SpikeVax Vaccine Approved by the U.S. FDA

The U.S. Food and Drug Administration (FDA) today announced the Approval of Moderna’s SpikeVax COVID-19 vaccine for adults 18 years and older.

SpikeVax has received Approvals from regulators in more than 70 countries, including Canada, Japan, Israel, the European Union, the UK.

Spikevax has the same formulation as the Authorized Moderna COVID-19 Vaccine and is administered as a primary series of two doses, one month apart.

About 807 million doses of Moderna's COVID-19 vaccine shipped globally in 2021.

The FDA confirmed Spikevax met its rigorous standards for safety, effectiveness, and manufacturing quality required for approval.

Acting FDA Commissioner Janet Woodcock, M.D., commented in a press release issued on January 31, 2022, “While hundreds of millions of doses of Moderna COVID-19 Vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in deciding to get vaccinated.” 

The Moderna COVID-19 Vaccine remains available under EUA as a two-dose primary series for individuals 18 years of age and older, as a third primary series dose for individuals 18 years of age and older who have been determined to have certain kinds of immunocompromise, and as a single booster dose for individuals 18 years of age and older at least five months after completing a primary series of the vaccine. 

It is also authorized for use as a heterologous (or “mix and match”) single booster dose for individuals 18 years of age and older following completion of primary vaccination with a different available COVID-19 vaccine. 

Spikevax can be used interchangeably with the EUA Moderna COVID-19 Vaccine to provide the COVID-19 vaccination series. 

Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, added, “Safe and effective vaccines are our best defense against the COVID-19 pandemic, including currently circulating variants. In addition, the public can be assured that this vaccine was approved in keeping with the FDA’s rigorous scientific standards.”

The Spikevax biologics license application (BLA) builds upon the data and information that supported the EUA. 

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.  

Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data about myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination with the Moderna COVID-19 Vaccine.

The FDA determined that the data demonstrate increased risks, particularly within seven days following the second dose, with the observed risk highest in males 18 through 24 years of age. 

Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. 

However, some individuals require intensive care support. And information is not yet available about potential long-term health outcomes.

The FDA has determined that the benefits of the SpikeVax vaccine outweigh the risk of myocarditis and pericarditis in individuals 18 years of age and older.

Furthermore, the FDA requires Moderna to conduct post-marketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Spikevax.

In addition, although not FDA requirements, the company has committed to conducting additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Spikevax during pregnancy.

The FDA Approval was granted to ModernaTX, Inc.

The Maryland-based FDA is an agency within the U.S. Department of Health and Human Services, that protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. 

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