US FDA (Food and Drug Administration) on Friday night authorized a second coronavirus vaccine for emergency use. As COVID-19 hospitalizations rose to another record and cases and deaths are piling up in unprecedented ways.
The FDA signaled it would issue the authorization quickly for Moderna’s vaccine candidate; after the agency’s vaccine advisers voted Thursday to recommend approval.
“The emergency use authorization allows the vaccine to be distributed in the US for use in individuals 18 years and older,” the FDA said in a tweet.
The Centers for Disease Control and Prevention still needs to green light the vaccine before shots can be administered — and a CDC advisory panel is meeting this weekend to discuss it.
If all hurdles are cleared, Moderna’s vaccine could be given in the US next week — joining Pfizer and BioNTech’s vaccine, which rolled out this week, with first doses primarily being given to health care workers and residents of long-term care facilities.
The move marks the world’s first authorization for Moderna’s shots. Moderna has about 5.9 million doses ready for shipment set to begin over the weekend.
In a study of 30,000 volunteers, the Moderna vaccine was more than 94% effective at preventing symptomatic COVID-19 in people 18 and older. It also strongly protected older adults, who are most vulnerable.
US President Donald Trump hailed the approval on Twitter.
“Today’s emergency use authorization by the Food & Drug Administration of the Moderna COVID-19 vaccine is another milestone in our battle to overcome the crisis our country is facing today,” President-elect Joe Biden said in a statement.
Early results show both vaccines appear safe and strongly protective although Moderna’s is easier to handle since it doesn’t need to be stored at ultra-frozen temperatures.
Both the new Moderna vaccine and the Pfizer-BioNTech shot require two doses several weeks apart. The second dose must be from the same company as the first.
The inoculated can’t throw away their masks as it’s not yet clear either vaccine prevents silent, symptomless virus spread. But there was a hint that Moderna’s shot might provide some protection against asymptomatic infection.
Both vaccines remain experimental, and authorities are closely monitoring safety in case problems crop up.
The FDA’s decision could help pave the way for other countries that are considering the Moderna vaccine. European regulators could authorize its use as soon as Jan. 6.
Moderna expects to have between 100 million and 125 million doses available globally in the first three months of 2021.
Britain, Canada and a few other countries already have cleared the Pfizer-BioNTech shot, with a European Union decision due Monday.