Moderna American Biotech Company announced on Tuesday that human trials will begin on July 27, which is the third phase of the experimental coronavirus vaccine, an mRNA vaccine, according to details posted on clintrials.gov database.
The Phase 3 test will assess how the vaccine can protect humans against the SARS-CoV-2 virus which causes COVID-19. Moderna became the first company in the United States to declare an estimated start date for the Phase 3 trial.
Shares of Moderna company – which will begin the Phase III Covid-19 vaccine test on 30,000 patients on July 27 – rose 9% in initial trading on July 15.
Moderna company declared the publication of an interim report of its open-label Phase 1 study of its COVID-19 vaccine candidate, mRNA-1273, in the New England Journal of Medicine. According to the company’s website data, mRNA-1273 has induced a rapid and strong immune response against the SARS-CoV-2 virus.
US President Donald Trump tweeted about the vaccine on Wednesday stated that the biotech company Moderna’s experimental vaccine against COVID-19 showed safe, effective, and stimulated an immune response in the early stages of the vaccine on 45 healthy volunteers.
Moderna’s COVID-19 drug is safe and induced immune responses
Massachusetts-based biotechnology company, Cambridge, stated that mRNA-1273 was generally safe and tolerable, and reported no serious side effects on day 57. The interim analysis evaluated a two-dose vaccination. The mRNA-1273 schedule is given for 28 days at three dose levels (25, 100, 250 μg) in 45 adult participants aged 18-55 years and reports the results by day 57.
The trial was conducted by the National Institute of Allergy and Infectious Diseases (NIAID) which is a part of the National Institutes of Health (NIH).
M.D, Ph.D., Chief Medical Officer of Moderna, Tal Zaks stated: “Phase 1 positive data confirm that vaccination with mRNA-1273 elicits a strong immune response at all dose levels and supports the selection of 100 micrograms in the initial regimen and boosts as the optimal dose to phrase 3 study”.
He further affirmed that ” to demonstrate our vaccine’s ability to dramatically reduce the risk of COVID-19 we look forward to commencing our Phase 3 study on mRNA-1273 this month”.
These positive Phase 1 data are inciting and showing an important step in the clinical development of mRNA-1273, our COVID-19 vaccine candidate, and we grateful the NIH for their continued cooperation.
The Moderna team is still focused on starting our Phase 3 study this month, and “if successful, filing a BLA,” stated Stéphane Bancel, CEO of Moderna, appending that the company is committed to advancing the progress of clinical mRNA-1273 as quickly and confidently as possible while investing in the scale of production so that we can help address this global health emergency.
Phase 3 trials evaluate the efficacy and safety of the mRNA-1273 vaccine
The Phase 3 trial will involve 30,000 participants in the United States, half of whom receive the vaccine at 100 micrograms dose and the other half receive a placebo.
Participants would be vaccinated on the first day and again on the 29th day. Similarly, the placebo group receives two consecutive doses of placebo on the same date. According to Xinhua, after receiving the second dose, participants will be monitored for two years.
In Phase 3 trials, which will be conducted in 87 locations across the United States, researchers will judge the effectiveness, safety, and assurance of the experimental vaccine in adults 18 years of age and older.
According to the company, the main endpoint will be the prevention of symptomatic COVID-19 disease. Key secondary endpoints include the prevention of critical COVID-19 disease and the prevention of infection by the coronavirus.
The company further appends that the target vaccine efficiency against COVID-19 for strengthening axioms is 60% and 95% confidence interval for prohibiting a lower limit greater than 30%.
Moderna company declared that it has completed the manufacture of vaccines required to study Phase 3. Moderna also stated that the final testing protocol has been reviewed by the US Food and Drug Administration and followed the recent FDA guidelines on clinical trial design for COVID-19 vaccine studies.
Meanwhile, Director of the US National Institute of Allergy and Infectious Diseases, Dr. Anthony Fausi, announced that the US government will provide funds and administer key trials on three experimental coronavirus vaccines.
Moderna is considered to be in a leading position in the global race to find a vaccine against the coronavirus, which has infected more than 13.2 million people and killed 570,000.
According to the statement led out by Moderna CEO, who vouched by the vaccine working stated that “We know our platform. It works on CMV, Zika, MERS, and so on. When you have the right order, you will get neutralizing antibodies. We are 80-90% sure of the vaccine working”.
It is worth noting that Moderna is the first company in the United States to begin testing the COVID-19 vaccine in humans.
Besides this, With Moderna company, Oxford’s vaccine candidate is also in the race to be the first company to produce an efficacious vaccine against Covid-19.
According to Bloomberg data, the University of Oxford candidate, led by Sarah Gilbert in collaboration with AstraZeneca, maybe conduct a human trial soon. According to Reuters, on July 16 positive news on initial trials of Oxford’s vaccine candidate could be reported.
Moreover, large-scale Phase III human trials are underway to assess the Oxford vaccine. Oxford’s vaccine candidate works differently than Moderna’s vaccine candidate.
We hope that at least one of these vaccines will soon prove to be safe and effective so that a sufficient number of vaccines can be produced to inoculate anyone who needs it.