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The Food and Drug Administration on Friday pushed back on a tweet from President Donald Trump that suggested Moderna’s coronavirus vaccine had won emergency clearance from the agency. Trump said Friday morning that Moderna’s vaccine had been “overwhelmingly approved” and it would be immediately distributed. (Lovelace Jr., 12/18)

The FDA intends to authorize the vaccine Friday, according to knowledgeable individuals who spoke on the condition of anonymity because they were not authorized to speak publicly about the schedule. “I just want to make the point of what a remarkable scientific achievement this is, and pay thanks to all the scientists, present and past, who contributed to this,” James E.K. Hildreth, president of Meharry Medical College and a member of the advisory panel, said at the close of the committee meeting on Thursday. “To go from having a [genetic] sequence of a virus in January, to having two vaccines available in December, is a remarkable achievement.” (McGinley and Johnson, 12/17)

The independent Vaccines and Related Biological Products Advisory Committee voted 20-0 with one abstention to support mRNA-1273, a vaccine made in collaboration with the U.S. government by Moderna, a decade-old Cambridge, Massachusetts-based biotechnology company. "There's no doubt in my mind – it looks like the benefits outweigh the risks from what I've seen," said Dr. Steven Pergam, a committee member and infectious disease and vaccine expert at the Fred Hutchinson Cancer Research Center in Seattle, expressing the group's consensus. (Weintraub, 12/17)

The Moderna vaccine can be distributed more widely because it can be stored at normal freezer temperatures and, unlike the Pfizer-BioNTech vaccine, does not require ultracold storage. It also comes in much smaller batches, making it easier for hospitals in less populated areas to use quickly. (Grady, Goodnough, Zimmer and Wu, 12/17)

There isn’t enough evidence regarding the use of the vaccine in a pediatric population younger than 18 or in pregnant or breast-feeding women, Rachel Zhang, an FDA medical officer, told the panel. Dr. Zhang said that there were three cases of serious side effects among Moderna vaccine recipients that appeared to be related to the vaccine. One was severe nausea and vomiting, and two involved facial swelling. Both cases of serious facial swelling happened in people who had prior dermal fillers for cosmetic purposes, and were successfully treated with medications. There was an additional case of lip swelling in another person who had prior dermal filler. (Burton and Loftus, 12/17)

Some side effects were common in the main clinical trial of the Moderna vaccine, which included more than 30,000 people, half of whom received two shots of vaccine and half of whom received two shots of placebo a month apart. Most everyone experienced pain at the injection site — 92%. Other common reactions included fatigue (69%), headache (63%) and muscle pain (60%). (Hensley, 12/17)