Moderna is one of several pharmaceutical and biotech companies receiving support from Operation Warp Speed to develop a COVID-19 vaccine before the end of the year.
The federal government announced the creation of Operation Warp Speed in May, describing it as a national program designed to “accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.”
A total of $472 million of funding for Operation Warp Speed was directed specifically for the Phase 3 study and development of Moderna’s promising vaccine. At the end of September, the federal government’s investment appeared to pay off when Moderna reported positive results from an early safety study of its vaccine candidate in older adults.
What is Moderna’s Investigational Vaccine?
Moderna’s investigational vaccine is known as mRNA-1273. 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.
Phase 3 Trial Is Already Underway
Moderna’s Phase 3 clinical trial is being conducted at 100 research sites across the United States. The first patient was dosed at a site in Savannah, Georgia. About 30,000 healthy adult volunteers are expected to participate in the trial.
Volunteers 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 placebo.
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.
New Clinical Trial in Older Adults Indicates Safety
Moderna’s Phase 3 clinical trial was followed by an early safety study of the vaccine in older adults. This study was an extension of Moderna’s original Phase 1 safety trial that tested the vaccine in participants aged 18-55. It increased the age group of participants to adults ages 56 to 70, and ages 70 and older. According to preliminary results, mRNA-1273 produces virus-neutralizing antibodies at levels similar to those seen in younger adults. That’s big news for the potential protective nature of this vaccine, especially for older adults whose immunity weakens with age and time.
However, side effects do occur. Clinical trials indicate headache, fatigue, body aches, chills and injection site pain after the vaccine. Most participants reported that the symptoms remained mild to moderate, but at least two volunteers had severe reactions.
“This is similar to what a lot of older adults are going to experience with the high dose influenza vaccine,” explained Dr. Evan Anderson, one of the study’s lead researchers from Emory University in Atlanta.