 Today, as the world navigates through this pandemic, our hopes lie on vaccinating each one of us to combat the deadly virus. Today's discussion revolves around understanding the various challenges involving vaccinations and learning about the operational efficiencies that can help accelerate delivery and support safe handling of COVID-19 vaccine. I'm extremely excited to welcome the speakers for today's workshop. We have with us Dr. Sameer Naik, QC Lead Kovishil from Serum Institute of India, Ms. Manjiri Gharat, Vice President of Indian Pharmaceutical Association and International Pharmaceutical Federation, FIP. We also have our USP experts with us today, Ms. Sirisha Yedlapalli, Regional General Manager, USP, Ms. Nakia Elrich, Senior Manager of Health Care Quality and Safety, and Ms. Diana Kwan, Senior Scientist at USP. With that, I would like to take the opportunity to begin the event with the first session by Ms. Nakia Elrich, who will give us an introduction of USP and Health Care Quality and Safety, HQS Center of Excellence, and an overview of USP's COVID-19 mission priority. Nakia Elrich leads the Activities of Health Care and Safety and Information Division of HQS Center of Excellence. She has worked with the Health Care Safety and Quality Expert Committee in drafting and publishing USP's COVID-19 vaccine handling tool kit, and co-leads the USP efforts around COVID-19 vaccine information for healthcare professionals. Good evening. I am happy to be here with you, along with Dr. Kwan, in order to share waste minimization strategies from the USP COVID-19 vaccine handling toolkit. That was developed for healthcare practitioners within the United States. I'd like to start by saying that Dr. Kwan and I have no conflicts of interest. And during this presentation, we are going to talk about some vaccines that have been used in the United States, but are currently on an off-label emergency use within our country. During today's presentation, I will discuss USP's mission and the stakeholder and expert engagement that resulted in the development of the USP COVID-19 vaccine handling toolkit. Dr. Kwan will share with you an overview of the rollout of the COVID-19 vaccines within the United States and the strategies from the USP COVID-19 vaccine handling toolkit to decrease vaccine wastage. We will also share our goal to develop a similar vaccine guide for the international COVID-19 vaccines. For those of you who may not know, I'd like to kind of introduce you to the United States Pharmacopeia, also known as USP, which was created over 200 years ago dedicated to instilling trust where it matters most in the medicines, supplements and foods people rely on for their health. The quality standards we develop help manufacturers deliver on their promises of safe products while building confidence among healthcare practitioners, patients and customers. Our mission is today to improve global health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. USP is an independent, non-profit, scientific organization and today what we are focusing on are three groups supporting our healthcare workers, our manufacturers and our regulators worldwide. Today we're going to talk about the support for our healthcare workers where USP has developed a range of toolkits, including the vaccine handling toolkit which we will discuss today, a hand sanitizer toolkit that was developed to help organizations meet the demand for these products, the shortages of commercially manufactured sanitizers occurred and a PPE guide for sterile compounding during shortages developed to help institutions meet demands during the PPE shortage within the US. Our start for the COVID-19 vaccine toolkit was in 2020 where USP wanted to help our practitioners on the front line struggling with this pandemic. Our first goal was to gather information from our stakeholders to better understand the challenges that they were facing with COVID vaccines. Our stakeholders shared gaps in compounding, preparation and packaging. Immediately we knew that we could convene our experts in these areas to address these gaps. Given the information shared, we established a work plan to develop a toolkit that was dedicated to filling the critical operational gaps from when the vaccines reach the pharmacy to when they get to the patient. Our priority was to address these gaps in hopes of helping our practitioners accelerate vaccine administration, provide techniques to maximize doses and provide strategies to minimize potential waste. To ensure ease of information access, we divided the toolkit to three focus areas, preparation and labeling, storing, handling and transporting, and finally, waste minimization and disposal. With the commitment to address these three focus areas, we reached out to our scientific experts with expertise in these particular areas. Over 30 independent experts from the healthcare safety and quality, package and distribution, nomenclature and labeling, health information and technology and compounding expert committees work together to provide content for the toolkit. The experts were led by the Healthcare Safety and Quality Expert Committee, a committee composed of healthcare practitioners that specialize in drug classification and patient safety and included input from the U.S. government entities like the Centers for Disease Control and Prevention and the Food and Drug Administration. All work together to create a toolkit that could serve as an essential resource to support safe handling and confidence in the consistency of processes across vaccination sites. This work was informed and driven in part by USP's public quality standards for compounding, microbiology, containers, labeling, distribution, stability and storage. This document is not a USP compendial standard. It reflects considerations developed by the experts based on their scientific and professional expertise and with input from stakeholders, regulatory agencies and manufacturers. The expert's goal was to empower practitioners with critical information that facilitates operational efficiencies during the handling process of the COVID-19 vaccines, always while preserving quality and safety. The toolkit originally addressed Moderna and Pfizer-BioNTech vaccines. It was later updated when the Janssen vaccine was approved for emergency authorized use in the United States. The experts continued to convene as updated information is provided and as additional vaccines are authorized for use within the US. To complement the toolkit strategies for preparation, USP has created several related infographics, fact sheets and frequently asked questions all available on our website. Dr. Kwan will now share with you some more details about the USP COVID-19 vaccine handling toolkit strategies to decrease vaccine wastage. Thank you, Nakia, for providing insights on the USP COVID-19 mission priority and HQ center of excellence. I would now request Ms. Diana Kwan to take the next session which is on USP COVID-19 vaccine handling toolkit, operational considerations for healthcare providers. Diana Kwan handles the scientific liaison for healthcare safety and quality expert committee at USP. She provides guidance and support to the expert committee work plan which includes collaborating with volunteers experts, FDA, Institute of Safe Medication Practices, ISMP and others to develop, strengthen, revise and promote adoption of healthcare quality standards related to the use of medication. Please go ahead, Diana. Thank you. Thanks Rajan, thanks Nakia. So my goal today is to share strategies to minimize vaccine waste presented in the USP COVID-19 vaccine handling toolkit that Nakia introduced. Just one point of disclaimer is that we originally published this toolkit with considerations from experts and available information in the states. So product availability and regulations differ worldwide. Parties relying on this information bear independent responsibility with federal, state or local laws and requirements. So today I'll start with a few background slides on the US rollout of COVID-19 vaccines and causes of vaccine wastage. Then I'll introduce the three sections of the USP COVID-19 vaccine handling toolkit and point out the strategies that have helped users minimize vaccine waste and maximize doses that are withdrawn so that there's less waste of drug in the vial. In the US as of early April we have the largest death toll per country with over 567,000 deaths from coronavirus. We also have over 200 million people receive at least one dose of vaccine and that's over 50 percent of our population that has gotten at least one dose. Roughly 27 percent of the population is fully vaccinated and this map on the right shows this. The turquoise color represents 27 percent fully vaccinated people. The statistic is quite amazing. That's an average of 2.7 million daily vaccinations. Although some experts are suggesting that the next part of the rollout will be more difficult due to future surges and variants, vaccine hesitancy in younger population, people who develop the disease despite vaccine, non-responders and kind of inconsistent reporting on the extent of vaccine waste. These current numbers weren't always obvious that the US was able to administer so many COVID-19 vaccine doses by this time. In late December last year there was a lot of concern that all the scientific achievements and efforts of developing the vaccine could be hindered by the distribution, administration or storage and handling of the vaccines or the last 25 feet. Lots of pizzas had to come together including supply and technological aspects like websites needed a schedule appointment and ensuring there's a supply of volunteers and vaccine administrators. One reason for the capability of getting the large number of vaccinations in arms is the opening and coordination of mass vaccination sites. In fact several physicians wrote an opinion article in the New England Journal of Medicine that these mass vaccination sites were an essential innovation to curb the COVID-19 pandemic. Some reasons they state is because these large venues including stadiums, arenas, convention centers are helpful not just alone but in addition to existing community based healthcare sites. Traditionally in the US that's doctors offices and pharmacies to get more shots in arms and facilitate space for physical distancing. These vaccination sites also help match supply with demand and able large batches of people to be vaccinated using the vials more efficiently and using every dose. Also compared to existing community based healthcare sites that may provide different services and many different drugs these mass vaccination sites can focus on the cold storage requirements and security of just the COVID-19 vaccines. Regarding vaccine waste some waste is is really expected. The World Health Organization estimates that up to 50% of vaccines are wasted globally every year. A large part because of lack of temperature control and the logistics to support an unbroken cold chain. Causes of vial wastage can be thought about in two ways. When the vials opened for use and when the vial is unopened throughout the process of getting the vaccine from the manufacturer to the patient's arm. When the vials opened there can be leftover doses at the end of a session. There may not be adequate ancillary supplies to draw maximum number of doses. There could also be poor aseptic technique leading to contamination of the vial and poor administration practices. When the vial is unopened the vaccine can expire, be exposed to extreme temperatures, break, be stolen or unused in vaccination sites. Despite these causes for vaccine waste there are dedicated health care workers that overcome these challenges and find solutions. For example the image on the right here depicts several health care workers who were stuck in the snow storm with six doses of COVID-19 vaccines that needed to be used within six hours. The health care workers went from car to car and eventually, this is in Oregon, six doses were given to six grateful drivers. Now I'll go into more detail on the techniques and strategies in the COVID-19 vaccine handling toolkit that directly mitigate these causes of vaccine wastage. The first section of the toolkit is regarding vaccination. Here you'll find the mitigation strategies related to the cause of COVID-19. Such as contamination and inability to draw maximum doses. The foundation of these considerations is USPs recognized public quality standards in ensuring sterility and freedom of contamination. The first three subheadings have general strategies to prevent contamination. This includes environmental considerations such as where the vaccine should be prepared such as away from food and drinks and how to disinfect surfaces where the vaccine preparation will take place. It also talks about what personnel should wear and hand hygiene considerations. Also considerations on aseptic technique such as how to disinfect entry points and to avoid touch contamination. The next three subheadings contain strategies to ensure the maximum number of doses are withdrawn in a vial and operational efficiencies of pre-drawing syringes. I'll go into more details in the next couple of slides. In the withdrawing dose section it talks about syringe and needle considerations. The type of the syringe and needle selected can affect the number of doses withdrawn due to residual drug product held in the dosing components. The type of syringe and needle that is preferred is called a low-dead volume syringe needle. These are designed with less space between the needle and the plunger and in the image on the right on the far left you can see that this is the preferred combination which is a low-dead volume syringe with a fixed low-dead volume needle. You can see here in the orange that there's less vaccine in the dosing components. The image in the middle is a standard syringe with a low-dead volume needle and the image on the far right is a standard syringe with standard needle which has the most amount of vaccine left over in the dosing components. Besides using low-dead volume syringe needles other considerations to ensure complete doses are withdrawn including using the smallest syringe appropriate to improve dose accuracy. Also using the same needle for withdrawal and administration to reduce the potential loss of volume. Knowing that low-dead volume syringe needles were preferred one scenario that USP helped strategize is when sites didn't have enough low-dead volume syringes. What combination of low-dead volume and non-low-dead volume would still be able to maximum withdraw the maximum doses per vial. Specifically for the Pfizer-BioNTech COVID-19 vaccine USP worked with a test site to come up with a strategy of three low-dead volume and three non-low-dead volume could successfully withdraw six doses of the Pfizer-BioNTech COVID-19 vaccine. There are also in this section some withdrawing techniques to minimize leakage and reduce loss of medicine. This includes the technique of inserting the needle in various parts across the vial septum to reduce leakage of vaccine. This is depicted in the image on the right. One thing to think about is to make sure that the needle and syringe are tightly lure locked to prevent leaking of the vaccine. And also one consideration is that try not to use these transfer devices such as mini spikes or dispensing pins due to potential loss of medicine in the dead space. The toolkit also talks about ways to increase efficiencies and withdrawing doses through pre-drawing syringes. The initial knowledge gap regarding pre-drawing syringes was twofold. Once we draw out the vaccine in a syringe how long before I have to use it or the beyond use state? Also when we prepare these pre-drawn syringes what's the best way to label the syringe in container? The toolkit provided the answer to the beyond use state question with manufacturer supplied information on the beyond use state in pre-drawn syringes. These were based on physical chemical stability and microbiological challenge studies by the manufacturer. The toolkit also provided the answer to the labeling question and drafted an example label and suggested components you see here on the image on the right. The benefit of utilizing the toolkit information on pre-drawn syringes is it helps drive consistency for pre-drawn syringes and gives confidence to practitioners on the beyond use state. It also supports different practitioners preparing the administration, administrating the vaccines. I experienced the benefits of pre-drawn syringes firsthand last weekend when I received my first dose of COVID-19 vaccine. The mass vaccination site I went to in Maryland was very organized and had tables with pre-drawn syringes in plastic containers, happily for me to see all labeled. We're already seeing a significant positive impact from the use of the USP vaccine handling toolkit. One toolkit user, her name is Patricia Slatum, she's actually a USP convention delegate, reported that she was able to use the toolkit strategies for pre-drawn syringes, streamlining processes to increase shots in arms by 50 per day. The second section of the toolkit is on storage and transportation. Here you'll find information on how to prevent unopened vial wastage, such as extreme temperatures and fact. This section discusses the importance of developing appropriate standard operating procedures for handling COVID-19 vaccines, as well as the importance of proper storage and temperature monitoring. We know that failure to store and handle vaccines properly can not only lead to vaccine wastage, but also if it's administered, it could potentially reduce, with reduced potency, lead to poor protection against COVID-19 for the patient. The foundation of these considerations is USP's recognized public quality standards and packaging and distribution. This section also has citations from the CDC storage and handling toolkit. The first subheading describes the aspects to include in a standard operating procedure or SOP as part of a robust quality management system, which is essential. The SOP should address receiving vaccines, that is when vaccines arrive at the facility, staff should aim to achieve transfers as quickly as possible to designated storage area. It should also handle problems that are identified, such as damaged packages. Also what to do in emergency situations, such as equipment malfunctions, power failures, or natural disasters, and what to do in the case of a temperature excursion. Usually when a temperature excursion occurs, each excursion is unique and really to determine the impact of an excursion and whether the vaccines are still viable or needs to be wasted, staff should contact the manufacturer for guidance on whether the affected vaccine should be discarded or can be utilized. But information that needs to be documented and included in the consultation is the magnitude of the temperature excursion and the total amount of time that the temperatures were out of range. While this determination is being made, the vaccine should be maintained at the appropriate temperature and clearly labeled do not use pending guidance by manufacturer. Proper vaccine storage is key to ensuring vaccines are not wasted. A pharmaceutical-grade refrigerator and freezer are preferred because they're specifically designed for storing biopharmaceuticals, including vaccines. Under no circumstances should a vaccine be stored in a dormitory-style refrigerator or freezer unit and definitely not stored with food, drinks, or biological specimens. There should also be routine maintenance to ensure proper function of the refrigerator or freezer depending on the time of year. When vaccine transport is necessary, you can use a portable refrigerator and a freezer unit with the temperature monitoring device or a qualified packout or manufacturer-supplied packaging as long as it's in accordance with manufacturer directions. Proper vaccine temperature monitoring is also key to ensuring vaccines are not wasted. A continuous temperature monitoring device is preferred and should be used. A specific device, a digital data logger with an external display is preferred. These temperature monitoring devices should be calibrated against naturally accepted standards to ensure accuracy of readings and this calibration testing should be done every one to two years or according to the manufacturer's suggested timeline. Alarm systems can also be used when a reading is above the desired temperature. When transporting vaccines the temperature should be monitored and validated whenever the storage containers open. Some considerations for security measures to prevent theft include securing with a tamper proof or tamper evident measure such as locks or tapes. Since demand for the vaccine is so high in the U.S., there were reported incidents where bad actors took used COVID-19 vaccine vials from the trash bin, filled it with saline, and gave it to patients. Therefore another aspect to think about is the disposal of the COVID-19 vaccine vial to make sure it's secured in a way to mitigate potential tampering. To complement the toolkit, USP developed a detailed guide on transporting COVID-19 vaccines off site. It addresses the importance of validating the temperature whenever the storage containers open. Also to minimize the total time for transport to reduce potential risks for a temperature excursion due to a storage unit or thermal packing system failure. The guide also outlines how to prepare a packout for transportation of pre-drawn syringes or vials. Let me see this here in the image on the left. This includes important considerations like ensuring that the temperature monitoring device is near the vaccine for most accurate temperature monitoring and how to protect the vaccine with bubble wrap or corrugated cardboard cushioning. So I'm now at the third section of the toolkit which is focused on waste minimization and disposal. Here you'll find general strategies to minimize waste as well as disposal considerations. We already kind of spoke at length about maintaining cold chain and importance of properly storing and temperature monitoring to prevent the need to discard any product due to temperature excursions. Contamination can also lead to vaccine waste. Therefore vaccine prepare should be properly trained and demonstrate competency for proper aseptic technique. In addition, a site should have plans in place to minimize vaccine waste of usable vaccine. For example, a waiting list for vaccines for patients who don't keep appointments, plans to distribute vaccines when that occurs, and agreements with pharmacies and other local centers for vaccine transport. Additionally, when pre-drying carefully consider the number of pre-drawn syringes to prepare to avoid drawing up unnecessary doses and use the pre-drawn syringe with the earliest discard time to avoid waste. Thanks all for your time and attention. I hope you found this information helpful and take away a few strategies to minimize opened or unopened vial waste. So having shared the USP COVID-19 vaccine handling toolkit and the ancillary resources with our US frontline practitioners, we received requests for a similar document addressing the international vaccines. On the next slide, what you'll see is that I shared today the toolkit summarizes strategies that have significantly helped our frontline practitioners accelerate vaccine administration, maximize doses, and minimize potential waste. We hope by sharing these strategies others will be able to minimize waste and maximize vaccine administration. We have started sharing this toolkit with our international partners to elicit feedback on the global specific challenges from the moment the vaccine reaches a site to when it is administered to a patient. With this information, we can work with our experts, manufacturers, and regulators to develop an international guide that covers four international vaccines, particularly the Sputnik, the Cova Shield, CoronaVac, and Covaxin. With this information we'll be able to create a guide that focuses on the challenges similar to what we did with the USP COVID handling toolkit. Thank you for taking the time today. I would now like to call upon Ms. Manjiri Gharat to provide her insights on addressing waste in vaccines, equity, access, and sustainability. From a pharmaceutical workforce perspective, Ms. Manjiri is the vice president of Indian Pharmaceutical Association. In fact, she's the first human VP of IPA and International Pharmaceutical Federation FIP. With her active work in academia, pharmacy councils, chemist associations, consumer organizations, NGOs, and IPA branches all across the country, Ms. Gharat has great practical knowledge and on-ground exposure on pharmaceutical workforce. Over to you, Ms. Manjiri. Thank you so much, Mr. Rajan, for this kind introduction. I bring greetings from International Pharmaceutical Federation to everyone and it's an absolute pleasure and honor to be part of this webinar organized by USP. Thank you very much. I would like Rajan to share my slides please if possible. Can you share the slides? Thank you. So as we move forward, I'll be focusing on the equity, equality, access, and sustainability in the pharmacy with special reference to the vaccines. For those of you who are not familiar yet with International Pharmaceutical Federation, as it is called FIF or FIP World Over, FIP is a global body of pharmacists, pharmaceutical scientists, and pharmaceutical educators. FIP represents four million pharmacists and pharmaceutical scientists and educators from around the world through 147 national organizations for members, as well as the academic institutional members. FIP is a non-governmental organization established way back in 1912 and has its headquarters in Hague, Netherlands, and it is led by President Dominic Jordan from Switzerland. FIP works with several partners across the world and it is in official relation with World Health Organization. FIP's vision and the mission, can we have next slide Rajan? So FIP works with the region of a world where everyone benefits from access to safe and effective medicines and pharmaceutical care and we are on a mission, can we have next slide? We are on a mission to improve the global health by supporting the advancement of pharmaceutical practice, sciences, and education. FIP, next slide, the FIP development goals deliver FIP's commitment to improve the global health through the pharmacy, which is very much reflected through its region mission and the strategic objectives. FIP is committed to improve the global health and to support the United Nations sustainable development goals, especially the health SDGs. As I told you, we are working with WHO since long and in World Health Assembly in May 2019, FIP signed the first memorandum of understanding between FIP and WHO to support the WHO's initiatives around workforce, the health resources, and the universal health coverage, patient safety, access to medicines. You can see the picture here with Dr. Catherine Duggan, the CEO of FIP with Dr. Ted Ross. Next slide. So the FIP's development goals, so we have got our goals for the next decade for the transformation of pharmacy worldwide and these one FIP goals have three major components that is pharmacy practice, pharmaceutical sciences, and workforce and education. We strongly believe that we can have no pharmaceutical care without a pharmaceutical workforce and we can have no pharmaceutical care without a scientific foundation for the next decade. Yes, next slide please. So these FIP's development goals have these three important components of practice, science, and workforce and we have mechanisms that is the tools and structures to facilitate and support the process of transformation of pharmacy across the globe and as well we have the indicators to measure the outcomes, to measure the impact of implementation of these goals across the world. Next one please. So we have in September 2020, we launched that is during the amidst the pandemic, we launched these FIP development goals. You can see that at 21 FIP development goals right from academic capacity, early career training, AMR anti-microbial resistance towards ship to the sustainability in the pharmacy. One more please. We are in the midst of pandemic and if we are talking of the COVID vaccine, so when we're talking about the vaccine equity, the most important goals which are linked to the vaccine equity are the FIP development goal 10, 18 and 21. Next one. The goal, the DG, the development goal 10 focuses next slide please, equity and equality and here we are talking the previous one, the FIP, yeah, the goal 10 please. Yeah, so here we are talking about the need for the clear strategies for addressing the equity and diversity inequalities in the pharmaceutical workforce as well as the need for clear strategies for equity and diversity in the pharmaceutical services as well as the equity in the global capacity of pharmaceutical sciences training. So this is the DG 10 focusing on equity and equality. The development goal 18, the next slide, focuses on the access to medicines, medical devices and services and here we emphasize on the need for the strategies in place to widen the access to medicines and services, the systems in place to optimize the access to effective medicines and access to innovative science and information. Next one. And sustainability, these two link together to the sustainability in pharmacy which is of utmost importance from the future point of view and here we focus the goals focus on the need for the strategies and systems in place that utilize the workforce to enhance the sustainable pharmacy and services, the need for the policies, regulations and strategies to ensure the sustainability of the environment and minimize the impact of pharmaceuticals and pharmaceutical services as well as the scientific, clear scientific strategies and policies in place to maintain the consistent supply of the medicinal products while limiting the negative consequences for the environment. Next one. So we have created a lot of resources around these goals and you can see some of these around the sustainability that is the sustainability of pharmacies, green pharmacy practice taking responsibility for the environmental impact of medicines as well as the sustainability of pharmacy services advancing global health. Next one. We have some more resources focusing on the access to medicines. For example, the pharmacist in supply chain or the reporting medicine shortages and all these resources are available on the FIP.org the website of FIP. Next one. We also have the resources created, the reports created around the equity and equality in practice. When it comes to vaccine equity, the pandemic has clearly demonstrated the inequalities in access and care for the vulnerable population. FIP came up with the statement of principle in May 2021 about the accelerating vaccine equity for the pharmacy teams basically the healthcare workers and also we developed an advocacy toolkit that was in 2019 because going forward we knew that the vaccination services through the pharmacies are very valuable to increase the coverage of vaccination that time COVID-19 was not in picture but advocating for the vaccination services through the pharmacy we had developed this FIP global vaccination advocacy toolkit which is also available on the FIP website. Next one. So FIP equity Rx is FIP's equity and equality program and it supports the progress and implementation of the development whole 10 on equity and equality locally, regionally and globally going beyond the gender and the diversity balances. We started working in the equity Rx that was initiated in 2018 which was basically focusing on the gender gaps and the diversity but then we extended it to equity in access to care for everyone leaving no one behind. Next one. And so we know that the impact of COVID-19 is basically linked to a lot of social determinants and hence it is very important that we don't leave anyone behind and everybody gets an access to the healthcare services. Next one. So you can see this website equityRx.fip.org where we have quick collection of the digital FIP equity Rx 2020. Next one. As we come to the pandemic, a pandemic has made everyone of us to wear the mask but it has unmasked a lot of inequities and inequalities. The fault lines are all exposed and we know that as I said that the impact of pandemic is very much linked to the social inequalities. So taking clue from this, recognizing this fact, FIP released a statement of principle impact of the COVID-19 pandemic on health equity and vulnerable patients and populations and never before the world realized the importance of the pharmacy services and the pharmacists before. So this pandemic showed, exhibited, demonstrated the value of pharmacy services. When everything was closed, the pharmacies were open and they were the one who were giving service to the population including the vulnerable and underserved population. Next one. So next one please. So a very interesting report we had created in 2020 before even the COVID vaccine came and this was actually an extension of our global survey which was held in 2016. Here we talk about an impact of pharmacy on vaccination coverage and the vaccination as my other colleagues from USP also mentioned the vaccination through the pharmacies has become quite common in many countries. In this global survey there were 99 countries who participated and it shows that the influenza hepatitis B antitanus were the most common vaccines administered to the pharmacies as well as the pneumococcal and typhoid vaccines. Pharmacy-based vaccinations were available in 47% of the high-income countries compared with just 11% of the low-income countries who participated in this global survey. So there is a clear difference, clear disparity between the high-income countries and LMIC, the low and middle-income countries as far as the services through the pharmacies for vaccination are concerned. According to this report a fact is revealed that the community pharmacies can give almost 1.8 billion people around the world the possibility of being vaccinated. So there are numerous pharmacies, they're right in the community, they're easily accessible to the people and they give an enormous possibility and opportunity to increase the vaccination coverage. It is evident from the report that there is increased vaccine accessibility and coverage have been demonstrated in countries where the pharmacies have the authority to administer the vaccines. Thanks. So in 2020 as we could not have the in-person congresses we focused on the digital events and FIP digital events are focusing on the digit 10 and 18. We had series of three digital events, transforming vaccination was the focus and it was a great learning platform for everyone, all the pharmacists across the world to learn about the vaccination and its impact on the communities. Next. So as we see that we are now in 2021 and the COVID vaccine is here and what is the response from the community pharmacists to COVID-19 vaccination? You can see in the United States vaccination has been done through the pharmacies, pharmacies are involved and direct to forefront. In vaccination drive you go to UK, UK has involved, NHS has involved next one please, next click there are many clicks in this line. Yeah so UK has involved the pharmacists and they are giving the jabs all the time to the, I mean they're because of them there is the increased vaccination coverage that you can see. Same as the case with Ireland, next clicks. You go to Europe or even the Philippines, they have realized the importance of the pharmacist and the government has included the pharmacist in the vaccination drive. Same is the case with Brazil and Australia, next click please. And also in many other France and many other European countries, yeah go ahead some more clicks yeah. Yes and you must have read many of the high celebrities or the high profile politicians have also taken their vaccine in the community pharmacists. So this is a global response of the pharmacies as far as the COVID vaccine or vaccination drive or rollout is concerned. From this global picture come to India and what's happening in India, yeah next slide. When we come to India we know that the role of pharmacist is not updated. Right now at least the pharmacists are considered more as traders than the healthcare professionals and the services, the patient-centric services are not yet common and so not the vaccination. But Indian Pharmaceutical Association with the support of FIP, we are in dialogue with the government and we are advocating for the larger role of pharmacists and how the pharmacists can be engaged in the vaccination. I completely understand it's a long way to go because there have to be policies, strategies, regulation, training, workforce development, the education has to change and orient itself but the COVID pandemic has demonstrated why we should need to increase the pool of healthcare workers and pharmacists are right there in the community who are underutilized. They're the first port of call for the people and people have good relation, friendly relation with their pharmacist and a pharmacist staff. So it will be very prudent to increase the vaccination coverage or to equip the pharmacist with this knowledge and skills. So as I said it's a long way to go but the journey of 1000 miles start with a small step and we have taken that with the support of FIP and many other countries. Can we go to the next slide? So since it is more of a futuristic, can we go to the previous slide, sorry, Rajan, previous slide? So as this is going to be not a near future action but we need to do that to have the services through the pharmacists. What can pharmacists do right now? In fact they have been doing it. They can create awareness about the vaccines. What are the vaccination centers? They can guide the people. They can also address the vaccine hesitancy because in India we see we see a lot of vaccine hesitancy especially in previous months and now that vaccine shortage is there we see that people are craving for the vaccine but overall people have a lot of questions doubts in their mind and this was also one of the reason for the vaccine wastage in the initial weeks when the vaccinations roll out started in India. So the pharmacists, we have 700,000 pharmacies, community pharmacies in India. Even if we can engage small percentage of it, we can definitely increase the pool of healthcare workers. This will be a new pool for the human resources in health and they can do a great job for the community. Next one. So to minimize the to minimize the waste and maximize the access to medicines or the vaccines we need equitable supply and sustainable practice in India, in Sierra region and across the world everywhere and pharmacies could be part of the solution. So I would really welcome the thoughts from everyone and we would love to work together to create to engage the pharmacists in such public health activities because we are on a mission. Next click please Siddhajan. We are on a mission to one more click to have a word where everyone benefits from access to safe and effective medicines and pharmaceutical care. Thank you Manjiri. Thanks a lot. That was really insightful. Your perspective on importance of pharma workforce during a pandemic and in the long term are really helpful. I would now request Dr. Sameer Naik, QC lead COVID shield from Serum Institute of India to talk about the dynamics of COVID-19 vaccination from a manufacturing perspective during a pandemic in India. Over to you Dr. Naik. Thank you Rajan, Dr. Gaur and Dr. Chaitanya for providing this opportunity to participate in this webinar and to share our views as a manufacturing perspective for the minimizing the vaccine wastage and its privilege and we feel honored to share this platform to share our views and thank you to my fellow panelists who has mentioned many things with respect to vaccine wastage minimization from USP team as well as Dr. Garath who has explained the role of pharmacist. I would just you know share my screen and we'll start the presentation. Of course like I would be very briefly touching from the manufacturing perspective and our views on minimizing the risk of COVID-19 vaccine wastage. Of course like everyone knows what is coronavirus structure. It's an RNA virus and now caused a pandemic across the world. So this is the global scenario as on April 38, 2021 and there are millions of people who are affected across the globe. Several deaths have been reported. Of course like coming to India there's a second wave has been reported in recent time and overall like it's a pandemic and the picture is not so good if you see this particular map which is taken from the WHO dashboard website which is accessible to everyone and can access the progress of the disease and the infection rate across the globe you can see. Well COVID-19 in India from January 3rd, 2020 till April 38, 2021 there are new cases that is approximately 0.3 million new cases has been registered in India and so far there are around 18 million confirmed cases has been recorded with 2 million deaths so sorry 0.2 million deaths in India. And at this point of time looking at the positive side we have two licensed vaccine in Indian market the Covashield and the Covaxin manufactured by Serum Institute and the Bharat Biotech Limited respectively and we are happy to share that as on 26th of April there are total approximately 14 or more than 15 million doses has been administered across the India. Coming to the Serum AstraZeneca vaccine just I'll briefly touch upon this particular aspect the AstraZeneca COVID-19 vaccine is a viral vector vaccine which uses the replication incompetent adenovirus as a carrier to deliver the SARS-CoV-2 spike protein antigen. When we say that it's a replication incompetent so the chimpanzee adenovirus has been modified in such a way that it cannot replicate in the human cell or in the subject in which the vaccine has been administered. This particular adenovirus has been again modified in such a way that it encodes the spike protein which is called as the S gene or the S protein of SARS-CoV-2 virus inserted into the adenovirus genes and it will express the spike protein. So when this particular vaccine is injected in the host cell the virus will infect the host cells the DNA will get expressed along with the host DNA translation and transcription machinery the spike gene inserted in the adenovirus gene will also express and it is presented to the immune system the immune system will react and produce the antibodies and memory T cells against the spike protein of the SARS-CoV genes and more importantly that this will not cause any disease. Of course there are some few post authorization concerns which are relevant to the present discussion that there is a possible variability in the stability and storage conditions for example the cold chain that may or may not be as rigidly maintained as in practice at it was in clinical trial and there are several examples has been given by my USP fellow colleagues in their earlier presentations that there are challenges with respect to the transport, storage, temperature excursion and maintenance of a specific temperature for the COVID vaccines and the challenges for the vaccine which are kept at frozen conditions are having more challenges and even those vaccines which are transported under refrigerated conditions will also face the similar situations especially in the developing countries as well as in the low-income countries where the major challenges faced is the temperature excursion, power failure, power outage and etc and that may lead to a huge vaccine wastage. The second point that we would like to mention is the use of vaccine in different groups of pre-authorization studies and now once the vaccine is in the market you have a large populations where their different medical conditions are not known and of course the third part which has been asked and you know what I would say people you know ask like if I've been vaccinated by suppose Covishield can I take co-vaccine or vice versa or maybe similar situation that may happen in the other part of the world so as on date there is no access any concrete data with vaccine interchangeability is available so that is again a major concern about after post authorization of these vaccines in India. Now coming to the point that preventing the vaccine wastage in the field the major points that we highlighted here is the vaccine storage recommendations are set out by the manufacturer and it is a part of the licensing and authorization conditions. So during authorizations the temperature recommended storage temperature for the vaccine is already been mentioned we have some basic stability study data for the vaccine that has been available and based upon that stability study data a specific recommended storage temperature is assigned and of course like if there is any excursion in the temperature either during storage or transport from the manufacturing side to the pharmacist side or to the immunization side is a challenge and of course it has been greatly discussed in different forums as well as there are several publications are available for the temperature excursion and how to minimize it. The vaccines that have been stored and recommended in the recommended temperature range are outside those conditions so again it is coming to the temperature excursion the apparent failure of the vaccine and the responsibility and the liability for the use will therefore lie with the immunization provider. The third point is that the vaccines that are not stored and transported correctly may need to be disposed of which leads to the increase in vaccine wastage and program cost. So again like one of the issues that we are also being reported by several sites is that because of the temperature excursion in the sites power outage or it may be like you know if there is a multi-dose vial then out of say for example if it is a 10-dose vial or 5-dose vial then either three doses has been consumed eight doses has been consumed seven doses has been consumed and remaining be thrown out because the people did not turn out in that stipulated period of time so that is also leading to the wastage of the vaccine. Then the second point is like adhering to the temperature recommended that will ensure the vaccine are in the optimum conditions for those individuals that are given to. So like most of the vaccines available in India are multi-dose vaccines so what the WHO or multi-dose policy says that the vaccine should be used up to six hours of time or one immunization session whichever is longer but it has to be not more than six hours so the Covishield data has suggested that the Covishield can be used up to six hours at room temperature that is the temperature not more than 25 degree Celsius or even at 2 to 8 degree Celsius. So this is a package of stability study what we called it as in use stability of the Covishield and this is how you can prevent the wastage like there are certain guidelines or recommendation to use the vaccine within say for example few hours after opening of the vial or maybe within four hours after opening of the vials. So it depends on the licensing condition of the each and every each and every vaccine and the nature of a vaccine it's recommended storage temperature and stability would then provide a guidance that up to what temperature and time this particular vaccine can be used in the field as an effective in a effective vaccination program. Another point is that when we started for the Covishield initially like we had very limited stability data and we had a very small shelf life of the vaccine based upon the limited available data but as you know that this vaccine has been rapidly developed across the globe by different manufacturers and as this stability study data is coming up now we have received the nine months of shelf life for Covishield which is licensed in India and this approval came from the Drug Control Governor of India and from initial six months of shelf life now the shelf life has been extended to nine months based upon the real-time stability data and its statistical extrapolation as per the ICH guideline. So this has also prevented a vaccine wastage in a considerable amount. Well thank you that's all from my side and from the manufacturing perspective. Thank you Dr. Naik. Thank you for enlightening us on the challenges of manufacturing vaccine. The production on such massive scale is definitely commendable. Your insights are truly valuable to us and we're honored to have such dedicated minds behind ensuring safety and quality in vaccine manufacturing. Thank you sir. Before we dive into the last session I would like to introduce an invite to the panel Ms. Sirisha Idlapalli Regional General Manager USP. Among her multiple responsibilities she wears many hats and among her multiple responsibilities she heads the government and regulatory engagement internationally and has several years of work experience in pharma and business. Now that we have discussed about the COVID-19 vaccination toolkit and the industry perspective we can discuss some critical questions. So the first question that I have is for Ms. Naikia what are the challenges what do you feel are the challenges faced by the different countries in the implementation of the strategies that you spoke about to minimize vaccine wastage? Over to you Ms. Naikia. Thank you for asking that question. The challenges that we have experienced or have heard about as we've been reaching out to our practitioners have been around information gathering. We've been hearing that it's been a very big challenge getting all of the information needed understanding that different countries are in different stages of the pandemic but the certain regions have shared that their greatest challenge is that lack of knowledge and information around storage handling and transporting specifically around specific vaccines which is similar to what we had struggled with earlier in the US and what our struggle at that time and the struggle we'll have now is gathering that information from the manufacturer from the regulators and aligning that information in a way that we're making sure we're all on the same page of having efficiency and having safety around the practices of the vaccines. Some other challenges that have been provided to us include lack of access and equity which I know we talked a little bit about today lost a follow-up from subsequent doses insufficient infrastructure to store and distribute the vaccines and some inadequate personnel training and staffing along with limited global vaccine supply and poor data quality are some other challenges that we're hearing. Thank you for sharing your insights Ms. Nakia that really covers a lot of ground into the various aspects and nuances that different countries should consider. My next question is to Ms. Diana you know you've shared really you've shared great strategies on open wild and you know unopened wilds and how we can use to minimize vaccine wastage. Practically what resources would be required for the government to put this toolkit into action? It requires a lot of good collaboration and partnerships with the manufacturers and with the healthcare practitioners who are actually on the front lines so this is something that we utilized in creating our vaccine handling toolkit by convening as USP all the important stakeholders including the important government regulatory authorities such as CDC and FDA CBER. Thank you Ms. Diana. Dr. Naik I'll move to you it's for the next question you'd mentioned the MBDP policy of WHO and also the duration for the open wilds. Do you feel there is enough data and evidence for the government to take a decision you know on implementing a policy change on open wild policy for vaccination or do you feel that there are more factors that we need to we still need to consider for the same? Yes the data is available and you know for the open wild policy of course it depends on the government to take a decision on open wild policy and the policymaker would take an appropriate stand on this but as far as the manufacturing perspective is concerned we generally share all our data during our licensing procedure for the in use of the open wild policy. Second challenges that may encounter like you know it is interesting to note from the Diana's presentation that the pre-filled syringes or the pre-use syringes you can have it's an interesting point to note and let's see how you know this particular toolkit being accepted by the regulators across the globe. Of course like the challenge in that particular case that we may foresee is the change in container closure system as the vaccine would be present in different container closure system you know when the vaccine is pre-built from its primary container closure system. However like during delivery it is being in contact with that particular container closure system. Second point that would come is if you keep the syringes ready and in the immunization schedule or immunization session those many number of individuals shall be present as a part of a predetermined schedule. Part two of this particular schedule is that particularly in the developing countries and the low middle countries is the temperature excursion. So that's what we would face and second point that would come is the breach of integrity of the vials when you transfer it from its hermetically sealed container to a syringes because if the vial is been exposed the microbial load is probably increased if it is not kept at proper temperature. Thank you Dr. Naik. Moving to Ms. Manjiri you know you've highlighted the importance of the value add that capability building in pharmacists make can make during a pandemic and during you know large scale vaccination drives. What do you think is a larger impact on healthcare programs of including pharmacists into training and capability building? Yes thanks Rajan. So the world over the pharmacists have shown what different roles they can play and what how is the scope of practice increased and enlarged and expanded and the pharmacists have been working right from the health promotion to the harm reduction and to the medicine use reviews as well as vaccination. So pharmacists along with the doctors and nurses are the pillars on the healthcare system and therefore even in the regions like south station region where the pharmacist role is not yet much upgraded and not yet many public health services are there. We need to enhance this role by increasing the workforce capability by way of early career training by increasing the improving the academic capacity as having the legal framework policies and regulations for the same. When I say that the pharmacist in India have more of a trader image I can also tell you whenever they were motivated trained and their capability was increased by training they have done a great job in a national health program for tuberculosis and they have worked as dots provider. So there is an evidence so when they are motivated mobilized and trained well they can do a great job for the public and that's what is needed today in the world and especially in India. Thank you. Thank you Mr. Menjiri that was really insightful. So now we have you know information moving to the last question and but a very critical one to Ms. Sirisha. You know we have the information on the challenges that different countries have in the implementation of the strategies and we have the resources that are required. We have a sense of what the resources that are required for different governments to implement it. So it seems like we are ready with a lot of information and resources in hand. What additional support do you think USP can provide to the government to implement the policy changes? Sirisha. So we do think the pandemic something like a pandemic this emergency situation requires a very swift policy making policy changing to address immediate need and immediate impact and that sort of a policy change requires a coalition of stakeholders to come together so that they can evaluate evidence and evaluate data and evidence and present that evidence to the right government stakeholders to be able to make those rapid policy changes. So USP has been working on this. We have been supporting evaluation of data and evidence so that we can work with the right stakeholders to present the evidence and bring about those policy changes both for COVID prevention as well as for treatments globally. Thank you. Thank you Sirisha. I completely agree implementing policy changes at a rapid quickly and swiftly requires a lot of consulting requires expert consultation coordination and USP certainly is very well equipped for the same. All right that brings us to the end of the panel discussion and the workshop. I thank all the panel members for participating and sharing their profound knowledge. Your insights would definitely help in minimizing vaccine wastage and bringing us a step closer to moving us out of the pandemic. Thank you so much. For the attendees who are watching this on a recorded recording, please feel free to drop your questions and inquiries to us over email or on social media. We'll try our best to address the same. Thank you everyone. Good day and good evening to all and stay safe.