The U.S. Food and Drug Administration on Jan. 31 gave full approval to Moderna Inc.’s COVID-19 vaccine for people 18 years of age and older. This makes it the second fully approved vaccine against the coronavirus, after “Comirnaty”, from Pfizer and BioNTech.
Moderna’s messenger RNA (mRNA) platform product had already been authorized for emergency use in the US, since December 2020. Now, with full approval, it can be marketed under the Spikevax brand.
This vaccine can be applied as a primary two-dose regimen (with a one-month interval between the two) and is also authorized for use as a heterologous booster dose.
"The public can be assured that Spikevax meets the high standards of safety, efficacy and manufacturing quality that the FDA requires of any vaccine approved for use in the US," said Deputy Commissioner Dr. Janet Woodcock. FDA, in a statement.
FDA Basics
According to the US agency, Spikevax meets the rigorous standards of safety, effectiveness and manufacturing quality required for approval.
The FDA’s safety analysis of Spikevax included approximately 15,184 vaccine recipients and 15,162 placebo recipients ages 18 and older. More than half of these participants were followed for safety outcomes for at least four months after the second dose. Approximately 7,500 participants originally assigned to receive Spikevax in the blinded phase of the clinical trial completed safety follow-up for at least 6 months after the second dose.
The side effects most frequently reported by clinical trial participants were pain, redness, and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, nausea/vomiting, swollen lymph nodes under the arm and fever.
Additionally, the FDA conducted a rigorous evaluation of post-clearance safety surveillance data related to myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) after vaccination with the Moderna COVID Vaccine -19 and has determined that the data demonstrate an increased risk particularly within seven days of the second dose, with the highest risk observed in men 18 to 24 years of age.
Available short-term follow-up data suggest that most people have had resolution of these symptoms. However, some people required care. There is still no information available about possible long-term health outcomes. The prescribing information for Spikevax includes a warning about these risks.
The FDA conducted its own risk-benefit assessment using models to predict how many symptomatic COVID-19 cases, hospitalizations, intensive care unit (ICU) admissions, and COVID-19 deaths would be prevented by the vaccine in people over 18 years of age. versus the number of possible myocarditis/pericarditis cases, hospitalizations, ICU admissions and deaths that could be associated with it. The FDA determined that the benefits of the vaccine outweigh the risk of myocarditis and pericarditis in this population.
