UPDATE: Moderna has requested emergency use authorization from the FDA, and the vaccine could be available to high-risk populations as early as the end of December.
More than a quarter million people in the United States and some 3,100 Coloradans have died of COVID-19 as of this date, but good news is on the horizon. Recently Moderna Therapeutics announced early analysis that found its coronavirus vaccine to be 94.5% effective. CU on the Air speaks with Dr. Thomas Campbell, professor of medicine and infectious disease and leader of the Moderna vaccine trials at the CU Anschutz Medical Campus.
Two companies, Moderna and Pfizer, have announced that their vaccines, which have a very similar technology base, are highly effective in preventing COVID illness. Pfizer announced that they were filing on Nov. 20 with the U.S. Food and Drug Administration to request an emergency use authorization, to allow them to begin to distribute their vaccine. Moderna, will follow suit, perhaps even before Thanksgiving.
The clinical trials are scientific experiments in those experiments where the vaccine efficacy it is precisely determined. Effectiveness is the term that’s used to apply to how well vaccines are working in the community. The effectiveness of the vaccines will be determined after their widespread use in the community.
Although we won’t know for a while how durable the vaccine is, there is evidence that we can expect protection from vaccines to be durable. Plus, symptoms in individuals who have had COVID-19 previously are less severe.
The COVID prevention network, of which CU Anschutz is a part, consists of about 60 sites around the country and internationally. All sites have a long track record of conducting clinical trials through the National Institute of Health. There has been a big private government partnership to get COVID vaccines to where we are now.
The trials comprised a little over 30,000 volunteers. Particular care was taken to enroll a significant portion of individuals who were 60 years and older as well as those with pre-existing medical conditions, such as diabetes and heart disease, kidney disease. And, importantly, ethnic and racial diversity.
The trial is designed to last for two years and it will be important to continue the trial to determine how durable the vaccine response is, and whether protection diminishes over time.
The scientific measures taken by Moderna and Pfizer include creating a messenger RNA molecule that has the instructions for making a coronavirus protein called the spike protein. The way the vaccine works is that messenger RNA that has all the information to tell ourselves how to make the spike protein and build immunity to the virus.
The reason that these trials came so quickly is because COVID-19 is raging in the United States. The number of cases in the vaccine trial participants occurred at a much faster rate than anyone expected. It’s unfortunate that we have such a raging epidemic pandemic right now, but the fact that we do enabled these two trials to get the efficacy answer very quickly.
Overall, there will be multiple, very efficacious vaccines around the world. There are over 160 different candidate vaccines in various stages of development here in the United States. There are six candidate vaccines that have either entered or will soon be entering phase three clinical trials.
It is very important that Coloradans come forward and get the vaccine when it becomes available. If a large portion of our population is vaccinated, that in effect will put an end to the pandemic Colorado. And across the country as well.
There is light at the end of the tunnel in that some very, very astounding progress has been made in vaccines to prevent COVID-19. It has been less than 12 months since this illness was first detected in humans. In less than 12 months, there are now two vaccines that are proven to be highly efficacious. And that’s unheard of.
- Moderna Therapeutics
- Moderna vaccine study (video)
- Pfizer Pharmaceuticals
- Coronavirus research at CU Anschutz
- Colorado Clinical Translational Sciences Institute
- National Institutes of Health