New Investigational Drug for COVID-19 Shows Clinical Efficacy and Safety

Despite investigating so many drugs in clinical settings, the world still does not have a potentially strong drug that can fight with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). An experimental vaccine for COVID-19, known as ‘mRNA-1273’, has already entered phase III clinical trials at 89 different U.S. clinical research sites. The two intramuscular injections of a 1-microgram (mcg) dose of the new vaccine have shown positive outcomes by making neutralizing antibodies in mice against SARS-CoV-2, says a recent study conducted by the researchers from the University of Texas at Austin with the help of scientists from Vaccine Research Center (VRC) situated at National Institute of Allergy and Infectious Diseases (NIAID). The findings of the study have been published in the journal Nature.

Previously, the new investigational vaccine that recently reached its phase III clinical trial has shown its effectiveness and safety to target the coronavirus in phase I and phase II clinical trials.

Also, the vaccine showed promising results in a recent study conducted on rhesus macaques. The two doses of ‘mRNA_1273’ drug reverse the infection caused by COVID-19 in macaques.

The researchers aimed to find out the atomic structure of the spike protein on the surface of the novel coronavirus that has plunged the world into a crisis as it affected more than 19 million people throughout the world with more than 708,000 mortality cases whereas the virus has impacted on the United States of America on a destructive level by taking above 158,000 lives. More than 4.8 million infected cases are still running into the country, according to data compiled by mixed resources including worldometer and Coronavirus Resource Center: Johns Hopkins University (CRC-JHU).

Source: Johns Hopkins University

To find the clinical efficacy of the new drug, the team collected a sample of mice that were infected with the deadly coronavirus. They experimented by injecting the vaccine mRNA-1273 on mice to observe the immune response. The scientists administered two intramuscular injections of a 1-microgram (mcg) dose of mRNA-1273 in mice after every three weeks.

Four Main Findings After Injecting mRNA-1273

  • The investigators came to know that the vaccine is giving promising results by producing neutralizing antibodies in animals.
  • The scientists also found out that the second dose of the drug showed its safety during 5 to 13 weeks by protecting the upper and lower airways including nose and lungs.
  • Another finding of the present study suggested that only one dose of 1 mcg or 10 mcg of mRNA-1273 was also found to be affected in reversing the virus from the lungs of the animals.
  • The fourth outcome revealed that the drug also induced strong CD8 T-cell response that can be defined as a serial killer of infected cells by releasing two types of proteins including cytotoxic protein and pore-forming protein perforin.
  • The drug did not induce those cellular immune responses that have been linked to vaccine-associated enhanced respiratory disease (VAERD) that can be occurred if the vaccine is not potentially strong to fight with the viral pathogens in protecting the immune system.

By taking all into account, the new investigational drug showed overall positive outcomes by reversing the effects of the deadly coronavirus from the animals and also the drug did not result in any extra diseases such as lung problems or increased mucus production.

The authors mentioned in the study: “This is a demonstration of how the power of new technology-driven concepts like synthetic vaccinology facilitates a vaccine development program that can be initiated with pathogen sequences alone”.

The pre-clinical project was conducted by a collaboration of the scientists from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the biotechnology company Moderna, based in Cambridge, Massachusetts, along with collaborators from the University of North Carolina at Chapel Hill, Vanderbilt University Medical Center in Nashville, and the University of Texas at Austin.

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