Moderna’s COVID-19 vaccine was granted approval by the Food and Drug Administration on Friday night — yet another glimmer of hope as infections continue to ravage the country.
The vaccine is now the second to get the OK for use in the US behind Pfizer-BioNTech, whose shot was approved on Dec. 11.
Moderna’s vaccine has been approved for use in people aged 18 and older.
Earlier this week, the FDA said Moderna’s vaccine was shown to be 94 percent effective in a 30,000-person clinical trial and did not pose any major safety problems.
“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” FDA Commissioner Stephen M. Hahn, M.D. said in a statement.
“Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA,” he said.
“These standards and our review process, which are the same we have used in reviewing the first COVID-19 vaccine and intend to use for any other COVID-19 vaccines, included input from independent scientific and public health experts as well as a thorough analysis of the data by the agency’s career staff.”
The agency’s advisory board voted unanimously to recommend its approval following an all-day hearing Thursday.
Health and Human Services Secretary Alex Azar said 5.9 million doses of Moderna’s vaccine will be shipped out to states next week.
Dr. Anthony Fauci, the nation’s top infectious disease expert, said inoculations could be administered as soon as Monday or Tuesday.
The Massachusetts-based biotechnology company’s shot is administered in two doses 28 days apart. Pfizer is also a two-dose shot, given 21 days apart.
Both shots use so-called messenger mRNA, genetic material that spurs an immune response to coronavirus by directed the body to create a tiny amount of coronavirus spike proteins.
The green light for Moderna comes after the US shattered daily records for new cases, deaths and hospitalizations on Wednesday.
Coronavirus infections are surging in the US, where 17 million cases and 311,000 deaths have been recorded since the start of the pandemic, according to the latest data from Johns Hopkins University.
More than 75 million infections and 1.6 million deaths have been recorded worldwide.
Other vaccines — including from Novavax, Johnson & Johnson and AstraZeneca — are in Phase 3 clinical trials.