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Researchers tell us that resistance to the spread of COVID-19 may not happen until we achieve herd immunity, which requires vaccination for at least 70 percent of humankind. That’s about 5.5 billion people, a mass inoculation effort on a scale the human race has never before attempted.
To illustrate the magnitude of this effort, 5.5 billion packaged vaccine doses lined up end to end would stretch nearly 240,000 miles — about 10 times around the world. In pharmaceutical supply chains, this would require 569,000 pallets of vaccines. Side by side, these would stretch 430 miles — roughly from New York City to Cleveland.
Like all vaccines, those needed to prevent COVID-19 will be temperature and time sensitive. They’ll need carefully controlled cold storage, some at temperature ranges between -80 and -20 degrees Celsius and others between 2 and 8 degrees Celsius.
Cold chain and storage cooler capacity will need scaling to handle the new vaccines, and so will temperature-controlled transport and passive packaging.
The task of making a SARS-CoV-2 vaccine available globally has many daunting aspects but none more challenging than distribution. Consider the following:
Let’s face a hard truth: Our pharmaceutical cold chains at this time do not have the equipment and scale to comprehensively deliver a temperature-sensitive vaccine for the COVID-19 pandemic.
It’s clearly time for companies and countries to rethink distribution strategies and cold chain investments.
Government resources, including grants, fuel the process of bringing a vaccine into use today. Even so, it traditionally takes 10 to 20 years to develop a safe, effective vaccine. Our new global pandemic, however, has forced the world to move faster.
For COVID-19, the first vaccine candidate (mRNA-1273) entered clinical trials only nine weeks after sequencing of the virus’s genome — and less than four months after the first officially diagnosed cases in China. In July, a Phase 1 trial of mRNA-1273 in the United States showed promising results. So did a trial of a second vaccine candidate, ChAdOx1, developed by researchers at Oxford University.
At the time of this writing, there were more than 95 vaccines in development, according to therapeutics and medical technology news service BioWorld. Assuming a 10-percent success rate, eight or nine vaccines could be ready by early next year.
The World Health Organization is aiming to deliver 2 billion doses of effective vaccines in 2021. Imagine 2 billion doses added to our cold chains in one year. That’s a staggering challenge to existing supply chains. Consider also that researchers say SARS-CoV-2 vaccines now showing early positive results may require two doses for effectiveness, doubling the supply chain challenge.
Companies that make investments now in a scalable global vaccine cold chain will soon look visionary. That’s because they’ll have capacity after the swell of SARS-CoV-2 vaccines to handle a rising tide of new vaccines and biologics introduced by pharma and bio-pharma.
These new drugs are the combatants of choice against our fastest-growing illnesses — cancer, respiratory diseases, heart disease, diabetes and others. Linked to health villains like fast food, sedentary lifestyles and air pollution, we can now diagnose such diseases early and manage them with new biologics, almost like chronic conditions. Patients can live 40 years with ailments that killed our ancestors in 40 days.
In fact, biologics will soon represent nearly half of all global pharmaceutical sales. And just like influenza and potential SARS-CoV-2 vaccines, these temperature- and time-sensitive biologics will require absolutely precise storage and shipping conditions.
Three key trends will emerge in logistics and distribution to meet the challenges of safely distributing a flood of temperature-sensitive vaccines, starting with COVID-19:
Sterile manufacturers and distributors will share temperature-sensitive storage and transportation assets, quality systems and expertise to minimize excess capacity in the cold supply chain. Many different organizations will collaborate, delivering supply chain efficiencies by sharing freezers, coolers and reefers.
Vaccines will move more directly to point of care, meaning faster administration. A shorter supply chain also means fewer handoffs among logistics providers and fewer temperature excursions. Fewer excursions mean more effective vaccines and a better defense against a virus.
The safe distribution of potential SARS-CoV-2 vaccines, seasonal flu vaccines and the growing number of biologics in general will, as explained earlier, stress our manufacturing and distribution capacity. Better collaboration must occur as organizations conduct more frequent self-assessments and provide improved transparency on processes and controls governed by their quality systems.
In cold chain logistics, the future belongs to the bold. Is it time to go big?
Don’t worry about overcapacity — it won’t be like building a church just for Easter Sunday.
We’re entering the Age of Biologics, and pharma companies will rush more and more specialty drugs to market for years to come.
The customized storage facilities and specialized supply chains that deliver them will save lives … and prove a long-term competitive business advantage.
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