Novavax Gets $1.6 Billion to Expedite COVID vaccine
The U.S. Department of Health and Human Services (HHS) along with the Department of Defense (DoD) announced it will be investing $1.6 billion to Fast-track a COVID vaccine. According to their Press Release the pharmaceutical company, a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, was selected to participate in the government program Operation Warp Speed. The objective of Operation Warp Speed (OWS) is to produce a coronavirus vaccine as quickly as possible and a goal of delivering 100 million doses before the end of 2020.
Novavax says its protein-based vaccine works by stimulating the immune system to produce high levels of neutralizing antibodies. Similar vaccines have been successful against other diseases, such as hepatitis B. “Adding Novavax’ candidate to Operation Warp Speed’s diverse portfolio of vaccines increases the odds that we will have a safe, effective vaccine as soon as the end of this year,” said U.S. Health and Human Services Secretary Alex Azar. “Today’s $1.6 billion investment supports the Novavax candidate, depending on success in clinical trials, all the way through to manufacturing 100 million doses for the American people.”
The Three Phases of Clinical Trials?
Clinical trials of vaccine candidates follow a rigorous series starting at early, small-scale, Phase 1 studies to late-stage, large-scale, Phase 3 studies. If a drug is successful in one phase, it moves on to the next phase.
Phase I – safety testing in a small cohort of 10-50 people
Phase II – investigate immune response in a larger cohort
Phase III – large group trials begin with (sometimes) thousands of people. This stage alone can take years as the vaccine candidate must show significant protection against infection.
Novavax’s COVID-19 vaccine candidate, NVX‑CoV2373, is currently in a phase 1/2 study which creates a seamless transition between trial phases. This allows research questions to be answered more quickly and with fewer patients. NVX‑CoV2373 demonstrated encouraging results in preclinical testing, including a significant immune system response and high levels of neutralizing antibodies that bind to the novel coronavirus and block infection. If all goes well, Novavax hopes to initiate a phase 3 clinical study with up to 30,000 participants in the fall. Government funding means it will not have trouble covering the costs of such a large-scale trial.
Fast-Tracking Vaccine Risk
While finding a vaccine for COVID-19 is urgent and highly desirable, scientists warn that bypassing essential clinical trial stages could have catastrophic consequences. Much of the required time is related to the pace of proper clinical trials which, by most estimates, could take 12 to 18 months. In an article published on Science Advances, St. Jude Children’s Research Hospital immunologist, Douglas Green, sites a large fast-tracked trial of a vaccine for RSV that caused the immunized cohort to suffer even worse symptoms upon infection. Research conducted much later showed that the vaccine failed because it did not generate the necessary protective antibodies as the immune system had not been properly primed against the virus. Green cautions that accelerated testing must be weighed against potential benefits.
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