In response to the COVID-19 outbreak, researchers and technology transfer professionals at the National Institute of Allergy and Infectious Diseases (NIAID) accelerated collaborations with COVID-19 vaccine developers that enabled the rapid study, emergency authorization and public use of urgently needed vaccines.
The results of these efforts became evident between December 2020, when the COVID-19 vaccination campaign began, and April 2021, when the rate of dose administration peaked. During that period, the number of COVID-19 cases in the United States dropped precipitously. It is estimated that global vaccination against COVID-19 could prevent several trillion dollars per year in economic losses.
The technology transfer effort began shortly after the genetic sequence of Moderna’s first vaccine candidate (mRNA-1273) was finalized and appropriate preclinical data had been obtained. NIAID’s Division of Microbiology and Infectious Diseases (DMID) took the lead as the sponsor of the “first in human” clinical study of this experimental vaccine.
In parallel with development of the clinical study protocol, DMID and the NIAID Technology Transfer and Intellectual Property Office (TTIPO) rapidly negotiated a Clinical Trial Agreement (CTA) with Moderna to obtain mRNA-1273 for the study. The first Phase I trial participant was dosed on March 16, 2020 — just five days after the COVID-19 outbreak was declared a pandemic. Positive findings from this trial led to Phase II and Phase III trials that were supported by funding from the Biomedical Advanced Research and Development Authority (BARDA). The Phase III trial used NIAID’s newly formed COVID-19 Prevention Trials Network (CoVPN).
Based on the outcomes of these trials, on Dec. 18, 2020, the Food and Drug Administration (FDA) granted mRNA-1273 Emergency Use Authorization (EUA) for the prevention of COVID-19 in individuals aged 18 years and older.
Based on the NIAID trials, in December 2020 the FDA granted mRNA-1273 Emergency Use Authorization for the prevention of COVID-19 in individuals aged 18 years and older.
SARS-CoV-2 variants and pediatric populations represent two classes of indications that remain to be fully addressed. TTIPO negotiated an amendment to the CTA with Moderna that enabled evaluation of new vaccine candidates against COVID-19 variants. In addition, TTIPO negotiated a new CTA with Moderna to initiate a trial (the KidCOVE Study) of the company’s original vaccine in children aged 6 months to 12 years.
DMID initiated another adaptive protocol for the “MixNMatch” vaccine trial to evaluate delayed doses (boosts) of a vaccine other than the one initially administered. TTIPO developed new agreements to cover the vaccine candidates included in this study.
If many of these clinical trials produce positive safety and efficacy results, a larger proportion of the US and global population could receive COVID-19 vaccines or booster shots to improve their collective immunity against SARS-CoV-2. These efforts, in part, could help end the COVID-19 pandemic.
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