A regulator in the US has had a dramatic change of heart on the new Moderna vaccine. Its shares rose 6%

Shares of the pharmaceutical company Moderna grew by 6% at the end of trading on February 18. Investors positively assessed the company's message that the US regulator FDA agreed to accept its new flu vaccine for consideration. Thus FDA, which is headed by Robert F. Kennedy, who is skeptical of vaccines, has dramatically changed its opinion: just a week ago it refused to consider the company's application.

Shares of Moderna rose by 6.1% - up to $46.6. During the day the value of securities rose even higher - by 8.5%, up to $47.68. This is the maximum since January 29.

Moderna announced Wednesday that the U.S. Food and Drug Administration (FDA) has accepted its application for review of its experimental mRNA-based flu vaccine, mRNA-1010, following a meeting with company representatives. To accomplish this, Moderna proposed to split the approval process into two tracks: a full track for adults between the ages of 50 and 64 and an accelerated track for people over 65.

Moderna has also pledged to conduct additional age-adjusted studies after the drug is approved and brought to market, in the event of accelerated approval. This work will be based on real-world data and will not require a new large-scale clinical trial, a Moderna spokesman told Bloomberg.

For Moderna, the flu vaccine is of strategic importance: the company expects to reach break-even by 2028 and diversify its business amid declining revenues from COVID-19 vaccines, Bloomberg wrote. The FDA plans to make a decision on the application by Aug. 5, the start of the next flu season in the U.S., the agency noted.

The FDA reversed its position after refusing to accept Moderna's application for review just over a week ago. The new approach to the approval process addresses the FDA's complaints about the design of clinical trials in elderly patients, according to Bloomberg. The regulator then pointed to the lack of an "adequate and well-controlled" study and the absence of a valid comparative analysis with the existing standard of care.

The rejection was signed by Vinay Prasad, head of the FDA's vaccines division, and was a rare move for the agency: such decisions usually involve obvious flaws in the application rather than disagreements over the control group, Bloomberg notes.

Moderna argued at the time that the regulator's position "contradicts previous written communications" and that the study design had been agreed to by the agency's previous leadership. CEO Stephan Bunsel criticized the decision and said that uncertainty in the FDA's work could undermine U.S. leadership in medicine, Bloomberg recalls.

The situation with the acceptance of new drugs in the United States comes amid a tougher attitude toward mRNA vaccines under U.S. Health Secretary Robert F. Kennedy Jr. who has been critical of the technology, CNN recalls.

Moderna shares are up 58% since the start of 2026. However, most analysts advise holding the company's stock: the bottom has 19 Hold ratings versus only four Buy (Buy and Overweight) and four Sell recommendations (two Sell and Underweight each), MarketWatch shows. At the same time, one less Hold rating and one more Overweight rating were issued last month.

Moderna has an average target price of $40.47 on Moderna stock, down about 13% from the closing price on Feb. 18.

This article was AI-translated and verified by a human editor