Is This Good News?
Dear Rich Lifer,
With coronavirus cases surging around the nation, it may seem we are headed into a bleak winter. However, we have received back to back good news about the future likelihood of a coronavirus vaccine.
Last week Pfizer and its partner BioNTech announced preliminary results that showed their vaccine to be more than 90% effective.
And today, Moderna said its experimental coronavirus vaccine was 94.5% effective, making it the second vaccine to hit a crucial milestone in the development of a vaccine.
Coronavirus has now infected 53 million people worldwide, and killed more than 1.2 million.
A vaccine could not be more needed, with cases rising every day in the U.S.
COVID-19 is killing more than 1,100 Americans a day, with the last million cases occurring in just six days.
As we mentioned earlier this week, some states and cities are reinforcing lockdowns, limiting gatherings, and shutting down schools once again.
The coronavirus pandemic, global economic shutdown, and social unrest is just the beginning.
There are still a lot of questions regarding the vaccines. Today, we will attempt to answer some of the most pressing.
What Kind Of Trials Have Been Performed?
Pfizer began the late stage trial of the vaccine in July, during which half of nearly 44,000 participants received the vaccine, while the other half received a placebo of salt water.
So far, 94 participants out of nearly 44,000 have gotten sick with COVID-19. As is standard for clinical trials, the data was “blinded,” meaning that no one except the independent board knows how many of the 94 people sickened by the virus got the vaccine or the placebo.
However, given the estimate that the vaccine is over 90 percent effective, we can safely assume very few people who were vaccinated got COVID-19.
The trial will continue until it reaches 164 cases of COVID-19. At that point, the study will be complete and the results analyzed.
In the Moderna trial, which consisted of 30,000 subjects and is ongoing, 95 people contracted the coronavirus: 5 who were vaccinated, and 90 who received placebo shots of saltwater.
Moderna’s results were reviewed by an independent data safety monitoring board, appointed by the National Institutes of Health. Analysis showed that the 95 cases of infection included 15 people aged 65 or older and 20 people who were Hispanic, Black, Asian or multiracial.
Moderna’s trial will continue until 151 people in the trial develop COVID-19 symptoms.
These preliminary results are certainly hopeful, but we must remember that clinical trials are not designed to tell us exactly how effective the vaccine is.
Clinical trials allow scientists to make an estimate based on statistics. This is called efficacy, and efficacy can only be firmly determined once millions of people get it.
How Good Is This News?
According to Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, the results are very inspiring, stating:
I had been saying I would be satisfied with a 75 percent effective vaccine. Aspirationally, you would like to see 90, 95 percent, but I wasn’t expecting it. I thought we’d be good, but 94.5 percent is very impressive.
The Food and Drug Administration had set a bar of 50% effectiveness for vaccine makers who wanted to submit their candidates for emergency authorization. Both vaccine trials are showing results far surpassing this mark.
Consider other licensed vaccines on the market. Influenza vaccines are about 40% to 60% effective, and the measles vaccine is about 97% effective. So there is clearly a range of acceptability when it comes to what can be released to the public.
We will have to see how the rest of the trials play out, and let the scientists determine efficacy, but for now this is good news, and all preliminary data leads us to believe the effectiveness of the vaccine will be high, which leads us to our next question…
What Happens Next?
Both companies have said that they will likely apply for emergency authorization in mid to late November, after they both collect the required two months of safety data that the FDA has mandated manufacturers submit.
The FDA will then have to consult with an outside advisory committee of experts to review data about both vaccine’s safety, effectiveness, and both companies’ ability to safely manufacture millions of doses.
Moderna forecasts that if approved, they will be able to supply 20 million, or enough for 10 million people (the vaccine consists of two shots), by the end of the year. Moderna is also working with contract manufacturers to boost production so it can make 500 million to one billion doses next year.
Pfizer believes they would be able to immunize about 20 million Americans by the end of the year if their vaccine is also approved. They then say they could ramp up production to 1.3 billion doses next year.
Doses by end of 2020 seems great, but also leads us to our next question:
Who Will Get The Vaccine First?
While no plan has been officially announced, the federal government may decide to vaccinate health-care workers and first responders first, followed by other segments of the population in phases until more doses are made next year.
A National Academy of Medicine committee recommended that the first phase of vaccination cover about 5% of the population and include front-line health workers such as those in hospitals and nursing homes and workers who provide transportation and other services to health-care facilities, and first responders.
The next phase would cover 10% of the population and include people with health conditions that put them at higher risk of severe coronavirus disease or death, and people age 65 and older, such as those who live in settings like nursing homes, long-term care facilities, homeless shelters and prisons.
Again, these are not official plans, just suggested actions from leading experts.
These are just a few of the many questions about the vaccines, so we will be dedicating a second article to bringing you the most up-to-date and accurate information possible.
To a Richer Life,
The Rich Life Roadmap Team