Moderna Vaccine

 Moderna Vaccine: Encouraging Results from Phase 3 COVE Trial

    Much of the world has grown tired of lockdowns, restrictions and sickness and death resulting from the COVID-19 pandemic. It's safe to say that many people would like the pandemic to come to an end so they can return to 'normal' life. As a result, much attention has been placed on the development of vaccines as pharmaceutical companies release clinical trial results and obtain FDA approval to administer their vaccine. 

    Two vaccines in particular, have shown promising results in effectively combating the coronavirus- a vaccine developed by the NYC-based drug company Pfizer, and a vaccine developed by the Massachusets-based biotechnology company Moderna. Just this week, Pfizer rolled out its vaccine to millions of people in the United Kingdom after being approved for emergency-use authorization. For more information about the Pfizer vaccine and vaccines in general, see Pfizer Vaccine and What You Need to Know About the COVID-19 Vaccines. Both the Pfizer and Moderna vaccines are mRNA based- meaning the vaccines use mRNA to code for a spike protein which is displayed on a cell surface and triggers an immune response including the production of antibodies to fight off the virus. Moderna recently published their press release on November 30, 2020, where the company provided detailed results from their vaccine's clinical study.

About the Study

    A little over a week ago, Moderna announced the final results of their independent phase 3 study for their COVID-19 vaccine candidate, mRNA-1273. This study, also known as the Coronavirus Efficacy and Safety (COVE) study, was conducted in collaboration with the National Institute of Allergy and Infectious diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). The phase 3 COVE trial was a randomized and placebo-controlled study, enrolling over 30,000 U.S. participants aged 18 years or older. The study comprised of a wide range of participants, including 7,000 Americans over the age of sixty-five, 5,000 Americans under the age of 65 with underlying conditions (such as diabetes, obesity, and cardiac disease), and 11,000 people of color. 

Study Results: Efficacy

    Of the 30,000 participants, 196 people tested positive for the coronavirus. Of these 196 COVID-19 cases, 185 were observed in the placebo group and only 11 cases were observed in the vaccinated group. Moderna confirmed that these findings result in a vaccine efficacy 94.1%, a much higher rate than expected by many scientists. (Approval for emergency-use authorization by the Food and Drug Administration requires an efficacy of at least 50% against coronavirus infection.) Additionally, one COVID-19 related death and 30 severe cases of COVID-19 were reported, all of which occurred in the placebo group. In other words, Moderna's vaccine was 100% effective against severe COVID-19 disease. What's more is that the vaccine's efficacy was consistent across age, race/ethnicity, and gender demographics, providing evidence that different groups  have a similar level of protection. 

Study Results: Safety and Durability

    The NIH-appointed Data Safety Monitoring Board did not report any significant safety concerns in the Phase 3 COVE study for Moderna's vaccine. According to Moderna's report, the most common adverse reactions from the vaccine included injection site pain, fatigue, muscle and joint pain, headaches, redness at the injection site. Data analysis also indicated that the frequency and severity of adverse reactions increased after the second dose of the vaccine.

    

    Another important factor to consider is the durability of the vaccine's immune response, or how long the vaccine's effects will last. Researchers with the U.S. NIAID published a report in the New England Journal of Medicine on December 3 where they analyzed the antibody of levels of participants who were given Moderna's mRNA-1273 vaccine. It was found that "antibodies continued to be detected in all participants at day 119." This occurred in participants who received two vaccination shots; the first shot was given on day 1 and the second on day 29. In other words, Moderna's vaccine was still able to provide COVID-19 protection after a period of 3 months. (Participants will continue to be assessed for an ongoing period of 13 months). While it's too early to conclude exactly how long the effects of Moderna's vaccine will last, researchers say "mRNA-1273 has the potential to provide durable humoral immunity."

       Antibody levels remain relatively high in all participants 119 days after vaccine injection

Going Forward

    Moderna has submitted a request to the Food and Drug Administration for emergency-use authorization for its vaccine and a similar application with the European Medics Agency. Stéphane Bancel, Chief Executive Monitor of Moderna, says that Moderna plans to charge $32-$37 per dose of the vaccine in developed countries and an even cheaper price in low-income countries. Additionally, Moderna hopes to provide 2 million doses of their vaccine to the U.S. government by the end of the year. In their press release, Bancel describes the role Moderna's vaccine will hold in the pandemic: "We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and prevent severe disease, hospitalizations, and death."

Sources

1. “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.” Moderna, Inc., investors.modernatx.com/news-releases/news-release-details/moderna-announces-primary-efficacy-analysis-phase-3-cove-study. 

2. A. T. Widge and Others, et al. “Durability of Responses after SARS-CoV-2 MRNA-1273 Vaccination: NEJM.” New England Journal of Medicine, 3 Dec. 2020, www.nejm.org/doi/full/10.1056/NEJMc2032195?query=featured_coronavirus.

3. Jon CohenNov. 30, 2020, et al. “'Absolutely Remarkable': No One Who Got Moderna's Vaccine in Trial Developed Severe COVID-19.” Science, 30 Nov. 2020, www.sciencemag.org/news/2020/11/absolutely-remarkable-no-one-who-got-modernas-vaccine-trial-developed-severe-covid-19.

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