December 22, 2020 Drug & Device Advisory Group FDA Briefs

COVID-19 News: MODERNA vaccine, App Design-a-thon winners, Holiday food safety tips

MODERNA COVID-19 Vaccine

ModernaTX, Inc

INDICATION: Prevention of COVID-19 in individuals 18 years of age and older

Administered via intramuscular injection as a series of two doses, one month apart

ADDRESSING UNMET NEED: Second vaccine to combat the pandemic

MECHANISM OF ACTION: Contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein; triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2

EFFECTIVENESS & SAFETY:

Ongoing randomized, placebo-controlled U.S. study, n=28,207 participants without SARS CoV-2 infection
94.1% effective in preventing COVID-19 disease; 11 cases in vaccine group vs. 185 in placebo with 30 severe cases
Data are not available to determine how long the vaccine will provide protection
No available evidence of prevention of person to person transmission
Most commonly reported side effects: Pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm as the injection, nausea and vomiting, and fever; mostly after second dose

REGULATORY PATHWAY:EUA

Pharmacovigilance plan to the FDA to monitor the safety and complete complete longer-term safety follow-up
Continue clinical trials to obtain additional safety and effectiveness information and pursue approval (licensure)

FDA website

Translations of Fact Sheet

CDC information