We have been greeted with good news of late — two vaccines, both built on an mRNA model, meaning an engineered solution rather than a dead vaccine model — will apply shortly for an Emergency Use Authorization from the Food and Drug Agency based on the successful completion of Phase 3, large scale (44,000 persons) trials and the attendant data with both showing an efficacy rate of 95%.
Efficacy rates, Big Red Car?
To put that 95% number into perspective, know that the common flu vaccine has an efficacy rate of 40-60% — meaning it shelters 40-60% of Americans who receive the shot from the flu.
So, the 95% efficacy rate for the engineered model is quite extraordinary.
American health officials required a 50% efficacy rate, had hoped for 60-70%, and are deliriously happy at 95%.
Who are the early winners, Big Red Car?
It looks like the leaders are as follows:
1. The Pfizer – BioNTech vaccine will apply for its EUA “within days” and will be able to provide as many as 50,000,000 doses of the two-shot vaccine by year end 2020 and another 1,300,000,000 by year end 2021.
Only 12,500,000 of the first 50,000,000 doses will come to the United States this year.
The United States through its Operation Warp Speed has pre-purchased from Pfizer – BioNTech 100,000,000 doses for $1,900,000,000 with the contractual right to extend that buy to more than 600,000,000 doses.
2. The Moderna test results show a 95% efficacy rate and they hope to produce 20,000,000 doses by the end of the year if they can get a quick approval from the US Food and Drug Agency.
What else, Big Red Car?
Here are some other facts:
1. There are ten other firms working on vaccines that are right behind Pfizer – BioNTech and Moderna, meaning in Phase 3 trials.
There are a number of other approaches under consideration rather than solely mRNA.
2. There are more than an additional 50 firms working on vaccines at an earlier stage of development.
3. This mRNA approach is a first time application and changes the game considerably as it relates to other illnesses. Stay tuned. This could be huuuuuuuuuuuge.
How did this happen, Big Red Car?
The anticipated time period for a COVID vaccine was initially enunciated in years, many years.
The solution to the pandemic was not envisioned as a short term vaccine, but here we sit with two vaccines on the verge of an FDA EUA within eight months of beginning work. Most impressive.
This was made possible by a task force called Operation Warp Speed.
Operation Warp Speed?
The US government called upon all of its resources to effectively fund some combination of research, development, testing, manufacturing, and distribution of proposed vaccines.
The US government accelerated certain of these phases by funding them, by pre-purchasing vaccines, by turning around approvals quickly, by evaluating test results quickly, and by compressing normal time frames for approvals.
The US government paid for manufacturing of promising vaccines before they were fully approved. In this manner, the normal time sucking heal-to-toe linear development was thrown over for parallel development that saved time, but risked money.
This focused and considered risk of enormous amounts of money is the secret sauce behind Operation Warp Speed.
In the end, it appears that Op Warp Speed will have been a worthy risk and will have compressed the normal development from years to months.
Bravo, Operation Warp Speed. Well played.
Tonight when you go to bed, say a prayer for the men and women who worked on these vaccines and the smart people who envisioned and executed Operation Warp Speed bringing us a COVID vaccine in less than nine months. Wow!
God bless us all.