Moderna’s mRNA vaccine has 94.1% efficacy in the final analysis of the Phase-3 trial involving 30,000 participants. The vaccine has 100% efficacy in preventing severe disease and is efficacious even in older adults aged over 65 years. As the Phase-3 trial has exceeded two months of median follow-up post vaccination as required by the U.S FDA, it has already applied for Emergency Use Authorization.
On November 30, Moderna announced the final safety and efficacy results of the mRNA vaccine in Phase-3 trial involving 30,000 participants. The vaccine has been found to be safe and has 94.1% efficacy, the company said in a press release. The efficacy of the vaccine to prevent severe disease has been 100%, the release says. Efficacy has been consistent across age groups including older adults aged over 65 years, the release says. Also, efficacy has been consistent across race and ethnicity, and gender demographics, it said.
According to the release, the Phase-3 trial has exceeded two months of median follow-up post vaccination as required by the U.S. FDA for the purpose of Emergency Use Authorization (EUA). While the company is continuing to review safety data, no new serious safety concerns have been identified so far. Based on prior analysis, the most common solicited adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site. The adverse events increased in frequency and severity in the vaccine group after the second dose.
The company has submitted the data for EUA with FDA on Monday, Moderna said in a tweet. “Moderna’s data for the Emergency Use Authorization request for mRNA-1273 has been submitted to the U.S. FDA,” the company tweeted. It will also be applying for a conditional marketing authorization with the European Medicines Agency (EMA).
In the Phase-3 trial involving 30,000 participants 196 COVID-19 cases were reported. Of the 196 cases, only 11 participants who received two doses of the vaccine had COVID-19, while the remaining 185 participants were in the placebo arm. Also, 30 severe COVID-19 cases were reported during the trial and all the 30 were in the placebo group.
“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease. We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,” said Stéphane Bancel, Chief Executive Officer of Moderna said in the release.
The interim results announced on November 16, Moderna’s mRNA vaccine showed 94.5% efficacy in preventing COVID-19. The interim analysis, which was based on 95 cases, found that 90 participants in the placebo group had symptoms of COVID-19, while only five participants in the vaccinated group had developed symptoms. Moderna had even then said that the vaccine might be able to prevent severe disease.
Unlike Pfizer’s mRNA vaccine which requires ultra-low temperature of -70 to -80 degree C cold storage, the Moderna mRNA is stable at -20 degree C for up to six months, 2-8 degree C for 30 days, and at room temperature for up to 12 hours.