The Biden Administration announced has plans to invest $2.7 billion into domestic supply network capabilities of essential vaccine components.  The effort is described as making the U.S. the “arsenal of vaccines for the world.”

The supply materials included in this effort include bioreactor bags, lipids, needles, syringes and other essential items. The effort is part of a broader Biden Administration outlined goal for the ability to rapidly produce effective vaccines to combat any broad virus threat, including the ongoing coronavirus variants.

The components of the broader plan include:

Enabling vaccine design, testing, review and authorization of a safe and effective vaccine against any human virus within 100 days after the recognition of a potential emerging pandemic threat.

Enable production of enough vaccine for the entire United States population within 130 days and for the global population within 200 days after its recognition as a potential emerging pandemic threat.

Delivery of vaccines rapidly and easily to anywhere in the world thru distributed manufacturing, eliminating challenging requirements for transportation and storage

Facilitating rapid, large-scale vaccination campaigns, by simplifying vaccine administration, including replacing the need for sterile injection with skin patches or nasal sprays and the need for multiple doses with time-released formulation.

Develop ways to rapidly adapt, test, and review modified vaccines to keep and review modified vaccines to keep pace with changes with a virus.

The funding for this augmented vaccine supply network will reportedly come from funds previously appropriated by the U.S. Congress via the $1.9 trillion American Rescue Plan signed into law in March of this year.

Supply Network Implications

While this effort aims to invest in a more responsive and resilient vaccine supply network, the effort does not include the production of actual “drug substance” and finished vaccine supplies. It is assumed that existing vaccine suppliers such as Pfizer, Moderna, Johnson & Johnson and others will make the necessary capacity investments in domestic manufacturing capability where it makes sense. Evidence to such actions are becoming more visible as individual governments are becoming more active in incentives to insure needed domestic vaccine supply production capabilities exists.

In the backdrop of efforts to accelerate the global wide availability of COVID-19 vaccines are organizations such as the Global Alliance for Vaccines and Immunization (Gavi) as well as the World Health Organization.


Broader Pharmaceutical Supply Network Challenges

The broader global supply chain manifestations of pharmaceutical drugs has its own set of challenges. Prior to the global outbreak of the COVID-19 coronavirus, an estimated 80 percent of the global supply of the Active Production Ingredients-APIs needed to produce a large variety of life saving pharmaceutical drugs had been sourced in either India or China.  Similarly, medical supplies and protective equipment were similarly sourced globally, particularly in China and Malaysia. Such vulnerabilities prompted the Administration’s 100-day review of strategic supply chains.

The global wide pandemic exposed the vulnerabilities of these supply networks which are critical to saving lives and responding to national or global health emergencies. Such vulnerabilities were especially visible when India and China were impacted by domestic outbreaks, or when global transportation capabilities were hampered by disruptions, which remain the case.

Drug manufacturers have been reluctant to invest in domestic drug supply networks and hence individual governments have stepped in either to stockpile emergency supplies or to promote more domestic sourcing capabilities. Drug manufacturers further have concerns in protecting their own intellectual property protection and drug distribution plans.

The Biden Administration’s strategic review of U.S. supply chains indeed highlighted the challenges of pharmaceutical supply networks, and of the needs for a more domestic supply network for vaccine needs but on the strategic vulnerabilities of globally sourced key ingredients. There remains critical shortages of life-saving drugs, medicines and supplies.

This new announcement in supplementing domestic supply network capabilities for critical vaccine needs is one step. Broader steps are obviously necessary but that will take additional time and effort.

For added information, we can suggest readers take a view of a Harvard Business Review commentary penned by Eric Edwards: The U.S. Needs to Reimagine Its Pharma Supply Chain.


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