A vial and a medical syringe seen displayed in front of the U.S. Food and Drug Administration and Moderna biotechnology company’s logos.
Pavlo Gonchar | LightRocket | Getty Images
Moderna has officially submitted its updated Covid vaccine for FDA approval. The biotech company is targeting the omicron subvariant XBB.1.5, which is currently the dominant strain of the virus in the U.S.
The decision to update the vaccine is based on the FDA’s recent recommendation for vaccine makers to target the XBB.1.5 strain, which is highly immune-evasive. Moderna, along with competitors Pfizer and Novavax, had already started developing versions of their vaccines for XBB.1.5 prior to the FDA’s recommendation.
All three companies are expected to make their updated vaccines available to Americans in time for the fall, pending FDA approval.
Moderna CEO Stéphane Bancel stated, “The agility of our mRNA platform has enabled us to update Spikevax, Moderna’s COVID-19 vaccine, to target XBB variants with speed and clinical rigor.”
The FDA will review Moderna’s efficacy and safety data to determine whether to approve the updated vaccine. Preliminary trial data on mice suggests that the XBB.1.5 vaccine produces a stronger immune response against XBB variants compared to Moderna’s current authorized vaccine.
Clinical trial data on over 100 people also demonstrates the effectiveness of the XBB.1.5 vaccine in producing protective antibodies against all XBB variants. These trial participants had previously received four Covid vaccine doses.
In the fall, the distribution of Covid vaccines is expected to shift to the private sector. This means that Moderna, Pfizer, and Novavax will directly sell their updated vaccines to healthcare providers instead of the government.
It remains uncertain how many people will choose to take the new shots. Currently, only about 17% of the U.S. population has received the latest boosters from Pfizer and Moderna since their approval in September, according to CDC data.
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