Biopharmaceutical company, Moderna, has announced that the US Food and Drug Administration has approved its experimental COVID-19 vaccine for a Phase II trial.
The vaccine, known as mRNA-1273, was developed by both Moderna and the National Institutes of Health. It was the first candidate to enter a Phase I human trial in March. Although the results of this trial remain unpublished, the FDA granted them federal approval to continue their research via Phase II trial soon. Meanwhile, the company hopes to begin phase III trials, the final trialing phase, early this summer.
One of the reasons for the vaccine’s swift approval is that it operates via a system used to make other vaccines that has shown to be both effective and without huge risk to patients’ health. Rather than using an inactive form of COVID-19, this method instead introduces patients to synthetic RNA molecules in the hope that their body will recognize them as the virus and produce antibodies that may also fight against the real thing.
In the vaccine’s Phase II trial, the researchers aim to assess the safety, reactogenicity and immunogenicity of two vaccinations given 28 days apart. They hope to recruit 600 healthy volunteers aged 18 and over, and will then follow each of them for 12 months after the second vaccination.
Should the vaccine pass the Phase II trial, Moderna anticipates working closely with the US government to decide where its first doses will be delivered. To this end, the company has already begun scaling up its manufacturing capacity to rapidly distribute the vaccine once available.
Optimistic, the company’s CEO Stephane Bancel nevertheless said that even if approved, supply of the vaccine will remain constrained for some time. Due to the number of cases of the virus globally, he added that soon, there will likely be more than one vaccine in circulation to fight the virus.
Sources: CNBC, LabRoots, Clinical Trials Arena