Moderna Announces Data Submission to European Medicines Agency for COVID-19 Vaccine Recall
Posted on Saturday 04 September 2021 14:13
MRNA-1273 at a dose level of 50 Âµg elicited more than 40-fold robust antibody responses against the Delta variant (B.1.617.2)
CAMBRIDGE, MA, USA I September 03, 2021 IModerna, Inc. (Nasdaq: MRNA), a pioneering biotechnology company in messenger RNA (mRNA) therapies and vaccines, today announced that it has applied for a Conditional Marketing Authorization (CMA) with the European Medicines Agency (EMA) for the evaluation of a booster dose of Moderna Vaccine COVID-19 (mRNA-1273) at the dose level of 50 Âµg.
âWe are delighted to submit a conditional marketing authorization application to the EMA for our booster candidate at the dose level of 50 Âµg. The modified phase 2 study and additional analyzes show that a booster dose of 50 Âµg of our COVID-19 vaccine induces strong antibody responses against the Delta variant, âsaid StÃ©phane Bancel, CEO of Moderna. âWe remain committed to staying one step ahead of the virus and to monitoring the evolving epidemiology of SARS-CoV-2. “
The phase 2 mRNA-1273 study was modified to provide a booster dose of 1273 mRNA at the dose level of 50 Âµg to interested participants 6 months after their second dose (n = 344). Neutralizing antibody titers significantly decreased before the booster at about 6 months. A booster dose of mRNA-1273 at the dose level of 50 Âµg increased neutralizing titers significantly above the phase 3 baseline. After a third dose, a similar level of neutralizing titers was achieved in all age groups, especially the elderly (65 years and over). The safety profile after Dose 3 was similar to that observed previously for Dose 2 of mRNA-1273. These data will be submitted for a peer-reviewed publication.
An additional amount of analysis showed that a booster dose of mRNA-1273 at the dose level of 50 Âµg induced robust antibody responses and significantly increased geometric mean titers (GMT) for all variants of concern, including Beta (B.1.351 ) by 32 times, Gamma (P.1) by 43.6 times and Delta (B.1.617.2) by 42.3 times.
About Spikevax (COVID-19 Moderna Vaccine)
The Moderna COVID-19 vaccine is a COVID-19 mRNA vaccine encoding a pre-fused stabilized form of the Spike (S) protein. On December 18, 2020, the US FDA cleared the Moderna COVID-19 vaccine for emergency use in people 18 years of age or older. Moderna has received emergency (or other conditional, interim or provisional) authorization for the use of its COVID-19 vaccine in adults from health agencies in more than 50 countries and an emergency use list (EUL ) of the World Health Organization (WHO).
In the 10 years since its inception, Moderna has grown from a company in the scientific research stage advancing programs in the field of messenger RNA (mRNA), to a company with a diverse clinical portfolio of vaccines and therapeutic products. through six modalities, a large portfolio of intellectual property in areas such as the formulation of mRNA and lipid nanoparticles, and an integrated manufacturing facility that enables both clinical and commercial production on a large scale and at low speed. previous. Moderna maintains alliances with a wide range of domestic and foreign government and business collaborators, which has allowed the pursuit of both groundbreaking science and rapid scale-up of manufacturing. More recently, Moderna’s capabilities have come together to enable the licensed use of one of the oldest and most effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advancements in basic and applied mRNA science, delivery technology and manufacturing, and has enabled the development of therapies and vaccines for them. infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Today, 23 development programs are underway in these therapeutic areas, of which 15 programs have entered the clinic. Moderna was named one of the top biopharmaceutical employers by Science for six years. To learn more, visit www.modernatx.com.
Spikevax (COVID-19 Vaccine Moderna) has obtained conditional marketing authorization from the European Commission for active immunization aimed at preventing COVID-19 caused by SARS-CoV-2 in people 12 years of age and older.
Click to Factsheet for healthcare providers administering the vaccine (vaccination providers) and full prescribing information from the EUA for more information.
THE SOURCE: Moderna Therapeutics