TechNet-21 - Forum

This forum provides a place for members to ask questions, share experiences, coordinate activities, and discuss recent developments in immunization.
  1. Lora Shimp
  2. Vaccines and delivery technologies
  3. Wednesday, 29 July 2020

Greetings, everyone. I hope that you are healthy and keeping your spirits up amidst these trying times.

In March this year, just before COVID-19 shutdowns, I visited health facilities in Kinshasa - where mothers were being asked to wait (one for over 2 hours) and turned away for measles vaccination because there were not enough infants to open the measles vial. I have witnessed this firsthand in over 20 countries, repeatedly. I’ve spoken with hundreds of health workers in facilities, including these dedicated staff in Kinshasa, who would welcome 5 dose vials to make their work easier and to enable them to provide a better service experience for their clients.

A new article published in VACCINE addresses many of the concerns that are being raised related to session size in the time of COVID-19 and how to continue to ensure that all children are routinely vaccinated. This article describes the results of an implementation study in Zambia, conducted by the MOH with technical support from JSI and funding from the BMGF, which compared the programmatic impact of using 5-dose MR instead of 10-dose MR for routine immunization. The results showed that coverage for both first and second doses of MR improved, and wastage rate decreased when using 5-dose MR. There was practically no difference in wastage-adjusted purchase price per dose, and a negligible effect on the cold chain. Importantly, healthcare workers reported being more willing to open a 5-dose vial than a 10-dose vial for one child, as they were less concerned about wastage. The Zambia study was part of the Dose per Container Partnership, which also developed the Decision Support Resource to help decision makers weigh the trade-offs of vial size.

These results are quite timely, as WHO guidance recommends frequent routine immunization sessions of smaller size due to the pandemic to reduce the risk of spreading COVID-19. As 5-dose measles containing vaccines are now available through UNICEF procurement, a few countries are already using 5-dose vials (e.g., India, Timor-Leste and Lao PDR) and others are planning to introduce 5-dose vials. This can improve health worker motivation and confidence - and caregiver satisfaction and trust - with the immunization program, while reducing missed opportunities for vaccination.


A few questions for discussion:

• For the countries that are using 5-dose MCV or have recently switched, what has been your experience, particularly related to health care worker willingness to open a vial?

• Do decision makers in your countries see benefit in smaller vial size? Is there interest in other places to consider introducing 5-dose vials of MCV?

• Do you have any concerns or guidance?


It seems to be an opportune moment to review the advantages and disadvantages of different vial sizes, including weighing the trade-offs and benefits within each country’s context and health system -- particularly as we are working to improve immunization confidence, trust, performance and the service experience to meet client and health worker needs. This is particularly timely as countries are preparing their annual vaccine forecasts for procurement through UNICEF.

We need to work innovatively and practically to help immunization programs rapidly adapt and act to address the challenges with ensuring immunization services and reducing missed opportunities that COVID-19 has caused. There are operational considerations that can be beneficial with 5 dose measles vials, for example: 

- ability to schedule appointments and ensure optimal use of the vials within the timeperiod;

- convenience for caregivers, who are not turned away or forced to wait until other clients are available;

- confidence-building with health workers that they can provide the service, meet client needs, and not be concerned with chastisement related to wastage (which can be substantially less with 5 dose vials, thereby saving on the number of doses needed in procurement).

That health worker in Kinshasa’s eyes lit up and she exclaimed “yes, please!”, when I mentioned the option of a 5 dose vial. I wish that I had it on video. What are we doing as an immunization community to prioritize solutions like this to improve the service experience?

Thanks in advance for sharing your perspectives, particularly from on-the-ground.

Best regards, Lora 

Lora Shimp, Director - Immunization Center, John Snow, Inc

Comment
MR 5-dose vials have been available through UNICEF Supply Division since 2018. Considering the advantages of 5-dose vials that Lora Shimp illustrates above and now the scientific evidence from the rigorous study in Zambia raises an important question: Why has the uptake of the MR 5-dose vial been slow? Is it possible that EPI managers consider the choice of vial size as dichotomous, as 5-dose OR 10-dose vials rather than 5-dose AND 10-dose vials? Clearly, 10-dose vials have advantages for large fixed and outreach vaccination sessions and during campaigns and other SIAs. But are there really any valid concerns about using different vial sizes in the same program? I am interested to hear from EPI managers about experiences from using two vial sizes in the same program, 5-dose vials in health centers and districts with small sessions and where long distances make it critical that a nurse doesn't feel that she has to ask a parent to return another day in order to save vaccine, and reserve the traditional 10-dose vials for health centers and districts with large sessions and for campaigns. It seems obvious that the benefits of 5-dose vials would by far exceed the challenges of managing two vial sizes in the same distribution system. aff about the 5-dose vial. There is strong evidence that MR 5-dose vials improve equity and coverage by reducing missed opportunities, open-vial wastage and hesitancy to open a vial for one child for the fear of stock-outs. Going forward, decisions about MR 5-dose vials should be based on reasoning and practical considerations. There is no longer reason for individual immunization program to demonstrate the benefits of 5-dose vials with scientific studies. The MR 5-dose vial can be pragmatically introduced where it makes sense to use smaller vials while monitoring the impact and solving any issues that arise along the way. Vaccination coverage has been stagnant for a decade. Elimination of measles depends on incremental improvements and the implementation of many different interventions that each contribute something to increasing coverage. Differential use of 5-dose MR vials is clearly among those interventions.
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Lora Shimp Accepted Answer

Thanks for the rich and thoughtful comments and suggestions on this. 

Further information (and your experiences) on how countries are addressing this is welcome and highly encouraged, so that we can also share these examples, continuous learning, and hopeful contributions to improving coverage, equity and service delivery.

This article has just been published on the important aspects of health care workers' perspectives and preferences from Senegal, Vietnam and Zambia. Happy reading!:   https://www.ghspjournal.org/content/early/2020/10/22/GHSP-D-20-00112

Best regards, Lora

 

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Robert Steinglass Accepted Answer

I am pleased to share the following information which was kindly sent directly to me for posting by Dr. Suresh Jadhav, who is Executive Director of the Serum Institute of India Pvt. Ltd. In Pune, India:

“From my discussions with my marketing team and few people who have already retired but were active in late 80s and early 90s, I can gather the following information.  Yes, you were right.  When Govt. of India introduced Measles in the EPI programme in the late 80s, they started with 10-dose presentation. However, it was mainly due to the issues of adverse drug reaction especially the toxic shock syndrome where many times after reconstituting the vial on one day it was subsequently used later on up to a month in the field causing severe reactions and sometimes death.  In addition to this, there was definitely the issue of coverage and opening of the vial even if less number of people were visiting the Primary Health Centre; and obviously ultimate aim was to reduce the wastage.  It was then talk with the Govt. of India started in 1993 and in the year 1994-95 we started supplying 5-dose Measles to Govt. of India.”

Here is the original message to which Dr. Suresh replied:

What can we learn from history to inform the present discussion?

In 1985, India became one of the last countries in the world to introduce measles vaccine.  Today approximately 20% of the world’s births occur in India, about 70,000 per day (more than many countries have in an entire year!).  India’s routine immunization program has exclusively used MCV in 5-dose vials for approximately 3 decades.  I think that it would be instructive for our discussions now to learn more about the evidence that was used then to make the decision to use 5-dose vials, especially since - at the time that decision was made - most of the LMIC world had already been using 10-dose vials for many years supplied through UNICEF. 

-Do any readers have any historical information on this decision by India – specifically about how, why and on what basis it was made?

-To situate the discussion within today’s context, as there are many TechNet listserv readers from India, I think it would be interesting to learn from them about benefits or issues in using this smaller vial size for routine vaccination programs (or their thoughts on using 10-dose vials instead of 5-dose vials for routine programs).

Robert

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Robert Steinglass Accepted Answer

What can we learn from history to inform the present discussion?

In 1985, India became one of the last countries in the world to introduce measles vaccine.  Today approximately 20% of the world’s births occur in India, about 70,000 per day (more than many countries have in an entire year!).  India’s routine immunization program has exclusively used MCV in 5-dose vials for approximately 3 decades.  I think that it would be instructive for our discussions now to learn more about the evidence that was used then to make the decision to use 5-dose vials, especially since - at the time that decision was made - most of the LMIC world had already been using 10-dose vials for many years supplied through UNICEF. 

-Do any readers have any historical information on this decision by India – specifically about how, why and on what basis it was made?

-To situate the discussion within today’s context, as there are many TechNet listserv readers from India, I think it would be interesting to learn from them about benefits or issues in using this smaller vial size for routine vaccination programs (or their thoughts on using 10-dose vials instead of 5-dose vials for routine programs).

Robert

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Wendy Prosser Accepted Answer

Interestingly, this article from Benin documents the process of switching PCV-13 from one dose to four doses, and lessons learned from that experience. It complements the discussion on 5-dose measles as it relates to the decision making process and how to practically implement the change. https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-020-09326-9

References
  1. https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-020-09326-9
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Thanks Lora for opening this relevant discussion. A few years back, nurse Samia Samad from Brazil, did her thesis on estimating wastage for MMR, as well as other biologicals, for different areas of Brazil. It discussed the different vial sizes. A summary of her study was published as "Brazil’s Experience with the Development of a Vaccine-Wastage EvaluationBrazil’s Experience with the Development of a Vaccine-Wastage EvaluationSystem" in PAHO's Immunization Nwsletter in Feb 2012, available here www.paho.org/immunization/newsletter . Samia can be contacted (send me a message if you want to talk with her) as she is working on this topic again.

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Thanks Lora for coming up with this topic. Bhutan has been using 5 dose MMR since 2018. Many vaccination sites, especially outreach clinics have small number of target children for MMR and so this has been very useful in terms of reducing wastage. 

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craig burgess Accepted Answer

Dear colleagues,

It is great to see the Zambia / MR prospective research component of the dose per container (DPCP) work published in Vaccine. It helps raise the profile of potential benefits for measles and rubella control programs. We all hope it may increase demand for appropriate sized vials that cater to the needs of different sub-national contexts of programs.

More broadly, the multi partner and country DPCP work helped highlight that considering dose per container is not measles, or antigen, specific and potentially has three main benefits:

1. Equity: Ensuring different sized vials are available for different immunization program contexts (eg. urban / rural / outreach / fixed site / mobile) can increase coverage and possibly decrease drop out - thereby increasing service access and use by the very communities who need vaccines the most: those in fragile, urban poor, rural remote contexts or those affected by stigma and discrimination; 

2. Market shaping - increase choice: Listening to and responding to the program needs of front line health workers, communities and district managers can increase demand for more context-specific vaccine products. Increasing the choice of product attributes (eg. different # doses per container of antigens) when planning and budgeting programs tailored for specific community contexts can stimulate demand at different levels. This increased demand, if taken on board by key entities, such as UNICEF supply division, development partners, MoHs and Gavi, can reassure / stimulate manufacturers to invest in new markets for different product attributes and help shape that market, by meeting demand.      

3. Assessing trade offs of product attributes: Actively and systematically considering the tradeoffs of different antigen vial sizes when planning and budgeting immunziation programs includes considering impacts on coverage / equity, wastage, cost, safety, HCW behaviour and  supply chain. Making decisions on these trade offs needs engagement of key stakeholders in MoHs, MoFs, partners, NITAGs and ICCs to give broad view points and prioritize vaccine product attributes when planning for immunization program goals and ordering vaccines.

Thank you to Robert Steinglass and colleagues who stimulated this journey many years ago!  

Best,

Craig

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Dr. Robin Biellik Accepted Answer

Many thanks to Lora, Wendy, Sarah, Craig, Vanessa and the rest of the team for this compelling report of the dose-per-container-project (DPCP) study in Zambia.  Combined with other wastage, cost-benefit modeling, public and professional acceptance and other studies in Africa, DPCP has effectively demonstrated the potential benefits of 5-dose M/MR/MMR vials, especially where vaccination session size is small.

In LMICs over the past 2 decades, as new vaccines have been introduced and costs have increased, more much emphasis has been placed by partner and funding agencies on managing costs by reducing multi-dose vial vaccine wastage.  In many LMICs, wastage has been successfuly reduced by increasing RI session size by scheduling fewer RI sessions per month. In others where session size remains small, pressure to reduce wastage has left clinic staff with little alternative but to turn eligible children away unless enough are present to consume at least half the doses in a 10-dose vial.  Most EPI Managers have been aware that these practices result in missed opportunities and stagnant coverage, but finding solutions has been difficult.

A classic example of the impact of this problem emerged during a measles outbreak investigation in which I participated in Ethiopia in 2015.  Despite reported high measles vaccination coverage in SNNP Region, a massive outbreak occurred and the Minister was concerned that the vaccine might be defective.  However, we found evidence of the widespread practice of turning children away unless 6-8 presented for measles vaccination.  This appeared to be the result of intense supervisory pressure to report low wastage and high coverage.  Coupled with inadequate cold chain in remote areas, it was clear that the large proportion of young children suscpetible to measles in that region was fuelling the outbreak.

In the field, I first saw the use of different vial-sizes in Zimbabwe, under the very practical management of Adelaide Shearley, where I was stationed in the 1990s.  She ordered single-dose vials for measles RI and 10-dose vials for SIAs, and I do not recall any issues related to the presence of 2 vial sizes in the country.  

In the current context of Covid-19 and reduced RI session size consistent with hygiene and safety guidelines, smaller M/MR/MMR vial sizes present a solution whose time has come.  DPCP has demonstrated that reduced wastage and higher coverage can be achieved without a significant increase in operational budget.  EPI Managers and NITAGs now have the opportunity to review these potential benefits for their own countries, and to advise their Ministers of their potential value in eliminating measles and rubella. 

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Bashir Abba Accepted Answer

Dear Lora. Thanks so much for sharing and bringing this important innovative approach. Vaccines wastages is on of the areas where health workers battle to strike the balance between getting eligible clienst vaccinated and concern on vaccine wastage. Covid-19 pandemic aggravates the situation here in Nigeria. We are seeing weekly MV wastage as high as 60% in some districts. We see even higher wastages with BCG. The introduction of 5 dose MV appeared to have the potential to reduce wastage and encourage health workers to vaccinate eligibles at any opportunity. This could also reduce missed opportunities. I think it will be helpful to actively engage national authorities on this and make the lower doses formulation of MV and BCG available particularly with the corona pandemic. Vaccine wastage will certainly be on of the concerns of health workers in reducing the size and increasing the frequency of vaccination sessions.

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Mauricio Ramirez Accepted Answer
Thanks Lora for sharing. Really good perspective. I have seen an increase of usage for single dose vials and also a combination of single and 5 doses vials for MMR. My thinking regarding this is related to the supply chain and also the immunization programs in remote areas and more populated cities. Reducing the waste is critical to ensure efficiency of the immunization programs and also to improve the financials.The current pandemic hopefully will leave us with good lessons of how to improve and invest in programs, forecast demand, supply chain and place the health as the primary focus for every government.
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