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Moderna’s COVID-19 vaccine has been fully approved by the U.S. Food and Drug Administration (FDA) for people 18 and over. With the approval comes a new name: Spikevax.

“The FDA fully approved the Pfizer COVID-19 vaccine last August for those 16 and older and now has done the same with the Moderna vaccine for those 18 and older. These approvals are further confirmation that these vaccines are effective and safe,” said DHS Secretary-designee Karen Timberlake. “We urge those folks that have waited to get vaccinated to do so now and join their nearly 3.7 million fellow Wisconsinites who have received their COVID-19 vaccine.”

While the Moderna vaccine has been in use for months, the FDA had only granted emergency approval due to the severity of the COVID-19 pandemic. As stated in a DHS news release, after “extensive data on safety and effectiveness, inspection of manufacturing facilities, and a comprehensive review of all clinical and real-world use,” the FDA was able to grant full approval.

As the vaccine was given to the public, “even more data were gathered and analyzed following the grant of emergency use authorization in December 2020 to further confirm that this vaccine works and is safe. All of the COVID-19 vaccines are extremely effective at preventing serious illness, hospitalization, and death – including from the Delta and Omicron variants,” the news release stated.

The application for the FDA’s full approval was done through a priority review.

The FDA’s decision to issue full approval to the Moderna vaccine reinforces what we have known since the initial emergency use authorization – this vaccine is safe and effective. This is another important milestone and builds on evidence that the Moderna vaccine is safe and effective for everyone ages 18 and up. It’s more important than ever that everyone who is eligible to get vaccinated get vaccinated so we can keep ourselves, our kids, our friends, family, and neighbors safe.

Stephanie Schauer, Ph.D., Division of Public Health Immunization Program Manager

COVID-19 Vaccine Locations

Wisconsin DHS is urging those who are unvaccinated to get the vaccine as soon as possible. COVID-19 vaccines have proven to be safe. They are both free and widely available throughout the state of Wisconsin.

The DHS COVID-19 webpage offers up-to-date information on the Wisconsin COVID-19 response. You can also follow the DHS on Facebook and Twitter.

The CDC’s is also a credible resource to find vaccinations anywhere in the U.S.

The Racine County Eye and Kenosha Lens is committed to publishing the most current and accurate information regarding the COVID-19 pandemic in our Coronavirus section. View both the Racine County COVID-19 Dashboard and Kenosha County COVID-19 Dashboard offering real-time (updated Monday – Friday) statistical reporting for Racine and Kenosha Counties. Subscribe today to stay up-to-date with local news.