30,000 people are participating in Phase 3 of this COVID-19 clinical trial, which is being conducted by the biotech company Moderna. After the previous phases, the vaccine has generated a high level of antibodies in the participants.
The race for the vaccine is accelerating. Since the beginning of the COVID-19 epidemic, scientists around the world have been working to develop an effective vaccine to stop this global pandemic. On Tuesday, July 14, Moderna an American biotechnology company announced that it will enter the final phase of clinical trials for a Covid-19 vaccine on July 27.
For this Phase 3 clinical trial, 30,000 people have been recruited. Half of them will receive a dose of 100 micrograms and the others will receive a placebo. The Purpose is to determine with certainty whether the vaccine can prevent infection with Sars-Cov2 by triggering sufficient antibody production. This study will also ensure that the vaccine is safe for humans. Phase 3 may also provide an indication of whether the vaccine can prevent disease progression in a person who would still be infected.
Even if symptoms are present, the vaccine can indeed be considered a success if it prevents severe cases of the disease.
Positive intermediate results
Initial results from previous studies are encouraging, according to the article published in the New England Journal of Medicine. In Phase 1, the vaccine triggered the production of antibodies against the virus in all 45 trial participants. These 45 people were divided into three groups of 15 people each, who were given doses of 25 micrograms, 100 micrograms, and 250 micrograms. They were then given a second dose 28 days later. Three participants developed rashes in their legs and symptoms of COVID-19 after the first injection.
After the initial results, more than half of the participants also reported post-vaccination side effects: fatigue, pain at the vaccination site, headaches, etc.
The researchers found that the higher the prescribed dose, the higher the antibody levels. After the second injection, participants had higher antibody levels than former Covid-19 patients. In addition, all screening tests were negative. At the moment, the results of phase 2 are not yet known to the scientific community.
“We really need to limit the extrapolations from a Phase 1 clinical trial because we want to see how it works when a person is exposed to the real virus,” said Amesh Adalja, an infectious disease specialist at Johns University.
If Phase 3 proves conclusive, Moderna Biotech assures that it can produce 500 million doses per year and perhaps even 1 billion. This study is now scheduled to last until October 2020, with preliminary results to be published before that date.