US drugmaker Moderna's coronavirus vaccine shows promise as all volunteers develop antibodies in phase 1
The FDA has already greenlit phase 2 trials where Moderna will give the vaccine to 600 volunteers to test its safety in a much larger group
Moderna's potential coronavirus vaccine showed promising early results from its first human trial. The drugmaker claims that its vaccine appears to be safe and has the potential to stop Covid-19.
After receiving the shot, all participants in the study developed antibodies against the virus. Further, the company said that animal tests also showed positive results: the potential vaccine kept the new coronavirus from multiplying in the lungs, thereby offering protection.
"These data substantiate our belief that mRNA-1273 has the potential to prevent Covid-19 disease and advance our ability to select a dose for pivotal trials," Dr. Tal Zaks, Chief Medical Officer at Moderna, said in a statement.
Many experts have applauded the development but added that they need to see more data before calling it a breakthrough. "The vaccine does not seem to cause severe adverse reactions in most patients. So that is good," Dr. Peter Hotez from the Baylor College of Medicine, told CNN. "But in terms of the level of antibody and whether that is efficient in protecting individuals against getting Covid-19 -- we are not there yet," he added.
This is because the first phase is designed to only study the safety of the vaccine. The real tests are phase 2 and phase 3 trials. Here, scientists will study its effectiveness by comparing results between vaccinated and unvaccinated individuals, Hotez explained.
What is Moderna saying?
Moderna joined forces with the National Institutes of Health (NIH) to kickstart human trials on their experimental vaccine called mRNA-1273. The study included eight participants aged 18 and 55. Of them, four first group received a smaller dose of 25 micrograms dose of the vaccine while the remaining received a much larger 100 microgram shot.
In response to the vaccine, all eight participants developed a type of antibody called neutralizing antibodies. These antibodies defend our bodies by binding to the virus and blocking infection.
Further, Moderna said the volunteers developed these antibodies in levels that are comparable to recovered coronavirus patients. “These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 µg,” said Dr. Zaks.
As for safety, the vaccine did not cause any immediate reactions. Only one of the eight participants developed a side effect: erythema or redness of the skin. The individual received a 100 microgram dose and developed redness around the injection site, the drugmaker said.
What is next?
The US Food and Drug Administration (FDA) has already greenlit the next step, phase 2 trials. As part of the study, Moderna will study the vaccine on 600 volunteers using a 25, 50 and 100 micrograms dose. The goal, according to the company, is to test its safety in a much larger group. And if it clears this hurdle, the drugmaker will enter phase 3 to evaluate if the vaccine works.
“With today’s positive interim Phase 1 data and the positive data in the mouse challenge model, the Moderna team continues to focus on moving as fast as safely possible to start our pivotal Phase 3 study in July and, if successful, file a BLA,” said Stéphane Bancel, Chief Executive Officer at Moderna. “We are investing to scale up manufacturing so we can maximize the number of doses we can produce to help protect as many people as we can from SARS-CoV-2.”