I wonder about this pandemic, will there be a vaccine soon? When will it be available? What will its presentation be? Will there be availability for poor countries? Cost? Are equipment manufacturers going to support poor countries with equipment? Could you share with us what are manufacturers doing?
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Thanks for the response.
We were able to achieve very high utilization rate (99.17%); minimal Vaccine Wastage Multiplying Factor (WMF: 100÷99.17=1.008) because of the following:
- The national guideline was to vaccinate the beneficiaries in batches of operable number for not disturbing the routine institutional work over 3 days.
- Accordingly the protocol was written in such a way that only one vial of 10 doses is opened at one time, cold chain maintained, being a mass programme, to a large extent, after screening for eligibility and exclusion criteria, batches of 10 beneficiaries were administered vaccine, spending the complete vial, after the last batch of the day we are left with nil partially used vial or one partially used vial with a minimum of one dose or a maximum of 9 doses. The vaccine was already in the liquid form not requiring reconstitution. With proper maintenance of cold chain, the partially used vial was permitted to be used on the consecutive day, with this after every phase the service delivery point was left with nil or only one partially used vial for discarding with a minimum of one dose or a maximum of 9 doses.
- They are provided with “all in one” tool for recording the denominator category wise, the numerator of vaccinated category wise, vaccine logistics, exclusion of beneficiaries at the screening site and the AEFI category wise: all in one tool for all the 3 phases so that it was 100% sensitive and 100% specific in deriving the 4 key indicators : Utilization rate; Vaccine Wastage Factor, exclusion rate and category wise AEFI rate and its outcome – hospitalized or not, recovered or not within how many hrs. With this simple and surest tool it was so easy for the programme implementers / service providers to derive the performance indicators without the help of any consultants.
- Optimal support to me by the Project Director, Health commissioner / Secretary in this regard and
- Highest compliance by the District and sub district level managers.
Uniquely, in this pandemic no other development partners had active role in vaccination either proactively or obligatorily and hence no stake holders other than both private and Govt Medical Colleges and private H1N1 service providing health institutions participated in this vaccination programme.
We hope to receive similar simple & surest “all in one Tool” this time also [previous tool available with the Karnataka State -- legacy], for documenting and deriving similar indicators.
The LMIC are trying to prepare the cold chain by ULT equipments but we don't have the presentation of any manufacturer of vaccine. We need the primary and secundary packaging dimensions. It`s interesting the results about 99.17 % of vaccine utilization rate, this indicator is extremely good even unidosis vial and vaccination to concentrated population.
India is getting ready to administer COVID-19 vaccine to the pre-registered beneficiaries as of now as per broad guidelines.
For equipping ourselves at service delivery point it is mandatory to know specific product information with regard to how many doses in one vial [single dose / 5 doses / 10 doses per vial]; in what form it is supplied -- liquid form ready for administering or lyophilaized powder requiring a diluent for reconstitution, temperature consideration at delivery point and the like. These are be product specific.
For calculating requirement of cold space; volume of the carton containing vaccine vials [length x breadth x height] and that of diluent if applicable is also important as the national general guideline in India is to keep vaccines and diluents in the cartons irrespective of number of doses / vials a planning unit wants -- practically difficult if the vials required are less than full carton as vaccine / diluent specific dummy cartons are not available: a common “cold problem” - shared with the global stakeholders a couple of years back.
In a similar situation in 2010, Karnataka was supplied with 1,24,200 doses of Panenza vaccine [H1N1] for administering to selected high risk group. Specific protocol and operational guidelines were developed by the author which enabled to achieve 99.17 % vaccine utilization rate, 1.03 % overall AEFI rate and 0.63% rejection rate at the screening site.
Hope on receiving similar protocol and operational guideline from the current programme mangers we may be able to derive similar performance indicators concurrently during the programme implementation.
I would like to share an article that was written in september 2020 by oxfam about numbers of covid 19 vaccine.
Will be that pharmaceuticals companies will reserve some of its production to sell this vaccine to developing countries?
If rich countries are buying vaccines for their entire population. Will reach the production of vaccines for at least 50% of the world`s population. Covax will have bargaining power in these circumstances?
Consideration should be given to releasing patents to achieve coverage, "We need a People’s Vaccine, not a profit vaccine.”
AS Pat Lennon pointed out we do not know how thermally stable the vaccine will be. The less thermally sensitive the easier it will be to distribute. Anna-LeaKahn made the point that if the vaccine has a high enough thermal stability it could be be distributed with the Controlled Temperature Chain (CTC).The CTC requires no cooling a feature which would greatly simplify distribution.
If the developed vaccine is more stable than a VVM 2 vaccine but not stable enough to be distributed in the CTC it could be be distributed by what I call the Buffered Cold Chain (BCC), see my post of 4months ago; "Buffered Cold Chain, a new approach". The BCC would keep storage temperatures below 25 deg C. If for example the vaccine has the same thermal stability as a VVM 7 vaccine it could be stored for 40 days at25 Deg C. If it's stability is the same as a VVM 14 vaccine it's storage life at 25 Deg C would be 80 days.
The equipment necessary to maintain this higher temperature would be simpler, less expensive and require less energy to operate than the refrigerators incorporated in the 2 Deg C to 8 Deg C temperature chain.If the vaccine developed is freeze sensitive storage at a higher temperature would eliminate freeze damaged vaccines. Freeze damaged vaccines is a common problem in the 2 Deg C to 8 Deg C temperature chain.
Good questions. There is COVID-19 vaccine development pipeline tracker from the LSHTM: https://vac-lshtm.shinyapps.io/ncov_vaccine_landscape/ that can be helpful
In addition to the insightful inputs from Pat Lennon, we as manufacturer also wonder what will be next.
We as Berlinger have secured our production and our devices have been identified as 'critical medical supplies' in the countries of production. This means that less or no restrictions apply compared to normal commercial goods. In the past decade Berlinger has supported lower income countries, either directly or indirectly through UNICEF, WHO and other agencies. We are ready to continue supporting, yet like all of us we are waiting to see what will be required.
Rafael - You raise important questions and I don't believe there are concrete answers to them yet. Here is some information that may be helpful.
WHO R&D Blueprint for COVID-19: https://www.who.int/blueprint/priority-diseases/key-action/novel-coronavirus/en/
The Bill and Melinda Gates Foundation is making significant investments in multiple vaccine candidates: https://thehill.com/changing-america/well-being/prevention-cures/491006-bill-gates-is-funding-factories-for-7-potential
The Foundation understands that a vaccine will be needed in all countries to protect everyone from a highly contagious virus. Given the amount of international travel still occuring just vaccinating a few rich countries won't be effective at stopping a pandemic.
The Foundation is also investing in research on treatment options until a vaccine is available: https://twitter.com/gatesfoundation/status/1246095455726886913?s=12
You posted your question to the cold chain equipment forum. What we don't know yet is how thermostable any new vaccines will be. Will the new vaccine(s) be able to be stored in 2-8C? Will they be freeze sensitive? Or will they have special requirements similar to the first Ebola vaccine? I believe we will need to track information on succesful candidate vaccines as they becomes available to see what the appropriate pandemic vaccine supply chain approach will be - and what new equipment, if any, is needed.
Before the lock-down in South Africa, we managed to manufacture 300 x Sure Chill vaccine fridges; 100L & 150L (E003/036, E003/044, E003/037 and E003/052) which are ready at our facory in Johannesburg, South Africa for urgent orders. Albert Wessels - Zero Medical, South Africa.
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