Cambridge-based Moderna achieved a significant regulatory milestone as the U.S. Food and Drug Administration granted full approval for its COVID-19 vaccine, now marketed as Spikevax, for prevention of COVID-19 in individuals 18 years of age and older. The approval marks Moderna's first product to achieve licensure in the United States and positions the company as the second firm to receive full FDA approval for a COVID-19 vaccine, following Pfizer's Comirnaty.
Clinical Trial Results Drive Approval Decision
The FDA's approval was based on comprehensive safety and effectiveness data from Moderna's ongoing Phase 3 COVE clinical trial, which included 14,287 vaccine recipients and 14,164 placebo recipients. The trial demonstrated that Spikevax was 93% effective in preventing COVID-19, with 55 cases occurring in the vaccine group compared to 744 cases in the placebo group. Additionally, the vaccine showed 98% effectiveness in preventing severe disease.
Acting FDA Commissioner Janet Woodcock emphasized that "the public can be assured that Spikevax meets the FDA's high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States."
Safety Profile and Administration
The FDA's safety analysis encompassed 15,184 vaccine recipients and 15,162 placebo recipients. The most commonly reported side effects included pain, redness and swelling at the injection site, fatigue, headache, muscle pain, chills, nausea, swollen lymph nodes under the arm, and fever. Federal regulators determined that the benefits of the vaccine outweigh the risk of myocarditis and pericarditis in individuals 18 years and older.
Spikevax maintains the same formulation as the emergency-use authorization version and is administered as a primary series of two doses, one month apart. The vaccine has been available under Emergency Use Authorization in the United States since December 18, 2020, and has been administered to hundreds of millions of people worldwide.
Global Regulatory Success and Distribution
The full licensure in the United States joins regulatory approvals in more than 70 countries, including Canada, Japan, the European Union, the United Kingdom, and Israel. Moderna reported shipping 807 million doses of its COVID-19 vaccine globally in 2021, with approximately 25% of those doses delivered to low- and middle-income countries.
"This is a momentous milestone in Moderna's history as it is our first product to achieve licensure in the U.S.," said Stéphane Bancel, Chief Executive Officer of Moderna. "The totality of real-world data and the full BLA for Spikevax in the United States reaffirms the importance of vaccination against this virus."
Continued Emergency Use Authorizations
While Spikevax receives full approval for the primary series, booster doses remain under Emergency Use Authorization. A booster dose at the 50 μg dose level is authorized for adults 18 years and older, while a third dose at the 100 μg dose level is authorized for immunocompromised individuals 18 years of age or older who have undergone solid organ transplantation or have equivalent levels of immunocompromise.
The approval submission package included follow-up data showing high efficacy and favorable safety approximately six months after the second dose, along with manufacturing and facilities data required by the FDA for licensure.
