Finally, some good news regarding the coronavirus pandemic may be on the horizon. Not one, but two America-produced vaccines have now proven their ability to produce virus-fighting antigens and T-cells in clinical tests.
Moderna, in partnership with the National Institutes of Health, and Novavax, Inc. have developed the two current contenders. Here’s what we know about each of them and their promise for the future.
Novavax, Inc. Uses Protein-Based Vaccine
Novavax’s experimental vaccine, known as NVX-CoV2373, was announced on April 8.
It uses a unique adjuvant technology designed to neutralize the “spike protein” found on the surface of the coronavirus. This spike protein enters the host cell and causes infection, which is why NVX-CoV2373 seeks to neutralize it before infection occurs.
Novavax describes its experimental vaccine as “a stable, perfusion protein made using its proprietary nanoparticle technology.” The vaccine is designed to enhance immune response and stimulate high levels of neutralizing antibodies to render the coronavirus powerless.
The first participants were enrolled into Novavax’s Phase 1/2 randomized, observer-blinded, placebo-controlled clinical trial on May 25, 2020. The Phase 1 research assessed the safety and immune-building power of the vaccine by testing 130 healthy participants between the ages of 18 and 59. Phase 2, meanwhile, assessed immunity, safety, and COVID-19 reduction among a broader age participant age range.
Novavax announced its Phase 1 results in early August, stating that NVX-CoV2373 was “generally well-tolerated and had a reassuring safety profile.” According to the data, the experimental vaccine induced neutralization titers in 100% of participants, which is highly encouraging.
“It’s a small number of people in each arm, and the study wasn’t designed to demonstrate efficacy, which are the standard caveats for a Phase 1 trial,” said Edward Belongia, an epidemiologist and vaccine researcher at the Marshfield Clinic Research Institute in Wisconsin. “Having said that, it looks very promising — at least as promising if not more so than the other vaccines we’ve looked at.”
Moderna and NIH Launch Phase 3 Trial
In late July, Moderna and the NIH launched America’s first Phase 3 clinical trial of a coronavirus vaccine.
“Results from early-stage clinical testing indicate the investigational mRNA-1273 vaccine is safe and immunogenic, supporting the initiation of a Phase 3 clinical trial,” explained NIAID Director Anthony Fauci. “This scientifically rigorous, randomized, placebo-controlled trial is designed to determine if the vaccine can prevent COVID-19 and for how long such protection may last.”
According to the NIH, Moderna’s investigational vaccine “directs the body’s cells to express the spike protein to elicit a broad immune response” against COVID-19. Phase 1 and 2 clinical trials found mRNA-1273 vaccine to be safe and able to induce antibodies with strong virus-neutralizing activity.
Moderna’s Phase 3 clinical trial will be conducted at 100 research sites across the United States. The first patient, for example, was dosed at a site in Savannah, Georgia. About 30,000 healthy adult volunteers are expected to participate in the trial.
Volunteers will receive either two 100 microgram injections of the vaccine or a placebo about 28 days apart. Neither participants nor investigators will know who has received the vaccine compared to the placeo.
The ultimate goal of Moderna’s Phase 3 trial is to determine if the vaccine can prevent symptomatic COVID-19 after two doses. Researchers will all study the data to find whether mRNA-1273 can prevent severe COVID-19 or laboratory confirmed SARS-CoV-2 infection with or without disease symptoms.
Results may be available as soon as November, lending hope to the potential for a vaccine in early 2021.