How do clinical trials assess the effectiveness of the new crown vaccine? Moderna announces detailed plans.

Today, Moderna announced the complete plan for its Phase 3 clinical trial of the new crown vaccine mRNA-1273.
mRNA-1273 is one of the candidates for a Phase 3 clinical trial, which has enrolled 25,296 participants as of September 16, more than 10,000 of whom have received a second dose of the vaccine or placebo, according to a report released today by Moderna on research and development day.
today, the Pharmaceutical Minder content team will explore several issues for evaluating the effectiveness of candidate vaccines in conjunction with Moderna's announced clinical trial program for the new crown vaccine.
The main endpoint for evaluating the effectiveness of the new crown vaccine In this clinical trial, the main endpoint for evaluating the effectiveness of the new crown vaccine was in patients with symptomatic COVID-19.
They are defined as: 1. Participants must develop two of the following symptoms: fever over 38 degrees C, chills, muscle pain, headache, sore throat, new olfactory and taste disorders, or one of the following symptoms: cough, shortness of breath or difficulty breathing, clinical or radiological evidence of pneumonia.
2. And at least one nasopharyngeal swab, nasal swab, saliva sample (or respiratory sample obtained in hospital) tested positive for the new coronavirus with RT-PCR nucleic acid.
this definition, the clinical trial tests the effectiveness of the new crown vaccine in preventing people from developing symptomatic COVID-19, rather than the ability to completely prevent new coronavirus infections.
past experience in the development of respiratory virus vaccines suggests that it may be easier to judge the effectiveness of candidate vaccines, with patients with symptomatic diseases as the primary endpoint.
in this trial, severe COVID-19 patients and asymptomatic COVID-19 patients were listed as the end of secondary efficacy.
potential timeline trial to assess the effectiveness of the candidate new crown vaccine states that participants who receive a second dose of mRNA-1273 candidate vaccine 14 days after they develop symptomatic COVID-19 will be counted as the primary endpoint.
the researchers made the following assumption: If the six-month prevalence of placebo-infested participants was 0.75 percent while the candidate vaccine provided 60 percent protection (reducing the six-month prevalence among vaccinated participants to 0.30 percent), Statistically, when 151 people in both groups who were vaccinated and given placebo had symptomatic COVID-19, the researchers had 90 percent statistical certainty about whether the vaccine was effective.
the hypothesis that the vaccine is effective (Photo source: Resources) However, since the protection capacity of the mRNA-1273 candidate vaccine may be higher than 60%, the study arranged three data analyses, the first of which The interim data analysis was performed when the number of patients with symptoms of COVID-19 reached 53, the second interim data analysis was performed when the number of patients reached 106, and the final data analysis was performed when the number of patients reached 151.
helps to confirm the effectiveness of candidate vaccines as early as possible.
Based on the above assumptions, Moderna's clinical trial program notes that if 30,000 participants were recruited and the placebo group's six-month prevalence remained at 0.75 percent, it would take about five months to accumulate 53 patients, with an estimated eight and 10 months of accumulation of 106 and 151 patients.
this time, a data assessment of vaccine protection effectiveness will occur.
Jacqueline Miller, Senior Vice President of Infectious Diseases Development at Moderna, which influences the assessment of vaccine protection effectiveness, used a chart at today's Research day event in Moderna to explain the cumulative number of patients and the impact of the vaccine's own effectiveness on vaccine protection effectiveness assessment.
She noted that if the vaccine itself was protected at 60 per cent, statistically less than 10 per cent of the vaccine was statistically likely to be confirmed to be effective at the time of the first mid-term data analysis (the data met statistically significant criteria) and that, as the cumulative number of cases increased, there was a approximately 65 per cent chance that the vaccine would be confirmed to be effective in the second interim analysis.
this value can be increased to 90 per cent in the final data analysis.
Effect of cumulative COVID-19 patients on vaccine effectiveness assessment, A, first interim analysis; Photo Source: Reference: However, if the vaccine is more protective, for example, at 75 per cent, there is a 50 per cent chance that the vaccine will be confirmed to be effective at the first interim analysis, and more than 95 per cent at the second mid-term analysis.
, if mRNA-1273 is more protective, it is more likely to confirm the effectiveness of the vaccine in earlier interim analyses.
effects of vaccine protection effectiveness on vaccine effectiveness assessment, a 15% increase in vaccine protection effectiveness can increase the probability of confirming vaccine effectiveness at the first data assessment to 50% (Photo source: Resources) Another factor affecting the vaccine assessment timeline is COVID-1 If the prevalence of COVID-19 is higher than the 0.75 percent expected, then clinical trials will accumulate at a faster rate to 53/106/151 patients, and it is possible to determine the effectiveness of the vaccine candidate earlier.
Moderna also took into account infection rates in the communities where the trial points were located and the risk of individual participants when setting up clinical trial points to recruit participants.
Moderna also noted that participants will be followed up for up to two years to track potential adverse reactions to the vaccine, regardless of whether the vaccine candidate is effective or not.
resources: s1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Retrieved September 17, 2020, from the Clinical Study Protocol. Retrieved September 17, 2020, from s.3. Retrieved September 17, 2020, from [4] Moderna Shares the Blueprint for Its Coronavirus Vaccine Trial. Retrieved September 17, 2020, from.