As the world continues to wait for the vaccine that will once and for all possibly end the COVID-19 nightmare, biotechnology company Moderna has announced that by July 27, they will be entering the final phase of clinical trials.
Moderna, which is based in Cambridge, Massachusetts is the first biotech company in the US that has announced an estimated date for the phase three of the SARS-CoV-2 vaccine trials. Additional information about the trials which included guidance for test volunteers was posted on Tuesday on clinicaltrials.gov.
According to a report from NBC News, Ray Jordan, spokesperson for Moderna stated that the company is already expecting participants for the trials to start registering for the tests at clinical sites starting next week. It can be recalled that Moderna was also the first US-based company to start human trials of the SARS-CoV-2 vaccine. They gave their first dose to volunteers on the 16th of March.
What happens in Phase 3?
In addition, the company stated that its target population for the clinical trial's final phase is around 30,000 adults. The last phase of trials is designed to test not only the vaccine's effectiveness but also if it is safe to administer.
During the trials, the participants will be given either the vaccine or a placebo. Then they will be tracked to check if they contract the coronavirus disease (COVID-19) or if their body will have any adverse reactions to the vaccine, this will be done in a span of two years.
Moreover, the antibody levels of the participants will also be measured periodically in the duration of the trials.
What happened in the previous phases?
On Tuesday, data from the initial phase of the clinical trials were published by Moderna in the New England Journal of Medicine.
The phase 1 of the trials was joined by 45 participants and was done in order to test the safety of the drug but not its effectiveness. However, upon checking the results the biotech firm stated that the 45 participants all showed promising results after they all developed antibodies which can fight the virus. The level of the antibodies developed was also four times the amount which is found in patients who have infected bu recovered from the virus.
The trial vaccine has also caused some side-effects when administered which included chills, headache, fatigue, and weakness.
Ohio State University Wexner Medical Center's chief quality and patient safety officer, Dr. Iahn Gonsenhauser stated that the results of the phase 1 of trials are very promising and what the experts want to see in early phases. However, he cautioned that despite the good results in terms of the antibodies produced, there have been no studies that prove COVID-19 antibodies can lead to immunity from the disease. But scientists who are involved in the studies are very optimistic.
Meanwhile, according to CBS News, Moderna has estimated that it could produce at least 500 million doses of the vaccine every year starting in 2021.
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