Tag: Moderna

Moderna asking for full FDA approval of its COVID vaccine

Written by Naples Mortgage Syndicated User on June 1, 2021. Posted in Naples Florida Mortgage, Naples Mortgage.

WASHINGTON / CNBC — Moderna officials asked the Food and Drug Administration to fully approve it’s coronavirus vaccine on Tuesday, making it the second drugmaker in the U.S. to do so. If approved, Moderna would be able to market their vaccine directly to consumers. The mRNA vaccine is currently on the U.S. market under an emergency use authorization, which was granted by the FDA in December. It gives conditional approval based on two months of safety data. It’s not the same as a biologics license application, or a request for full approval, which requires at least six months of...

Moderna COVID-19 vaccine safe for children ages 12 to 17, company says

Written by Naples Mortgage Syndicated User on May 25, 2021. Posted in Naples Florida Mortgage, Naples Mortgage.

CNN – Moderna appears to be safe and effective in adolescents, the company said on Tuesday. In a Phase 2/3 trial of 3,732 children ages 12 to 17 in the United States, blood tests showed that the vaccine produced an immune response that was equivalent to earlier findings in adults, CNN reported. While the trial did not specifically look at efficacy, initial observations showed that none of the children got sick with COVID-19 starting 14 days after their second dose. Four of the children who received the placebo tested positive for COVID-19, which Moderna says is “consistent with...