FDA Finds Moderna Vaccine To Be Safe, Effective; Could Be Approved By Friday
In an important step toward emergency authorization, a report released ahead of a Thursday FDA advisory panel meeting shows that the agency's review confirmed Moderna's efficacy and safety data for its coronavirus vaccine.
CNBC:
FDA Staff Endorses Emergency Use Of Moderna’s Covid Vaccine In A Critical Step Toward Approval
The staff of the Food and Drug Administration endorsed the emergency use of Moderna’s coronavirus vaccine in a report released Tuesday, a critical step forward in winning formal clearance to be administered to the public as early as next. It comes two days before the FDA’s Vaccines and Related Biological Products Advisory Committee, a group of outside medical advisors, is scheduled to review Moderna’s vaccine. The group recommended Pfizer’s vaccine for emergency use last Thursday, and the FDA approved it for emergency use the next day. (Lovelace Jr., 12/15)
The New York Times:
Moderna Vaccine Is Highly Protective And Prevents Severe Covid, Data Show
Based on the encouraging findings, the agency intends to grant emergency authorization for use of the vaccine on Friday, people familiar with the F.D.A.’s plans said. The decision would give millions of Americans access to a second coronavirus vaccine beginning as early as next week. (Weiland, Grady and Zimmer, 12/15)
Reuters:
U.S. FDA Staff Raises No New Concerns With Moderna's Coronavirus Vaccine
The FDA staff said a two-dose regimen of Moderna’s vaccine was highly effective in preventing confirmed cases of COVID-19. The comments were made in documents prepared for Thursday’s meeting of outside experts, who will discuss whether to endorse a U.S. emergency use authorization (EUA) for the Moderna vaccine. The FDA reviewers did not raise any specific safety issues with using the vaccine in adults over the age of 18. They said that serious side effects in the trial of the vaccine represented medical events that occur in the general population at a similar frequency as observed in the study. (12/15)
The Hill:
Moderna To Distribute 6 Million COVID-19 Vaccines As Soon As Friday Upon FDA Emergency Approval
U.S. officials said on Monday they are planning to ship just under 6 million doses of Moderna’s COVID-19 vaccine once it receives emergency use authorization from the Food and Drug Administration. CNBC reports that McKesson, a medical supply company, will receive doses of the Moderna vaccine for packaging and distributing to 3,285 sites, according to Gen. Gustave Perna who is in charge of logistics for Operation Warp Speed, the White House’s COVID-19 vaccine program. Perna said that UPS and FedEx have been tasked with getting the vaccine doses to their final locations. (Choi, 12/14)
