The Food and Drug administration (FDA) in the US has given approval to biotech company, Moderna to begin the next phase of testing on its coronavirus vaccine candidate, the company has announced.
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.
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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.
Moderna’s vaccine, called mRNA-1273, uses a new technology that has not been used in any approved vaccines to date.
The idea is that the immune system will then create antibodies that will recognize that spike protein and fight off the coronavirus.
This technology is faster to produce and is typically more stable than conventional vaccines, according to The New York Times.
In a related development, French researchers are preparing to launch a human trial to test their hypothesis that nicotine can help the body combat the COVID-19 infection.
The trial will involve groups of healthcare workers and patients wearing nicotine patches and other groups wearing placebo patches. Then they will be tested to see if there is a difference in how their bodies respond to the virus.
The trial is a follow-up to a French study, published this month, of public health data which appeared to show that people who smoke are 80% less likely to catch COVID-19 than non-smokers of the same age and sex.
The scientists hypothesised in their study that nicotine, which is contained in cigarettes, could influence whether or not the coronavirus molecules are able to attach themselves to receptors in the body.
Other companies, including Inovio, CanSino and Pfizer, are also using this mRNA technology to develop vaccines against the coronavirus.