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BCG vaccination increase the risk of severe Miliary Tuberculosis?

By narong kun | 04 Jul, 2016

Dear all member, i am from Cambodia. I have some queries about BCG vaccination increase the risk of severe Miliary Tuberculosis.

Recently, Dr. Beat Richner, Founder and Head of Kantha Bopha Hospital, have suggested to our MoH to stop the BCG vaccination for new born. Can any expert here share me the information concerning to this topic? Should we stop BCG vaccination in Cambodia?

Replies

 

BAMAL'EMPYULO AUGUSTIN KARUMBA Replied at 1:49 PM, 4 Jul 2016

Greetings to you colleague Doctor
Stop BCG vaccine is a multifaceted issue where by TB post vaccine is
well-known documented disease in pediatrics; BCG efficacy being not so good
has been as well documented and scientific/biologists are working on
getting one better TB vaccine; Vaccination cold chain should not be left
behind in the matter and may be one leading BCG failure vs. efficacy
Your alert on stopping BCG vaccine in Cambodia does not have supportive
sturdy/survey to inform us at which rate? proportion? odds ratio or any
other statistical analysis to assist us make our minds
Kindly provide the Cambodian study to assist us and will look at other post
vaccine Tb issues to consider the Cambodian alarm
Thanking you for sharing as we watching waiting for the article

narong kun Replied at 2:50 PM, 4 Jul 2016

As i know, there is no supportive study about complication of TB post vaccination or BCG efficacy in Cambodia yet. BCG vaccine is recommended by WHO for the countries where the prevalence of TB is moderate to high such as the situation in Cambodia. For my idea, it should have a well documented studies before decide to erase the BCG vaccination out off our National Vaccination Program.
Correct me if i have any mistake.

Vijaya Srinivasan Replied at 12:11 AM, 5 Jul 2016

Dear Doctor,

I agree entirely with you (Dr.BAMAL'EMPYULO AUGUSTIN KARUMBA) on this
issue of stopping BCG vaccination stating that there is an increased risk
of Miliary tuberculosis. As a clinical epidemiologist, I would not tend to
give any increased risk beyond 2 and with lower limit of confidence
interval not exceeding 1.5.

Please consider reanalysing the Cambodian data.

Vijaya Srinivasan Replied at 12:16 AM, 5 Jul 2016

Dear Doctor,

I mean the relative risk should be more than 2 and the lower limit of
confidence interval should not be lower than 1.5 for any factor to be
considered as a risk factor. I am sure this is not a possibility since in
a country like India, we give BCG in millions and our rates of miliry
tuberculosis has not increased.

Edward Nardell, MD Moderator Replied at 10:25 PM, 5 Jul 2016

There is no vaccine that has been more carefully studied than BCG. There are several meta analyses listing the many studies and their outcomes. Among the many outcomes reported - a GREATER risk of miliary TB is not one of them. In fact, the main reason that BCG continues to be given in my high burden settings is because it clearly LOWERS the risk of hematogenous seeding of other organs - meningitis in children in particular. There has been some concern that enhanced delayed type hypersensitivity could result in worse local lung destruction if reactivation was not prevented by the vaccine - but not a lot of evidence that that is the case. However, there is the possibility of BCG miliary infection among infants with immunodeficiency, which is why the vaccine should not be given to anyone with symptoms of AIDS or known HIV infection. Some laboratories cannot easily distinguish BCG from Mtb and miliary BCG could be mistaken as miliary Mtb. Miliary BCG has occurred in immunosuppressed adults as well as children, including adults receiving bladder BCG as adjunctive therapy for bladder cancer. Conclusion: it is highly unlikely (and not biologically plausible) that BCG causes increased miliary TB.

Thomas Mohr Replied at 6:24 AM, 23 Aug 2016

I was hoping to see such a response as that provided by Ed. Dr. Richner is infamous for things he has written and stated in his books and the things he says during his regular Cello (Fund raising) performances he provides at the Kantha Bopha hospitals. Even if his statements at first glance seem outrageous, there is no doubt about the quality of the services the Kantha Bopha hospitals provide. I have visited the hospitals, received services, and seen the huge numbers of patients attending the hospitals (They are a great example for the debate on sustainability of such efforts and efforts to strengthen health systems). Still this discussion on BCG raises additional questions for me and what is needed in Cambodia.

"Dr. Beat Richner, Founder and Head of Kantha Bopha Hospital, have suggested to our MoH to stop the BCG vaccination for new born."

What do Dr. Richner and his staff see to prompt such a statement? Presumably miliary TB ... (?).

Is it the context? As Ed stated, "However, there is the possibility of BCG miliary infection among infants with immunodeficiency, which is why the vaccine should not be given to anyone with symptoms of AIDS or known HIV infection."

The question that comes to my mind is not whether or not Cambodia should ban BCG but rather are the Kantha Bopha hospitals seeing children with immunodeficiency that were vaccinated with BCG by the national health system without having been properly screened for symptoms of AIDS or HIV infection, who subsequently developed miliary TB infection?

From the WHO estimate HIV+ TB rates are still significant in Cambodia:
Number (thsnds)
Prevalence (includes HIV+TB) 100 (87–120) 668 (565–780)
Incidence (includes HIV+TB) 60 (54–66) 390 (353–428)
Incidence (HIV+TB only) 1.8 (1.6–2) 12 (10–13)

Will an epidemic estimated at this magnitude results in Kantha Bopha finding many miliary TB cases among new born children if the health system does not screen properly before providing BCG? If so, how best to address that issue?

This discussion seems to me also to be warranted.

Jacqueline Gautier Replied at 10:56 PM, 23 Aug 2016

I would concur with Dr Richner.
1.- The risk of Tb from BCG vaccination is real.

2.- But without HIV, many studies have shown efficacy for BCG vaccines to be from none to at best 65% and only for severe cases of TB.

Do we need to invest in such a vaccine that requires families to travel to get to the health centers given it is most of the time not given in assembly posts, in Haiti at least?
Countries like ours experience many cases of pediatric TB in children with their BCG scars well visible and with no HIV. We could save the money used for BCG to buy other Antigens. Removing a burden because of poor efficacy seems the right thing to do.

3.- We would use the PPD test under one year of age freely with no BCG vaccines: a real advantage to investigate TB in children < 1 year of age.

Let’s advocate to stop BCG until we get a better TB vaccine.

Edward Nardell, MD Moderator Replied at 12:08 AM, 24 Aug 2016

With all due respect, the call to stop BCG vaccination is nonsense. The
effectiveness of BCG in preventing disseminated TB and meningitis in
children is very well established by decades of studies. The risk of
disseminated TB is not. Even in low prevalence situations like
Scandinavia, the reasonable decision to stop BCG resulted in a prompt
increase in TB meningitis - often fatal - and a clear complication of NOT
preventing dissemination.

ed

Arne von Delft Replied at 5:56 AM, 24 Aug 2016

Dear Colleagues

I agree with Ed completely. The benefits of the BCG vaccine far outweigh
the risks, as the evidence clearly shows. But I also agree that as far as
vaccines go, it is not nearly good enough at preventing all forms of TB.

So let us rather focus our efforts on advocating for a better vaccine!

Samuel Kudzawu Replied at 6:56 AM, 24 Aug 2016

Hello All,
BCG vaccine doesn't prevent TB disease but prevents the dangerous forms of TB in children. It doesn't also make irrelevant the tuberculin testing in children because the interpretation of tuberculin test is done vis a vis the BCG scar presence or otherwise. Above all tuberculin test in children cannot be used alone in diagnosing active TB in children. So BCG still has a role to play especially in high burden developing countries.

Jhoanne Kerline Philippe Replied at 2:42 PM, 24 Aug 2016

Hi all,

I would like to have some advices about how to conduce MDR -TB traitment for women with 8 months of pregnancy with diagnosis of MDR-TB. And what is the best follow up for the newborn?

tkhs

Edward Nardell, MD Moderator Replied at 9:38 PM, 24 Aug 2016

Although treatment of MDR-TB during pregnancy is not a topic for the TB Infection Control Community, if anyone wants to offer a quick summary or referral (to the new WHO guidelines for example) please do so. Re. The infant, although there is a small risk of transmission in utero, this is rare. If the mother is on effective treatment for MDR TB, there is little risk of transmission to the baby. Skin test conversion would be the first sign of transmission, but there is o agreement on exactly what to give infants as prophylaxis if exposed to UNtreated MDR TB, for example. There is work from the Marshall Islands that a FQ containing regimen is both well tolerated and effective, as would be expected.

Ed

Adriano Duse Replied at 7:34 AM, 25 Aug 2016

Could not agree with you more, Ed !

Best

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Kim Eam Khun Replied at 10:03 AM, 25 Aug 2016

I do agree with Nadell 100%.Regards, Eam  ***********************************************************************************Mr. Khun Kim Eam. MD, MPH.Vice Chief of Technical Bureau Focal Point for National TB/HIV CollaborationNational Center for Tuberculosis and Leprosy Control, CENATOffice address: Street 278/95, Boeung Keng Kang 2, Khan Chamkamon, Phnom Penh, CAMBODIA.Tel: (+855)23 224 971, Mobile phone:(+855)12 856 146; (+855) 977 856 146Fax: (+855)23 224 671E-mail: , ***********************************************************************************

Jacqueline Gautier Replied at 10:28 AM, 25 Aug 2016

I respect your opinion.

I do maintain mine: the current BCG vaccine is relatively useless looking at the big picture.
As an experienced pediatrician in infectious diseases I see way too many pediatric TB cases with BCG scar on.
And also knowing that many children DO not get diagnosed and die from TB despite Haiti coverage for BCG vaccine being good compared to the other vaccines.

If the BCG did not protect them, why this burden for the EPI system and the families having to go to health centers to get this vaccine.
We can use this money and energy better for the children: improve how we test bacteriology:
look in stools for MTB with GenExpert for instance
do a better job at prophylaxis with INH with better contract tracing. The adults diagnosis is easier: that’s where we can concentrate our energy to prevent the disease in children while we wait for a good TB vaccine.

Edward Nardell, MD Moderator Replied at 10:56 AM, 25 Aug 2016

Dear Dr. Gaudier,
Have you read the extensive BCG literature? We know that BCG is not the perfect vaccine and millions of dollars are being spent on finding a better one - so far nothing is better. And BCG is NOT useless - convincingly preventing TB meningitis in study after study. Disseminated TB and TB meningitis is the most fatal form of TB in children and it is reduced substantially by BCG. It is why WHO continues to recommend it in high burden settings.

A rash suggestion to discontinue BCG, if followed, will result in unnecessary deaths at very little cost. There is even good evidence among household contacts that children and adults with BCG scars are less likely to become infected with TB. For that reason, because I work in several high burden TB countries with high rates of MDR TB that I personally had BCG vaccination as an adult only a few years ago. If my immune system has to deal with Mtb I want it to have had prior experience - resulting in accelerated granuloma formation and enhanced delayed type hypersensitivity - both proven responses to BCG vaccination.

Yes, those areas of the world where BCG is widely used are in fact the areas with the highest rates of TB, so many children who have had BCG will present with TB. Even natural TB infection does not uniformly prevent TB re-infection or disease. But it does help prevent dissemination and that is an important function in children.

Ed Nardell, MD

Jacqueline Gautier Replied at 12:15 PM, 25 Aug 2016

Dear Dr Nardell

Thank you for taking the time to continue this discussion.

I did read and please do share any new ones with me.
I wish we made some studies of BCG efficacy ourselves too in Haiti. My institution did not have the culture of research and already they were talking about the new candidates better vaccines. So we thought the good vaccine would be coming earlier .

I can tell you that the milliary and meningitis cases in pediatrics are the trees that mask the forest. Most children who die present simple pulmonary TB recognized too late or die with no diagnosis: relatives will tell you about index cases and children dying of malnutrition or something else around them.
If a child dies of a disease he was supposed to be immunized against, does it matter if he dies of a severe form rather than a simple pulmonary one?

Our efforts, until we get a good vaccine should be in good contact tracing, prophylaxis, early diagnosis, strengthening adherence and finding and disseminating good tools of diagnosing TB in children.
I wish the current BCG vaccines money/energy could be used toward getting S. pneumococcal vaccine who will only be coming next year in Haiti: pneumococcal infection # 1 killer here , with pneumonia, empyema and devastating meningitis.

It is important for us to reassess what we do in term of real impact.

In the meantime though, my institution will continue to follow the Haitian national guidelines and offer BCG vaccines to newborns in our target area.

Edward Nardell, MD Moderator Replied at 12:42 PM, 25 Aug 2016

I think this will be my last response on this issue, but I am compelled to write one more time. This time I would like to agree with almost everything Dr Gautier has written, except to add that we should not make "the good the enemy of the perfect".
I agree completely that it does not matter whether children die of pulmonary TB or meningitis, that acute respiratory infections are an even greater threat to children worldwide, and that BCG is far from a fully effective vaccine. As to studying BCG in Haiti in the past or in the future, not likely simply because these are extraordinarily expensive studies and they have been done in many, many places - with variable results - but some understanding of what the issues have been.
I conclude that the WHO recommendations to continue BCG is well-reasoned even if it is hardly the answer to the global TB epidemic. In fact, given the importance of re-infection in TB pathogenesis, it is possible that no vaccine will offer more protection than natural infection, but that remains to be proven.

As interventions go, BCG is inexpensive and does prevent some deaths and neurological complications of TB meningitis. Those deaths are in addition to the other deaths from pulmonary TB and acute respiratory infections. I suspect the cost is worth the benefit. Your justifiable rage that not enough is being done should not lead to throwing out interventions that are inexpensive and do prevent deaths and disability. We have too few effective interventions to throw out any at this stage in the global epidemic. We can only hope that new diagnostics, better vaccines, new drugs, and access to vaccines against a cute respiratory infections will be forthcoming, but those interventions will not likely come one minute sooner if BCG is abandoned, but the children lost were that to happen will be very real.

Jacqueline Gautier Replied at 1:02 PM, 25 Aug 2016

Agreed. J Gautier.

Samuel Kudzawu Replied at 3:02 AM, 26 Aug 2016

Dear Ed Naddel,
You're right on point.
That has been my opinion at the beginning.
We cannot estimate the deaths BCG has prevented because it's one of the vaccines that has been widely used especially in high burden developing countries.
Maontoux test or TST is one of the tools we use to aid tuberculosis diagnosis in children and this test is interpreted with reference to BCG scar.
The DEVIL we know might be better than the ANGEL we are expecting.
Let the substitute for BCG come then we can discuss whether to continue it's use or not.
Thanks for all the opinions.

Francine Birungi Replied at 3:34 AM, 26 Aug 2016

I totally agree with Samuel Kadzawu.

george uchouane Replied at 11:56 AM, 5 Sep 2016

Samuel Kadzawu has made a good observation

Mark M.C. Replied at 5:37 PM, 5 Apr 2017

I agree that BCG vaccination should not be stopped. Here in Latin America, it is a way to reduce secondary TB and especially in countries with high prevalence and incidence such as Peru.

Amira Bahour Replied at 1:32 AM, 6 Apr 2017

I agree that BCG vaccine has great benefit but what about its complications . Here in Egypt we have reported about 30 cases in the last year of tuberculous lymphadenitis in infants of one year old following BCG vaccine.

Edward Nardell, MD Moderator Replied at 6:16 AM, 6 Apr 2017

Every intervention has some complications, but in high burden settings, the
young lives saved from disseminated TB and meningitis are thought to far
outweigh the cases and morbidity of TB lymphadenitis. We all agree a better
vaccine is needed, but until then..it is the devil we know. Part of the
problem is an infectious disease where reinfection is common and may even
play an important role in pathogenesis. Expecting an attenuated live
version of Mtb (BCG) to prevent the disease when natural infection is
incompletely protective is asking a lot. New immunization strategies may be
needed. There are examples where vaccines are more protective than natural
infection.

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