Moderna COVID-19 Vaccine Granted Full Approval by FDA: Report

by Jennifer Shea

The U.S. Food and Drug Administration on Monday approved a second COVID-19 vaccine, Moderna’s Spikevax, for people 18 years old and older.

The FDA approved Moderna’s COVID-19 vaccine for emergency use authorization on Dec. 18, 2020. But the vaccine had yet to receive full approval from the FDA. The latter involves a longer process. It requires independent verification of analyses from the company. It also entails a detailed assessment of Moderna’s manufacturing processes, test methods and manufacturing plants.

Meanwhile, Spikevax is the same formula as the EUA vaccine from 2020. People take it in two doses one month apart. They also take it as a single booster five months after the initial two doses.

Moderna Vaccine Approval ‘May Instill Additional Confidence’ in the Unvaccinated, Officials Say

This approval “is a significant step in the fight against the COVID-19 pandemic,” Acting FDA Commissioner Janet Woodcock, M.D. said in a statement. It “mark[s] the second vaccine approved to prevent COVID-19. The public can [trust] 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.”

Moreover, Woodcock noted that “hundreds of millions of doses of Moderna COVID-19 vaccine” have already gone out to people under the emergency use authorization. But “we understand that for some individuals, FDA approval of this vaccine may instill additional confidence” in choosing to get the vaccine.

The FDA approved Pfizer’s COVID-19 vaccine, Comirnaty, in August, The Hill reports. Both vaccines are Messenger RNA, or mRNA, vaccines. They work by instructing our cells to make a protein that will trigger an immune response. That, in turn, produces antibodies against the virus. (Unlike traditional vaccines, mRNA vaccines do not contain a weaker germ of the actual virus.)

Approval Drew on Data Showing High Efficacy

The FDA’s full approval drew upon follow-up data from the company. It showed high efficacy and safety roughly six months after the second dose. The FDA also recommends getting a booster shot of the vaccine five months after the initial jabs.

“Our COVID-19 vaccine has been administered to hundreds of millions of people around the world,” Moderna CEO Stéphane Bancel said in a statement. What’s more, “[it has] protect[ed] people from COVID-19 infection, hospitalization and death. The totality of real-world data and the full [approval] for 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 achieve licensure in the U.S.”

Meanwhile, CDC data shows that 74 percent of U.S. adults have received the initial two doses of a vaccine. Many fewer have received a booster. Just 44 percent have gotten the third shot, according to the CDC. So as omicron surges, public health experts say the latter number needs to rise. At least, it does if people are to enjoy higher protection from the variant.