Operation Warp Speed and the Search for a Cure
This week Moderna Therapeutics announced positive results from its Phase 1 trial of a novel coronavirus vaccine candidate. Over 43 days, 45 patients were given different doses of a vaccine developed using messenger RNA (mRNA). All 45 patients developed binding antibodies to the novel coronavirus — and those given a 100 micrograms dose had significantly higher antibody levels than people who have recovered from COVID-19.
The vaccine candidate, mRNA-1273, was generally safe — any adverse reactions were transient and self-resolving. The vaccine will begin the Phase 2 trial soon, followed by the pivotal Phase 3 trial in July.
It is unclear whether these antibodies confer immunity in humans. The binding antibody results were positive, but neutralizing antibody data was only available for the first four participants in the 25 micrograms and 100 micrograms cohorts. For this subgroup, the neutralizing antibody results aligned with the binding antibody results — all eight participants had neutralizing antibodies at or above levels observed in those who have recovered from COVID-19.
This welcome news boosted Moderna’s stock price by 20%. It’s encouraging that a viable vaccine candidate has emerged this early in the process. Anthony Fauci, MD, director of the National Institute for Allergy and Infectious Diseases, recently acknowledged the importance of mRNA-1273, telling National Geographic on May 4, “These vaccines are inducing, at least in animal models, really rather substantial immune responses, particularly the mRNA vaccine. When we look at the immune response that you can induce with a modest dose — one that’s feasible to be translated into humans — and the amount of time it takes to get to that level of immunity, it is really quite impressive. It is also really easy to scale up with [mRNA-1273], in the sense of making a lot of doses pretty quickly.”
If mRNA-1273 passes the Phase 3 trial, Moderna will file a Biologics License Application (BLA) to receive approval to produce and distribute the vaccine. If approved, the Army will play a vital role in ensuring it is distributed throughout the United States.
President Donald Trump recently announced that Gen. Gustave Perna, commander of Army Materiel Command, will co-lead the U.S. effort to find, produce, and distribute a vaccine for the novel coronavirus. The effort, dubbed, “Operation Warp Speed,” is tasked with finding and producing 300 million doses of the vaccine and then distributing it across the United States by early next year.
In the press conference announcing the decision, Defense Secretary Mark Esper said, “We will deliver, by the end of this year, a vaccine, at scale, to treat the American people and our partners abroad.”
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Brennan Randel
@BrennanRandel
