"Remedial" measures
The requirements for ultra-low temperatures have to some extent stolen the vaccine's "limelight", but also for this reason, the recent Pfizer in the vaccine research and development at the same time, but also did not forget to put out some transportation news one after another.
Nov. 19, according to Surfing News, the Pfizer vaccine is stored at minus 70 degrees Celsius. November 19, according to surging news, Pfizer mentioned that the company is developing a freeze-dried preparation, which is expected to remain stable under normal refrigeration. Depending on technical success and regulatory approval, the lyophilized formulation is expected to be available in the first quarter of 2022.
And just two days ago, Pfizer CEO Albert Bulla mentioned that Pfizer had developed a special "isothermal box" with an internal thermometer and GPS that could track not only where the box was at each point in time, but also what the temperature was to make sure that it was not higher or lower than the specification. In its response to the Beijing Business News reporter, Pfizer also mentioned that its specially designed temperature-controlled carriers using dry ice can keep the vaccine stored at -70°C ± 10°C for up to 10 days, which is exactly what Pfizer has done for its vaccines during transportation. Subsequently it will need to be stored by other countries or regions in their own way.
Pfizer, which has frequently made efforts in transportation, was not unexpected. on Nov. 9, Pfizer announced that its mRNA New Crown vaccine, developed with Germany's BioNTech, showed effectiveness of more than 90 percent in a phase III clinical trial, which was a stone's throw from a thousand waves. And that became the beginning of a round of global outbreaks in the new crown vaccine track, shortly followed by an announcement from Russia's health ministry that a new crown vaccine developed in that country was more than 90% effective.
After that came another "big brother" of the new crown vaccine track, Moderna announced on Nov. 16 that its new crown vaccine had achieved a 94.5 percent protection rate in a Phase III clinical study, a bit higher than Pfizer's shocking 90 percent effectiveness. Two days later, the "battle" escalated again when Pfizer and BioTech jointly announced that an efficacy analysis of the ongoing Phase III clinical trial of the new Crown pneumonia vaccine candidate showed that the vaccine met all primary efficacy endpoints, with a vaccine efficacy rate of 95%. The companies plan to file an emergency use authorization application with the U.S. Food and Drug Administration (FDA) within days.
Clearly, effectiveness has become a key metric in the global vaccine race. But it should be added that the other side of the effectiveness coin, concerns about the transportation of the new crown vaccine, have also begun to grow by the day. That starts with Pfizer, which, thanks to the latest mRNA technology, needs to keep its vaccines at temperatures below minus 70 degrees Celsius, which exceeds the need for cold-chain security under realistic conditions in many countries. Moderna's vaccine is a bit stronger by comparison, with its ability to be stored at a regulated chilling temperature of 2-8°C for 30 days, and hopefully for up to six months at a regulated freezing temperature of -20°C.
The Transportation Conundrum
Professor Toby Peters of the University of Birmingham in the UK has cited the fact that most vaccines are stored at 2-8°C, and that Pfizer's new crown vaccine candidate's stringent temperature requirements will limit its mass distribution. Pfizer, which has the most stringent low-temperature requirements, had to do something about it. On the 17th of this month, Pfizer then launched a pilot delivery program for the New Crown mRNA vaccine in four U.S. states so that states can better plan, deploy and manage to address the challenges of their vaccine's supercooled storage requirements. "We hope that the results of this vaccine delivery program will provide a template for other U.S. states and international governments as they prepare to implement effective neocoronavirus vaccine programs." So said Pfizer in a statement.
Together with the lyophilized formulation and the "isothermal cartridges" that utilize dry ice, it's clear that Pfizer is determined to pave the way for its vaccine, except that things may not be going as smoothly as Pfizer would like during the shipping process. Liu Kuikui, an international air freight consultant, said the two key unknowns about vaccines that now make logistics planning difficult are the type of packaging that will be used and how much dry ice will be needed.
"The package size will affect the amount of product that can be put into a reefer or shipping container, and the lack of data on vaccine dosage, vial type and package type by drugmakers in the air logistics makes it difficult to plan the right aircraft, warehouses, refrigeration equipment and staff for the job." Liu Kuikui added that some vaccines ultimately approved for use may require more dry ice to stay frozen during transportation, and that hazardous materials regulations strictly limit how much dry ice can be carried on planes.
Economist Ding Meng also mentioned that when it comes to transporting vaccines like the Pfizer vaccine, the main thing to face is the bottleneck of low-temperature storage equipment, which also extends to long-distance low-temperature transportation equipment. However, from the current situation in Europe and the United States, the production and subsequent storage and distribution in the above countries is not difficult, the greater difficulty lies in the distribution of production. But for other countries to face is the share of production and get a share of how to transport and storage of the double difficulties. In some less developed countries, for example, the problem is even greater.
It is known that in some countries, 30-40 percent of medical centers do not even have access to basic electricity, and in others, less than 10 percent of medical centers may have refrigerators. This also means that it may be difficult to keep this vaccine, which has strict requirements for ultra-low temperatures, for a long time. Pfizer's vaccines are known to last up to six months in an ultra-low-temperature freezer, but only five days in regular refrigeration at 2-8 degrees Celsius.
"Mission of the Century"
The test of cold-chain logistics brought about by the need for ultra-low temperatures has led to concerns about Pfizer's vaccines beginning to skyrocket. However, CNN 17 reported that Bulla said he had "zero concerns" about the cold chain requirements associated with Pfizer's new Crown vaccine. And in a response to Beijing Business News, Pfizer also mentioned that they have extensive experience in distributing vaccines globally, and are therefore confident in manufacturing and distributing large quantities of the New Crown vaccine.
In contrast, Tao Liner, a former senior vaccine expert at Shanghai's CDC, is less optimistic about Pfizer's vaccines, which require ultra-low-temperature shipping conditions. According to Tao Li Na, Moderna's vaccine can be stored stably at 2-8 degrees Celsius for 30 days, compared to Pfizer's vaccine, which can only be stored for five days and can only be "scrapped" if not injected in a timely manner. Who would want to use self-funded vaccines in foreign countries if they are wasted at the expense of the vaccination organization? If Pfizer doesn't come out with a version that's close to Moderna, or a version that's stored at 2-8 degrees Celsius, then Pfizer is in danger of having to buy $10,000 or so in ultra-low-temperature refrigeration equipment to use their vaccine.
And in Taurina's view, vaccines that require ultra-low-temperature refrigeration are inherently counterintuitive. Tao Li Na explained that previously only the live oral polio vaccine needs to be stored at minus 20 degrees Celsius, but the vaccine is also due to the obvious shortcomings so the application is less and less, thus switching to inactivated vaccines, which require temperatures of 2-8 degrees Celsius is the normal. From this point of view, the world's overall vaccine outlook is to 2-8 ℃ development, very few vaccines need to be frozen. It is understood that, in general, active vaccines can be stored at 37 degrees Celsius for seven days, and at 2-8 degrees Celsius for about two years.
It is worth noting that there are three routes for vaccines entering phase III clinical trials in China, including inactivated vaccines, adenovirus vector vaccines and recombinant protein vaccines, with the inactivated vaccine only one step away from success. And all three vaccines require only 2-8℃ storage conditions, which means the existing vaccine cold chain can fulfill.
But regardless of whether ultra-low temperatures will become a barrier to limiting vaccine transportation, right now, at the critical juncture of the vaccine's imminent introduction, capacity must keep up. Just a few days ago, the International Air Transport Association (IATA) issued guidance to ensure that air cargo is ready for the large-scale handling, transportation, and distribution of the new CAPV vaccine. "Efficiently transporting and storing billions of doses of deep-frozen vaccine around the world will present extremely complex transportation challenges throughout the supply chain." So said Alexandre de Juniac, chairman and CEO of the International Air Transport Association (IATA).
Previously, IATA's General Manager, Membership and External Relations, North Asia, Guoxian Cai, had revealed that "at one dose of vaccine for each of the world's 7.8 billion people, it would take 8,000 fully loaded Boeing 747 freighter flights of capacity to meet it." That's why Juniak called it the "Mission of the Century", and in his view, the time has come for the global air cargo industry to plan carefully to ensure the safe transportation of vaccines. Governments need to take the lead in promoting cooperation across the logistics chain to ensure that facilities, security, and border control processes are smooth and ready for the difficult and complex distribution tasks ahead.