NIH Posts Promising Interim Data From Phase 1 Moderna Vaccine Trial

Moderna’s potential COVID-19 vaccine generated neutralizing antibodies in patients, according to a phase 1 trial run by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID).

The trial’s initial findings, which were published in the New England Journal of Medicine, showed that Moderna’s promising vaccine candidate, mRNA-1273, produced high levels of neutralizing antibodies in all participants when given two doses.

More than half of the participants experienced mild side effects, including fatigue, headache, chills, myalgia or pain at the injection site. Systemic adverse events were more prevalent after the second vaccination and in participants who received the highest dose. Three of the 14 participants in the highest dosing group reported one or more severe events, Moderna said.

The data from the trial, which included 45 healthy adults aged 18 to 55, supports a phase 3 study set to begin on July 27, the company said.

“These positive phase 1 data are encouraging and represent an important step forward in the clinical development of mRNA-1273,” said Moderna’s CEO Stéphane Bancel. “The Moderna team continues to focus on starting our phase 3 study this month and, if successful, filing a biologics license application (BLA),” he added.

Read the New England Journal of Medicine article here: bit.ly/2AZAZS5. — James Miessler