FDA Approves Moderna COVID-19 Vaccine: Spikevax

Moderna's COVID-19 vaccine, now dubbed "Spikevax," has received official approval from the US Food & Drug Administration (FDA) and is no longer contingent on emergency use authorization (EUA). This also makes Spikevax the second COVID-19 vaccine to receive FDA approval, following after Pfizer's "Comirnaty" vaccine in August of 2021.

According to the announcement, "The approval of Spikevax is based on the FDA's evaluation and analysis of follow-up safety and effectiveness data from the ongoing randomized, placebo-controlled, blinded clinical trial that supported the December 2020 EUA for the Moderna COVID-19 Vaccine and information from post EUA experience to further inform safety and effectiveness."

The FDA's testing results showed that, after analysis of over 14,000 people given Spikevax and over 14,000 given a placebo (all at least 18 or older, and showing no prior signs of infection), the vaccine was 93% effective in preventing COVID-19 and 98% effective in preventing severe symptoms. The FDA states that follow-up testing showed just 55 cases of COVID-19 in the vaccinated group, and 744 cases in the group given the placebo. Though it's also noted that data used was collected before the Omicron variant appeared in November of 2021.

Some common side effects reported with Spikevax during analysis included pain and redness or swelling at the injection site, headache, muscle or joint pain, and nausea or vomiting.

First and foremost, the FDA hopes that official approval will help alleviate vaccine hesitancy for many individuals who haven't felt comfortable with getting a vaccination yet. The FDA's Acting Commissioner, Janet Woodcock, M.D, acknowledged in the announcement, "... we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated. The public can be assured 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."

Also worth noting is that Moderna will be continuing to conduct its own post-marketing safety studies to assess whether or not there are any risks to parents or infants when taking Spikevax during pregnancy. Additionally, the FDA has acknowledged that there is an increased risk of inflammation of the heart muscle and surrounding tissues within a week of taking the second dose, and that Moderna has been required to continue its own studies to further assess those risks. After its own risk-assessment, it believes the benefits of Spikevax do eclipse the documented risks.

Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research offered reassurance in the announcement, stating that "Safe and effective vaccines are our best defense against the COVID-19 pandemic, including currently circulating variants. The public can be assured that this vaccine was approved in keeping with the FDA's rigorous scientific standards."