United States Approves Moderna COVID-19 Vaccine

On Monday, the United States Food and Drug Administration (FDA) approved Moderna's COVID-19 vaccine, which until now had authorization for emergency use.

RELATED:

Venezuela Gets One Million 'Sovereign Plus' Vaccines from Cuba

This vaccine will be marketed under the name of Spikevax to prevent COVID-19 in individuals 18 years of age and older. Moderna's serum was approved for emergency use in the U.S. for the elderly on Dec. 2020, and is the second COVID-19 vaccine to get full FDA approval 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 may be used by the FDA during health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating disease.

Unlike an emergency use approval, a full authorization lasts indefinitely unless some sort of unexpected side effect develops. To achieve this type of approval, a company must provide extensive data on the manufacturing process and is subject to extensive inspections by the FDA.

Moderna Director Stephane Bancel indicated that the totality of the real data and the complete approval of Spikevax 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 U.S.," he said.

Vaccination against COVID-19 has stalled in the U.S., 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 U.S. Centers for Disease Control and Prevention (CDC), over 211 million people (63.8 percent of the population) have received the full schedule of the vaccine, while 87.8 million have received the booster dose.