The PPD clinical research business of Thermo Fisher Scientific and Moderna, whose pioneering mRNA vaccine for COVID has been administered to hundreds of millions globally, were named “Clinical Research Team of the Year” during the 2021 Citeline Awards.
As Moderna’s clinical research organization partner, the PPD team, now part of Thermo Fisher, supported Moderna’s mRNA-1273-P301 vaccine trials, including its pivotal Phase III COVE study. The study enrolled more than 30,000 participants, ages 18 and older, across 99 U.S. sites in 12 weeks in the summer/fall of 2020. The Citeline Award for “Clinical Research Team of the Year” recognizes this massive joint undertaking.
“The PPD and Moderna team worked tirelessly to deliver the COVE trial, working long days side by side in partnership,” said Melanie Ivarsson, Ph.D., chief development officer at Moderna. “We would also like to acknowledge and thank all the clinical trial investigators and staff, and all the participants who took part in the COVE trial.”
The Moderna and PPD teams worked closely with the Biomedical Advanced Research and Development Authority and the National Institutes of Health, including National Institute of Allergy and Infectious Diseases’ COVID-19 Prevention Network, to conduct the Phase III COVE study under Operation Warp Speed.
Moderna’s COVID-19 vaccine was available under emergency use authorization in the U.S. beginning in December 2020, and in January 2022, the U.S. Food and Drug Administration approved the biologics license application for the vaccine, marketed as Spikevax®, to prevent COVID-19 in individuals 18 years of age and older.
“This recognition honors our strong collaboration with Moderna and reinforces our shared commitment to develop life-saving vaccines and therapies,” said David M. Johnston, Ph.D., senior vice president and president, clinical research, Thermo Fisher Scientific. “We’re excited to continue supporting Moderna on next-generation, multivalent and variant-specific vaccines in Phase I-III studies through our infrastructure, experience and complementary services.”
The Citeline Awards recognize accomplishments across the biopharmaceutical industry and honor the highest achievers. Citeline presented the award during its annual ceremony, held in Boston.
The PPD clinical research team has supported Moderna’s research initiatives since 2016 across its expanding portfolio, including vaccines, oncology, rare diseases and autoimmune conditions. In February 2022, Thermo Fisher announced a 15-year strategic collaboration agreement with Moderna for dedicated large-scale manufacturing in the U.S. of Spikevax® and other investigational mRNA medicines in its pipeline. This expanded agreement includes dedicated capacity for a range of aseptic fill-finish services, including lyophilized and liquid filling, and inspection, labeling and final packaging services.