The race for the development of a Covid-19 vaccine has been an incredible story of fast tracked innovation. The story of the safe distribution of the vaccine to consumers is proving equally extraordinary.
Different vaccines on the market have different storage requirements and as governments battle to ensure roll outs are effective they need absolute certainty that the risk of failure is being contained.
But that’s easier said than done.
Demanding new distribution requirements
The two companies responsible for the development of the earliest approved vaccines are Pfizer/BioNTech and Moderna. Their products are mRNA vaccines, a relatively new type that are extremely sensitive to environmental conditions. Highly effective, but often unstable, they risk ‘breaking apart’ if they are kept at temperatures above freezing for certain lengths of time.
Regulators around the world are therefore mandating demanding new handling practices to ensure active ingredients are not compromised as they are distributed..
GPS and temperature tracking is mandatory
In the US, the phials of the Pfizer vaccine are stored in pizza like boxes fitted with a GPS beacon, a temperature monitor and a barcode attached that’s scanned on receipt:
“If the doses deviate from their target destination in each of the 41,689 U.S. zip codes, or if the vials get too hot or cold, officials at the companies and the government are immediately alerted to the problem. The information streams into the Vaccine Operations Center, known internally as the VOC.”
source Time magazine
There have been occasions where dips in temperature of the drugs during transportation have been recorded and consignments scrapped.
New standards require more investment
The life span and temperature requirements are so hard to maintain that distributors have had to invest in expensive new hardware to meet regulatory standards. They’ve also had to acquire large amounts of dry ice, leading to shortages and inflated prices.
New types of unit are being developed for the transit of these drugs in lorries, planes and cargo ships.
- Stirling Ultracold have built portable ultracold freezers with temperatures that go as low as -114°F
- UPS and FedEx, have expanded their refrigeration capability, developing so called “freezer farms,” to ensure vaccines can be properly looked after at every stage of long-distance journeys across the US.
New quality regimes and SOPs required
In unprecedented requirements in the US, the vaccine must now travel with security guards, including US marshals, and must be stored in locked refrigerators.
And then there are specific requirements for packing and unpacking that need to be followed precisely.
“After Pfizer boxes are opened, they need to be placed in an ultracold freezer or be re-packed with fresh dry ice every five days for up to four weeks. “
Once it has been transferred from ultracold storage to a refrigerator the vaccine has a shelf life of five days. This leaves only a short window to actually administer the drug.
Opportunity and risk for distributors
There is significant opportunity for those companies who can become part of these supply chains, as well as considerable operational risk for those who do.
Even in a normal year a large number of vaccines have to be destroyed because their storage has been compromised in transit. In 2019 $34bn worth of drugs suffered this fate. Given the instability and quantity of Covid vaccines entering the market right now this risk is currently significantly increased.
Not only this, but the BBC has recently reported that:
“IBM has uncovered a hacking campaign aimed at the delivery "cold chain" used to keep vaccines at the right temperature during transportation.”
There are clearly new risks emerging that need to be managed at every level.
Regulators have sweeping powers
The requirements to observe GDP (good distribution practice) extend to every part of the supply and distribution chain for both pharma and medical devices.
And the storage sensitivity of these new vaccines underline just how necessary these standards are to guarantee the efficacy of the medical products that are being transported.
GDP requirements extends across the chain
Distributors, manufacturers and their agents face ‘joint and several liability’ for quality failings in end products. Manufacturers need to be confident that their suppliers and distributors are implementing GDP in a trackable and auditable way throughout every single stage of the cycle.
Operators in this sector need to have digital quality systems that specify, define and record the measures taken to ensure:
- Transportation and storage of drugs meet required conditions
- Theft, contamination and tampering is prevented
- Recall and complaint management procedures are in place
- All workers are trained in relevant SOPs
- Products entering the distribution network are officially authorised
Given how fast distribution and storage requirements for these vaccines are changing we need a new breed of digital Quality Management Systems that are incredibly robust - yet flexible enough to ensure that current GxP are documented and maintained across organisations in real time.
Quality under scrutiny
There is currently significant operational and security risk around every aspect of quality management in the vaccine distribution network.
Everyone involved in the Coronavirus vaccine roll out has to ensure GDP is understood and observed within their organisations.
All eyes are now on the supply and distribution network to get vaccines safely out to those who need it. Transparency is key to ensure standards are not compromised and the public is convinced of the vaccines’ efficacy. The quality management systems these distributors use are going to be tested to their limits.