By Dhirendra Tripathi
Investing.com – Moderna stock (NASDAQ:MRNA) rose 5% on Monday after the company’s life-saving mRNA Covid-19 vaccine secured the U.S. Food and Drug Administration’s full approval for individuals 18 years and older.
The company said the approval to Spikevax is based on a comprehensive submission package including efficacy and safety data approximately six months after the second dose.
Moderna said 807 million doses of the Covid vaccine were shipped globally in 2021. Spikevax has received approval by regulators in more than 70 countries.
The vaccine has been available under Emergency Use Authorization in the U.S. since December 2020. Under this, the vaccine is applied in an emergency scenario when alternatives are available.
Moderna is also working on mRNA vaccines to treat tuberculosis, cardiac as well as other serious health ailments.
The company declared its third-quarter numbers in November. July to September revenue jumped nearly 32 times to $5 billion. It swung to a net profit of $3.33 billion from a loss of $233 million in the same quarter a year ago.
It has guided for 2022 sales to come in between $17 billion and $22 billion with 2021 product sales seen at $15 billion-$18 billion. Deliveries of its Covid-19 vaccine in the year through December 2021 are seen between 700 million and 800 million doses at 100 µg dose level.