mRNA-1273 at 50 µg dose level induced robust antibody responses of more than 40 times against the Delta variant (B.1.617.2)
CAMBRIDGE, MA, USA I September 03, 2021 IModerna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced it has submitted for a conditional marketing approval (CMA) with the European Medicines Agency (EMA) for the evaluation of a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg dose level.
“We are pleased to submit for a conditional marketing approval with the EMA for our booster candidate at the 50 µg dose level. The amended Phase 2 study and additional analyses shows that a 50 µg booster dose of our COVID-19 vaccine induces robust antibody responses against the Delta variant,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We remain committed to staying ahead of the virus and following the evolving epidemiology of SARS-CoV-2.”
The Phase 2 study of mRNA-1273 was amended to offer a booster dose of mRNA-1273 at the 50 µg dose level to interested participants 6 months following their second dose (n=344). Neutralizing antibody titers had waned significantly prior to boosting at approximately 6 months. A booster dose of mRNA-1273 at the 50 µg dose level boosted neutralizing titers significantly above the Phase 3 benchmark. After a third dose, a similar level of neutralizing titers was achieved across age groups, notably in older adults (ages 65 and above). The safety profile following dose 3 was similar to that observed previously for dose 2 of mRNA-1273. These data will be submitted to a peer-reviewed publication.
An additional analysis showed that a booster dose of mRNA-1273 at the 50 µg dose level induced robust antibody responses and significantly increased geometric mean titers (GMT) for all variants of concern including Beta (B.1.351) by 32- fold, Gamma (P.1) by 43.6-fold and Delta (B.1.617.2) by 42.3-fold.
About Spikevax (COVID-19 Vaccine Moderna)
COVID-19 Vaccine Moderna is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein. On December 18, 2020, the U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older. Moderna has received emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine in adults from health agencies in more than 50 countries and an Emergency Use Listing (EUL) from the World Health Organization (WHO).
About Moderna
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. Today, 23 development programs are underway across these therapeutic areas, with 15 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.
AUTHORIZED USE
Spikevax (COVID-19 Vaccine Moderna) has been granted conditional marketing authorisation by the European Commission for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.
Click for Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information for more information.
SOURCE: Moderna Therapeutics
Post Views: 89
mRNA-1273 at 50 µg dose level induced robust antibody responses of more than 40 times against the Delta variant (B.1.617.2)
CAMBRIDGE, MA, USA I September 03, 2021 IModerna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced it has submitted for a conditional marketing approval (CMA) with the European Medicines Agency (EMA) for the evaluation of a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg dose level.
“We are pleased to submit for a conditional marketing approval with the EMA for our booster candidate at the 50 µg dose level. The amended Phase 2 study and additional analyses shows that a 50 µg booster dose of our COVID-19 vaccine induces robust antibody responses against the Delta variant,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We remain committed to staying ahead of the virus and following the evolving epidemiology of SARS-CoV-2.”
The Phase 2 study of mRNA-1273 was amended to offer a booster dose of mRNA-1273 at the 50 µg dose level to interested participants 6 months following their second dose (n=344). Neutralizing antibody titers had waned significantly prior to boosting at approximately 6 months. A booster dose of mRNA-1273 at the 50 µg dose level boosted neutralizing titers significantly above the Phase 3 benchmark. After a third dose, a similar level of neutralizing titers was achieved across age groups, notably in older adults (ages 65 and above). The safety profile following dose 3 was similar to that observed previously for dose 2 of mRNA-1273. These data will be submitted to a peer-reviewed publication.
An additional analysis showed that a booster dose of mRNA-1273 at the 50 µg dose level induced robust antibody responses and significantly increased geometric mean titers (GMT) for all variants of concern including Beta (B.1.351) by 32- fold, Gamma (P.1) by 43.6-fold and Delta (B.1.617.2) by 42.3-fold.
About Spikevax (COVID-19 Vaccine Moderna)
COVID-19 Vaccine Moderna is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein. On December 18, 2020, the U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older. Moderna has received emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine in adults from health agencies in more than 50 countries and an Emergency Use Listing (EUL) from the World Health Organization (WHO).
About Moderna
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. Today, 23 development programs are underway across these therapeutic areas, with 15 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.
AUTHORIZED USE
Spikevax (COVID-19 Vaccine Moderna) has been granted conditional marketing authorisation by the European Commission for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.
Click for Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information for more information.
SOURCE: Moderna Therapeutics
Post Views: 89
