccinated children. 2002, Bai, Indian Pediatr

In children vaccinated with BCG, all forms of tuberculosis are observed, and the disease progresses to the disseminated form in 16% of them. The authors conclude that the protective effect of BCG is possible only with an adequate nutrition and with improved socioeconomic conditions.
Also: 1]


Evaluation of non-specific effects of infant immunizations on early infant mortality in a southern Indian population. 2005, Moulton, Trop Med Int Health

Study of the nonspecific effects of the vaccine in southern India (11,000 infants). Receipt of either one of BCG or DTP vaccines was associated with significant reductions of one‐half to two‐thirds of mortality hazards. However, the mortality rate was the same for those who received both BCG and DTP.
Girls who received both vaccines experienced 4.5 times higher mortality than those who received only one of the two vaccines.
The authors eliminated deaths in the first week, thinking they could not be due to non‐specific effects of BCG vaccine, and that the high mortality in that first week might cloud relevant associations.


Association of subclinical vitamin D deficiency with severe lower respiratory infection in Indian children under 5 y. 2004, Wayse, Eur J Clin Nutr

Children with a vitamin D level above 22.5 nmol/L suffered from pneumonia 91% less frequently. Exceptional GV over the course of 4 months reduced the risk of pneumonia by 58%.


Polio eradication in India: some observations. 2004, Paul, Vaccine

The global eradication of poliovirus was to be completed by 2000, but this goal shifted first to 2002 and then to 2005. Despite concerted efforts, poliovirus in India could not be eradicated. Perhaps, instead of again and again shift the deadline for eradication, it's time to stop and think about why this goal is not achieved.We believe that it has four reasons.
1) The ineffectiveness of a live vaccine.Already in the 1960s it was known that in countries with warm climates OPV is less effective.In Uganda in the early 70s, the seroconversion The appearance of antibodies in the blood of the vaccine was very low, and only improved when the oral horse antiserum was given along with the vaccine, which neutralized the inhibitors of the virus in the saliva of children. In 1989, 14% of children with paralytic poliomyelitis were vaccinated as at least three doses, and their number increased to 22% in 1994. In Rajasthan, the number of children with paralytic poliomyelitis after six or more doses of the vaccine was 25% in 1999, and 58% in 2000.
2) High incidence of vaccine-associated poliomyelitis.It is believed that h about VAPP usually occurs only after the first vaccine dose. However, in 1999, out of 181 cases of VAPP in only nine cases, it occurred after the first dose of the vaccine, 51 paralysis came from subsequent doses, and the remaining 121 only contacted with grafted.
3) Resistance to vaccination.Some parents believe that the vaccine leads to infertility. These fears are unscientific and ignorant. In addition, children receive countless doses of vaccine, and parents begin to doubt its effectiveness, and also, do the authorities know how many doses are needed for protection.
During the massive vaccination campaigns, very sick children are vaccinated as well. And when such a child dies, parents mistakenly believe that he died because of the vaccine, and this has a negative impact on the vaccination campaign.
Parents are aware of two facts: a) many children get poliomyelitis despite multiple doses of the vaccine, b) some children (4) Inaccessibility of inactivated vaccine. Although IPV is more expensive (OPV costs 10 cents, and IPV costs 10 dollars), many children became ill with polio, although more than 10 were immunized. times, so the issue of price becomes irrelevant. Moreover, children are given 5 doses of DTP, and they are going to inject the vaccine against hepatitis B, and no one is embarrassed by their high cost.
In the pre-vaccination era, paralytic poliomyelitis was mainly affected by children from wealthy families, possibly due to increased hygiene. Today they are sick mainly from children from poor families. If the rich really got sick because of hygiene, then in the future outbreaks, rich children will again become victims of paralytic poliomyelitis. Poliomyelitis can not be eradicated by the program used today, because the vaccine is ineffective, and in itself leads to paralysis.


Some ethical issues arising from polio eradication programs in India. 2005, Paul, Bioethics

The WHO program on eradicating poliomyelitis in India raises many ethical issues, here we will focus on two.
1) The balance between the risks and benefits of a polio eradication program.
Unlike inactivated vaccine, the live vaccine also generates collective immunity.As the vaccinated child isolates the virus, it also infects those with whom it contacts, that is, every vaccinated person continues to spread the vaccine further.
True, the virus mutates during the spread of vaccine strains, and according to a Japanese study, 69% of serotype 1 poliovirus mutations, 92% of serotype 2 mutations, and 55% of serotype 3 mutations turned out to be neurovirulent.
2)Informed consent.
In India, no one informs parents WHO's recommendations focus on the promotion of vaccination, but WHO does not mention informed consent anywhere.If it has long been known that vaccination can lead to paralysis, doctors in India are advised not to report this fact to the people and discuss it only in academic circles. When it turned out that the vaccine causes more cases of paralysis than previously thought, one of the founders of the Policies Eradication Committee stated: "We can dare to publish the true VAPP figures only if we have an alternative strategy for immediate implementation."
Of course, if the benefits of the eradication program clearly outweigh its harm, it may not be worth informing parents. But is this really so? To answer this question it is necessary to find out:
a) how many cases of poliomyelitis have been prevented due to vaccination? This question can not be answered. Of course, the number of cases of poliomyelitis in India fell from 13-38 thousand in the 80s, to 1,126 in 1999. However, this was mainly due to a change in the definition of the disease. Before 1990, every case of acute flaccid paralysis (AFP) was classified as polio, and then only cases caused by poliovirus were considered. In 1996 and in 1999, the definition of poliomyelitis changed again. However, the number of AFP cases over the years has not changed. Moreover, today the number of cases of poliomyelitis is understated, since far from always available stool analyzes. And cases of VAPP are not considered polio at all. In addition, many of them are erroneously classified as other diseases.
b) how many cases of paralytic poliomyelitis occurred despite adequate vaccination? In 1998-2003, 33-60% of all cases of paralysis were inoculated with four or more doses of the vaccine. C) How many cases of paralysis were caused by the vaccine? In the same years, there were 120-206 cases per year, but according to some estimates, they are about 300 per year.
Even if the benefit of eradicating the virus outweighs the concealment of information about the dangers of the vaccine, at least compensate parents if their children fall ill with VAPP , or if they become disabled, or die from polio despite being fully vaccinated.


New strategies for the elimination of polio from India. 2006, Grassly, Science

In the Indian states of Bihar and Uttar Pradesh, children under the age of five received an average of 15 doses of vaccine. In other states of India, children received only 10 doses by age 5. Only 4% of children received less than three doses of the vaccine , of which 90% were below the age of 6 months, a high level of vaccination should have led to the elimination of the virus.
So, the authors tested the effectiveness of the vaccine and found that the effectiveness of each dose in these states is 9%.This is much lower than the estimated effectiveness vaccines in other states (21%). Low effective The trivalent vaccine, as well as the eradication of serotype 2, and the elimination of serotype 3 in most states of India, motivated the replacement of trivalent monovalent vaccine (serotype 1), but this may lead to outbreaks of poliovirus serotype 3.
Here reported that 54% of children with paralytic poliomyelitis were vaccinated with at least three doses. (Pondicherry, India)
Here write that educated and well-off parents are starting to get bored when their child had already received 32 doses of vaccine by the age of five.
Here tells of a year and a half-year-old boy in India, to which vaccinators came to the house a month ago (September 2017), and, despite the parents' protest, woke him up and gave him a vaccine. Half an hour later, foam came from his mouth and he died.
This, of course, happened accidentally after vaccination, as nothing happened with the remaining 375 thousand vaccinated children.
Thus the vaccines become absolutely safe. Since this is the first case of death after vaccination, in the medical literature, death from OPV is not described (in fact described), and other children from the same the vaccines did not die, it means that the vaccine has nothing to do with it, and this is an accidental coincidence. After a while, when the next child dies in half an hour after vaccination, this will again be the first such case, which also will not be associated with vaccination.


Protective efficacy of a monovalent oral type 1 poliovirus vaccine: a case-control study. 2007, Grassly, Lancet

Despite the coverage of more than 90% of vaccinations in children under the age of 5 in India and Egypt, the spread of poliovirus was not managed, which led to the eradication of poliomyelitis under serious threat, and in October 2004 it was decided to develop a new, more effective oral vaccine only for serotype 1. After an extraordinary effort, a new monovalent vaccine was licensed in April 2005 and was immediately tested in India and Egypt.The outbreak of poliomyelitis in India in 2006 revealed the clinical effectiveness of the new vaccine, and compared with the effectiveness of a conventional trivalent vaccine.
122,000 cases of acute flaccid paralysis were recorded, 4.7% of them were caused by serotype 1 poliovirus. The effectiveness of each dose of a monovalent vaccine was 30%, and the effectiveness of each dose of a conventional trivalent vaccine was 11%, which means that five doses of a monovalent vaccine will protect 78% of children.To achieve the same degree of protection, 14 doses of a trivalent vaccine are needed.
Most likely, the increased effectiveness of a monovalent vaccine compared to a trivalent vaccine is called the absence of interference between the three serotypes of the virus. Even balanced trivalent vaccine formulations lead to infection with vaccine serotype 2, which is why this serotype was probably eradicated in 1999.
(Wild serotype 2 although it was eliminated, but the vaccine strain of this serotype is quite epidemic.In August 2017, 33 children in Syria were paralyzed by this strain.)


Polio program: let us declare victory and move on. 2012, Vashisht, Indian J Med Ethics

It was hoped that after the eradication of poliomyelitis, vaccination could be abolished, but in 2002, the poliovirus was synthesized that making it impossible to eradicate it, therefore, the world vaccination will have to last forever.Organization of poor countries in the last 10 years to spend their scarce resources to achieve an unrealizable dream was unethical. Moreover, despite the fact that India has not had a year one case of poliomyelitis, there was a huge jump in cases of non-poliomyelitis acute (NPAFP), with 47,500 new cases registered in 2011. This is 12 times higher than expected.In the states of Bihar and Uttar Pradesh, where polio is vaccinated almost every month, 25-35 times more cases of NPAFP are registered than in other countries, clinically, NPAFP does not differ from poliomyelitis, but it is twice as lethal.The number of cases of NPAFP is directly proportional to the number of doses received. Although these data were officially collected, no one investigated them. The principle of "do no harm" was broken.
From India's perspective, $ 2.5 billion spent on eradication might have been better spent on water, sanitation and routine vaccination. Then it would be possible to achieve control or elimination of poliovirus, as it happened in developed countries.
The authors believe that the huge bill of $8 billion spent on this program is a small price if the world learns to beware of such vertical programs in the future.


Here’s some data from India, one of the last countries in the world where diphtheria still exists. Despite the increased vaccination coverage, the number of diphtheria cases has barely decreased since the 80s.


Deaths reported after pentavalent vaccine compared with death reported after diphtheria-tetanus-pertussis vaccine: an exploratory analysis. 2018, Puliyel, Med J DY Patil Vidyapeeth

В 2011 году Индия начала переходить с трехвалентных вакцин (DTP) на пятивалентные (DTP-Hib-HepB). Благодаря этому, появилась возможность сравнить смертность после них. Авторы проанализировали 45 миллионов младенцев. Смертность в течение 72 часов после пятивалентной вакцины была в 2 раза выше, чем после трехвалентной (4.8 vs. 9.6 на миллион). Авторы замечают, что не все случаи смерти от прививок происходят в течение 72 часов, поэтому смертность от вакцинации в этом исследовании занижена.
Смертность в разных штатах значительно различалась, что, вероятно, связано с тем, что в некоторых штатах плохо велся учет. Если учитывать средние данные, то вакцина приведет к 122 дополнительным случаям смерти в течение 72 часов (на 26 миллионов рожденных в год младенцев). Но если считать согласно статистике штатов, в которых была самая лучшая отчетность, то вакцина приведет к 7020-8190 тысячам случаям смерти. (Это примерно 1 на 3200 привитых. А если учитывать, что считаются лишь дополнительные смерти поверх DTP, и что DTP, вероятно, тоже приводит к смерти, то смертность от этой вакцины будет доходить 1 на 1600 привитых. И это только в первые 72 часа.)
Большинство этих смертей были рассмотрены экспертами, и ни в одном случае вакцинация не была признана причиной смерти. Согласно новым критериям ВОЗ, только побочные эффекты, которые описаны в научных статьях, могут быть признаны как побочные эффекты вакцинации. Во вкладыше к DTP и к пятивалентной вакцине смерть не указана в качестве возможного побочного эффекта, поэтому неудивительно, что ни одна расследуемая смерть не была признана как побочный эффект вакцинации.
Эта пятивалентная вакцина была введена также в Шри Ланке, в Бутане и во Вьетнаме, и в во всех странах она была ассоциирована с побочными эффектами, включая необъясненные смерти. В Индии тоже были спорадические случаи смерти вскоре после этой прививки, включая смерть двух младенцев через день после вакцинации. ВОЗ исследовала эти случаи, и заключила, что они вряд ли связаны с прививкой. 3 смерти в Шри Ланке были изначально признаны как вероятно вызванные вакциной. После этого, в 2013 году ВОЗ отредактировала алгоритм определения побочных эффектов вакцинации, и эти смерти были реклассифицированы, как несвязанные с вакцинацией. Еще: [1] [2]


Deaths following pentavalent vaccine and the revised AEFI classification. 2017, Puliyel, Indian J Med Ethics

Согласно новому алгоритму ВОЗ, смерть, произошедшая после лицензирования вакцины, не может быть классифицирована как причинно-следственно связанная с вакцинацией, если в небольших клинических исследованиях не было зарегистрировано статистически значимое увеличение смертности. Если же вакцина привела к значительному увеличению смертности в клинических исследованиях, онa не будет лицензирована. После лицензирования, все смертельные случаи просто обозначаются как случайные.
Также, согласно новому протоколу, если, например, у ребенка с сердечной болезнью развивается декомпенсация сердца после прививки, то декомпенсация не будет считаться причинно связанной с прививкой, хоть вакцинация и способствовала ей.
Последствия новой классификации проиллюстрированы в анализе серьезных побочных случаев в Индии. Из 132 младенцев 78 были госпитализированы и 54 умерли. Было установлено, что среди выживших у 47% побочные эффекты связаны с вакцинацией, а среди умерших ни один случай не был связан с вакциной.
Автор заключает, что протокол должен быть срочно пересмотрен, и что в центре внимания должна быть безопасность детей, а не безопасность для вакцин.


Здесь сообщается, что более 10,000 детей в Индии умерли от побочных эффектов вакцин за последние 10 лет.

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