Moderna moving into Phase 2 coronavirus vaccine testing and plans for mass production

Scientist working in Moderna’s Cambridge lab.
BOSTON GLOBE VIA GETTY IMAGES

There are many frontrunners in the race to make a coronavirus vaccine. Moderna Therapeutics is one of them, and they’re putting their all into this race.

mRNA vaccines and Phase 1 results

Moderna is in the middle of their production for their version of a coronavirus vaccine, named mRNA-1273. The testing is split up in phases. Phase 1 of testing was recently concluded, with mostly positive and safe results. This phase proved the vaccine to be seemingly safe, however the volunteers were healthy and between the ages of 18 and 55.

The vaccine is based on mRNA, an unconventional type of vaccine. Most vaccines are based on DNA. The vaccine moved from laboratory research to human testing in a record-breaking 63 days. The lab, located in Cambridge, Massachusetts, has workers putting their all into this research. If this is possible, then it’s not unlikely that Moderna can have the first mRNA vaccine on the market. Many other companies, for example Pfizer, are also developing mRNA vaccines. These vaccines are popular for COVID-19 purposes as they’re fast to produce and test.

On May 18, Moderna announced that volunteers were producing antibodies similar to those made after people recovered from the virus.

Phase 2 testing

The FDA reviewed Moderna’s application for Phase 2 testing and granted them Fast Track designation. This means that there is an urgent need for the coronavirus vaccine. The FDA supports the production and testing of Moderna’s vaccine, due to the economic and health concerns this virus imposes.

Phase 2 trials, being conducted by the U.S. National Institute of Allergy and Infectious Diseases, will have 600 volunteers, 300 of those being between 18 and 55, and the other 300 being over 55. They will all be healthy individuals. The dosages will be between 25 and 100 micrograms and will be given to each person 28 days apart. They will be followed by the study for 12 months after the second injection. The testing will include subjects spanning from 10 sites and eight states. After undergoing physical tests, some qualified individuals will start to receive the injection as soon as Monday.

Modifications to the vaccine will need to be made quickly, considering Moderna wants to start Phase 3 in July. Some tweaking with the vaccine does indeed to be accomplished by then, as an incident similar to Ian Haydon’s must be avoided.

Mass production of the vaccine

Moderna is ambitiously aiming for a vaccine to be ready for mass production by 2021. If this isn’t feasible, they want vaccines to be ready for use in medical offices for victims of the virus. Manufacturer CordenPharma will supply lipids for Moderna’s vaccine candidate. This is being done in order to meet Moderna’s big plans for mass distribution.

Moderna and their new partner CordenPharma has their eyes on the prize right now. They want to be the first company with the vaccine ready and with the assistance of the FDA’s Fast Track approval, they might just beat the competition. Regardless, many other companies are still producing their version of the vaccine, which according to experts, will be neccessary to meet demand.

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