Thanks to an unprecedented partnership between the U.S. government and private companies, America is developing effective treatments and vaccines for COVID-19 at a record pace.
National Institutes of Health Director Francis S. Collins, MD, PhD, detailed the most promising treatments and vaccines—along with a projected timeline those will be ready—during a live JAMA Network YouTube event on May 19.
As part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, NIH’s role is to “figure out how to accelerate treatments and vaccines, to see what we can do to shorten what otherwise is going to be a painfully long process,” Collins said.
Four or five vaccine candidates show promise of being ready for production quickly—possibly as early as this fall, he noted. Plus, several pharmaceutical manufacturers are close to obtaining FDA approval for their monoclonal antibody therapies, which utilize antibodies from patients recovered from COVID-19.
“Remdesevir was okay, now let’s get something that really works,” Collins said. “Monoclonal antibodies derived from people who survived…and maybe cell-based therapies are pretty darn effective.”
More than a dozen companies are developing monoclonal antibody treatments and are “some are pretty close to being ready,” Collins said. “Regeneron and Eli Lilly said they are close. I’ll be optimistic and say maybe by August we will start to see results.”
Plus, the Therapeutics Clinical Working Group of ACTIV is presenting six to eight of the most promising therapeutic agents that should be tested in clinical trials to treat COVID-19 to ACTIV’s executive committee on May 20.
The working group of 25 people—about half from NIH and academia and half from the private sector—First had to sort through a list of more than 600 potential treatments. “They got it down to 170, then a little less than 40, and now have come up with six to eight that are most promising for clinical trials,” Collins said.
“If they agree, those will need to go quickly into large-scale clinical trials. We don’t want to wait,” he added.
ACTIV’s Preclinical Working Group is focused on therapeutic agents that were developed to treat other conditions. The agents would have already been tested in human trials somewhere else and have passed through the FDA approval process, Collins explained. “Maybe in that pile of compounds, will be something that [can be] very effective to treat SARS-CoV-2.”
Collins also lauded the breakneck pace at which the NIH, other government agencies, and pharmaceutical manufacturers are developing vaccines.
“Fortunately, the U.S. is in the situation to scale up the manufacture of vaccines even before you know they are going to work — maybe as early as the fall with billions of doses; that is the hope,” Collins said. “I don’t want to be over the top in confidence about that, but I can ensure you that everyone in the public-private partnership is doing everything they can to make that happen.”
For example, Moderna just released positive interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2), from its Phase 1 study led by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID).
Moderna plans to start its Phase 3 study in July and, if successful, file a BLA [biologics license application], Moderna CEO Stéphane Bancel said in the press release. “We are investing to scale up manufacturing so we can maximize the number of doses we can produce to help protect as many people as we can from SARS-CoV-2.”
“These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 µg,” said Tal Zaks, MD, PhD, chief medical officer at Moderna. “When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials.”
In a new JAMA Viewpoint, Colins and Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson, explained how ACTIV’s Vaccine Working Group is developing a harmonized master protocol for adaptive trials of multiple vaccines.
The FDA is “very onboard” with the accelerated pace of vaccine development, Collins noted, but challenges persist. “You have to find 10,000 healthy volunteers for each vaccine platform and you have to test it in a place that the vaccine is actively circulating. You won’t know if it works if the vaccine is not actively around them,” Collins said.
Fortunately, SARS-CoV-2 is not changing as rapidly as influenza changes, so there is not much concern that a vaccine developed now would not be effective in two years or more, Collins added.