COVID Vaccine Set for New Trial with 30,000 Participants

American biotech company, Moderna Inc., and the National Institute of Allergy and Infectious Diseases (NIAID), have just announced the publication of the results of a Phase 1 trial of their COVID-19 vaccine. The results, published in The New England Journal of Medicine, showed an appropriate immune response from all participants, as well as no “trial-limiting safety concerns.” These positive results pave the way for a new trial that’s set to begin on July 27 and include 30,000 participants.

The study outlining the Phase 1 trial and results, which comes via AP News, included 45 healthy adults. Three groups of 15 adults, ages 18 to 55, took part. One received 25 micrograms of the vaccine; one received 100; and one received 250. Doctors distributed the vaccine in two doses.

All three groups showed an immune response to the vaccine, which has the designation of mRNA-1273. As its name implies, mRNA-1273 is an RNA vaccine that aims to develop immunity in patients with the introduction of an RNA (or Ribonucleic acid) containing vector, such as a lipid nanoparticle.

Essentially, this RNA vaccine works by injecting a patient with vectors that contain the RNA sequence of SARS-CoV-2. The vectors infiltrate a patient’s cells, allowing said cells to identify and make copies of the SARS-CoV-2’s spike proteins. These cells, which develop the same spike proteins, then interact with the body’s immune system. This allows it to generate suitable antibodies.

The lead author of the study, Dr. Lisa Jackson of the Kaiser Permanente Washington Research Institute in Seattle, told AP News that these results are “an essential building block that is needed to move forward with the trials that could actually determine whether the vaccine does protect against infection.”

Although the study doesn’t identify any trial-limiting safety concerns, some participants did experience mild to moderate adverse side effects. Those adverse effects, which more than half the participants experienced, included fatigue, chills, headache, myalgia (muscle pain), and pain at the injection site. Three participants in the 250-microgram group also “reported one or more severe adverse events”. One even reported a fever of 103 degrees Fahrenheit, which experts consider severe.

On July 8, Moderna announced that it had already completed participant enrollment of the Phase 2 study for the vaccine. This second phase, which is ongoing, includes 300 young adults (18 to 55) and 300 older adults (55 and up), with each participant receiving a placebo, a 50-microgram dose of the vaccine, or a 100-microgram dose. Thirty of the older participants enrolled are 71 and up, as “additional evidence for the potential of a vaccine to protect this population is an urgent priority.”

Looking forward, Moderna plans to execute its Phase 3 trial beginning on July 27 with approximately 30,000 participants receiving 100-microgram doses of the vaccine. If Moderna’s vaccine is ultimately approved by the FDA, the company says it could deliver “possibly up to 1 billion doses per year, beginning in 2021.”

What do you think about mRNA-1273 as a potential COVID-19 vaccine? Do you think this vaccine will indeed be able to hit the market in early 2021? Let us know your thoughts in the comments!

Feature image: SELF Magazine 

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