In 2018, it closed a $604 million IPO, the biggest ever for a biotechnology company. Moderna spent years exciting investors with its mRNA platform and endeavoring to live up to it. The mRNA vaccines prompt human cells to produce the protein, recognize it as a foreign antigen and make antibodies, mimicking the natural immune response to a viral infection. mRNA encodes a protein-in the case of COVID-19 vaccines it is the SARS-CoV-2 spike protein, which the virus needs to bind and invade human cells. The first two COVID-19 vaccines granted an EUA are based on the mRNA platforms pioneered by Moderna and German immunotherapy company BioNTech, which partnered with Pfizer for clinical development, manufacturing, commercialization and distribution of vaccines for COVID-19 in March 2020. Pandemic proving groundĪll three COVID-19 vaccines that have been issued EUAs by the FDA are built on platforms so new that they still haven’t produced a fully approved vaccine in the USA (Fig. For one, in the USA, the experience of previous viral outbreaks prepared government agencies such as the Food and Drug Administration (FDA), which carved a clear regulatory path for vaccines via Emergency Use Authorizations (EUAs), and the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), which handled vaccine procurement under Operation Warp Speed. Other factors were important as well, Nabel says. “Those two things together gave a lot of insight.” For example, “There really has been an explosion in our understanding about both the determinants of viral spikes that can be recognized by neutralizing antibodies, and the mechanisms by which viruses can enter cells,” he said. According to Nabel, improved understanding of both viruses and human immunology over the past few decades has allowed for the rational design of vaccines in a way that was never possible before. Nabel cofounded ModeX in 2020 after leaving Sanofi, where he had been CSO since 2012, following more than a decade as head of the Vaccine Research Center at NIAID. The foundation for the latest wave of vaccine technologies rests on government and industry investments in basic research and novel technology platforms, says Gary Nabel, President and CEO of multispecific immunotherapy company ModeX Therapeutics.

But it also laid bare the work left to do to prepare for the future. In one regard, the timing of the pandemic was fortuitous, in that novel vaccine technologies that could be rapidly applied to respond to the threat had already been evaluated in clinical trials. RNA vaccine company Moderna was shipping vials for clinical testing at the US National Institute of Allergy and Infectious Disease (NIAID) just 6 weeks after accessing a draft of the virus’s genome, built upon decades of research and platforms years in the making. The pace of development for vaccines against SARS-CoV-2 was extraordinary.

New findings about covid vaccine