MANILA, Philippines – American biotechnology company Moderna announced today the progress on late-stage development of mRNA-1273, the company’s mRNA vaccine candidate against coronavirus disease 2019 (COVID-19).
Moderna said they already finalized the Phase 3 study protocol based on feedback from the U.S. Food and Drug Administration (FDA). The trial, expected to begin in July 2020, includes approximately 30,000 participants.
The trial’s primary endpoint will be the prevention of symptomatic COVID-19 disease, key secondary endpoints include prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by SARS-CoV-2, the virus that causes COVID-19.
The primary efficacy analysis will be an event-driven analysis based on the number of participants with symptomatic COVID-19 disease. Based on the results of the Phase 1 study, the 100 μg dose level was chosen as the optimal dose level to maximize the immune response while minimizing adverse reactions.
"With the Phase 3 dose being finalized at 100 μg, the Company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021 from the Company’s internal U.S. manufacturing site and strategic collaboration with Lonza," Moderna said.
READ: Duterte readying money to buy COVID-19 vaccine
During the Phase 2 study, Moderna evaluated the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart.
On May 18, Moderna announced initial data from the Phase 1 study of mRNA-1273 led by National Institute of Allergy and Infectious Diseases (NIAID). The Phase 1 study is ongoing with the original cohorts in long-term follow-up and enrollment in 9 of 12 cohorts complete. The National Institutes of Health (NIH) will be submitting the Phase 1 data to a peer-reviewed clinical publication.
— The Summit Express
Moderna said they already finalized the Phase 3 study protocol based on feedback from the U.S. Food and Drug Administration (FDA). The trial, expected to begin in July 2020, includes approximately 30,000 participants.
The trial’s primary endpoint will be the prevention of symptomatic COVID-19 disease, key secondary endpoints include prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by SARS-CoV-2, the virus that causes COVID-19.
The primary efficacy analysis will be an event-driven analysis based on the number of participants with symptomatic COVID-19 disease. Based on the results of the Phase 1 study, the 100 μg dose level was chosen as the optimal dose level to maximize the immune response while minimizing adverse reactions.
"With the Phase 3 dose being finalized at 100 μg, the Company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021 from the Company’s internal U.S. manufacturing site and strategic collaboration with Lonza," Moderna said.
READ: Duterte readying money to buy COVID-19 vaccine
During the Phase 2 study, Moderna evaluated the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart.
On May 18, Moderna announced initial data from the Phase 1 study of mRNA-1273 led by National Institute of Allergy and Infectious Diseases (NIAID). The Phase 1 study is ongoing with the original cohorts in long-term follow-up and enrollment in 9 of 12 cohorts complete. The National Institutes of Health (NIH) will be submitting the Phase 1 data to a peer-reviewed clinical publication.
— The Summit Express
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