The U.S. Food & Drug Administration has given its full and final approval for the use of Moderna’s ‘Spikevax’ Covid vaccine, the drugmaker said Monday.
Moderna (MRNA) – Get Moderna, Inc. Report shares moved higher Monday after the U.S. Food & Drug Administration gave full and final approval to the drugmaker’s ‘Spikevax’ Covid vaccine.
The full approval for patients 18 and old follows the FDA’s first Emergency Use Authorization ruling in December of 2020. Since then, more than 204 million doses of the messenger-RNA based vaccine have been distributed in the United States, according to figures from Statista, with another 316 million coming from the Comiranty vaccine produced by Pfizer (PFE) – Get Pfizer Inc. Report and its German partner BioNtech (BNTX) – Get BioNTech SE Report.
“Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization and death. The totality of real-world data and the full BLA for Spikevax in the United States reaffirms the importance of vaccination against this virus,” said CEO Stéphane Bancel. “This is a momentous milestone in Moderna’s history as it is our first product to achieve licensure in the U.S.”
“The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the European Union, the UK, Israel, and other countries, where the adolescent indication is also approved,” he added. “We are grateful to the U.S. FDA for their thorough review of our application. We are humbled by the role that Spikevax is playing to help end this pandemic.”
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Moderna shares were marked 2.25% higher in late-morning trading Monday to change hands at $163.605 each immediately following the FDA decision.
Moderna, which is expected to publish its fourth quarter earnings on February 24, said late last year that 2021 sales of its mRNA-1273 coronavirus vaccine would likely tally in the region of $15 billion to $18 billion, down from its prior forecast of $20 billion based on signed contracts, amid what it called broader production challenges.
Sales for the 2022 fiscal year, Moderna said, would likely be within $17 billion to $20 billion.
Moderna also said last month that its developing seasonal flu vaccine showed promising data from a recent early stage trial while showing no significant side-effects. A phase 2 study is now fully-enrolled, Moderna said, with plans for a phase 3 study also underway.
The early data, however, appears to match that of rival Novavax NVAX, which published updated details from a phase 3 study of its NanoFlu vaccine in September, as well as the Fluzone HD offering from France-based Sanofi SNY.
