Running Head: REGULATORY ENVIRONMENT
Regulatory Environment
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REGULATORY ENVIRONMENT
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Introduction
Proper handling and storage of vaccine practices play a critical role in protecting people
and communities from vaccine-preventable diseases. The quality of the vaccine is a shared
responsibility across the supply chain from the time it is manufactured by Current Good
Manufacturing Practice (CGMP) until its delivery and administration. The case scenario states that
the quality control manager at TRU was away on an away trip. However, he noted the pallets had
been damaged and therefore necessitated a report to the CMI (Rollo, 2021). According to the
vaccine laws in the United States, the Adverse Event Reporting System regulations specify whom
to report the events. The manufacturer is above the recommended temperature in the room. Any
temperature readings in the package beyond the recommended by the manufacturer are considered
a temperature excursion (Rollo, 2021). The appropriate action for the TRU manager is to take
corrective action and correct the temperature readings. As a result, it can prevent the waste and
potential need to revaccinate the patients (Shabrov, Lusch & Shadrin, 2015).
Safe and secure storage and delivery in compliance with a regulatory framework that
guides the handling of the vaccine is critical in ensuring the anthrax vaccine is delivered to the
recipients and mitigating the risks of vaccines being diverted to the black market (Food and Drug
Administration, 2018). The CMI must develop a proper mechanism to ensure the anthrax vaccines
are delivered appropriately and without contamination (Bonie et al., 2010). Some measures may
include storage in an undisclosed location, using dummy trucks, and using a GPS tracking system.
This report examines the regulatory risks of the anthrax vaccine and corrective actions to prevent
a recurrence (Shabrov, Lusch & Shadrin, 2015).
Regulatory Risks
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Hundreds of organizations in the United States solely perform a significant function of
vaccine manufacturing. For this reason, it is important to adapt to the operations to satisfy the
needs for speed, capacity, and enhanced technology. Contractors, regulators, and manufacturers
are teaming up to scale up the production of the vaccines (Food and Drug Administration, 2018).
The immense volumes distributed, handled, and stored in cold chains must observe by safety laws.
The logistical staff, vaccine handlers, and pharmacists at DOD require training on handling the
specific CMI distinct vaccine (Black, 2007).
Ensuring the value in Anthrax vaccine rollout in DOD encompasses guaranteeing the safety
and efficiency of each dose by alleviating quality assurance setbacks. The Clinical Immunization
Safety Assessment (CISA) Network is the tool by the FDA to evaluate anthrax vaccine safety. To
manufacture a novel batch of anthrax vaccines, CMI must have the required massive input
requirements, a massive technical labor force, and an expanded collection of manufacturing
facilities (Black, 2007). At the same time, even with ongoing mass-scale manufacturing, state
regulators such as U.S Food and Drug Administration (FDA) continue developing vaccine
standards. Quality assurance in the context of the Anthrax vaccine remains a vital concept.
According to the vaccine laws, the FDA is given authority to oversee, regulate and enforce the
vaccine development and research process (Shabrov, Lusch & Shadrin, 2015).
The popular model of operation offers details of the delivery of vaccines. This model has
possible regulatory risks in delivering vaccines in the United States and elsewhere. Delivering the
anthrax vaccines by CMI is a complex task. It requires a chain of accurately synchronized events
in temperature-regulated settings to manage, store and distribute these life-saving vaccines (Black,
2007).
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The risk of potency: The anthrax vaccines should constantly be kept in a controlled
temperature range from when they are manufactured until the vaccine is supplied. It is because the
temperatures that are extremely high or too low can result in the vaccine losing its potency. Once
the vaccine potency is lost, it cannot be recovered or restored. When the vaccines are sent from
CMI to the DOD, they are stored in low temperatures and cold storage facilities. The storage and
distribution appliances such as refrigerators, cold boxes, freezers, and pallets must conform to the
standards and regulations of the World Health Organization (WHO). The inventory management
regulations must comply with the WHO rules specific to the anthrax vaccine (Shabrov, Lusch &
Shadrin, 2015).
The product license may be rendered invalid: Exposing the Anthrax vaccine at the TRU to
a temperature beyond the manufacturer's limit is regarded as a break of the cold chain rules and
can render its production license invalid (CDC, 2022). As per regulators, the extent of time spent
outside the cold chain settings and the temperatures to which the vaccine was exposed can interfere
with the vaccine potency and therefore governs the breach's significance. The significance of the
breach varies, and TRU should immediately act upon every breach of the cold chain and seek
specialists to ascertain the action (Bonie et al., 2010). The fluctuation of the temperature rising
above the recommended by the manufacturer may occur while stock-taking and, as such, do not
need more action (CDC, 2022). The source of the temperature excursion should be recorded on
the temperature document chart, the lowest or highest thermometer reset, and vaccines to be
utilized to the expiry date. The practical method is founded on research from the U.S National
Institute of Standard and Technology, which has shown that vaccine vials can remain stable despite
the constant temperature of 20 minutes despite the constant influx of ambient air into the freezer
(Bonie et al., 2010). They should store the vaccines in the original packing to maintain a stable
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temperature, and manufacturers should ensure that the vaccines have been appropriately stored
(Bonie et al., 2010).
Risk of loss in product quality: Any vaccination program's success and credibility depend
on the safe administration and quality vaccines. The quality is only guaranteed through stringent
observance of the vaccine storage, preparation, and handling processes. Damaged vaccine pallet
or improper storage or handling may cause vaccine potency or diminish product quality, efficiency,
reactogenicity, and effectiveness in some anthrax vaccines. The suboptimal handling of the anthrax
vaccine may inadvertently result in patients at the DOD receiving vaccine that has been
compromised. While there can be no guarantee of no harm to those who received such vaccines,
regulatory challenges may result from the afforded protection in the long and short term.
Eventually, the patients may be called for revaccination (Shabrov, Lusch & Shadrin, 2015).
The Corruption Risks: The delivery of anthrax vaccine results from public investment by
the CMI in exploration and development. A significant amount of the activity has been directed at
finding a safe and effective anthrax vaccine for the DOD. It is presumed that the regulatory body
is tracking down the candidates that undergo clinical trials on humans (CDC, 2022). The successful
implementation of the anthrax vaccine program at DOD will depend on efficient supply chains.
The systems will ensure efficient vaccine storage, stock management, and handling. In addition,
appropriate temperature regulations in the supply chain and preserving adequate logistical
management information structures. It is critical in safeguarding the vaccine supply and preventing
any disruptions from manufacturing to distribution (CDC, 2022). Improper handling and storage
of vaccines may result in corruption risks in vaccine deployment. In addition, anthrax vaccines are
also at risk once they arrive at the DOD facility if there are no regulatory measures.
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Administration error in storing or handling the anthrax vaccine is a significant concern for
carer and recipient patients at the DOD. It could result in minimal confidence in the manufacturer
of the vaccine or vaccination program in its entirety (Shabrov, Lusch & Shadrin, 2015). While it
is acknowledged that the cold chain regulations break and administration faults can result from the
well-managed organizations or clinics, when they happen, an informed decision is required as to
whether the vaccine has been contaminated and whether the anthrax vaccine presents any risks to
the patients (CDC, 2022). The efficient management of faults would ensure patient safety, preserve
patients' confidence in the vaccination program and minimize the waste from damaged pallets.
Although every anthrax vaccine incident will require to be investigated individually, managing
these incidents should be consistent with alleviating misunderstandings for vaccine manufacturers
and recipients of vaccines. The learned lessons from the damaged pallet and temperature excursion
incident at CMI should be lessons learned (Shabrov, Lusch & Shadrin, 2015). The occurrence
should be shared and utilized for future practice and to avoid reappearance.
Corrective or Preventive Actions
Monitoring vaccine temperature: The vaccine storage equipment should constantly be
monitored as part of the daily responsibilities to ensure vaccine supply viability and patient safety
(Bower et al., 2019). Routine monitoring activities will aid in identifying temperature excursions
faster and institute immediate actions to correct them, preventing patients' loss or potential
revaccination. Power disruption can destroy the vaccine supply even with appropriate equipment
and temperature monitoring practices. For this reason, precautionary measures should be in place
to protect the power supply (Bower et al., 2019).
Building into distribution redundancy: The CMI manufacturing company and allocation
teams can alleviate future distribution risks by rapidly finding the points of failure in delivering
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the anthrax vaccine and creating redundancies at the initial stages. For instance, at TRU, where the
warehouses will be installed with ultracold freezers, the dry ice could be an alternative for power
loss or machine failure (Bower et al., 2019). During the delivery to the DOD, the company could
identify the sources of dry ice to replenish the cool box as necessary. Also, the company could
utilize the feedback loops where they could capture the disruption in the supply chain in real-time.
As a result, the gathered data could be used to design the best procedures and practices to avoid
future losses (Shabrov & Shadrin, 2016).
Using the point of care managing and handling of the stock: If the demand for anthrax
vaccine reduces to the limits where the point of care stocks is consumed instantly, the vaccine
stocks could be distributed to the stations with higher demand. Proper planning should ensure that
over-stockpiling is avoided, thus ensuring the cold chain maintenance and prevention of the risks
to the DOD administration site (Black, 2007). CMI should design the long-term storage where it
is not practical by restocking the dry ice or prioritizing freezer size (Shabrov & Shadrin, 2016).
Resilience Planning: The CMI manufacturers can collaborate with world suppliers of raw
materials and contractual vaccine producers to design redundancies where possible in the handling,
distributing, and managing the anthrax vaccine (Bower et al., 2019). Additionally, better diversity
of the world dealers is required to satisfy the regulatory approvals of the vaccine. CMI could
negotiate contracts with CGMP early by offering the incentives for distributors to invest early in
increasing production and maintaining enough stock of the vaccines (Shabrov & Shadrin, 2016).
Additionally, the CMI manufacturers could reevaluate stock management to lessen the risk of
stockouts in primary materials (Wahab, 2010).
The association between the government and CGMP in the safe delivery of anthrax
vaccines: The constant liaising with the government is critical for scaling vaccine manufacture and
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maintaining high production quantity. In several instances, CMI manufacturers and its delivery
companies CGMP could work closely with the government to manage the resource allocation and
storage (Bower et al., 2019). There should be constant collaboration on the public health and
economic impacts of faltering the outsourcing of the raw products and enhancing the production
lines for the anthrax vaccine (Shabrov & Shadrin, 2015). Also, the contract manufacturers such as
the CGMP could collaborate with the government to design technology transfer timelines and
create new ways of upgrading to more volumes of vaccines to the administration site and
enhancing inventory management to the last mile distribution (Shabrov & Shadrin, 2015).
Scaling manufacturing the existing and new facilities: As the manufacturers accelerate the
operations in the new manufacturing facilities, they could look for opportunities to accelerate
capacity as rapidly as possible. Several digital analytics tools could increase the capacity and scale
more rapidly (Bower et al., 2019). The company could also accelerate the technology transfer
timelines. Some of the operations that the company could conduct include engineering runs,
stability studies, and validation run simultaneously, and the companies could both speed up and
expand the production (Wahab, 2010).
Quality and assurance in the TRU facilities: The company should organize with regulators,
contract manufacturers, and the system to ensure that handling processes and the package meets
the long-established guidelines (Shabrov & Shadrin, 2015). The higher throughput can be realized
through close coordination and understanding, considering the higher probability of attaining
quality standards. Similarly, the investors can cooperate in setting up standards for the production
of anthrax vaccines by employing new biotechnology inventions (CDC, 2022). Incorporating the
best guidelines at the repository facilities and manufacturing help create a strategic plan for new
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production facilities. It enhances the production speed while meeting the necessary standards of
anthrax vaccine quality (CDC, 2022).
Establishing predictable supply plans: Each contracted manufacturer can stick to a clearly
defined strategy in constant communication with the production control tower with the skilled
teams to prioritize tasks across the functions. They can perform consistent cross-functional risk
assessments that ensure quality is not compromised and involve evaluation progress at each
periodic interval (Bower et al., 2019).
Conclusion
Although not a single company is in charge of handling the anthrax vaccine distribution in
DOD across the current operating model, the risks should be fully addressed through stakeholder
collaboration. To create this collaboration, the working teams at the DOD could meet with CMI,
CGMP, and TRU to identify the risks of improper handling of the anthrax vaccine, evaluate the
potential and likelihood impact, and determine whether specific risks have evolved and urgent
need to address them. These groups can align with primary organizations to handle the issues while
building scenarios to test the responses to the crises. Managing the risks that accompany improper
handling of the vaccines could be established with convincing metrics and communications(CDC,
2022). At this point, defined roles, activities, and risk management capabilities could be
recognized, creating accountability across the stakeholders in the supply chain (CDC, 2022). Most
importantly, the company could undertake the critical steps to ensure distributors, governments,
and manufacturers of the anthrax vaccine facilitate and minimize the setbacks related to immense
anthrax vaccine deployment at DOD. As a result, it will help in the efficient and effective rollout
of anthrax vaccines (Shabrov & Shadrin, 2015).
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References
Black, L. (2007). Informed Consent in the Military: The Anthrax Vaccination Case. AMA Journal Of
Ethics, 9(10), 698-702. https://doi.org/10.1001/virtualmentor.2007.9.10.hlaw1-0710
Bonie, R., Dennison, K., & Adepoju, N. (2010). Vaccine Cold Chain: Part 1. Proper Handling and
Storage of Vaccine. AAOHN Journal, 58(8), 345-346. https://doi.org/10.3928/0891016220100801-03
Bower, W., Schiffer, J., Atmar, R., Keitel, W., Friedlander, A., & Liu, L. et al. (2019). Using Anthrax
Vaccine in the United States: Recommendations of the Advisory Committee on Immunization
Practices, 2019. MMWR. Recommendations And Reports, 68(4), 1-14.
https://doi.org/10.15585/mmwr.rr6804a1
CDC. (2022). Vaccination Laws. Center for Disease and Control. Retrieved 12 June 2022, from
https://www.cdc.gov/phlp/publications/topic/vaccinationlaws.html.
CDC. (2022). Vaccine storage & handling toolkit. Centers for Disease Control and Prevention, National
Center for Immunization and Respiratory Diseases.
Food and Drug Administration. (2018). Anthrax. U.S. Food and Drug Administration. Retrieved 12 June
2022, from https://www.fda.gov/vaccines-blood-biologics/vaccines/anthrax.
Gleim, S., & Smyth, S. (2018). Scientific underpinnings of biotechnology regulatory
frameworks. New Biotechnology, 42, 26-32. doi: 10.1016/j.nbt.2018.01.004
Rollo, B. (2021). Five Shipping Challenges That Put Vaccine Delivery at Risk. Supplychainbrain.com.
Retrieved 12 June 2022, from https://www.supplychainbrain.com/blogs/1-think-tank/post/32581five-shipping-challenges-that-put-vaccine-delivery-at-risk.
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Shabrov, R., & Shadrin, A. (2015). Licensing of pharmaceutical activities: regulatory
issues. Remedium. Journal About The Russian Market Of Medicines And Medical Equipment,
(10), 58-63. doi: 10.21518/1561-5936-2015-10-58-63
Shabrov, R., & Shadrin, A. (2016). Public procurement of medicinal products: new regulations - old
problems. Remedium. Journal About The Russian Market Of Medicines And Medical Equipment,
(4), 8-19. doi: 10.21518/1561-5936-2016-4-8-19
Shabrov, R., Lusch, N., & Shadrin, A. (2015). Law against counterfeit medicines and nutritional
supplements. Remedium. Journal About The Russian Market Of Medicines And Medical
Equipment, (1-2), 8-13. doi: 10.21518/1561-5936-2015-1-2-8-13
Wahab, S. (2010). India's biotechnology policies and biosafety regulations. African Crop Science
Journal, 3(3). doi: 10.4314/acsj.v3i3.54534
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