Neucrad Health May 20, 2020
Moderna, the Massachusetts based biotechnology company, involved in the vaccine development for COVID-19 infection have revealed encouraging news about their clinical studies. In a press release issued on May 18th, 2020, the firm announced that eight candidates receiving 25 µg and 100 µg dose of their vaccine developed a sufficient level of virus-fighting antibodies in their blood circulation. Studies revealed that the level of these antibodies was similar or more than the COVID-19 recovered patients. The biotechnology company has published its data on a scientific journal. It was a significant step in establishing the safety of their vaccine. However, at this stage, it is worth pointing out that these studies are still in the preliminary stage. We may have to wait for a year or more for the commercial release of these vaccines.
What happened in phase 1 study of the Moderna vaccine?
Moderna conducted the phase 1 study of the mRNA-1273 vaccine with the aid of the National Institute of Allergy and Infectious Diseases (NIAID). 45 healthy volunteers within the age group 18 to 55, signed up for the scientific study of the development of the vaccine. On March 16th, scientists administered the first dose of this vaccine to a volunteer. After this, researchers gave two doses of 25 µg and 100 µg mRNA-1273, and a single dose of 250 µg level to their body of eight candidates and awaited for the development of antibodies in the response of the vaccine. On day 43 of 25 µg and 100 µg dose level, and day 29 of 250 µg level dose, researchers confirmed a high level of neutralising antibodies in their blood.
How did the candidates react to the administration of the mRNA-1273 vaccine?
All the eight candidates tolerated the 25 µg and 100 µg dose of mRNA-1273 vaccine in their body without any significant adverse reactions. Only a single participant receiving 100 µg dose developed grade 3 erythema (redness) near the immunisation site. Three participants receiving the 250 µg dose level developed some systemic symptoms. However, all these medical issues were transient and self-resolving within a few days. There were no reports of any grade 4 adverse reactions among the vaccine candidates.
Now scientists are eagerly waiting for Phase 2 and Phase 3 study of the mRNA-1273 vaccine. There is speculation, that in Phase 2, two dose levels, 50 µg and 100 µg, and in Phase 3, 25 µg and 100 µg dose of the vaccine will be studied in detail on a wide range of participants. The Phase 3 study will commence from July 2020 onwards.
What is the scientist community excited about the mRNA-1273 vaccine?
Researchers at Moderna are developing an mRNA-1273 vaccine to work against the SARS-CoV-2 virus. Scientists at the Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID) are also collaborating with Moderna in this vaccine development programme. The U.S. Food and Drug Administration (FDA) reviewed the working of the mRNA-1273 vaccine on May 6th and allowed them to further go ahead with their studies. Moderna has long been associated with the development of prophylactic vaccines against various infectious diseases. They are also developing immunisation against other viruses like Human metapneumovirus (hMPV), Respiratory syncytial virus (RSV), and Influenza H7N9 (mRNA-1851). The advantage of initiating research on mRNA of the SARS-CoV-2 virus is, it is convenient to combine several mRNAs in a single injection, they respond rapidly, and have manufacturing agility.
This was all about the result of the Phase 1 clinical study of the mRNA-1273 vaccine developed by Moderna. Stay tuned to Neucradhealth to know about the latest development of the COVID-19 pandemic.