Pfizer’s New Vaccine Storage Temperature Requirement

There is a welcome development in Pfizer’s vaccine storage! The US Food and Drug Administration recently gave the green light to store Pfizer’s covid vaccine in standard refrigeration. The storing can last at least a month. On the other hand, the Department of Health Canada authorized the Pfizer vax for storage between 2°C and 8°C.   

The covid vaccine from Pfizer has many limitations in terms of storage. With the authorization for emergency use, the vaccine should be stored in an ultra-cold freezer. The storage temperature ranges from -80°C and -60°C. These temperature conditions are restrictive to mass inoculation efforts.

The new storage guideline comes after the recommendation of the European Medicines Agency (EMA). After EMA analyzes Pfizer’s data, vaccine stability is met at relatively normal temperature ranges. Of course, proper handling is a must. The 2°C and 8°C storage temperature is a good condition for unopened and thawed vaccine vials.

Vaccine Distribution Challenge

When Pfizer’s vaccine was authorized for public use, many are skeptical of its storage conditions. The practicality and cost involved from a logistics standpoint are massive. Not to mention the many deployment touchpoints that make distribution a challenging endeavor.

Why Does the Pfizer Vaccine Need an Ultra-Low Storage Temperature?

To answer the question, we have to trace back to vaccine makeup. Pfizer employs mRNA technology in this new vaccine. The technology copies the spike protein in the virus structure. The synthetic mRNA will induce an immune response once injected into the body. When the vaccine is injected, it will trigger the body to create harmless S proteins. If the body can detect the S protein’s accumulation, it will signal an immune response. It will build antibodies to counter present S proteins. These antibodies will then act as a frontline defense, in any case, a “true” S protein from the COVID-19 virus invades the body.

The mRNA that is fundamental in the vaccine makeup tends to be fragile. Hence, the lower storage temperature condition. This prerequisite entails investment in thermal shippers. It requires an integration of a top-of-the-line monitoring system. Thus, it needs comprehensive, quick-scale delivery management.

The unfortunate bottleneck is how to get these vaccines to recipients given the rigid parameters to abide.

Implication to Rollout

The new storage temperature allows better flexibility in vaccine deployment. The storage requirement is now convenient to attain, especially in mass rollout settings. Experts believe that the Pfizer vaccine will pave better local access. The new temperature storage will also negate any risk of wastage.

Relegating standard compliance will ease out the burden for cold storage facilities. The vaccine distribution can now adapt to the smaller package of doses. These kinds of distribution mechanisms need not require more significant cold storage capacities. The smaller units are adaptive to reach last-mile areas. 

Temperature Change “Much Needed” in Developing Countries

Many developing nations were vulnerable to the onslaught of the pandemic. With lesser health sector capacities, COVID-19 caused too many casualties in third-world countries. 

The Philippines is an example of the many developing nations struggling to fight this pandemic. The country breached the 1 million COVID case in April. Currently, the Philippines ranks second highest COVID hotspot in Southeast Asia. 

With lacking health capacity, the position of developing nations to vaccine access is also not promising. The creation of a local clinical setting for vaccine rollout is challenging. The inadequate infrastructure aggravates this to facilitate easy logistics. 

The limitations for vaccine distribution can pile up for a developing nation to act. It is a burden to carry out cold storage logistics that require ultra-low freezers. Thus, the temperature change can turn the situation around. 

While there are still many considerations, the relatively average storage temperature gives a glimmer of hope to developing countries. They now have at least a chance to “get a piece of the pie.” They can accommodate localized vaccine rollout with lesser facility investment.   

Ongoing Safe Distribution and Monitoring

It is a good thing that storage temperature issues are now an easy task to hurdle. However, the mission does not end there. As distribution is an iterative process, monitoring capacities should keep pace.

It is always best to adhere to safety standards and regulatory guidelines. A sound distribution system aims to operate the cold storage facilities in the best condition. To check these conditions regularly, monitoring management will supplement it. There are monitoring checkpoint to account for a good vaccine rollout:

• continuous supply of vaccine and equipment
• good state of vaccines and equipment (random sampling)
• limit spoilage and expiration
• accurate inventory records
• efficient access to vaccine supply during touchpoints
• transit planning
• safe disposal of vaccine wastage
• prevent any security incidence
• supply forecasting

These are the many considerations to monitor to attempt good delivery turnover. Beyond the environmental parameters especially, temperature, there are other facets to take note of. 

Other monitoring capacities will streamline distribution efforts. Technological advancement can ease monitoring activities to ensure that parameters are within range. Some of the many monitoring capacities are:

1. Wireless sensors
2. Central monitoring management software
3. Live tracking
4. Data logging
5. Access control and security

These solutions are essential to achieve comprehensive monitoring. With real-time monitoring capacities, distribution is tracked throughout the whole delivery duration. And because it is in transit, wireless sensors are effective in remote monitoring setup. AKCPro Pharma Mon server is an example of central monitoring software. Connected to deployed sensors on the ground, the software can access control and live tracking. AKCP’s array of environmental sensors assure accuracy and precision, depicting granular visibility of vaccine deployment. 

Designing a Sound Distribution System

The key to an effective vaccine rollout is to achieve the shortest possible delivery time. This is why the new authorized storage temperature for Pfizer’s vaccine can be a game-changer. With lesser transport time, vaccine quality is at its prime.

• Distribution Actors

There are three to four distribution levels. In principle, the three actors are:

1. central hub
2. intermediate stores
3. service points

Why is the New Storage Relevant to this Distribution Setup?

Again, the value of time is fundamental in the delivery process. But beyond that, achieving ultra-low temperature conditions is essential to these distribution points. Any chance of temperature change in any of these points will be a chokepoint to vaccine relay. This is why easing the storing temperature requires easy maintenance for all distribution actors.

• Vaccine storage requirements

As vaccines are a commodity for disease prevention, especially COVID-19, storage outlines stringent prerequisites. But vaccine storage will revolve around these factors:

1. Vaccine type

The type of vaccine will determine the refrigeration rule. Because of vaccine makeup, there are also specific environmental parameters to follow.

2. Vaccine storage

The indicator of good vaccine storage is its ability to achieve the recommended temperature condition. Storage temperature is a fundamental reference point for vaccine safety and quality. Hence, the need to achieve temperature ranges and monitoring fluctuations.

Other than that, storage will also pertain to capacity. In most cases, significant volume is a serious consideration. With the new storage temperature for the likes of the Pfizer vaccine, capacity can double as well.

3. Vaccine management 

There are specific inventory requirements to account for in vaccine management. The inventory facilitates an efficient flow of supply and reserves during transit. Projections are also necessary to augment wastage and spoilage. These forecasts, thereby, helps in calculating the carrying capacity of the cold storage.

Other considerations

Choice of hardware

The vaccine distribution ecosystem is interconnected, that any issues arising from one component may affect the whole system. One primary consideration in vaccine rollout is storage hardware. Refrigerators and freezers are the backbones of cold storage. In the end, the use of equipment is an indicator of the temperature range to be achieved. The equipment can also be specific to the commodity type for delivery. Medical-grade refrigerators, for instance, are specially designed for storing drugs and vaccines. 

There are also other notable information to check to help in choosing the proper refrigeration for vaccine deployment:

• product information sheet
• equipment performance specification

These pieces of information are excellent reference points in terms of the operational efficiency of the hardware. It also provides space requirements that are relevant to storing capacity. 

Geographic infrastructure

While these may be long-term capacities, vaccine delivery is expedited with good road networks. This is the downside of vaccine deployment in developing nations. With lesser infrastructures such as power and road, vaccine deployment is affected. In return, vaccine rollout is dependent on the existing logistical infra.

A Real Gamechanger

The potential change in storage temperature is one of the many developments that healthcare is welcoming. With such development, we may hear a few more along the way as scientists are continuously streamlining the mechanisms for these vaccines.

Other developments on the efficacy of the vaccine to lower ages are following suit. This news can accelerate our vaccination targets. In the long run, with a significant number of people vaccinates, herd immunity will result. 

Along with sound monitoring solutions and an adequate distribution ecosystem, the COVID-19 vaccine is well within our hands soon.

Reference Links:

https://www.mayoclinic.org/diseases-conditions/coronavirus/in-depth/coronavirus-vaccine/art-20484859

https://www.cbc.ca/news/health/pfizer-vaccine-canada-storage-temperature-1.6031823

https://abcnews.go.com/Health/greenlighting-pfizers-vaccine-storage-requirements-dramatically-improve-access/story?id=77841139

https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/downloads/storage-summary.pdf

https://www.cnbc.com/2020/11/25/challenges-pfizer-faces-distributing-covid-19-vaccine-to-the-masses-.html

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use