FDA awards record number of review designations to mRNA vaccines in 2023

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FDA awards record number of review designations to mRNA vaccines in 2023

The success of the COVID-19 mRNA vaccines highlighted the major advantages of utilizing mRNA technology in vaccine development. Consequently, the FDA has awarded a rising number of review designations to mRNA vaccines in recent years. In 2023, a record nine designations were awarded to mRNA vaccines for eight conditions, displaying the FDA’s commitment to encouraging the development of these products across a broader range of indications, says GlobalData, a leading data and analytics company.

Following FDA approval in August 2021, Pfizer’s Comirnaty became the first mRNA vaccine to enter the global market, followed by Moderna’s Spikevax in January 2022. The mRNA portion of these vaccines encodes a disease-specific antigen, prompting cells to display the antigen and stimulating an immune response.  Implementation of these vaccines is estimated to have prevented 14.4 million deaths from COVID-19 globally (The Lancet., 2022), showcasing the utility of mRNA technology in controlling epidemic outbreaks.

Jasper Morley, Pharma Analyst at GlobalData, comments: “Since the first FDA review designation for an mRNA vaccine in 2018, a total of 25 have been awarded. The onset of the pandemic saw increased FDA activity, where five designations were awarded to mRNA vaccines across three indications in 2021. A surge occurred in 2023, with the FDA awarding a record nine review designations, an 80% increase from 2021. In 2023, the designations were awarded across eight indications, including the first designations for human metapneumovirus, various influenza A and B subtypes, metastatic melanoma, and paramyxoviridae infections.”

Morley adds: “2023 saw nearly double the number of review designations compared to the previous peak of five in 2021, as well as a substantial increase in the variety of associated indications. This surge suggested the FDA was turning its attention to, and promoting the development of, mRNA vaccines for indications outside of COVID-19. This conclusion was confirmed by the FDA approval of Moderna’s mRESVIA, an mRNA vaccine for respiratory syncytial virus (RSV), in May 2024—the first non-COVID-19 approval for an mRNA vaccine.”

In 2023, Moderna’s mRNA-1083 received four fast track designations across its Phase III indications: Influenza A and B infections and COVID-19. This product has now received the most review designations of all mRNA vaccines, and is expected to launch commercially before the end of 2025.

Morley concludes: “mRNA vaccines demonstrated their viability by successfully combating COVID-19. Consequently, since 2021, the FDA has begun awarding increasing levels of review designations, which suggests that the regulator is promoting the development of mRNA vaccines for a variety of indications outside of COVID-19.”

Source: GlobalData