The Food and Drug administration (FDA) has given approval to biotech company Moderna to begin the next phase of testing on its coronavirus vaccine candidate, the company.
There are dozens of vaccine candidates worldwide that are being developed to fight the coronavirus outbreak, and a handful of them are already being tested on 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 for a COVID-19 vaccine.
The purpose of phase 1 trials such as the one Moderna just completed, is to understand the safety and dosage of the candidate drug or vaccine, according to the FDA. Now, the testing will move to phase 2, in which the researchers will test the efficacy and side effects of the vaccine on about 600 people.
“The imminent phase 2 study start is a crucial step forward,” Stéphane Bancel, Moderna’s chief executive officer, said in a statement. The goal is to start the “pivotal” phase 3 trial early this summer, he added. Phase 3 trials recruit hundreds to thousands of people to further understand whether or not a vaccine (or drug) is working and to monitor any adverse reactions to it, according to the FDA. After phase 3 trials, the FDA then decides whether to approve the vaccine or drug. The FDA will approve a drug only if “it’s safe and effective” and its “benefits outweigh risks,” according to the U.S. Centers for Disease Control and Prevention.
Moderna is already making plans to accelerate manufacturing of the vaccine. On May 1, the company announced plans to work with Swiss drugmaker Lonza to make up to 1 billion doses of the vaccine per year to distribute globally, according to CNBC. The first doses are expected to be made in the U.S. Lonza facility in July, CNBC reported. That is, of course, if the vaccine is proven to be safe and effective.
Moderna’s vaccine, called mRNA-1273, uses a new technology that hasn’t been used in any approved vaccines to date. Most traditional vaccines introduce an inactive or weakened version of the virus itself into the body to train the immune system to create antibodies to fight it, whereas this vaccine takes one step back and uses a molecule called messenger RNA (mRNA) to instruct cells to build viral proteins themselves, according to a previous Live Science report.
Specifically, the mRNA provides instructions to cells to build the coronavirus’ spike protein, which the virus uses to infect human cells. The idea is that the immune system will then create antibodies that will recognize that spike protein and fight off the coronavirus.