It’s Official! Moderna’s COVID Vaccine Receives FDA Approval

Moderna is one of the most recognized companies in the United States. It is hard to remember that before the COVID-19 pandemic, Moderna was a relatively small and obscure company. However, after developing a highly effective vaccine against SARS-CoV-2, Moderna jumped to the spotlight.

Now, their vaccine, marketed as Spikevax, becomes the second vaccine to receive full approval by the Food and Drug Administration (FDA). The approval comes just months after the FDA approved Pfizer and BioNTech’s vaccine in August 2021. 

“The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the European Union, the UK, Israel, and other countries, where the adolescent indication is also approved. We are grateful to the U.S. FDA for their thorough review of our application. We are humbled by the role that Spikevax is playing to help end this pandemic.” said Stéphane Bancel, Chief Executive Officer of Moderna.

The announcement of the approval, together with news of the initiation of Phase 1 clinical trial for Moderna’s HIV vaccine send the stock higher by almost 6%. In comparison, the NASDAQ Biotechnology Index rose only 2.9%.

mRNA technology and COVID-19

Although scientists had been working on mRNA vaccine technology for decades, the first time the technology was approved was during the COVID-19 pandemic. Messenger RNA (mRNA) is genetic material, which delivers instructions to cells to produce specific proteins. 

Nucleic acids are faster to manufacture and modify when compared to attenuated viruses, recombinant proteins, and other approaches for vaccine development. Together with government investment, this allowed the vaccine to be developed in record time. Altogether, the design, testing, and manufacturing occurred in under 1 year. 

Spikevax received emergency use authorization by the FDA in December 2020, after showing it was 94.1% effective in preventing COVID-19 in clinical trials. It became the second vaccine approved just days after the Pfizer and BioNTech vaccine.

Spikevax became Moderna’s first commercially approved product. However, it validated the technology, and open the way for Moderna’s next vaccines against HIV, influenza, Zika, and other viruses. There are plans to extend the therapeutic modalities of mRNA therapeutics with personalized cancer vaccines and others.  

Receiving full FDA approval

Now, a little over a year after receiving emergency authorization, Spikevax has received full approval as a two-dose series for people 18 years of age and older. The approval was based on results from tracking over 14,000 vaccine recipients and over 14,000 placebo recipients. Analyses show Spikevax was 93% effective in preventing COVID-19, and 98% effective in preventing severe disease. Additionally, the FDA assessed the manufacturing processes and facilities to ensure the quality and consistency of the vaccine. 

With full FDA approval, the government hopes some vaccine hesitancy is removed and more people get vaccinated. As explained by Acting FDA Commissioner Janet Woodcock, “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 making the decision to get vaccinated.”

Author

Daniel Ojeda