FDA Fully Approves SpikeVax Moderna COVID-19 Vaccine

Photo Credit: Marco Verch on Flickr, Creative Commons License

On January 31, the U.S. Food and Drug Administration (FDA) approved the Moderna COVID-19 Vaccine for those 18 and older. Moderna is the second COVID-19 Vaccine to be fully approved, after Pfizer on August 23, 2021. 

The approval of the Moderna COVID-19 Vaccine during this specific time is likely associated with a recent outbreak of the Omicron variant of COVID-19. Omicron is highly infectious, even for those vaccinated and even boosted.

Moderna reached this approval by proving its “rigorous standards of safety, effectiveness, and manufacturing quality.” This aforementioned effectiveness refers to its over 90% effectiveness for preventing symptomatic COVID-19, as determined by early randomized trials.

The Moderna COVID-19 vaccine will now be marketed as SpikeVax, though it has the same makeup as the emergency use-authorized Moderna COVID-19 vaccine of the past year. Because of these circumstances, SpikeVax can be used interchangeably with the EUA Moderna COVID-19 Vaccine.

The vaccine is available through a two-dose primary series for those 18 and older, and a third-dose primary series for those 18 and older who have been deemed to be immunocompromised, as well as a booster dose for those 18 and older at least five months after completing the primary series of the Moderna vaccine.

The Moderna vaccine is also authorized to serve as a “mix-and-match” single booster dose for those 18 and older who had received the primary series of a different vaccine. For example, the Pfizer-BioNTech vaccine and Johnson & Johnson vaccine.

Though receiving a full vaccination series and a booster is the best defense against COVID-19, the CDC still recommends wearing masks and social distancing in public settings, among other precautionary measures to prevent the transmission of COVID-19.

Grace Evans is a senior at Jamesville-DeWitt High School. Grace enjoys writing both professionally and personally. In addition to RamPage, she is involved in RamFeed and a few other clubs. Grace is also the Student Board of Education Representative at J-D.