Moderna (MRNA -0.91%) was the first to begin human trials of a coronavirus vaccine back in March. The clinical-stage biotech company delighted investors when it announced encouraging data from phase 1, quickly moved on to phase 2, and promised to start phase 3 in July. As a result, the stock has climbed more than 200% since the March market crash.
While Moderna remains a front-runner in the race to develop a vaccine for COVID-19, the illness caused by the novel coronavirus, the company has fallen into the shadow of big pharma. I'm referring to AstraZeneca (AZN -0.19%), which had been a rather quiet participant in the COVID-19 vaccine playing field until announcing its candidate was about to enter a late-stage trial -- ahead of Moderna. But is AstraZeneca really ahead in this race, and if so, what exactly does that mean for Moderna?
AstraZeneca entered the vaccine race in late April when it partnered with the University of Oxford. Researchers there had already been working on a candidate, and also in April, started human trials. At about this time, Moderna's phase 1 trial was well under way.
A phase 2/3 trial
In May, Moderna reported encouraging interim results and began dosing the first participants in a phase 2 trial. Most recently, the company said a phase 3 trial with 30,000 participants would begin in July. As for the AstraZeneca candidate, researchers in May began recruiting volunteers for a phase 2/3 trial. A design that combines both phases usually speeds up the trial through efficiencies in dosing or other areas. Though the use of the combination trial has helped AstraZeneca gain ground -- and may help it spring ahead eventually -- for the moment, it's fair to say both companies are neck and neck in the clinical testing timeline.
Funding is a different story. AstraZeneca has an advantage when it comes to funding through Operation Warp Speed, a U.S. government effort to help bring a COVID-19 vaccine to market by January. The Department of Health and Human Services granted Moderna as much as $483 million for the development of its vaccine, then a month later offered a whopping $1.2 billion to AstraZeneca. Both remain front-runners, according to the government's list of top candidates.
Two billion doses
Manufacturing capacity is another AstraZeneca strength. The company promises two billion doses, while Moderna said a collaboration with Lonza will allow it to produce one billion doses per year. And finally, AstraZeneca is taking steps to assure the widespread use of its vaccine. Supply agreements don't represent a financial gain for the pharmaceutical company since it has pledged to supply the vaccine without taking a profit during the pandemic. Still, the efforts can help it establish its vaccine as the market leader. The company struck a deal with Europe's Inclusive Vaccines Alliance to supply 400 million doses as of the end of the year. AstraZeneca also signed similar deals in the U.S., U.K., and India.
When it comes to commercialization time frames, comments by AstraZeneca and Moderna teams indicate they may be on track to meet the Operation Warp Speed goal. Oxford researchers say "the best-case scenario" would be the availability of phase 3 efficacy results in the fall. And Moderna says it is on schedule to deliver doses by 2021.
Though AstraZeneca might be a slight step ahead in certain areas, the key point clearly will be late-stage testing of the vaccine candidates themselves. Anything can happen in a clinical trial, so AstraZeneca and Moderna still face risks. Inefficacy, safety issues, and other problems can throw a program off track in an instant.
What would an AstraZeneca win mean for Moderna?
But let's imagine that AstraZeneca's trials proceed smoothly and this big pharma company wins the vaccine race. What would that mean for Moderna? It's likely Moderna's shares would suffer, as investors are counting on this biotech company to reach the finish line first.
But if Moderna steps past the finish line soon afterward, I think there are more stock gains ahead, mainly because successful development of this vaccine shows the company's method of using messenger RNA to instruct the body to protect itself works in humans. Moderna's entire pipeline is built around this technology, so an initial victory could be significant. Also, there is the idea that considering the depth of the COVID-19 pandemic, the world surely will need more than one vaccine. So there is room for AstraZeneca, Moderna, and others in the space.
Still, if Moderna doesn't arrive at the finish line first, the pace of share gains may slow considerably. For a stock performance anything like what we saw from March through June, Moderna will have to assure its lead in the race to develop a COVID-19 vaccine.