Submitted by Devendra Mishra, Executive Director, BSMA (9/3/2020)
Winning the war on the Coronavirus pandemic with the immunization of people across the globe is as daunting a task as the Apollo Mission was five decades ago. The Apollo 11 Moonshot which landed the first human on the moon in 1968 was an exceptional collaboration between the government, the public sector, academia and research institutions. Today after six million people have been tragically infected by COVID-19 and 180,000 human live lost in the USA, science is on the verge of producing vaccines which will help control the pandemic. More than 20 vaccine candidates are in human testing and another 150 in development, according to the World Health Organization. Among the first vaccine candidates to start the final round of clinical testing are the products of the University of Oxford and AstraZeneca, Pfizer partnering with BioNTech, and Moderna. A vaccine from a Chinese company, CanSino Biologics, is expected to begin the pivotal testing soon and two are in the 3rd phase of clinical trials in India.
The agencies that will decide whether a vaccine is ready and who gets it first are the Food and Drug Administration and the U.S. Centers for Disease Control and Prevention. The optimistic goal of having vaccines before the end of the year does not leave adequate time to have scalable manufacturing and end-to-end distribution network in place. The disruptions encountered in the delivery of PPE and medical supplies at the outset of the pandemic are a rude reminder that vaccine supply chains required will be exponentially more complex. The industries that will enable the transportation of goods around the world on ships, planes and trucks acknowledge that they are n0t ready to handle the challenges of shipping approved vaccines from drug makers to billions of people.
The challenge of immunizing the world population in the shortest timeframe is comparable Mission Impossible. Like the Moonshot, a massive government planning and coordination effort, at both the federal and state levels, is needed for rapid manufacturing, financing, distribution, and administration of COVID-19 vaccines. Saving millions of lives and livelihoods and restoration of a normal way of life are at stake in an environment of scarce supply, transportation capacity and technological capability in the supply chain.
Operation Warp Speed (OWS), established by the US Government, is accelerating the development of COVID-19 vaccines. This program coordinates the component agencies of the Department of Health and Human Services (HHS), the Department of Defense, private industry, and other federal agencies for the development, manufacturing, and distribution of COVID-19 vaccines. OWS initially selected the Moderna (RNA), Pfizer (RNA), Johnson & Johnson (nonreplicating vector), and Oxford/AstraZeneca (nonreplicating vector) vaccines for federal support. Recently, OWS selected the Novavax (protein) vaccine as well. The federal government has tapped drug wholesaler McKesson Corp. to manage distribution of coronavirus vaccines to hospitals, clinics and other sites in the USA.
Vaccines do not save lives, vaccinations do. Fortunately, we have learned how highly lethal influenza virus, polio, measles, and other viral outbreaks have been brought under control or effectively eliminated. History has proven the power of vaccines. Thanks to national governments and the work of UNICEF, Gavi, Médecins Sans Frontières, the World Health Organization, and the Bill & Melinda Gates Foundation, immunization against potential pandemics have reached more than 80% of children worldwide and saved 2 million to 3 million lives annually. It is reported that to win the fight, we need to immunize 60% to 70% of all individuals. This will not only require massive manufacturing and logistic capabilities but also adequate capacity and placement of cold-chain systems.
VACCINE STABILITY: THE ACHILLES’ HEEL OF DISTRIBUTION OF VACCINES
Drug makers with vaccines in final-stage clinical trials expect their products to require strict temperature controls. Moderna expects its vaccine to require minus 20 degrees Celsius storage. Pfizer has stated the vaccine it is developing with German partner BioNTech SE will probably have to be stored at minus 70 degrees Celsius, plus or minus 10 degrees. AstraZeneca PLC expects the vaccine it is developing with University of Oxford researchers to require refrigeration.
In the Clinical Trials Phase, the biopharma companies are bringing in best possible science while simultaneously shifting their attention to manufacturing and distribution of the vaccine. Logistics operations around Covid-19 vaccine are predicted to be time-and temperature-sensitive and tremendously reliant on air cargo. As these unique manufacturing initiatives see adoption around the world, supply chain service companies are placing air cargo right in the center of logistics operation. It is also anticipated that the storage, distribution and handling requirements of these vaccines will make it very difficult for community clinics and local pharmacies to store and administer. Administration of immunization may require centralized sites with adequate equipment and high throughput.
A STATE OF DISTRIBUTION PREPAREDNESS
Drug makers have been racing to build secure supply chains for their coronavirus vaccine candidates, finding manufacturing sites and ordering specialized production equipment. The distribution operation, taking vaccines from far-flung manufacturing sites to medical sites via warehouses, cargo terminals, airports and final storage points, all in a matter of days, represents an onerous logistics high-wire act. Shipping companies are preparing in advance of receiving vaccine information from manufacturers and the U.S. government.
Distribution of vaccines is a formidable challenge for there are numerous transfer points from manufacturing to immunization sites. Vaccines, travelling by truck and airplane, with stops and storage at the distributor before arriving at the terminal point, will once again go into cold storage. The last mile to the healthcare provider could be a van or a bike delivery to a medical center. It has been reported that a quarter of vaccines are degraded by the time they arrive at their destination, due to incorrect shipping procedures, according to the International Air Transport Association’s Center of Excellence for Independent Validators in Pharmaceutical Logistics. And 20% of temperature-sensitive biopharmaceutical products, including plasma, are damaged during cold chain transport.
Companies producing temperature-controlled containers for air cargo, like Envirotainer, SkyCell, va-Q-tec, DoKasch and others are gearing up for this logistics operation because of their involvement in the clinical trials of vaccines. The Covid-19 outbreak has gravely impacted the air cargo capacity because nationwide lockdowns have forced many airlines to ground their passenger aircraft, leading to serious crunch in the cargo capacity in the bellies of these passenger planes. In May 2020, belly capacity for international air cargo shrank by 66.4 percent according to data for global air freight markets released by International Air Transport Association (IATA).
UPS is lining up rows of freezer units, packed together in what the company calls freezer farms, for vaccines requiring minus 80 degrees Celsius in Louisville, Ky., and Venlo in the Netherlands, near the delivery giant’s global air hubs. UPS expects certain vaccines to require minus 80 degrees, but the freezer units, which can each hold up to 48,000 vials of vaccines, can be dialed down to minus 85 degrees and up to minus 20 degrees if temperature requirements for vaccines change. After taking delivery of frozen vaccine vials packaged in large trays, UPS expects to thaw them and then rearrange them in separate trays so that multiple smaller shipments can be sent on to their destinations.
Lufthansa Cargo, the freight arm of Deutsche Lufthansa AG, sped up construction of two pharmaceutical storage facilities, at Chicago’s O’Hare International Airport and Munich Airport, in part to be ready for a vaccine. A working group of European airlines, Air France, KLM and Martinair Cargo have formed a task force to work with pharmaceutical suppliers on requirements for shipping Covid-19 vaccines.
DIGITAL TRACKING OF VACCINE
COVID-19 has brought an onerous degree of fragility to the supply chain, with billions of vaccine doses needed which are fundamentally cold chain products. Digital technology will be required to manage distribution once the products leave the factory, with sensors placed on every pallet, case or unit on the production floor to be tracked through their journey to the healthcare facility. The current practice of not tracking vaccines by dose because of their low cost may have to change with vaccines of a higher cost. Tracking with IoT sensors will help identify weak links along the supply chain, keeping in mind that more than 50% of the temperature excursions occur during airline and airport handling, according to IATA. Blockchain and cloud services with sensors can provide the real-time visibility required.
THE FINAL IMMUNIZATION CHALLENGE
If private industry is unable to rise to the delivery task, one option is government intervention. In the U.S., for instance, the Pentagon can call on commercial airlines contracted as part of the Civil Reserve Air Fleet, a program established in 1951 after the Berlin airlift, to invoke in peacetime for national security reasons.
History has also shown us that a vaccine is not a panacea. Its delivery will be the beginning of a long war against a virus that has spread at a breakneck speed across more than 150 countries. To win the fight, it is believed that 60% to 70% of all individuals will have to be immunized. A major concern brewing is the growing opposition to immunization in general. Public confidence in effectiveness and delivery of COVID-19 vaccines must be established to win the battle against the pandemic. Educating the public about how vaccines will work and their efficacy will be a media challenge.
0 Comments