Moderna’s Coronavirus Vaccine Has Moved To Second Phase Of Testing

The Food and Drug Administration (FDA) announced Thursday (May 7) that it has approved biotechnology company Moderna to begin the next phase of testing of its coronavirus vaccine candidate.

Dozens of vaccine candidates are being developed around the world to combat coronavirus outbreaks, and a few have already been tested in humans.Moderna began testing their vaccine on 45 healthy adults in Seattle in March, becoming one of the first companies to begin human clinical trials of the COVID-19 vaccine.

According to the U.S. Food and Drug Administration (FDA), the goal of a Phase 1 trial like the one Moderna just completed is to understand the safety and dosing of a drug or vaccine candidate. The tests will now move into phase 2, where researchers will test the efficacy and side effects of the vaccine on about 600 people.

“The upcoming Phase 2 study is a critical step,” Moderna’s CEO Stéphane Bancel said in a statement. He added that the goal is to begin “pivotal” phase 3 trials early this summer. According to the FDA, Phase 3 trials recruit hundreds to thousands of people to learn more about whether a vaccine (or drug) is effective and to monitor any adverse reactions to it.After the Phase 3 trial, the FDA then decides whether to approve the vaccine or drug. According to the Centers for Disease Control and Prevention, the FDA will only approve a drug if it is “safe and effective” and if the “benefits outweigh the risks,” according to the FDA.

Moderna is already making plans to speed up the production of the vaccine. On May 1, the company announced plans to partner with Swiss drugmaker Lonza to make up to 1 billion doses of vaccine per year for sale around the world, CNBC reported. The first vaccines are expected to be produced in July at Lonza’s U.S. plant, according to CNBC. Of course, that’s if the vaccine is proven to be safe and effective.

Moderna’s vaccine, called mRNA-1273, uses a new technology that has not been used in any of the approved vaccines to date. While most traditional vaccines introduce an inactive or weakened version of the virus itself into the body in order to train the immune system to produce antibodies to fight the virus, this vaccine takes a backseat and uses a molecule called messenger RNA (mRNA) to instruct cells to build their own viral proteins, according to a previous report by Live Science.

Specifically, the mRNA provides the cell with instructions to build the coronavirus spike protein, which the virus uses to infect human cells. The idea is that the immune system then produces antibodies that recognize the spike protein and fight the coronavirus.