Moderna's COVID-19 vaccine gets FDA nod for phase 2 trial
Moderna Therapeutics, one of the select few companies trialing a COVID-19 vaccine, has received US Food and Drug Administration's approval to move into the second phase of the tests. The company announced that its vaccine candidate has been cleared for the next stage of human trials, which will begin shortly, ultimately paving the way to bring it into the market. Here's all about it.
In the phase 1 trial, the experimental vaccine, which was developed jointly by researchers at Moderna and the National Institutes of Health, was tested on 45 volunteers - in different doses - over the course of six weeks. Now, in the mid-stage study, the company will expand the trial and test the potential solution with 600 healthy adults.
While Moderna did not share the exact timeline for the phase 2 trial, it did say that the study would begin shortly, with results expected in June-July. Then, provided all goes according to the plan, the company hopes to start phase 3 of human trials in summer itself, lining up the vaccine for approval for public use in early 2021.
Notably, both upcoming trials of the experimental vaccine are aimed at determining its effectiveness in neutralizing the novel coronavirus as well as establishing its safety for widespread public use.
Along with the trials, Moderna is also moving to set up manufacturing so that sufficient doses are available for distribution if their candidate gets necessary approvals. The company has already partnered with Swiss drugmaker Lonza for this purpose and is planning to start manufacturing as early as July, just when it expects to move towards phase 3 of trials.
"We are accelerating manufacturing scale-up and our partnership with Lonza puts us in a position to make and distribute as many doses as possible, should it prove to be safe and effective," CEO said, noting the company hopes to deliver a billion doses every year.
Typically, vaccines for viral diseases carry a weakened/killed strain of the virus that causes the disease. But, this one, officially dubbed mRNA-1273, doesn't carry the coronavirus causing COVID-19; instead, it uses a short segment of genetic code copied from the virus, which primes the immune system to detect and fight the actual infection. The team says it has been developed with a tried-and-tested process.
In addition to Moderna, a few more organizations are carrying out human trials of COVID-19 vaccines, including Oxford University. The institute says its solution could become publicly available by September-October or 3-4 months sooner than all other vaccines currently being developed/tested.
