Shares of Moderna (MRNA -0.05%) were rising 2.3% as of 10:59 a.m. ET on Tuesday after jumping as much as 4.5% earlier in the day, based on data from S&P Global Market Intelligence. The gain came following the company's announcement on Monday that the U.S. Food and Drug Administration (FDA) granted full approval to Moderna's messenger RNA (mRNA) COVID-19 vaccine Spikevax (mRNA-1273). This approval applies for individuals ages 18 and older.
In one sense, the full FDA approval for Spikevax doesn't mean all that much for Moderna. The vaccine has been available in the U.S. under the FDA's Emergency Use Authorization (EUA) since Dec. 18, 2020. The full approval won't change anything about which patients can receive the vaccine or how they do so.
However, Moderna will now be able to market its COVID-19 vaccine. The company wasn't allowed to do so while only the EUA was in effect. Moderna can also now use its Spikevax brand name in the U.S. as it already does in Canada, Japan, the European Union, the U.K., Israel, and other countries.
Perhaps the biggest impact for Moderna is a symbolic one. CEO Stéphane Bancel stated, "This is a momentous milestone in Moderna's history as it is our first product to achieve licensure in the U.S." FDA approval is certainly an important milestone for the company, even if it doesn't materially affect Moderna's sales.
Moderna still awaits an FDA decision on EUA for its vaccine in adolescents. The future fortunes of the vaccine stock hinge even more on whether or not regular COVID-19 booster shots will be needed on an ongoing basis.