Moderna Inc. (MRNA) - Get Moderna, Inc. Report shares slipped lower Friday after the Food & Drug Administration pushed back on a Tweet from President Donald Trump suggesting its coronavirus vaccine had received emergency use approval.
The FDA said there has been no final decision on the Cambridge, Massachusetts-based drugmaker's mRNA 1273 vaccine, which was given the thumbs-up by the Vaccines and Related Biological Products Advisory Committee with a 20-0 vote last night, despite the President's assertion that it was "overwhelmingly approved".
Vice President Mike Pence, who received the first dose of the Pfizer PFE/BioNtech BNTX vaccine during a live television event at the White House, said the Moderna decision could come "within hours". The FDA will make its final decision in the coming days, as per the typical Emergency Use Authorization procedure that applied to its approval of Pfizer/BioNTech vaccine last Saturday.
Moderna shares were marked 3.6% lower in early trading Friday to change hands at $139.00 each, a move that still leaves the stock with a six-month gain of around 114%.
Johns Hopkins University reported 233,000 new coronavirus infections in the United States yesterday, a 3% increase from last week's levels that takes the overall total past 17.3 million.
In Europe, Christmas lockdowns have been put in place in France, Italy and Germany with a multi-tiered system of travel and gathering restrictions in the United Kingdom
Modena has said it could have 20 million doses available for the U.S. market this year, as well as a total supply of between 500 million and 1 billion doses worldwide next year.
U.S. Army General Gustave Perna, who is coordinating the government's Operation Warp Speed vaccine rollout, said some 5.9 million doses of the Moderna vaccine could be rolled out next week.
Contracts with the U.S. government, as part of Operation Warp Speed, as well as those signed with Britain and the European Union, provided an early revenue boost for the Cambridge, Massachusetts-based biotech, while extended orders into 2021 and beyond could boost its topline to around $4.5 billion, analysts have estimated.