There are a lot of competing drugs in the running to be the first official cure for the Coronavirus disease in 2019. A recent breakthrough by Moderna biotech company has the world on its toes as it shows promising results in all the clinical trials it has gone through. The vaccine under development is set to start its Phase 3 trial by late July, and this will be the last stage that the vaccine has to go through before authorities decide to push through with mass production.
The Moderna vaccine called mRNA-1237 did well during the Phase 1 trials - it was shown to have triggered immune responses in the body with only slight, manageable, and predictable side effects such as fatigue accompanied with chills, headache, muscle pain, and the typical pain at the site of injection. It achieved the safety and response goals that were set for it, according to the results that were released last May. The information from the first phase will then be used as the basis for the succeeding trials. The mRNA-1237 will then be the first drug to enter the third phase trials in the US.
As Phase 1 focused on determining the candidate drug’s safety and response in a few volunteers, Phase 2 will proceed to administer the drug to patients suffering similar symptoms with the disease for which the vaccine is intended. Phase 3 will involve a large number of volunteers to test the drug’s overall effectiveness against the actual disease.
Assuming the trials go smoothly and successfully, Moderna will push through with its plan to produce and distribute 500 million to 1 billion doses in a year starting 2021.
mRNA-1237: Clinical Trials
During the Phase 1 trial, 45 healthy volunteers with ages ranging from 18 to 55, were divided into three groups, each group receiving a different dose (25, 100, or 250 micrograms). A 28-day interval was set between the first and second administrations of the vaccine. The first shot is intended to introduce the drug to the body, allowing an initial counter response. The second shot will then produce an even stronger response. However, researchers were surprised to discover that the first dose already produced a response that they expected in the second dose.
There were adverse effects present, but none that compromised its overall safety. The side effects increased in severity with every higher dose but it only affected a select few in each group.
Phase 1 results showed that all subjects were found to have developed virus-neutralizing antibodies alongside the intended antibody production response. These virus-neutralizing antibodies resembled those produced by patients who have recovered from Covid-19. This kind of antibodies works by binding to the virus cell and prevents it from being able to attack the host cell.
In the second phase, 600 participants were involved in the study, the population was divided into two age groups, 18-54 year-olds and 55 years old and above. The Phase 2 trial will follow an almost similar process with Phase 1. Moderna received a Fast track designation from the FDA, signaling an urgent need for developmental studies with regards to the global Coronavirus outbreak that is still currently increasing in a number of cases.
What to watch out for
Phase 3 is set to begin later in July. 30,000 participants are aimed to be enrolled, involving high-risk volunteers. The optimal dose to be given will be 100 micrograms, still with a 28-day interval. One group will be given a placebo to evaluate a significant difference. The trial will take place in 87 locations all over the US. Another potential vaccine that is also set to proceed to the final trials is the AZD-1222 collaborated on by Oxford University and AstraZeneca, which is also a promising contender.