The highly contagious coronavirus disease (COVID-19) outbreak has not only impacted health systems, economies and governments, it has also rapidly grown into a global health crisis that is now threatening the lives of millions of people. And as of now, there is no clear evidence that any pharmaceutical drug with proven clinical efficacy has been developed that can fight against the deadly virus.
Recently, the investigational drug for COVID-19 known as ‘mRNA-1273’ has entered phase III trial that will be held at 89 different U.S. clinical research sites, aimed at enrolling around 30,000 non-infected adults, says a recent report published by the National Institutes of Health (NIH).
We’re excited to announce the start of a phase 3 clinical trial of investigational vaccine mRNA-1273 for #COVID19, co-developed by @NIAIDNews and @Moderna. It will assess safety and preventive power, enrolling 30k+ volunteers over the next 3 months https://t.co/r1Li3GhSw3
— NIH (@NIH) July 27, 2020
Previously, the investigational drug mRNA-1273 for the novel coronavirus has shown safety and effectiveness in targeting COVID-19 in its Phase I and Phase II trials. The results from early trials showed that the drug has made antibodies with high levels of virus-neutralizing activity. So, the initial positive outcomes support the drug to further inquiry. Therefore, the drug that co-developed by the Cambridge, Massachusetts-based biotechnology company Moderna and the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH has now entered its phase III trial.
Moderna’s vaccine was among the first to begin testing in humans. There currently are at least 25 vaccines that have advanced to human studies and another 141 that are being tested in a laboratory, according to the WHO. pic.twitter.com/Kmm6zPQkRv
— Arielle Mitropoulos (@AMitrops) July 28, 2020
The experts have designed a rigorous, randomized, placebo-controlled trial to check the efficacy and potency of the drug. The trial has been started on Monday in which scientists have aimed to collect approximately 30,000 healthy adult volunteers for the testing of the drug and planned to make an effective vaccine by the end of 2020.
Out of the total 89 research sites in the US, 24 sites are the part of NIH Coronavirus Prevention Network (CoVPN) that will also participate in the phase III trial for the COVID-19 vaccine. The investigators from CoVPN will collect the data from the high rated infected areas. The red zoned areas will be gained from public health data and incidence trajectory modeling.
Every month through fall, the government-funded COVID-19 Prevention Network will roll out a new study of a leading candidate. https://t.co/lCm1ydvCBb
— HuffPost Women (@HuffPostWomen) July 27, 2020
How mRNA Works and Major Goals behind 3rd Trial
Experts from NIAID have developed the stabilized SARS-CoV-2 spike immunogen (S-2P) that has been the primary focus, considered as the ideal target for COVID-19 immunotherapies as it is a specific type of antigen that has a potential to evoke an immune response.
The investigators will collect the nasopharyngeal swab and blood samples of the volunteers after applying every dose of the drug to find out the immune responses to COVID-19 that has plunged the world into a crisis like no other virus. COVID-19 has affected nearly 16.5 million people throughout the world with more than 654,000 mortalities whereas the virus has impacted the United States of America on a destructive level by taking above 148,000 lives. Almost 4.3 million infected cases are still running into the country, according to data compiled by Coronavirus Resource Center: Johns Hopkins University (CRC-JHU).
Ass for the 3rd trial, the team will divide the data into two groups. The first group will have those non-infected volunteers that will be injected with the 100 micrograms (mcg) of mRNA1273 after every 28 days. On another hand, the second group or the placebo will be received a placebo saline solution which is a mixture of sodium chloride in water.
1st Goal: However, the first goal of the team of experts to use two doses of the investigational drug and then check the feasibility and safety of the drug that whether it can counter with the symptomatic coronavirus or not.
2nd Goal: The second goal is to inspect whether the drug can remove the virus completely from the body if the person is with or without the symptoms of the COVID-19.
3rd Goal: As per the third aim, the experts will also test to investigate whether the vaccine is potentially strong to save the infected population from death or not. Also, to find out if only one dose of the drug is effective or there will be a need for the second dose.
The volunteers will also be provided by a diary and thermometer to write down every symptom after applying the drug and to measure the body temperature, respectively. If any of the volunteers will be suspected of COVID-19, the team will administer swab sampling and if the person tested positive for COVID-19, he/she will be provided with every care and medical facility.
NIH Director Francis S. Collins, M.D., Ph.D. said: “Having a safe and effective vaccine distributed by the end of 2020 is a stretch goal, but it’s the right goal for the American people. The launch of this Phase 3 trial in record time while maintaining the most stringent safety measures demonstrates American ingenuity at its best and what can be done when stakeholders come together with unassailable objectivity toward a common goal.”