The success of COVID-19 mRNA vaccines has underscored the significant advantages of utilizing mRNA technology in vaccine development. In response, the FDA has increasingly awarded review designations to mRNA vaccines. ()

In 2023, a record nine designations were granted for mRNA vaccines targeting eight different conditions, demonstrating the FDA’s commitment to expanding the development of these products across a wider range of indications, according to GlobalData, a leading data and analytics company.

What are mRNA Vaccines

These vaccines use mRNA to encode a disease-specific antigen, prompting cells to display the antigen and stimulating an immune response. The 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, states: “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, with five designations 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, designations were awarded across eight indications, including the first 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 indicates that the FDA is focusing on and promoting the development of mRNA vaccines for indications beyond 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.”

Reference:

1. FDA awards record number of review designations to mRNA vaccines in 2023, reveals GlobalData – (https://www.globaldata.com/media/pharma/fda-awards-record-number-review-designations-mrna-vaccines-2023-reveals-globaldata/)

Source-Medindia