Moderna's COVID-19 vaccine to go into final-stage trials in July
Moderna Therapeutics has announced that its COVID-19 vaccine is set to go into the third and final stage of clinical human trials. The American biotech company, touted as the frontrunner in the race for developing a vaccine for the deadly disease, says it has made all the arrangements as required by the FDA and will start the study next month. Here's more about it.
Trial with 30,000 individuals
In a recent announcement, Modern said it has finalized the protocol for the Phase-3 study, which will see the vaccine candidate, mRNA-1273, being administered on as many as 30,000 individuals in the US. It will be a randomized, placebo-controlled trial that will establish whether the vaccine can entirely prevent COVID-19 infection or prevent the development of its symptoms and severe cases of the disease.
Dose finalized, vaccines also manufactured
The company says it will administer 100 microgram dose of the experimental vaccine for maximum immune response and minimum adverse effects in the Phase-3 trial. It has manufactured sufficient doses to start the Phase-3 study and is working with Swiss drugmaker Lonza to scale up capacity and deliver 500 million to 1 billion doses per year, starting in 2021 (considering it gets approved).
Committed to advancing development quickly and safely
"We look forward to beginning Phase-3 study of mRNA-1273...in July," said Moderna's Chief Medical Officer Tal Zaks. "Moderna is committed to advancing the clinical development of mRNA-1273 as safely and quickly as possible to demonstrate our vaccine's ability to significantly reduce the risk of COVID-19."
Results of Phase-2 trials will be crucial
That said, it must be noted that the beginning of the Phase-3 trial will directly depend on the FDA's nod, which will be given in accordance with the results of the Phase-2 trial. The second phase is currently progressing, with as many as 350 of the targeted 600 participants already being enrolled for the study.
In Phase-1 trial, the results were promising
In Phase-1 trial, the vaccine candidate produced detectable antibodies (immune response) in all the volunteers, with a dose-dependent increment in immunogenicity. The participants who got the 25 microgram shot generated antibodies at levels seen in the blood of recovered COVID-19 patients, while the 100 microgram group had antibodies that "significantly exceeded levels" seen in recovered cases, which explains why the company took this dose.