Operation Warp Speed brought to the market a new technology in combating infectious disease such as COVID-19, one based on the use of mRNA (messenger RNA) technology (1). The use of mRNA technology has been in development for other diseases such as cancer and genetic disease as well as infectious disease since the 1990s. (2). Since then no drugs using mRNA technology have been approved or brought to the market until Moderna released their COVID-19 vaccine.
This article is meant to help shed some light on the EUA approval of the available COVID-19 vaccines currently in the U.S. It is not meant to provide treatment recommendations or advice, but as talking points or points to further follow and investigate and we continue to learn more about these vaccines, their efficacy, short and long term safety and use in the future. Please discuss your medical treatment decisions with your physician for individualized medical recommendations based on your own personal risk factors. As a reminder, a medical decision should never be made out of peer or societal pressure, but as an individual decision based on each unique person's needs and comfort level. We encourage all our patients to do their own research and use resources coming from multiple reputable sources including other physicians, the CDC, the FDA, NIH, medical journals and peer reviewed research as well as the VAERS database and groups like the Physicians for Informed Consent.
EUA: Emergency Use Authorization by the FDA, what does it mean?
At time of this writing (June 2021), these vaccines have not been approved or licensed by the FDA, and are still under investigation until about 2023.
Under an EUA, the FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives...
...(although one could argue this point considering everything we know about Vitamin D, Zinc, NAC and other anti-viral and immune support).
Pfizer-BioNTech clinical trial is currently scheduled to end May 2, 2023. https://clinicaltrials.gov/ct2/show/NCT04368728
Moderna-NIH clinical trial is currently scheduled to end October 27, 2022. https://clinicaltrials.gov/ct2/show/NCT04470427
Johnson & Johnson (Janssen) clinical trial is currently scheduled to end January 2, 2023. https://clinicaltrials.gov/ct2/show/NCT04505722
You can read more about EUA here: https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained
What do the Studies Say?
A 2018 publication sponsored by the Bill and Melinda Gates Foundation categorized new vaccine technology such as mRNA vaccines as "unprecedented", a category of vaccines against diseases that we have never developed a suitable vaccine for yet. According to their analysis, unprecedented vaccines were expected to take 12.5 years to develop and have only a 5% chance of passing phase II trials, and then a 40% chance of making it through phase III trials which assess population benefit. This can be further calculated as about a 2% chance of success to make it past phase III trials. The authors stated this was a "low probability of success, especially for unprecedented vaccines" (3).
It's interesting to see that only two years later we now have an unprecedented vaccine being given to the general public with a reported 90-95% efficacy (4). This is indeed, unprecedented!
The Pfizer vaccine had approximately 22,000 subjects who received the vaccine with 22,000 subjects who did not receive the vaccine with an observation period of two months (5). The Moderna vaccine used 15,000 subjects who received the vaccine with 15,000 subjects who did not receive the vaccine. Both trials included a median observation period of about 2 months and about half of subjects were followed up with for about two months after the second dose (5, 6). The FDA states that due to the length of both studies clinical trial observation period, “it is not possible to assess sustained efficacy over a period longer than 2 months.” (7)
Pfizer vaccine effectiveness was calculated by observing the vaccination status of 178 COVID-19 cases. The Pfizer vaccine was reported as 89%–98% effective over a two-month observation period. (8) However, since there were only 15 COVID-19 cases observed in subjects 65 to 74 years old and only five cases in subjects 75 years or older, the clinical trial did not have enough statistical power to accurately measure the vaccine’s effectiveness in those age groups. In fact, the Pfizer vaccine may be only 53% effective in subjects 65 to 74 years old and 0% effective in subjects 75 years or older (8). This is our most vulnerable population! For the Moderna vaccine, in subjects 18 to 64 years old the vaccine was 91%–98% effective over a two-month observation period (13). However, since there were only 33 COVID-19 cases observed in subjects 65 years or older, the clinical trial did not have enough statistical power to accurately measure the vaccine’s effectiveness in that age group as well. The Moderna vaccine may be only 61% effective in subjects 65 years or older and 0% effective in subjects 75 years or older (12).
The fact we were able to develop such a successful vaccine in 1 year, when the odds of developing one in 12.5 years was estimated around 2% - this is miraculous to say the least.
Because of this, the analytical methods used by both the Pfizer and Moderna trials have been criticized by several authors and publications due to these reasons:
The exclusion of over 3400 "suspected COVID-19 cases" that were not included in the Pfizer vaccine data reported to the FDA.
A low-but-non-trivial percent of individuals in both studies were deemed to be COVID-19 positive at baseline, despite this being a criteria for exclusion from the study (so they were likely already immune).
The use of relative risk reduction vs. absolute risk reduction. Relative risk reduction is much less specific and is how the Pfizer and Moderna studies came to the 90-95% efficacy conclusion. Had they looked at absolute risk reduction, the Moderna vaccine would be calculated at 1.1% and the Pfizer vaccine would be calculated at 0.7% for absolute risk reduction (9, 10).
What about the Johnson & Johnson vaccine?
The J&J vaccine is different from Moderna and Pfizer in that it uses “old-school” technology. J&J requires 1 shot whereas Moderna and Pfizer require 2 shots, spaced apart 4 weeks, and 3 weeks, respectively. Moderna and Pfizer use mRNA technology discussed above.
The J&J vaccine uses an adenovirus vector, meaning it uses a common virus that isn’t normally dangerous to carry the SARS-CoV-2 gene that codes for the spike protein. This gene is inserted into this adenovirus’ genome and the adenovirus is modified to prevent replication. This gene is like the instruction pamphlet for the adenovirus. Now the adenovirus knows how to make the SARS-CoV-2 spike protein. Once the virus is injected into a person, the virus infects our cells, our cells use the information to make the spike protein, and then our body begins making antibodies to the spike protein tagging the spikes as an invader.