https www pcronline com Cases resources images Zoom on COVID 19 vaccines efficacy and safety of mRNA 1273 SARSCoV 2 vaccine Moderna against SARS CoV 2 Weaknesses The trial Investigational New Drug sponsor, Moderna, was responsible for the overall trial design, site selection and monitoring, and data analysis The short duration of follow up for safety and efficacy This is of relevance since the length of the protection period conferred by vaccination is important both for individual health status and epidemiological planning Although the planned number of cases exceeded what was statistically required for a power calculation, the fact that this happened during the pandemic surge in cases is a potential weakness of the trial Per the trial's statistical plan, an infection rate of 0 75 was expected, which would have amounted to 151 cases in 30 000 participants over a 6 month follow up The fact that 196 events accrued over a significantly shorter period of time (2 months) was due to a surge in cases in autumn of 2020 in the USA This is inevitable in a pandemic, but the question remains whether the estimated vaccine efficacy that depends strongly on the rate of infection in the control group would be constant when the infection numbers in a population are at peak vs nadir No reliable correlate of protection (e g level of antibodies post vaccination) could be assessed due to very low numbers of COVID 19 cases in vaccinated participants (n 11) Read the above article regarding the SWOT analysis of the Moderna's Vaccine Do you agree with the weaknesses portion of this analysis If you were the CEO of Moderna, how would you try to remove the weaknesses

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Posted on Jul 03, 2024

https://www.pcronline.com/Cases-resources-images/Zoom-on/COVID-19/vaccines/efficacy-and-safety-of-mRNA-1273-SARSCoV-2-vaccine-Moderna-against-SARS-CoV-2 Weaknesses The trial Investigational New Drug sponsor, Moderna, was responsible for the overall trial design, site selection and monitoring, and data analysis. The short

https://www.pcronline.com/Cases-resources-images/Zoom-on/COVID-19/vaccines/efficacy-and-safety-of-mRNA-1273-SARSCoV-2-vaccine-Moderna-against-SARS-CoV-2

Weaknesses

The trial Investigational New Drug sponsor, Moderna, was responsible for the overall trial design, site selection and monitoring, and data analysis.
The short duration of follow up for safety and efficacy. This is of relevance since the length of the protection period conferred by vaccination is important both for individual health status and epidemiological planning.
Although the planned number of cases exceeded what was statistically required for a power calculation, the fact that this happened during the pandemic surge in cases is a potential weakness of the trial. Per the trial's statistical plan, an infection rate of 0.75% was expected, which would have amounted to 151 cases in 30 000 participants over a 6-month follow-up. The fact that 196 events accrued over a significantly shorter period of time (2 months) was due to a surge in cases in autumn of 2020 in the USA. This is inevitable in a pandemic, but the question remains whether the estimated vaccine efficacy that depends strongly on the rate of infection in the control group would be constant when the infection numbers in a population are at peak vs. nadir.
No reliable correlate of protection (e.g. level of antibodies post vaccination) could be assessed due to very low numbers of COVID-19 cases in vaccinated participants (n=11).

Read the above article regarding the SWOT analysis of the Moderna's Vaccine.

Do you agree with the "weaknesses" portion of this analysis? If you were the CEO of Moderna, how would you try to remove the weaknesses?