Biotechnology company Moderna has announced the first results from its Phase 1 trial of a vaccine for the coronavirus, showing that a small number of participants developed antibodies to the virus after treatment.
A Phase 1 trial is a small trial of typically around 10 to 20 people that tests whether a potential new treatment is safe and whether it shows signs of its intended effects. Moderna has released the results of the first 8 participants whose data has been analyzed, and they show that the vaccine appears to be safe and not have any serious negative effects.
The vaccine appeared to increase the production of antibodies, which are the body’s natural defenses against viruses like the coronavirus. The data which were shared covered two groups of participants who were given two shots each of the vaccine at two different doses, and it appeared to be effective at both the lower and higher dose.
As exciting as these results are, they are still a long way from definitive and from the development of a usable vaccine. Moderna still needs to analyze the rest of the data from the Phase 1 trial. Then, the next stage of vaccine development, which Moderna is currently running, is a Phase 2 trial in which a larger group, comprising hundreds of participants, receive the treatment to see how well it works and whether there are any side effects. The researchers can use the data from this Phase 1 trial to hone in on the dose for this Phase 2 trial.
After that comes the Phase 3 trial, which involves hundreds or thousands of participants to check whether the vaccine is effective and safe for a broader group of people.
If all the preceding stages work out well, the Phase 3 trial set to being in July this year, according to Stéphane Bancel, Chief Executive Officer at Moderna. “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 [Biologics License Application, a submission for FDA approval],” Bancel said. “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.”
For the latest updates on the novel coronavirus outbreak, visit the World Health Organization’s COVID-19 page.
Monday, May 18, 2020
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