30,000 people participate in Phase 3 of this COVID-19 clinical trial, which is being carried out by the modern biotechnology company. After the previous phases, the vaccine has generated a high level of antibodies in the participants.
Vaccines
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, a US biotech company, announced that it will enter the final phase of clinical trials for a Covid-19 vaccine on July 27.
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For this phase 3 clinical trial, 30,000 people have been recruited. Half of them will receive a 100 microgram dose and the rest will receive a placebo. The purpose is to determine with certainty whether the vaccine can prevent Sars-Cov2 infection by triggering sufficient antibody production. This study will also ensure that the vaccine is safe for humans. Phase 3 can 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 be considered a success if it prevents severe cases of the disease.
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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 administered doses of 25 micrograms, 100 micrograms and 250 micrograms. Then they were given a second dose 28 days later. Three participants developed rashes on the legs and COVID-19 symptoms 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.
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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. Furthermore, all screening tests were negative. At the moment, the scientific community does not yet know the results of phase 2.
“We really need to limit 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 is conclusive, Moderna Biotech ensures that it can produce 500 million doses per year and perhaps even a billion. This study is scheduled to last until October 2022, and preliminary results will be published before then.
References
A SARS-CoV-2 mRNA Vaccine – Preliminary Report
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