On December 18, the FDA determined that Moderna’s vaccine met the statutory criteria for issuance of an emergency use authorization (EUA), thereby permitting vaccine distribution across the U.S. Here’s the complete story.
The Food and Drug Administration, on Friday, issuedOpens a new window an emergency use authorization (EUA) for Moderna’s COVID-19 vaccine. The FDA determined that the vaccine met the statutory criteria for issuance of an EUA, thereby permitting vaccine distribution across the U.S.
Moderna plansOpens a new window to deliver about 20 million doses in the U.S by the end of December 2020. The allocation and distribution of the vaccine in the U.S. will be managed by Operation Warp Speed, the Department of Defense (DoD), in partnership with the Department of Health and Human Services (HHS) and the U.S. Centers for Disease Control and Prevention (CDC). The Operation Warp Speed officials said that the vaccine will be delivered to about 3,285 locations in the U.S.
The authorization of the Moderna vaccine at such a critical juncture of the pandemic will promote the shipment of immunization to rural communities and nursing homes, according to Army Gen. Gustave Perna, COO of Operation Warp Speed. He further added that the manufacturing of the Moderna vaccine is slated to take place in the U.S.Â
“Because of the planning and what was available, we were able to send out more Moderna on the first dose than we were able to send out on Pfizer — almost double,†Perna said.
In a press conference held on December 16, Alex M. Azar, health and human services secretary, saidOpens a new window that the Army Corps of Engineers has worked with Moderna to increase the company’s manufacturing capacity for the vaccine to ensure that the vaccine demands are met.
Moderna’s Vaccine Distribution Vs. Pfizer Vaccine Distribution
Moderna’s vaccine distribution comes at the backdrop of Pfizer vaccine distribution, which began last week. On December 12, the packing was done, followed by vaccine relocation on December 13, and finally, the first vaccine was delivered on December 14.
“Now we’re starting our drumbeat of continuous execution of vaccine,†Perna saidOpens a new window in a press conference on December 14, 2020.
According to Perna, the distribution of Moderna’s vaccine will be similar to Pfizer’s. It will “hit initial sites on Monday, follow on Tuesday and Wednesday, and then by the end of the week, we’re just in a routine cadence of execution.â€
However, the distribution protocols opted by Moderna will be unlike Pfizer, as it will work through McKesson for distribution rather than going directly from manufacturing sites to immunization locations using FedEx and UPS. Thus, the vaccines will be initially taken from Moderna’s manufacturing facilities to McKesson distribution centers, and then the filled and finished products will be packed, and the addresses of the final delivery location will be added. The final delivery duties will be undertaken by FedEx and UPS.
The primary point of differentiation between the manufacturers’ vaccines and Moderna’s vaccines is the temperature requirements. Moderna’s product presents fewer cold chain hurdles than Pfizer’s. According to Perna, the distribution of vaccines will take a break on Friday, i.e., Christmas Day, following which, the packing will immediately resume (on Sunday).
6 Lessons Supply Chains Should Remember When Distributing Vaccines
A vaccine supply chain involves manufacturing, packing, transportation, delivering, and intrinsic processes associated with them. It is a complex system to deliver vaccines to people who need them from places where they are manufactured.
In addition to this, the vaccine supply chain is generally called cold chain as the vaccines being transported need to stay refrigerated or frozen throughout the delivery process. Maintaining the necessary conducive environment is of paramount importance in the vaccine supply chain as most vaccines consist of perishable materials that don’t last long at room temperature.Â
Moderna expects its mRNA vaccine to stay stable at normal fridge temperatures of 2 to 8 degrees Celsius (36 to 48°F) for 30 days and can be stored for up to six months at -20C. However, Pfizer’s vaccine must be stored at -70C, the sort of temperature observed in Antarctica during winters. For such extreme vaccine demands, ‘deep freeze’ supply chains may also be necessary.
Considering the complexity and sensitivity of vaccine distribution, supply chains need to consider the following pointers to ensure smooth and seamless vaccine delivery.
1. Coordinate the Packaging With the Operations
Even small changes in the vaccine container or packaging size, and the number of doses per container, can considerably alter vaccine supply chain operations. If we dig a bit deeper into vaccine distribution history, then we might as well recollect the rotavirus vaccine event.Â
In 2006 and 2007, the introduction of the rotavirus vaccine in Latin America was disrupted as the vaccine packing was too large to handle and occupied too much space in refrigerators and cold transport devices. The issue blocked the supply chain for this vaccine and, at the same time, obstructed the flow of other products. This forced manufacturers to redesign the vaccine packaging, thereby leading to delays and missed opportunities to alleviate suffering and deaths due to the virus.
Manufacturers are free to design vaccine containers and packaging based on the production needs and what suits their assembly lines. However, they must also consider how packaging may impact the overall supply chain operations.
2. Monitor the Dosing Schedule Closely
Supply chain operations and designs are greatly affected by the number of vaccine doses needed per person. It seems highly likely that the COVID-19 vaccination may require two doses per person and may be administered on two separate occasions. This doubles the vaccine count to be delivered.Â
This may further get complicated in cases where more than one vaccine is available in the market, and the first dose of the first vaccine may be different from the first dose of the second one. This calls for an integrated information system that can keep track of who has received the first dose of which vaccine and when they need to be reached for a second dose of the appropriate vaccine
3. Strategize for Different Vaccines, Production Schedules, and Intended Target Populations
Multiple COVID-19 vaccines are reaching the market, such as one each from Pfizer and Moderna. Each vaccine may have its own attributes such as efficacy, side effects, dosing, storage requirements, and costs. Besides, different vaccines could have a different set of the target population. Moreover, each vaccine will probably be produced in different stages, waves, or time periods in general.Â
Understanding this dynamic nature of different vaccine deployments, the supply chain will require substantial coordination. Plans are bound to change, and adapting to this changing timeline can largely benefit the supply chain, as was evident in 2009 when the production schedules for the H1N1 flu vaccines changed from week to week. As a result, continuous updating of models was essential for the supply chains to account for delays in vaccine availability.
The shifting timelines are already apparent with Covid-19 vaccine distribution in the U.S. — even before the rollout starts in the coming days.
The timeline for Covid-19 vaccine distribution keeps slipping. Experts say it will change again— STAT (@statnews) December 12, 2020Opens a new window
4. Plan for COVID-19 Vaccine Accessory Supply Chain
Vaccine shots to be given on the recipients’ arms require different accessories such as syringes, needles, alcohol swabs, rubber gloves, and other personal protective equipment (PPE). These accessories ensure that the personnel administering the vaccine is protected from the infection while performing the act.
As we’ve already witnessed, the shortages of cotton swabs affected COVID-19 testing. Thus, missing one or more of these components can affect vaccination rates, and the vaccine supply chain needs to be mindful of it. Therefore, it is recommended that each of these products or accessories are either a part of the COVID-19 vaccine supply chain or in supply chains that are coordinated with other supply chains. This will guarantee that all necessary products are in stock all the time.
5. Ensure That the Supply Chain Is Adaptive
The design and operations of different parts of the supply chain must be tailored to different circumstances and needs. Supply chains can’t ignore populations that are too difficult or too costly to reach, such as people living far away from traditional vaccination facilities or locations. Instead, supply chains must adapt according to changing circumstances and reach out to those living in lower-income neighborhoods or distant rural locations.
6. Ensure Transparency and Communication Across Contributing Parties
Supply chain’s success depends on transparency and communication between different parties, as everyone involved needs to know what the plans are to coordinate accordingly. Right from healthcare personnel to professionals working across all nodes of the supply chain must know when they need to be available and how to handle different scenarios.Â
At the same time, people wanting to get vaccinated must know where to go and when. Otherwise, long lines, stock-outs, and unfulfilled demand can create chaos. Besides, vaccination sites and storage locations need to coordinate if circumstances change and policies need to be altered. Consider, for example, a vaccination location runs out of vaccines. It needs to immediately communicate with the other nearby vaccination sites so that the surplus vaccines from the other sites are sent to the out-of-stock site in time.
In Conclusion
The success of vaccines depends not only on the efficacy of the vaccines but also on whether they are actually delivered to everyone in need. As history has shown, vaccine supply chains are far more complex than what they seem from the outside.
While Moderna’s rollout of the COVID-19 vaccine comes as good news to humanity, however at the same time, supply chains need to be wary of the fact that COVID-19 vaccine release may as well affect the delivery of other vaccines. Although COVID-19 has emerged as an unknown enemy, the other infectious diseases haven’t stopped being threats just as yet. Therefore, there is still a need to continue giving routine vaccines like shots for other diseases like measles, seasonal flu (influenza), to name a few. Supply chain players must take care that not all existing refrigerators, freezers, and transport vehicles can be co-opted by the COVID-19 vaccines. The delivery of other vaccines is of equal importance for everyone’s well-being.
Do you think that the current supply chain facilities will be able to manage Moderna’s rollout of the COVID-19 vaccine? Comment below or let us know on LinkedInOpens a new window , TwitterOpens a new window , or FacebookOpens a new window . We’d love to hear from you!