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▎ WuXi AppTec content team editor May 25, 2021, Moderna announced that its mRNA new crown vaccine (mRNA-1273) phase 2/3 clinical study in adolescents (12-17 years old) has reached its main immunogenicity endpoint.
Shows a high degree of protective efficacy as much as that of the adult vaccination group.
In this study, adolescents who had received 2 doses of the vaccine did not develop new coronavirus infection, which is consistent with the vaccine's 100% efficacy.
This vaccine is safe and well tolerated.
All vaccinators will be monitored for 12 months after the second vaccination to continuously evaluate the ability and safety of this vaccine to provide long-term immune protection.
Moderna plans to submit trial data to the US FDA and regulatory agencies around the world in early June.
This randomized, double-blind, placebo-controlled Phase 2/3 TeenCOVE clinical trial enrolled 3732 adolescents between the ages of 12 and 17 and received two doses of 100 µg mRNA-1273 or placebo at a 2:1 ratio.
Agent.
The trial reached the primary endpoint of immunogenicity no less than that of the comparison group of adult Phase 3 clinical trials.
After two doses, no COVID-19 cases were observed in the vaccination group (4 in the placebo group), and the vaccine efficacy calculated based on these data was 100%.
mRNA-1273 is generally well tolerated, and its safety and tolerability characteristics are basically the same as those in adult phase 3 clinical trials.
No serious safety issues have been found so far, and most of the adverse events are mild or moderate in severity.
The most common side effect is pain at the injection site, and the most common side effects after the second dose of mRNA-1273 are headache, fatigue, myalgia and chills.
"We are encouraged that mRNA-1273 is highly effective in preventing adolescent COVID-19.
"Moderna CEO Mr.
Stephane Bancel said, "We will submit these results to the US FDA and global regulatory agencies in early June, and apply for authorization.
We remain committed to doing our part to help end this pandemic.
"Reference: [1] Moderna Announces TeenCOVE Study of its COVID-19 Vaccine in Adolescents Meets Primary Endpoint and Plans to Submit Data to Regulators in Early June.
Retrieved May 25, 2021, from https://investors.
modernatx.
com/ news-releases/news-release-details/moderna-announces-teencove-study-its-covid-19-vaccine Note: This article aims to introduce medical and health research progress, not a treatment plan recommendation.
For treatment plan guidance, please go to See a doctor in a regular hospital.
Shows a high degree of protective efficacy as much as that of the adult vaccination group.
In this study, adolescents who had received 2 doses of the vaccine did not develop new coronavirus infection, which is consistent with the vaccine's 100% efficacy.
This vaccine is safe and well tolerated.
All vaccinators will be monitored for 12 months after the second vaccination to continuously evaluate the ability and safety of this vaccine to provide long-term immune protection.
Moderna plans to submit trial data to the US FDA and regulatory agencies around the world in early June.
This randomized, double-blind, placebo-controlled Phase 2/3 TeenCOVE clinical trial enrolled 3732 adolescents between the ages of 12 and 17 and received two doses of 100 µg mRNA-1273 or placebo at a 2:1 ratio.
Agent.
The trial reached the primary endpoint of immunogenicity no less than that of the comparison group of adult Phase 3 clinical trials.
After two doses, no COVID-19 cases were observed in the vaccination group (4 in the placebo group), and the vaccine efficacy calculated based on these data was 100%.
mRNA-1273 is generally well tolerated, and its safety and tolerability characteristics are basically the same as those in adult phase 3 clinical trials.
No serious safety issues have been found so far, and most of the adverse events are mild or moderate in severity.
The most common side effect is pain at the injection site, and the most common side effects after the second dose of mRNA-1273 are headache, fatigue, myalgia and chills.
"We are encouraged that mRNA-1273 is highly effective in preventing adolescent COVID-19.
"Moderna CEO Mr.
Stephane Bancel said, "We will submit these results to the US FDA and global regulatory agencies in early June, and apply for authorization.
We remain committed to doing our part to help end this pandemic.
"Reference: [1] Moderna Announces TeenCOVE Study of its COVID-19 Vaccine in Adolescents Meets Primary Endpoint and Plans to Submit Data to Regulators in Early June.
Retrieved May 25, 2021, from https://investors.
modernatx.
com/ news-releases/news-release-details/moderna-announces-teencove-study-its-covid-19-vaccine Note: This article aims to introduce medical and health research progress, not a treatment plan recommendation.
For treatment plan guidance, please go to See a doctor in a regular hospital.