Global vaccine is at stake, will cold chain transportation be a big trouble?

In COVID-19, a global epidemic, vaccines have become the last "light of hope". Fortunately, after waiting, the vaccine research and development has finally made substantial progress, 90%, 94.5% and 95%. In this global competition, COVID-19 vaccine is finally out of reach. But now, the new question seems to come again: after the vaccine has gone through all kinds of hardships, will the requirement of ultra-low temperature cold chain transportation become another obstacle to the global spread of the vaccine? In particular, the storage conditions of Pfizer vaccine at MINUS 70℃ are even more worrying, although Pfizer has tried every means to deal with it.

"Remedial" measures

The requirement of ultra-low temperature has robbed the vaccine of the limelight to some extent. So recently, Pfizer released some transportation news while developing vaccines. 165438+1October 19, according to the paper, Pfizer mentioned that the company is developing a freeze-dried preparation, which is expected to remain stable under normal refrigeration conditions. According to the technical success and the approval of regulations, it is expected that the freeze-dried preparation will be listed in the first quarter of 2022.

Two days ago, Burla, CEO of Pfizer, just mentioned that Pfizer has developed a special "isothermal box" with a thermometer and GPS, which can not only track the position of the box at each time point, but also track the temperature to ensure that its temperature is not higher or lower than the specification. In the reply to beijing business today Today reporter, Pfizer also mentioned that its specially designed carrier using dry ice to control the temperature can keep the vaccine at -70℃ 10℃ for as long as 10 days, which is exactly what Pfizer did for its vaccine during transportation. In the future, other countries or regions need to preserve it in their own way.

Pfizer, which has made frequent efforts in transportation, is not surprised. 165438+1On October 9th, Pfizer announced that its mRNA COVID-19 vaccine developed in cooperation with German BioNTech Company showed an effective rate of more than 90% in phase III clinical trials, which caused a thousand waves with one stone. This has also become the beginning of this round of global COVID-19 vaccine tour. Soon after, the Russian Ministry of Health also announced that the effective rate of COVID-19 vaccine developed in this country exceeded 90%.

Then, another "big boss" appeared in the field of vaccines in COVID-19. In June 165438+1October16, Moderna announced that the protection rate of its COVID-19 vaccine in phase III clinical research was 94.5%, which was higher than Pfizer's shocking 90% effective rate. Two days later, the "war situation" was upgraded again. Pfizer and Biotechnology Co., Ltd. jointly announced that the efficacy analysis of the third phase clinical trial of COVID-19 candidate vaccine shows that the vaccine has reached all the main efficacy endpoints, and the effective rate of the vaccine has reached 95%. The two companies plan to apply to the US Food and Drug Administration (FDA) for emergency use authorization within a few days.

Obviously, effectiveness has become a key indicator of global vaccine competition. But what needs to be added is that, on the other hand, concerns about vaccine transportation in COVID-19 are also increasing. This should start with Pfizer. Due to the latest mRNA technology, Pfizer vaccine needs to be kept below-70℃ at low temperature, which exceeds the cold chain guarantee requirements of many countries. In contrast, the vaccine of Moderna is stronger, which can be stored for 30 days at the standard refrigeration temperature of 2-8℃ and is expected to be stored for up to 6 months at the standard refrigeration temperature of -20℃.

Transportation problem

Professor Toby Peters of Birmingham University in the United Kingdom once mentioned that the storage temperature of most vaccines is 2-8℃, and Pfizer's strict temperature requirements for COVID-19 vaccine candidates will limit their large-scale distribution. Pfizer, which has the highest requirement for low temperature, must do something. 17 In June, Pfizer launched the pilot delivery project of COVID-19 mRNA vaccine in four states in the United States, so that the states can better plan, deploy and manage, and solve the challenge of their vaccine cryopreservation requirements. "We hope that the results of this vaccine delivery project will provide a template for other US States and international governments to prepare for the implementation of effective COVID-19 vaccine projects." Pfizer said this in a statement.

Coupled with the freeze-dried preparation and the "isothermal box" using dry ice, we can see Pfizer's determination to pave the way for its vaccine, but the transportation process may not be as smooth as Pfizer imagined. Liu Kuikui, an international air transport consultant, mentioned that two key unknown factors that make vaccine logistics planning difficult now are the type of packaging to be used and how much dry ice is needed.

"The size of the package will affect the number of products that can be put into the refrigerator or transport container. In air logistics, pharmaceutical manufacturers lack data on vaccine dosage, bottle type and packaging type, so it is difficult to plan suitable aircraft, warehouses, refrigeration equipment and staff for this work. " Liu Kuikui added that some vaccines that are finally approved for use may need more dry ice to keep frozen during transportation, and dangerous goods regulations strictly limit how much dry ice can be carried on the plane.

Economist Ding Meng also mentioned that when transporting vaccines such as Pfizer vaccine, the main problem is the bottleneck of low-temperature storage equipment, which will also extend to the bottleneck of long-distance low-temperature transportation equipment. However, judging from the current situation of European and American countries, the production and subsequent warehousing and distribution in these countries are not difficult, and the greater difficulty lies in the production and distribution. For other countries, they have to face the dual difficulties of production share and how to transport and store after obtaining the share. For example, in some underdeveloped countries, this problem will be even greater.

It is understood that in some countries, 30%-40% of medical centers can't even meet the basic power supply. In some countries, less than 10% of medical centers may be equipped with refrigerators. This also means that this vaccine with strict requirements for ultra-low temperature may be difficult to preserve for a long time. It is understood that Pfizer's vaccine can be stored for 6 months in ultra-low temperature freezer, but it can only be stored for 5 days under ordinary refrigeration conditions of 2-8℃.

"mission of the century"

Due to the cold chain logistics test brought by ultra-low temperature demand, the attention to Pfizer vaccine has also started to rise linearly. However, CNN reported on June 17 that Burla said that he had "zero concerns" about the cold chain requirements related to Pfizer's COVID-19 vaccine. Pfizer also mentioned in its reply to the reporter of beijing business today Today that they have rich experience in distributing vaccines around the world, so they are confident in manufacturing and distributing a large number of COVID-19 vaccines.

In contrast, Tao Lina, a former senior vaccine expert at Shanghai CDC, is not so optimistic about vaccines that need ultra-low temperature transportation conditions, such as Pfizer. Tao Lina said that Moderna vaccine can be stored stably for 30 days at 2-8 degrees Celsius. Comparatively speaking, Pfizer vaccine can only be stored for 5 days, and if it cannot be injected in time, it can only be "scrapped". If the waste of foreign self-funded vaccines is also borne by vaccination agencies, who will be willing to adopt this vaccine? If Pfizer does not release a version close to Moderna or a version stored at 2-8℃, it will be very dangerous. After all, using their vaccine means buying about $654.38+0 million of ultra-low temperature refrigeration equipment.

In Tao Lina's view, the vaccine that needs ultra-low temperature refrigeration itself is against the trend. Tao Lina explained that in the past, only oral polio live vaccine needed to be stored at MINUS 20℃, but the vaccine was used less and less because of its obvious shortcomings, so it was switched to inactivated vaccine, which required a normal temperature of 2-8℃. From this point of view, the international prospect of the whole vaccine is to develop to 2-8℃, and few vaccines need to be frozen. It is understood that under normal circumstances, active vaccines can be stored for 7 days at 37 degrees Celsius and for about 2 years at 2-8 degrees Celsius.

It is worth noting that there are three routes for China to enter the third phase of clinical trials, including inactivated vaccine, adenovirus vector vaccine and recombinant protein vaccine, in which inactivated vaccine is only one step away from success. All three vaccines only need storage conditions of 2-8℃, that is, the existing vaccine cold chain can meet them.

However, whether the ultra-low temperature will become an obstacle to vaccine transportation or not, the transportation capacity must keep up at the critical moment when the vaccine is about to come out. A few days ago, the International Air Transport Association (IATA) just issued guidelines to ensure that air transportation can prepare for the large-scale processing, transportation and distribution of vaccines in COVID-19. "In order to effectively transport and store billions of doses of deep frozen vaccines on a global scale, the entire supply chain will face extremely complicated transportation challenges." Alexander de Juniac, Chairman and CEO of International Air Transport Association (IATA), said so.

Earlier, Cai, member of the North Asia Region of the International Air Transport Association and general manager of foreign relations, revealed that "if you give a dose of vaccine to 7.8 billion people around the world, you need 8,000 fully loaded Boeing 747 cargo planes to meet the demand". So Juniac once called it "the mission of the century". In his view, it is time for the global air cargo industry to carefully plan and ensure the safe transportation of vaccines. Governments of all countries should take the lead to promote the cooperation of the whole logistics chain, ensure the smooth flow of facilities, safety and border inspection, and prepare for the arduous and complicated distribution tasks in the future.