Vaccine researchers are fervently working behind the scenes to hustle a COVID-19 shot to market. Dozens of projects are in the works. FiercePharma convened a panel of experts to assess progress—and outline the challenges that remain.
In a conversation streamed live Monday, Kizzmekia Corbett, the scientific lead for the coronavirus program at the National Institute of Allergy and Infectious Diseases’ Vaccine Research Center, said her team’s mRNA project—in partnership with Moderna Therapeutics—entered the clinic 66 days after they received the viral sequence, a "world record” as far as she knew. That timeline compares with the team's own record of six months for Zika.
In all, about 50 vaccines are in early development across the biopharma landscape, and researchers are exploring about 10 different vaccine approaches, said Jim Mayne, vice president of science and regulatory advocacy at PhRMA.
“Not only is it important that we’ve got 50 shots on goal, but it’s important that there are different novel approaches being taken,” he said. That type of “variety” bolsters chances of success.
Among those projects are two at Sanofi, plus Pfizer’s partnership with BioNTech. GlaxoSmithKline is letting other players use a proprietary adjuvant as well, Michael Breen, associate director of infectious diseases at GlobalData, pointed out.
“Across the whole industry we are seeing lots of coordination,” Breen said. “This is actually a proven method for success in vaccines for pathogens related to outbreaks." Consider Merck’s Ebola vaccine Ervebo, which started at a research institute in Canada. NewLink Genetics licensed the prospect, then Merck picked it up, and finally—years later—it won FDA approval in December.
The Moderna partnership hopes to continue moving much faster than that. The team has a “fairly robust” amount of immunogenicity data from animal models, Corbett said, and it's been in human testing for about two weeks, so early samples are starting to come back for analysis. As for next steps, the team is “putting together the type of data package that we need to get IND clearance for phase 2,” Corbett said on the panel, referring to the filing for agency approval to move ahead.
While cautioning that timelines are tentative, she said the vaccine may be able to reach healthcare workers in the fall and then a general population in 12 to 18 months. That’s with “every single piece of the puzzle going well” along the way.
On potential timing for a novel coronavirus vaccine, Breen agreed that it'll depend on “how well any of the vaccines work.”
If the Moderna vaccine already in testing is successful and it’s “rushed through development and emergency plans are put in place for approval,” it’s possible we could see the vaccine in a year, Breen said. But in vaccine R&D, trial hiccups are “more of the rule than the exception,” and setbacks could slow things down to 18 months and beyond, he said.
As for challenges in the vaccine hunt, Breen cited one that’d actually be a favorable outcome during the pandemic. He said that “should our social distancing measures work, we could actually see a decline in the number of cases such that it’s difficult to demonstrate the efficacy of a vaccine.”
In other diseases such as dengue, he explained, you can run a trial “any day of the week” because there are so many cases. But if COVID-19 cases start declining, it could be “really hard to prove a vaccine worked.” Plus, with so many vaccines in development, a dwindling number of cases might make it difficult to trial all of them.
There are at least two other potential challenges or roadblocks, panelists said. One is scaling up from clinical supply levels to a commercial product in the millions or even billions of doses. Johnson & Johnson, in partnership with the Biomedical Advanced Research and Development Authority, Monday committed to building capacity so it can make 1 billion doses of its vaccine should it be approved, Mayne pointed out.
“Many of these companies are not waiting to see what the results are from the definitive clinical studies,” Mayne said. “They’re creating the manufacturing capacity ahead of time, at risk, at expense, to make sure that if they are successful the [vaccines] will be available as rapidly as possible.”
Another challenge is vaccine-induced enhancement, Corbett said, where the vaccine could actually make a patient’s response to the infection worse. She’s faced numerous questions on the topic recently, but said she thinks the group is on the “right track.”
The perspectives come as the pandemic worsens around the globe and in the U.S. As of Tuesday, cases worldwide passed 800,000, and deaths passed 39,000, according to Johns Hopkins University.