Data is finally in from completed small-scale trials of a leading novel coronavirus vaccine, and the news is good. The vaccine candidate, from Massachusetts-based pharma Moderna, produces antibodies.
But there’s a lot of testing left to do, not only for Moderna’s vaccine but also for the five other top vaccine candidates that the U.S. government is backing as part of Operation Warp Speed, the feds’ $13-billion vaccine and therapy push.
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Officials surely are breathing a sigh of relief. At the very least, the Moderna vaccine didn’t fail in early trials. That alone is reason to celebrate. Still, there are glaring questions about how this new kind of vaccine will be stored and shipped—if and when it clears the trial process.
“In the world of vaccine-development, there are a lot of go, no-go decisions,” Paul Offit, chief of the division of infectious diseases at the Children's Hospital of Philadelphia, told The Daily Beast. “This says, ‘Continue work on the vaccine.’”
There’s still a lot scientists don’t know about Moderna’s vaccine, a so-called “messenger RNA” vaccine that carries a delicate, man-made strand of genetic material that should, in theory, encourage the immune system to produce protective antibodies.
MRNA vaccines are a new, unproven technology. Even if Moderna’s vaccine is safe and works—and very early indications are positive on both fronts—it’s unclear just how well and how long it might work, and how the pharmaceutical industry will ship, store, and administer it. MRNA vaccines will probably require careful handling and cold storage to remain viable prior to dosing.
Moderna’s initial trial involved 45 test subjects in three groups of 15, with each receiving a different dosage. Testers administered two doses of the vaccine over a two-month period, then checked for antibodies and adverse effects. They published their initial findings, which they had teased back in May, in The New England Journal of Medicine on Tuesday.
“After the second vaccination, serum-neutralizing activity was detected by two methods in all participants evaluated,” the testers wrote. The 100-microgram dosage worked the best, and the quantity of antibodies roughly matched the antibody level the testers observed in blood plasma drawn from recovered COVID-19 patients.
Tests also revealed that the second dose of the vaccine was crucial to producing antibodies.
There were some negative side effects, the testers reported. “Solicited adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site.” One 29-year-old man in Seattle reported suffering a severe fever after participating in a trial of Moderna’s mRNA vaccine.
Vaccine experts canvassed by The Daily Beast said they’re cautiously optimistic, at least from an immunization standpoint.
“There’s still a long road ahead of us, but this is about as much good news as we could have hoped for from the early-stage study,” Keith Jerome, a University of Washington virologist, told The Daily Beast.
“The next phases will be critical,” Jerome added. “We’ll be able to make sure that the vaccine is safe in a larger group of recipients, start to get a sense of how long the antibodies last, and most important, find out once and for all whether the antibodies protect from future infection and COVID-19 disease.”
Moderna began large-scale, phase three trials—the last before potential FDA approval—involving tens of thousands of test subjects last week in the United States. Operation Warp Speed’s goal is to produce 300 million doses of a safe, effective vaccine by January 2021. Anthony Fauci, the head of the National Institute for Allergy and Infectious Diseases, stressed that the January goal was “aspirational, but it’s certainly do-able.”
To that end, the feds have tapped five other companies for major federal support: a consortium of AstraZeneca and Oxford University, Johnson & Johnson, Merck, Pfizer, and Novavax.
AstraZeneca and Oxford have already begun large-scale, phase-three trials in the United Kingdom, Brazil, and South Africa. Pfizer (also with an MRNA candidate) and Johnson & Johnson plan to begin their own large-scale trials later this month. Novavax is currently in phase-one and -two trials with its vaccine and expects to begin phase-three trials with 30,000 patients in the fall.
Operation Warp Speed officials have been saying for weeks that Moderna is ahead of the other companies in developing a vaccine. But the feds stressed the importance of simultaneously testing multiple vaccine candidates. “The more horses you put in the race, the more likely you are to win,” Offit explained.
Several of the leading pharmas have already begun manufacturing doses in the hope of having sizable stockpiles if and when the FDA approves their vaccines. In June, Moderna announced a new partnership with New Jersey-based medical-manufacturer Catalent to begin setting up vaccine production facilities.
The company will need to figure out how to handle doses of the mRNA vaccine. “This is an unstable molecule,” Offit explained. In a laboratory setting, testers store the vaccine at temperatures as cold as -110 degrees Fahrenheit.
That could pose problems if and when Moderna gets the go-ahead to distribute its vaccine.
“Storage is likely an issue,” Lola Eniola-Adefeso, a University of Michigan bio-engineer, told The Daily Beast. “The vaccine will need to be refrigerated to maintain stability.”
Moderna did not respond to a request for comment about its plan for handling the vaccine. But production, shipping and storage are moot issues if the mRNA vaccine doesn’t work on a large scale—and safely.
Only time, and a lot more testing, will tell, Offit stressed.
“There’s a lot of room between 15 people and 500 million doses,” he said.
