- On Monday Moderna announced it would apply for emergency approval of its coronavirus vaccine
- The pharmaceutical company released data showing its vaccine is 100% effective at preventing severe COVID-19 infection.
- By end of the year, approximately 20 million doses of Moderna’s coronavirus vaccine can become available.
On November 20th, Pfizer became the first company to apply for emergency approval of its coronavirus vaccine. Following in its footsteps, Moderna announced on Monday that it plans to apply for an emergency use authorization from the U.S Food and Drugs Administration (FDA). Some 30,000 volunteers from across the U.S received Moderna’s coronavirus vaccine.
The pharmaceutical company will submit data from the primary efficacy analysis of its Phase 3 clinical trials. Earlier results from the first interim analysis had found the vaccine 94.5% effective at preventing COVID-19.
This is striking. These are amazing data.
Dr. Paul Offit, member of the FDA’s vaccine advisory committee
Moderna’s coronavirus vaccine – 100% Prevents Severe COVID-19
Similar to Pfizer, Moderna’s coronavirus vaccine uses mRNA (messenger RNA) to evoke an immune response in healthy adults. Moreover, the vaccine is administered in two doses, a few weeks apart.
In a sample of 30,000 participants, half received a placebo while the other half received the vaccine. Based on the primary analysis report released by the company, the vaccine efficacy was 94.1% at preventing COVID-19 in healthy adults. Researchers observed 185 cases of COVID-19 in the placebo group. Whereas only 11 cases were observed in the vaccine group, none of whom had a severe disease.
Thus, confirming a 100% vaccine efficacy against severe COVID-19.
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,
Stéphane Bancel, Chief Executive Officer of Moderna
Other than mild fever, headaches and fatigue, researchers have reported no adverse outcomes of the vaccine.
FDA Approval by Mid-December
FDA’s Vaccines and Related Biological Products Advisory Committee will review Moderna’s application by December 17th. The company believes that once approval for emergency use authorization is received, it can immediately start administering the vaccine. The first few doses will likely go to high-risk groups such as healthcare professionals, police officers, and residents of nursing homes.
Moderna plans to produce 20 million doses of its vaccine by the end of 2020. Moreover, 500 million to 1 billion doses of the vaccine could become available for use across the world by 2021.
Moderna’s statement is highly encouraging at a time when the world is struggling to stay afloat, battling the second wave of COVID-19.
Reference:
Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization. (2020, November 30). Retrieved November 30, 2020, from https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-primary-efficacy-analysis-phase-3-cove-study
