New Delhi : COVID-19 mRNA Vaccines Highlighted the key advantages of using mRNA technology in vaccine development. FDA An increasing number of awards have been presented Review designation A record nine designations have been granted for mRNA vaccines in recent years. In 2023, a record nine designations were granted to mRNA vaccines for eight conditions, reflecting the FDA’s commitment to encouraging the development of these products across a broad range of indications, says GlobalDataA leading data and analytics company.

Following FDA approval in August 2021, PfizerComirnaty became the first mRNA vaccine to enter the global market, followed by ModernSpikeVax in January 2022. The mRNA portion of these vaccines encodes disease-specific Antigeninduces cells to display antigens and stimulates an immune response. The implementation of these vaccines is estimated to have prevented 14.4 million deaths from COVID-19 worldwide (The Lancet, 2022), showing the utility of mRNA technology in controlling pandemic outbreaks.

Jasper Morley, pharma analyst at GlobalData, said, “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 a surge in FDA activity, where five designations were granted to mRNA vaccines across three indications in 2021. A surge followed in 2023, with the FDA granting a record nine review designations, an 80 percent increase from 2021. In 2023, designations were granted across eight indications, including the first designations for human metapneumovirus, various influenza A and B subtypes, metastatic melanoma, and paramyxoviridae infections.” Pointing out that 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 diversity of relevant indications, Morley said this surge suggests that the FDA is shifting its focus

“This conclusion was confirmed by the FDA’s approval of Moderna’s mRESVIA, an mRNA vaccine.” respiratory syncytial virus (RSV), in May 2024 — will be the first non-COVID-19 approval for an mRNA vaccine,” Morley said.

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

“mRNA vaccines have demonstrated their viability by successfully combating COVID-19. As a result, starting in 2021, the FDA has begun granting increasing levels of review designations, which suggests that the regulator is promoting the development of mRNA vaccines for various indications besides COVID-19,” Morley concluded.