POST 01106E : VVM ANNIVERSARY
Follow-up on Post 01101E
15 June 2007
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This is a really excellent posting, full of interesting stories, interviews and policy statements. Congratulations to everyone who labored so hard over so long a period. The interviews went into great length about having this excellent tool (VVMs) matched to the stability of the vaccines to reduce reliance on the cold chain and to expand possibilities for vaccination in hard-to-reach situations.
But one concern that I had was the absence of discussion concerning the safety of relying on VVMs to remove each type of vaccine from the cold chain - for example, reconstituted measles vaccine. Indeed, the policy statement's final recommendation confused me: it permits use of vaccines (without distinguishing between some freeze-dried preparations such as measles vaccine from other vaccines) "beyond the cold chain where warranted for routine immunization activities." "Where warranted" is also not explained. The policy statement then goes on to also permit use of all vaccines on a "limited basis" (without explaining what that means) or under "special circumstances" such as NIDs, hard to reach areas, home vaccination, cool seasons, during storage and transport of certain specified vaccines at risk of damage from freezing. Many of these "special circumstances," such as periodic intensifications of routine immunization, are being increasingly relied on in many countries.
On the basis of this policy, does measles vaccine no longer need to be carried to the field with icepacks during routine outreach or six-monthly child health days? As long as the expiration date and discard point have not been reached and irrespective of season, can health facilities without refrigerators now store measles vaccine for routine immunization at ambient temperature, reconstituting and using it over 4-6 hours without keeping it cold? How is the reconstituted vaccine to be kept cold, so that bacteria accidentally introduced during unsterile reconstitution or unsterile removal of doses do not multiply at ambient temperature and possibly cause life-threatening adverse reactions?
For such a policy to be implemented with safety and without compromising vaccine effectiveness, very clear operational guidelines will be needed. Transmitting these guidelines to health workers will not be an easy task. I remain concerned by the broad scope of a policy recommendation covering all vaccines without distinction. I hope my questions and concerns above can be addressed.
Again, congratulations to all on the 10th anniversary of the introduction of VVMs. I know how difficult a struggle it has been.
Robert
Robert Steinglass
Technical Director
IMMUNIZATIONbasics
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======================================================================== Date: Sun, 17 Jun 2007 23:26:14 -0400 Reply-To: [
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[email protected][/email] Sender: Technical network for strengthening immunization services Comments: RFC822 error: MESSAGE-ID field duplicated. Last occurrence was retained. From: TechNet Subject: POST 01107E : ORAL POLIO VACCINE COLOUR MIME-version: 1.0 Content-type: text/html; charset=us-ascii Content-Transfer-Encoding: quoted-printable TECHNET21 E-FORUM
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POST 01107E : ORAL POLIO VACCINE COLOUR
Follow-up on Post 01050E, 01058E and 01100E (An archive error occurred in this last posting and only attachments were retained in the archives)
17 June 2007
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The first message is from Anil Varshney from India. He rightly points to reluctance from health workers to use OPV that doesn=92= t look normal.
This is followed by contributions from Hans Everts and Jacqueline Fournier-Caruana, both fr= om WHO/ HQ providing answers to Salah Haithami.
I have the feeling that this leaves some unanswered questions, at least in my mind. As nobody asked these questions, I will do myself in a comment at the end of this posting.
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Hello all,
It is pertinent to note that no health worker will administer OPV with changed color irrespective of ph or potency. Change of color denotes degradation of any of the compounds in the OPV by heat or long time (expired OPV)?
Regards ,
Dr Anil Varshney
Consultant
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The explanatory note was not meant to suggest that people actually estimate the PH in the field, but that the pH variation leading to a change in the OPV colour from yellow to reddish does not affect the efficacy of the vaccine. The note meant to give some technical background for managers.
1) all OPV supplied by UNICEF comes from pre-qualified manufacturers
2) all batches are seperately tested for approval by the NRA, including the ones with vials with colour change
3) due to a change of PH there can be colour variations between vials, but this is a known phenomenon and does not affect the potency of the vaccine
4) because there is no correlation between the colour and the potency, it would lead to utter confusion and erroneous conclusions if health workers would start judging OPV quality on basis of colour.
Hans Everts
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I can understand the reluctance from health workers and parents in giving such yellow OPV while the usual colour is pink. At the question raised by Dr Salah, "Can we estimate the PH from just seeing the colour?", it is easy to answer "yes, we can" since the rationale of adding phenol red is to know the pH at a glance.
It's very risky to advise any country to reject yellow OPV, even when only few vials are concerned, as the wastage would increase and we know that the vaccine is still potent.
In conclusion, I believe we need to strictly stick with our previous position confirming that the pH variation leading to a change in the OPV colour from yellow to reddish does not affect the efficacy of the vaccine.
Thanks, Jackie
Jacqueline Fournier-Caruana,
WHO/Geneva
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All living organisms require a certain range of pH to live and grow, usually around the neutral point, the polio virus being no exception. Referring to posting 01058E, we learnt that this range is 6.5 to 7.2. Growing polioviruses obviously calls for pH control and phenol red is used as an indicator, sometimes further added in the formulation.
We all agree, phenol red is a pH indicator so it can be assessed at a glance but I am sure that Jackie did not mean that it can be done with any accuracy or reliability. As Hans said, it is not meant to be done by anyone in the field.
Thus I have two questions of a different order.
The vaccine production industry appears to still be using phenol red. Is it really the case? Because I just find it difficult to believe that it relies on such an indicator for a large scale production in 2007.
If the vaccine, given all other conditions met, is to remain perfectly potent whatever its pH and color, and should be used, then what is the purpose of sometimes adding some more red phenol? Is it only cosmetic so that vaccines leave the plant all looking identical?
I don=92t question that the vaccine is still potent, given such a large security margin in terms of immunogenic dose. I just wonder what is the significance of something that appears to be operationally irrelevant in the field.
The moderator
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======================================================================== Date: Tue, 19 Jun 2007 21:11:32 -0400 Reply-To: [
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[email protected][/email] Sender: Technical network for strengthening immunization services Comments: RFC822 error: MESSAGE-ID field duplicated. Last occurrence was retained. From: TechNet Subject: POST 01108E : NEEDLE REMOVER EVALUATION MIME-version: 1.0 Content-type: text/html; charset=us-ascii Content-transfer-encoding: 7BIT TECHNET21 E-FORUM
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POST 01108E : NEEDLE REMOVER EVALUATION
19 June 2007
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NOTE : Adjustments, to be expected, have been made to the Expert database, to solve the few reported problems, especially those concerned with updating one's own data. Some modifications to the design have also been made. We hope that this database will now be fully operational. We thank all those who recently registered and invite potential consultants who haven't done so yet.
The message below comes from Huong Vu, from PATH/ Vietnam, who presents a needle-remover evaluation report.
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PATH announces the publication of "Evaluation of a Needle Remover Demonstration Project : A Study from Huong Khe District, Ha Tinh Province, Vietnam." This report ( download) provides background, methodology, results, discussion, and references associated with an evaluation of the project.
PATH and National Expanded Program for Immunization, the Vietnam Ministry of Health implemented a six-month demonstration project in Huong Khe District, Ha Tinh Province, Vietnam, to assess the acceptability, performance, and impact on waste disposal of a manual needle remover introduced at commune health centers (CHCs).
The evaluation identified opportunities for significant improvement in the management of medical waste at CHCs. Needle removers were found to be a technically appropriate and feasible solution for CHCs, accepted by most health workers and managers, and able to address problems of health care waste disposal in rural areas. Based on the results of this demonstration project, the evaluation team recommended broader introduction of needle removers in CHCs located in rural and mountainous regions of Vietnam. Training and maintenance are critical issues for ensuring successful introduction of needle removers. Should they be introduced more broadly, it would be important to strengthen supervision at the CHCs. Before any device can be introduced more broadly, an evaluation must be conducted to ensure that it is compatible with the types of syringes being used in Vietnam.
Safety boxes continue to be an important tool for managing sharps waste in Vietnam. However, unreliable supplies (safety boxes are only supplied enough for immunization injections) and lack of final disposal options present challenges for use. Since this study was completed, needle removers have recently been included in draft health care waste management guidelines developed by the Ministry of Health as an option for sharps waste handling in CHCs in Vietnam.
For more information about this evaluation conducted in Vietnam, contact Huong Vu.
For more information on needle removers, visit the Needle Remover Resource page published by PATH. This web page is intended to serve as a resource for countries and programs considering the introduction of needle removers. Visit the page
Huong Vu, MD, PhD
Senior Program Team Leader
PATH
Hanoi, Vietnam
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======================================================================== Date: Thu, 21 Jun 2007 22:59:49 -0400 Reply-To: [
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[email protected][/email] Sender: Technical network for strengthening immunization services Comments: RFC822 error: MESSAGE-ID field duplicated. Last occurrence was retained. From: TechNet Subject: POST 01109E : SOLAR REFRIGERATOR MIME-version: 1.0 Content-type: text/html; charset=iso-8859-1 Content-transfer-encoding: quoted-printable TECHNET21 E-FORUM
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POST 01109E : SOLAR REFRIGERATOR
Follow-up on Posts 01019E, 01027E, 01032E, 01037E, 01045E, 01095E and 01102E
21 June 2007
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This posting contains two contributions. The first comes from S=F8ren Spanner from UNICEF/India. The second is from Gregory Kiluva from UNICEF Supply Division
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All the Solar Powered Refrigerators, listed in the PIS are working perfectly well. Provided that:
The system is correctly sized.
Installation is done as per manufactures recommendations
Maintenance is done as per manufactures recommendations.
Proper training of users.
As for the size, if you need 30l buy 30l, if you need 50l buy 50l.
A bigger SPR is more expensive than a small, like a house, car or whatsoever.
As for Jharkhand, I could not disagree more see the reasons above.
Solar panels might be stolen, so might generators.
Many of the generators I have seen, in the same area are idle because of lack of fuel.
I would question the cost effectiveness of the generator solution.
Soren Spanner
Project Officer Cold Chain
Health Section, UNICEF, India Country Office,
New Delhi
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Dear All,
I have read the two contributions on this post and would like first to respond to Lydie.
The three numbers you refer to in the Supply Catalogue refer to