The United States Food and Drug Administration (FDA) fully approved Moderna’s anticovid vaccine on Monday, which until now had authorization for emergency use.
In a release, the US regulator explained that after this measure the vaccine will be marketed under the name Spikevax “to prevent covid-19 in individuals 18 years of age and older.”
Moderna’s serum was approved for emergency use in the US for the elderly on December 18, 2020, and it is the second vaccine against covid that obtains the approval full FDA after Pfizer’s.
Outgoing FDA Commissioner Janet Woodcock noted that full approval “may instill greater confidence in making the decision to get vaccinated” among the population.
Emergency authorizations are used by the FDA during health emergencies to provide access to medical products that are effective in preventing, diagnosing, or treating disease.
Unlike an emergency use approval, a full authorization lasts indefinitely unless some kind of unexpected side effect develops.
To achieve this type of approval, the company must provide extensive data on the manufacturing process and is subject to extensive inspections by the FDA.
One more achievement for Moderna
Moderna CEO Stéphane Bancel said in a statement: “The totality of the actual data and full (approval) of Spikevax in the United States reaffirms the importance of vaccination against this virus.”
“This is a momentous milestone in Moderna’s history as it is our first product to be licensed in the US,” said Bancel.
Vaccination against covid-19 has stalled in the US, where the immunization campaign or the use of the mask have become politicized amid the deep political polarization in the country.
According to data from the US Centers for Disease Control and Prevention (CDC), more than 211 million people (63.8% of the population) have received the complete schedule of the vaccine, while 87.8 million ( 41.5%) have received the booster dose.