Announcement! Moderna Receives U.S. FDA Approval for The Second mRNA Vaccine

The first RSV vaccine available in single-dose pre-filled syringe

On May 31, 2024, Moderna announced that its RSV mRNA vaccine MRNA-1345 was approved by the FDA. The "first commercially available non-COVID-19 mRNA vaccine" will be used to prevent RSV-associated lower respiratory disease (RSV-LRTD) and acute respiratory disease (ARD) aged 60 years or older. If it receives a positive recommendation from the CDC, Moderna's vaccine would be able to compete with GlaxoSmithKline and Pfizer, which launched their vaccines in the U.S. last fall. But both vaccines have sold hundreds of millions of dollars so far.

mRNA-1345 is an mRNA vaccine that encodes the F-glycoprotein of the virus before stable fusion and induces a superior neutralizing antibody response compared to the post-fusion state. At the same time, the product is delivered using the same lipid nanoparticle (LNP) as Moderna's COVID-19 vaccine and contains optimized protein and codon sequences that improve the stability and effectiveness of the mRNA vaccine.

As a platform technology, mRNA has the advantages of simple production process, short production cycle and high flexibility, which has the potential to encode almost all proteins, and has broad application prospects. Moderna quickly launched RSV mRNA vaccine after the COVID-19 mRNA vaccine. Once again, the potential of mRNA vaccines is demonstrated.

In the R&D cycle of mRNA vaccines and drugs, the most critical steps of early target screening and verification include sequence design and DNA template and stock solution preparation. With the advantages of platform, as many and complete schemes as possible can be designed for potential targets through sequence design and optimization, and the most appropriate sequence scheme can be screened. Based on in-depth research and rich experience in mRNA vaccines and drugs, Hzymes can provide target sequence design, high-quality mRNA plasmid template preparation, IVT process optimization development and target proof of concept and other services. Help customers quickly obtain the mRNA stock solution of potential targets, and verify the feasibility of the target, accelerate the project cycle, compared with the traditional vaccine and drug early target verification, the experiment cycle, cost and other inputs are greatly reduced.

Hzymes has built a pharmaceutical grade special enzyme production system with super-large production scale and ultra-high equipment standards, and has a professional R&D team, which can provide mRNA vaccine and drug IVT process development, mRNA purification process development, LNP preparation process development and other mRNA vaccine and drug complete solutions. In addition, according to customers' application scenarios and individual needs, the company launched mRNA vaccine and drug proof-of-concept services, mRNA and LNP customized synthesis services and mRNA third-party quality inspection services to help customers research and development of mRNA vaccines and drugs, and provide customers with a full range of product development support.