key: cord-0687930-z6bau2yy
authors: Lazarus, Jeffrey V; Abdool Karim, Salim S; van Selm, Lena; Doran, Jason; Batista, Carolina; Ben Amor, Yanis; Hellard, Margaret; Kim, Booyuel; Kopka, Christopher J; Yadav, Prashant
title: COVID-19 vaccine wastage in the midst of vaccine inequity: causes, types and practical steps
date: 2022-04-26
journal: BMJ Glob Health
DOI: 10.1136/bmjgh-2022-009010
sha: 419776411018d79ac137199f5f9f745a282d32f3
doc_id: 687930
cord_uid: z6bau2yy

nan

Vaccination is the cornerstone of current strategies to mitigate the COVID-19 pandemic, through reductions in transmission, morbidity and mortality. 1 To optimise the impact of vaccination, an approach for equitable global distribution which minimises vaccine wastage is essential. Yet, after more than a year of distributing COVID-19 vaccines, unnecessary vaccine wastage continues, with wastage rates as high as 30%. 2 Globally, highly inequitable distribution of COVID-19 vaccines persists, despite the approval and mass manufacturing of COVID-19 vaccines in high-income countries (HIC), and agreements with initiatives such as COVAX-the vaccines pillar of the Access to COVID-19 Tools Accelerator-to support vaccination in low-and middle-income countries (LMIC). To date, HIC have administered over 2.3 billion doses (79% of the population) and have procured over 7 billion doses, 3, 4 some of which may go to waste as vaccination rates are stagnating, while in low-income countries only 15% of the population has been vaccinated. 5 Of equal importance, effective supply chain management for the distribution of COVID- 19 

with specialised low dead space (LDS) syringes; however, when regular syringes with high dead space are used, only five doses can be extracted, meaning that when no LDS syringes are available, one out of every six vaccines will be wasted. 7 Closed vial wastage occurs due to both vaccine expiry and loss of product integrity in the supply chain, often due to non-compliance to storage temperature and other distribution requirements. A key logistical challenge with COVID-19 vaccines is the short expiration date that, despite recent shelf-life extensions, remains well under 1 year. 8 9 In addition, vaccine storage requirements, including maintaining the cold chain, 10 have resulted in transportation and storage logistical issues, especially in early 2021 and in LMIC. Now, with the European Medicines Agency approval for storing the Pfizer/BioNTech vaccine at 2°C-8°C for up to 1 month after thawing, 11 which was already the case for the other approved COVID-19 vaccines, vaccine doses can be stored in a simple refrigerator. This has mitigated some of the initial transportation and storage issues, increasing access in rural and remote communities.

Ultimately, some vaccine wastage is inevitable. For all vaccines, the GAVI Alliance recommends countries to aim for a maximum wastage rate of 25% for the first year, with a gradual reduction to 15% by the third year. For vaccines in single-dose or two-dose vials, the maximum wastage allowance is 5%. 12 For calculations on COVID-19 vaccines delivery, COVAX uses a 10% vaccines wastage rate, 13 though countries should strive for less wastage. However, accurate reporting of vaccine wastage rates per country is currently lacking. The WHO has developed a Vaccine Wastage Rate Calculator, which aims to improve the overall accuracy of forecasting vaccine waste rates, 14 but it remains underused in planning and reporting. Despite the lack of exact numbers, many striking examples of COVID-19 vaccine wastage have been reported worldwide (table 1) , highlighting the urgent need to better report, identify the root cause of wastage and, ultimately, reduce vaccine wastage rates globally.

While accurate data on the difference in wastage between COVID-19 vaccines are not yet available, based on the characteristics of the various vaccines, differences in wastage are expected (table 2) . Although vaccines with fewer doses per vial, such as the Pfizer/BioNTech vaccine, might have lower open vial wastage, those benefits may be offset due to higher closed vial wastage as a result of more stringent storage and distribution requirements, for example. Therefore, the optimal COVID-19 vaccine to minimise vaccine wastage rates is context dependent. Finally, public trust in vaccines plays an important role, and this trust is highly influenced by communication and the spread of misinformation. 15 16 For example, the media's sensationalisation of possible risks related to the AstraZeneca vaccine, starting in March 2021, led several countries to temporarily stop using the vaccine, which likely led to increased levels of vaccine wastage. 17 Further, although initially questioned due to adapting the practice of heterologous dosing (eg, dosing with an adenovirus-based vaccine, followed by an mRNA vaccine) with a weak evidence base, it has now shown advantageous immunogenicity outcomes and could provide additional flexibility in using vaccines that might otherwise be wasted. 18 

One mechanism to reduce wastage is for all countries, irrespective of their income classification, to provide regular and transparent data on COVID-19 vaccine wastage. This helps identify key drivers of wastage (eg, whether the predominant cause of wastage in a specific country is closed or open vial wastage) which, in turn, helps identify effective interventions to minimise such wastage. We suggest that individual countries include vaccine wastage data in their national COVID-19 vaccine tracking portal, which many countries and regions already have in place. Once a sufficient number of countries start reporting, this could be organised as a global repository by COVAX. Open vial wastage can be reduced by having vaccination centres report their available supply of doses daily, such as via an online portal, while increasing demand in parallel, when 

needed, via targeted outreach to unvaccinated individuals, who could be allowed to get vaccinated without an appointment. Another option is overbooking vaccine appointments to overcome no-shows. In the Canadian province of Alberta, for example, overbooking appointments to avoid wastage from no-shows led to waste on site being reported at only 0.3%. Furthermore, using artificial intelligence (AI) can allow for better matching of demand and supply through new data and analytical tools. An example is the Connected Health AI Network vaccine forecasting tool, which was able to reduce vaccine wastage in Tanzania by 96%, using realtime data sources. 19 In addition, simple technology such as LDS syringes can effectively reduce open vial wastage by increasing the effective number of doses from one vial by up to 20%. Admittedly, some of these measures could lead to higher operational and programmatic costs, but if these measures are undertaken for routine immunisation, then the resulting per unit cost implications of some such one-time fixed investments will be relatively small. In addition, reducing vaccine wastage leads to cost-savings, which can offset new one-time costs. For example, the production cost of a single LDS syringe is less than 1 dollar while one additional dose extracted from a vial can save more than 20 dollars. 20 Closed-vial wastage can be reduced via improved tracking and more timely redistribution of surplus vaccines. First, the number of donated vaccines to LMIC should be increased drastically, as HIC have not been fully honouring their commitments of delivering vaccines to the rest of the world. Redistributed doses should have sufficiently long expiration dates to allow the receiving countries to administer them. For example, unless it is explicitly intended for mass vaccination sites or use in a very large hospital, redistributed doses should have a minimum of 90 days remaining at the time of in-country arrival to allow for storage, delivery and administration. This requires HIC to improve advanced planning and operations regarding their donations and reallocations. In addition, laws preventing redistribution of surplus vaccines should be reformed. For example, a law in the Netherlands states that medicines cannot be traded or donated once they have been delivered to physicians to be used for their patients-this has prevented physicians from reallocating vaccines. 21 Second, countries can consider swap-deals to prevent vaccines from expiring, such as seen in the agreements made between Israel and South Korea, 22 as well as those between Australia and Singapore. 23 Furthermore, manufacturers of vaccines should continue to apply for shelf-life extensions and remove any contractual barriers impeding donating to LMIC. For example, the contracts between vaccine manufacturers and the US Federal government included clauses such as 'The Government may not use, or authorise the use of, any products or materials provided under this Project Agreement, unless such use occurs in the United States or U.S. territories'. 24 Further, to complement manufacturers' printed expiry dates, the Vaccine Presentation and Packaging Advisory Group, 25 UNICEF and other LMIC vaccine delivery-focused agencies should accelerate the use of electronic lookup of expiry date for new vaccines where stability has not yet been fully established. Dynamic lookup of expiry date based on batch number avoids the problem of static printed expiry dates, and allows for dynamically adjusting the expiry date when new stability information to extend shelf-life becomes available.

Finally, in addition to increasing donations and limiting vaccine wastage parallel efforts are necessary to ensure vaccine access in LMIC. Plans to produce more COVID-19 vaccines in LMIC, for example in sub-Saharan Africa, 26 are underway, and may contribute in the long run to increased availability and access to vaccines. To facilitate this process, governments and vaccine developers should prioritise know-how transfer, enhance the supply chain for critical input materials and help remove any patents barriers coming in the way. Vaccines such as the Corbevax vaccine, developed with no patent and transferred without payment to vaccine manufacturers in several LMIC, including Botswana and India, play a vital role in improving access and also reducing wastage. 27 CONCLUSION COVID-19 has highlighted critical issues of vaccine wastage and the need for all countries to develop detailed plans to monitor and reduce vaccine wastage. Importantly, current plans should include well-organised donations to minimise closed vial wastage and the use of strategies such as overbooking or appointment-free vaccination to minimise open vial wastage. While supply constraints were initially due to the low number of vaccines being manufactured, this is no longer the case. Therefore, it is time for high-income countires to share their vaccine surpluses with low-and middle-income countries, where many vulnerable individuals, including frontline healthcare workers, are still awaiting their first dose of a COVID-19 vaccine.

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