A few days ago, Pfizer boasted that its coronavirus vaccine exceeded 90% effectiveness. Today, Moderna has a similar claim – 94.5% effectiveness for its COVID-19 vaccine.
https://www.nbcnews.com/health/health-news/covid-19-vaccine-candidate-94-5-percent-effective-moderna-says-n1247888 Clinical trials from several pharmaceutical companies around the world are coming to fruition towards the end of 2020. It is expected. Phase 3 clinical trials are continuing.
There is more information about Moderna’s testing than Pfizer offered. However, Pfizer requested an emergency use authorization immediately while Moderna is waiting.
FDA Clinical Trials
https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap The FDA created an emergency program to expedite the development of COVID-19 therapies. It is called the Coronavirus Treatment Acceleration Program (CTAP).
More than 560 drug development programs are in various stages of planning and testing. 370 clinical trials have been reviewed by the FDA to date. Emergency use authorizations have been granted for 5 COVID-19 treatments. One treatment has been approved by the FDA for use in COVID-19
These treatment programs include antivirals, cell & gene therapies, immunomodulators, neutralizing antibodies, and others. Early-stage clinical trials concentrate on safety and dosing while later stages test efficacy along with safety. The number of participants grows greatly as the clinical tests are moving towards the final release.
Moderna Vaccine Testing
https://investors.modernatx.com/news-releases/news-release-details/modernas-covid-19-vaccine-candidate-meets-its-primary-efficacy mRNA-1273 is the COVID-19 vaccine candidate identification but it is also known as the COVE study. More than 30,000 volunteers are in this clinical trial and almost 26,000 received their second vaccine injection on October 22, 2020.
The report released today was the first interim analysis of subjects contracting the coronavirus. 95 cases were reported of which 5 were in the mRNA-1273 group and 90 from the placebo group.
Scientists determined that the efficacy of this vaccine is 94.5% effective. 11 cases from the placebo group were evaluated as severe with the COVID-19 virus, and none of the mRNA-1273 cases were in that category. The 95 participants broke down into 15 people over the age of 65, 20 being from diverse backgrounds.
The overall test group of 30,000 had over 6,000 Hispanics, over 3,000 African Americans, over 14,000 females, over 6,000 with chronic diseases, and almost 2,000 retail, restaurant, and hospitality workers. Nine percent were educators and students, 22% healthcare workers, 39% between the ages of 45-64, 29% between the ages of 25-44, and 25% over the age of 65.
Moderna Vaccine Logistics
https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-longer-shelf-life-its-covid-19-vaccine The Pfizer vaccine requires storage at nearly 100 degrees below freezing Fahrenheit. Moderna’s vaccine is stable for up to 30 days at temperatures between 36 to 46 degrees Fahrenheit. At minus 4 degrees Fahrenheit it is stable for up to six months.
Pfizer’s refrigeration requirements exceeded most hospitals around the United States. Moderna’s vaccine can be stored at nearly every available pharmaceutical refrigerator and freezer in the US and many other parts of the world.
Twenty million doses are planned to be produced by the end of December and Moderna is ramping up manufacturing to make between 500 million to 1 billion doses next year.
Like Pfizer, the Moderna vaccine will be fast-tracked to healthcare workers and other high-risk categories. Whether the final test results from either Pfizer or Moderna go up or down a point or two, it does not matter. The vaccine is effective and forthcoming.
Outside the rapid development of coronavirus vaccines, normal clinical testing would be done for years to ensure that safety is monitored for more than a couple of months. This scares many people who might be reluctant to take the vaccine to later find out it impairs their health in a few years. For the elderly, this is critical.
On the surface, the results of the Pfizer and Moderna trials seem good. As I think about the numbers though, there were 30,000 participants divided into two groups. At the end of the second dose around 26,000 remained. Of those 26,000 one would assume that half are placebo and the other half vaccinated.
13,000 placebo participants had 90 infections which equal 0.7% infection rate and no deaths. I would want to know what these 13,000 people did to live their lives during this clinical trial – social distancing, washing hands, facial masks, interactions at work, school, home, church, and more.
Live Longer & Enjoy Life! – Red O’Laughlin – RedOLaughlin.com