Performing at the Speed of Science Yields Complex Covid-19 Vaccine
Author
Sally R. K. Fisk - Pfizer Inc.
Pfizer Inc.
Current Issue
Issue
3
Sally R.K. Fisk

When the pandemic began, the challenge for Pfizer and our partner BioNTech wasn’t just developing a vaccine—we also had to make it, and by the billions. This was no small feat—especially when you consider that the companies were looking to do what would normally take five years in less than one. Until the very end of 2020, no mRNA vaccine had ever been authorized and thus, one had never been manufactured at scale by any company. Pfizer invested more than $2 billion at risk on our Covid-19 vaccine development program—with $500 million of that spent on scaling up our manufacturing capabilities, before we knew the results of our clinical trials. There were no guarantees. But, with 172 years of experience on our side, we’ve arguably developed the most efficient vaccine manufacturing machine that the pharmaceutical industry has seen.

In addition to the technical aspects of making a complex mRNA vaccine while moving at the speed of science, we focused on always prioritizing quality, safety, and compliance; keeping colleagues in our research and manufacturing plants safe; and continuing to protect the environment. That message has been consistently reinforced by our CEO and leaders and includes amplified messaging about our Open Door policy, office of the Ombuds, and anonymous Compliance Hotline, to encourage our colleagues to speak up. And when issues or concerns are raised, we listen and respond.

Our speed was driven by working on activities in parallel, being flexible, and adding extra resources and innovative thinking. For example, in 2020 our manufacturing facility in Kalamazoo, Michigan, designed two separate vaccine manufacturing lines, one in an existing production area while the second was being designed as a prefabricated modular system constructed at an off-site facility and transported and placed in existing space at the Pfizer site. That meant two separate environmental permitting scenarios, two separate safety profiles, and the need to have both designs completed and constructed more quickly than we ever had before—because that is what patients around the world needed. This generated financial risk for the company, and our teams worked incredibly hard, but it enabled Pfizer to be ready with manufacturing capability if, and immediately when, we received emergency use authorization from the FDA.

We eliminated hierarchy in internal reporting and made meetings more efficient. The right subject matter experts and decisionmakers were in daily core meetings, irrespective of titles or reporting lines, to assure that all colleagues involved in the process design, construction, and startup stayed connected. We redesigned our processes to enhance efficiencies and drive effectiveness. That does not mean we eliminated critical decisionmaking processes; in fact, it was streamlined processes that enabled us to move fast with confidence, ensuring we maintained our high standards for quality, safety, and integrity.

We established a risk management framework specific to the vaccine project to ensure that we were developing mitigation strategies for existing and emerging risks. Elevated risks were escalated to leadership to enable the rapid deployment of resources and support so identified risks could be proactively mitigated and not become roadblocks. For example, relative to process safety and environmental risks, we implemented an OSHA Process Hazard Assessment approach for all steps in the production process regardless of whether the step used flammable or hazardous materials. And we repeated the PHA at key phases of design, construction, and startup.

We established open, transparent, and cooperative lines of communication with the government, including environmental agencies. We needed new authorizations for air emissions from state agencies and for wastewater discharges from local publicly owned treatment works. Having authorizations timely issued and compliance at all stages was of paramount importance, so we developed detailed environmental data in advance to cover multiple potential operating scenarios. Our facilities established early lines of communication with their regulators, who recognized the urgency of our mission and our commitment to environmental compliance. They were flexible when we presented multiple scenarios for operation while we awaited the decision on final design. With this common purpose, the agencies were able to prioritize and expedite our applications while maintaining their rigorous and robust review processes.

These were important aspects of our ability to deliver the vaccine in unprecedented time. However, the most important factor was ultimately our colleagues and the individuals employed by our partners and government who, working collectively with shared purpose, delivered breakthroughs and innovation in record time—proving that when humanity works toward common goals with urgency and focus, we can address the world’s greatest challenges.

Performing at the Speed of Science Yields Complex Covid-19 Vaccine

Time for Environmental Crimes
Author
Rena Steinzor - University of Maryland Carey Law School
University of Maryland Carey Law School
Current Issue
Issue
3

Criminal prosecution for major regulatory offenses, for a while the norm and then the exception, is once again on the rise. Government officials, facing dwindling enforcement budgets, are hauling malfeasant corporations and their executives into court to face charges.

The Debate: Dangerous Intersection: Climate Change and National Security
Author
Francesco Femia - The Center for Climate and Security
Leo Goff - Center for Naval Analyses
Alice Hill - National Security Council
Thilmeeza Hussain - Voice of Women -- Maldives
Marcus King - George Washington University
Maureen Sullivan - Department of Defense
The Center for Climate and Security
Center for Naval Analyses
National Security Council
Voice of Women -- Maldives
George Washington University
Department of Defense
Current Issue
Issue
33

The dangers of climate change are not usually couched in terms of national security, but awareness of the issue is growing rapidly. What could be more basic to security than a climate conducive for agriculture, abundant water supplies, ecosystem health, industrial production, biodiversity, and human comfort? What could be more threatening than extreme weather events or mass migrations because of rising seas and crop failures? The annual ELI-Miriam Hamilton Keare Policy Forum brought together top experts on the topic.

Climate Canaries
Author
Barry E. Hill - Vermont Law School
Caitlin O'Sullivan -
Vermont Law School
Current Issue
Issue
6

The people of Bangladesh are already suffering from the effects of global warming, serving as an early-warning indicator of its ultimate imprint on humanity as a whole. But for right now, the developed world owes the poor countries assistance in their struggle.

Artisanal and Small-Scale Gold Mining in Nigeria: Recommendations to Address Mercury and Lead Exposure - Executive Summary
Author
Environmental Law Insitute
Date Released
November 2014

This executive summary introduces ELI’s assessment of legal and policy challenges underpinning the informal artisanal and small-scale gold mining (ASGM) sector in Nigeria. The assessment presents legal, institutional, and financial recommendations designed to improve long-term health and environmental outcomes from the ASGM process. These recommendations are intended to accelerate the formalization of artisanal miners in order to encourage the development and dissemination of best mining practices.

Artisanal and Small-Scale Gold Mining in Nigeria: Recommendations to Address Mercury and Lead Exposure
Author
Environmental Law Institute
Date Released
November 2014

This assessment examines the legal and policy challenges underpinning the informal artisanal and small-scale gold mining (ASGM) sector in Nigeria. The assessment presents legal, institutional, and financial recommendations designed to improve long-term health and environmental outcomes from the ASGM process. These recommendations are intended to accelerate the formalization of artisanal miners in order to encourage the development and dissemination of best mining practices.

Homeland Security and Drinking Water: An Opportunity for Comprehensive Protection of a Vital Natural Resource
Date Released
October 2003
Homeland Security and Drinking Water:  An Opportunity for Comprehensive Protecti

Fact Sheet on Selected Environmental Authorities Relevant to Homeland Security Presents examples of federal environmental laws their potential applicability to homeland security issues.

Fact Sheet on Opportunities for Constructive Interaction Identifies five areas for constructive interaction – water ifrastructure, public engagement, public health, technological advances, and emergency preparedness.

Safe Drinking Water Workshop for Consumers
Author
Suellen T. Keiner, Environmental Law Institute
Date Released
December 1997

The Environmental Law Institute convened a one-day workshop on May 6, 1997 to allow citizens in the Washington, DC area to discuss the new community right-to-know amendments to the Safe Drinking Water Act. The objectives of the workshop were to: (1) develop citizen awareness about drinking water quality issues; (2) help state and local governments understand the information needs of citizens who want to learn more about the quality of their drinking water; and (3) help water companies prepare user-friendly information about the quality of drinking water.

Community Environmental Health Assessment Workbook: A Guide to Evaluating Your Community's Health and Finding Ways to Improve It
Author
Paul Locke, Suellen T. Keiner & Devon Payne-Sturges, Environmental Law Institute
Date Released
December 2000

This Workbook will help community leaders, local organizers, and citizens groups assess environmental health problems in their neighborhoods and assist them in tackling these problems. It outlines an approach to identifying problems, gathering information, and establishing the community`s priorities for improving the environmental health of its residents. Examples for Washington, D.C. serve as illustrations and possible examples. Residents of other cities and localities can find equivalent resources and data within their own communities.