The Hidden Faces of Operation Warp Speed: How Contract Organizations Accelerated COVID-19 Vaccine Efforts
Prior to the COVID-19 pandemic, vaccine development typically took 10-15 years. Through Operation Warp Speed, COVID-19 vaccines were developed and authorized for use in under a year. COVID-19 vaccine efforts were grand-scale collaboration between several cross-industry stakeholders. Big pharma companies, biotech startups, contract organizations, and governmental regulatory bodies all had to coordinate their operations for successful deployment of the vaccine.
Contract organizations such as CROs, CMOs, and CDMOs have been crucial in accelerating COVID-19 vaccine development through partnerships with pharmaceutical and biotech companies. Contract organizations were often the point of contact between several key stakeholders. In this blog post we examine notable contract organizations that were involved in COVID-19 vaccine development. We also discuss trends contract organizations can play in the future post COVID-19 pandemic.
Supporting Clinical Trials
Pharmaceutical companies invest in quality clinical trial research to ensure the safety and efficacy of new vaccines. However, running clinical trials can be very expensive. A few studies have shown that clinical development takes up 50-58% R&D costs per new medicine.
Also, clinical trials require extensive coordination to conduct. Coordinating an entire clinical trial start-to-finish requires expertise in trial design, data analytics, pharmacovigilance, and regulatory affairs. Several personnel are also involved, such as research nurses, study physicians, research pharmacists, study coordinators, data managers, and site principal investigators.
Contract Research Organizations (CROs) help with clinical trials, and nearly three out of four clinical trials are now executed by CROs. They ensure that vaccine deployment is successful by providing diverse services in study design planning, patient recruitment, execution, regulatory affairs, and laboratory services. Several offer digital tools to track and monitor clinical trial progress. They are also often the main point of contact between pharma companies and governmental regulatory bodies, ethics committees, and hospital clinicians.
During the COVID-19 pandemic, big pharma companies took advantage of CROs’ already existing and comprehensive infrastructure to conduct well-run clinical trials.
Pfizer-BioNTech developed the first FDA-approved COVID-19 vaccine, which utilized novel mRNA technology. It employed ICON, a CRO that provides comprehensive services for clinical trials. For the Pfizer-BioNTech vaccine, ICON worked on 153 sites globally and recruited over 44,000 trial participants. They were involved in regulatory affairs, ethical consent coordination, and clinical supply management services.
Shortly after Pfizer-BioNTech announced approval of its vaccine, Moderna also obtained FDA approval for its mRNA vaccine. The pharma company enlisted the help of PPD, a CRO which provides end-to-end clinical trial services to expedite vaccine development. Services include study design, site selection and activation, patient-enrollment epidemiology modeling, patient recruitment & follow-up, biostatistics, and laboratories for serology testing and antibody testing. PPD helped Moderna conduct Phase 2 and Phase 3 studies which recruited 600 people and 30,000 people respectively.
IQVIA, one of the largest CROs, collaborated with AstraZeneca to deliver their vaccine. Prior to this collaboration, IQVIA provided their own COVID-19 trial matching tool and registry for trial participants to self-report their symptoms and outcomes. For the AstraZeneca-IQVIA collaboration, IQVIA partnered with a regulatory review company Advarra to comply with IRB protocols. This partnership illustrates the diversity of CRO clinical trial services; some provide end-to-end services where others are specialized in niche offerings.
Scaling-Up Manufacturing Capacity
The COVID-19 pandemic brought the greatest vaccination campaign in history. More than 12.3 billion doses have been administered around the world. Yet there is still a huge demand to manufacture more vaccines. Alongside rapid R&D efforts, pharma companies must also meet the demands of scaling-up vaccine manufacturing capacity.
Pharma companies must produce enough vaccines to meet increasing demand, or else there will be a bottleneck effect. According to a report from LEK Consulting, three major bottlenecks include material and equipment shortages, manufacturing process complexity, and capacity constraints.
Oftentimes, pharmaceutical companies begin manufacturing in-house but then realize that they need to outsource to Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) to be able to efficiently scale production. CMOs and CDMOs must ensure that their manufacturing is tightly regulated and controlled to remain competitive, thus providing pharma companies with a marketplace of options.
Some COVID-19 vaccines use novel mRNA technology, so CMOs and CDMOs have to readily adapt to new manufacturing methods and more complex manufacturing processes.
For instance, Pfizer spent $2 billion developing its cold-chain network, as the vaccine must be stored in a negative 70 degrees freezer. Several safeguards were employed to ensure quality control, including thermal sensors with GPS so Pfizer can stop distribution of compromised vaccines. Additionally, the vaccine contains 280 ingredients from 19 countries and more than 40 individual quality control tests for each batch.
Pfizer-BioNTech vaccine manufacturing was first completed in-house, but then the pharma company realized that it needed to greatly expand its manufacturing efforts. In the United States, the CMO Exelead stepped up to help Pfizer-BioNTech meet manufacturing demands. To meet Pfizer’s demands for more vaccines, Exeland hired more manufacturing engineers, expanding its workforce from 140 to 250 people by the end of 2021.
Moderna also was able to scale-up its manufacturing efforts through a partnership with Lonza, Ltd. The partnership aims to produce 300 million doses per year out of Moderna’s 500 million doses per year goal. Moderna also partners with CDMO Catalent, which provides aseptic vial filling and packaging.
The pandemic has also accelerated adaptation of new technologies to monitor clinical trials. The top newly adopted technologies include remote monitoring, video visits, phone visits, eConsent, and electronic health records, with 82% of organizations involved in clinical research (biopharmaceuticals, CROs) responding that they thought the newly adopted clinical trial technologies had a positive impact on clinical trials overall. Additionally, previous technology infrastructure estimates for CROs for 2025 are now estimated for 2021.
We expect contracting organizations to play a greater role in the R&D and manufacturing process of vaccines. Currently existing partnerships will be deepened, and new partnerships will be established to ultimately ensure more efficient deployment of critical therapies.