A company working on a vaccine for COVID-19 says early results from its phase 1 clinical trial has been found to be safe and well-tolerated in a small group of patients.
In a press release published Monday, Moderna, a pharmacuetical company located in Cambridge, Massachusetts, said eight patients who received two doses of the COVID-19 vaccine, were able to develop neutralizing antibodies for the coronavirus. Researchers believe those are crucial to providing people protected from the virus.
In the Phase 1 trials, about 45 study participants each received two doses of the vaccine, about a month apart. Participants were given one of three dosage levels: 25 micrograms, 100 micrograms and 250 micrograms. The study looked at three dosage levels for patients: 25 micrograms, 100 micrograms and 250 micrograms.
Researchers found that those study participants who received the two lower doses developed COVID-19 antibodies about two weeks after the second dose was administered.
“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,” saidTal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna. “When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, 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.”
Phase 1 trials for vaccines are meant to evaluate the safety of the drug in a small group of patients to ensure it's safe - and not necessarily its effectiveness. The drug will now be tested in larger studies where researchers will study 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.”
The only reported side effect from the vaccine was a redness or irritation around the area where people received the vaccine shot.
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