2 vaccine candidates compete to become first FDA-approved mRNA vaccine
Moderna’s new COVID-19 vaccine candidate, utilizing mRNA technology is nearly 95 percent effective, according to early data from its Phase 3 Coronavirus Efficacy and Safety Study (COVE).1
Results were announced on Monday, November 16, 2020, on the heels of Pfizer and BioNTech’s competing vaccine candidate’s study results, which showed more than 90 percent efficacy. The encouraging news adds to growing confidence in upcoming pandemic relief.
Moderna says it is a “pivotal moment in the development of our COVID-19 vaccine” in a statement and has announced plans to apply in the coming weeks for Food & Drug Administration (FDA) approval to use the vaccine.1 The company is still gathering the safety data necessary for an emergency use authorization (EUA)—which would allow distribution.1
There has never been a FDA approved mRNA vaccine, to date.2 Now that 2 have emerged in the span of a month, many key questions have arisen, such as, “How does the vaccine work?” and “How good is it?”
How does it work?
Both the Moderna and Pfizer vaccines use the same technology.3,4 They contain a molecule known as mRNA, or messenger RNA, which houses genetic instructions for making proteins inside cells.
Researches figured out a way to create an mRNA code that produces the coronavirus spike protein.3 This protein is what triggers the immune system to create antibodies against the virus, without a live virus or risk of infection.3
In the Phase 3 trial, Moderna’s vaccine candidate took part in a randomized, stratified, observer-masked, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine in adults aged 18 years and older.5
Some 30,000 volunteers took part in the study.6 Half received 2 doses of the vaccine 28 days apart, and half received 2 shots of a placebo on the same schedule.6 Participants were not counted in the Moderna study unless they had at least 2 symptoms of COVID-19 in addition to a positive test for the virus.5
The company recruited a diverse set of participants: 6,000 identified as Hispanic or Latinx, and more than 3,000 participants identified as Black or African American, as well as 7,000 people over the age of 65 and 5,000 who suffer from high-risk chronic diseases.5
How good is it?
Moderna’s vaccine candidate appears highly effective in preventing illness following exposure to the virus that causes the disease, according to the company.
An interim analysis of the study’s safety data did not report significant safety concerns, and the vaccine was generally well tolerated.1 The majority of adverse events were mild or moderate in severity and included injection site pain, fatigue, myalgia, arthralgia, and headache.1
1. Moderna. Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study. Available at https://investors.modernatx.com/news-releases/news-release-details/modernas-covid-19-vaccine-candidate-meets-its-primary-efficacy. Accessed 11/16/20.
2. Moderna. Moderna Announces IND Submitted to U.S. FDA for Phase 2 Study of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus. Available at https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-ind-submitted-us-fda-phase-2-study-mrna. Accessed 11/16/20.
3. Moderna. Moderna Announces Phase 3 COVE Study of mRNA Vaccine Against COVID-19 (mRNA-1273) Begins. Available at https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-phase-3-cove-study-mrna-vaccine-against-covid. Accessed 11/16/20.
4. Pfizer. Pfizer and BioNTech accounce vaccine candidate against COVID-19 achieved success in first interim analysis from phase 3 study. Available at: https://investors.pfizer.com/investor-news/press-release-details/2020/Pfizer-and-BioNTech-Announce-Vaccine-Candidate-Against-COVID-19-Achieved-Success-in-First-Interim-Analysis-from-Phase-3-Study/default.aspx. Accessed 11/9/20.
5. Moderna. Phase 3 COVE study protocol. Available at https://www.modernatx.com/sites/default/files/mRNA-1273-P301-Protocol.pdf. Accessed 11/16/20.
6. Moderna. Demographic data for the Phase 3 COVE study. Available at https://www.modernatx.com/sites/default/files/content_documents/2020-COVE-Study-Enrollment-Completion-10.22.20.pdf. Accessed 11/16/20.