Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has concluded that a booster dose of Spikevax, the Company’s vaccine against COVID-19, at the 50 µg dose level may be considered in people aged 18 years and older at least six months after completion of the primary series.
“This recommendation is supported by clinical evidence that a 50 µg booster dose induces a strong immune response against COVID-19. We thank the EMA and the CHMP for their review,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We believe that mRNA vaccines are well positioned to adapt to the evolving epidemiology of SARS-CoV-2. We are grateful for the opportunity to provide individuals in the EU with another layer of protection.”
The EMA based this positive opinion on scientific evidence shared by the company, including a data analysis from the Phase 2 clinical study of mRNA-1273, which was amended to offer a booster dose of mRNA-1273 at the 50 µg dose level to interested participants 6-8 months following their second dose. Neutralizing antibody titers had waned prior to boosting, particularly against variants of concern, at approximately 6 months. Notably, a booster dose of mRNA-1273 at the 50 µg dose level boosted neutralizing titers significantly above the Phase 3 benchmark. After a booster dose, a similar level of neutralizing titers was achieved across age groups including in older adults (ages 65 and above). The safety profile following the booster dose was similar to that observed previously for dose 2 of mRNA-1273.
In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past six years.