In this video, Dr. Roger Seheult of MedCram explains regarding the Pfizer vaccine and what was known about its ability to prevent transmission of the SARS-CoV-2. It has been alluded to recently that Pfizer was not being truthful regarding the study it did. Dr. Seheult unravels that statement.
How to get Emergency Use Authorization
To get EUA (emergency use authorization) for a vaccine, you only need to show you can block primary infection i.e. primary cases. For EUA, you do not need to show you can block transmission for secondary cases. When doing a trial to determine the amount of secondary cases and even hospitalization and death, it takes a lot more time, people and money to study this secondary end point. These studies may still be done, but don’t need to be done before the product goes to market. An article written in October 2020 describes this issue. This article was written before any vaccines had even received EUA.
What was Pfizer’s endpoint?
Pfizer in their studies went after primary cases to reach their endpoint because trying to determine secondary endpoints would not only cost time and money but also people were dying in hospitals during this time. It was critical to try and get something that might prevent primary infection and prevent death down the road. Pfizer’s study was well powered to get the primary endpoints they were looking for. They also were upfront in stating they were not looking to see the interruption of transmission (ie person to person spread) in the initial studies. None of the vaccines for COVID-19 that were being initially investigated had this as an end point. These types of studies can be done and normally are done in after market studies.
What did the FDA know?
The FDA released a statement in December stating that Pfizer’s vaccine may be effective in preventing COVID-19 in the primary individual. The statement did not say anything about the vaccine preventing death or transmission or even hospitalization. The FDA further stated that data was not available to make a determination about how long the vaccine would provide protections or whether there is evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.
What happened after market release?
After marketing, there were several studies done that looked at the effect of vaccination on household transmission of SARS-CoV-2. One such study, published in the NEJM, showed that overall the likelihood of household transmission was 40-50% lower in households of index patients who had been vaccinated 21 or more days before testing positive than in households of unvaccinated index patients. Another article again reiterates that vaccination reduces transmission of SARS-CoV-2. These studies were not funded by pharmaceutical companies.
Why is all of this necessary?
If the endpoints are so rare, then why do we even have to do the studies later or even get vaccinated? With COVID-19, even though the chance of death is 1%, and even though this is a small number, when it is applied to a large population as in the U.S. population of 350 million it can be seen that it will still affect a large number of persons. Furthermore with a hospitalization rate of 3-4%, it is easy to see how the hospitals can easily be overrun even with such a small percentage.
What are crisis protocols?
What many people don’t realize is that when hospitals become overrun, then resources become limited, especially in the healthcare industry. When this happens, hospitals turn to crisis protocols. Crisis protocols essentially limit resources to persons who are more likely to survive based on a series of algorithms. Depending on where a person lives, they probably had crisis protocols implemented or almost implemented at their local hospitals and many people were not even aware it was happening. If a significant amount of people are not treated early to prevent hospitalization, it will overwhelm those resources and the institutions will have to institute crisis protocols. MedCram is dedicated to trying to prevent that by educating individuals on how to be healthy and avoid hospitalization and/or death from illnesses.
LINKS / REFERENCES:
Effect of Covid-19 Vaccination on Transmission of Alpha and Delta Variants (NEJM) | https://www.nejm.org/doi/full/10.1056…
Effect of Vaccination on Household Transmission of SARS-CoV-2 in England (NEJM) | https://www.nejm.org/doi/full/10.1056…
Impact of BNT162b2 Vaccination and Isolation on SARS-CoV-2 Transmission in Israeli Households: An Observational Study (American Journal of Epidemiology) | https://academic.oup.com/aje/article/…
Vaccination with BNT162b2 reduces transmission of SARS-CoV-2 to household contacts in Israel (Science) | https://www.science.org/doi/epdf/10.1…
The indirect effect of mRNA-based COVID-19 vaccination on healthcare workers’ unvaccinated household members (Nature) | https://www.nature.com/articles/s4146…
Will covid-19 vaccines save lives? Current trials aren’t designed to tell us (BMJ) | https://t.co/NInSYrkjj1
Pfizer exec laughs when asked whether they knew their product stopped transmission prior to release (Real Rukshan) | https://youtu.be/2YagXbprzFE
FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine (FDA) | https://www.fda.gov/news-events/press…
Fast Facts on U.S. Hospitals, 2022 (AHA) | https://www.aha.org/statistics/fast-f…
Coronavirus (COVID-19) Cases (Our World in Data) | https://ourworldindata.org/covid-cases
“I am frightened by what is coming”: Texas hospitals could soon be overwhelmed by COVID-19 caseload, officials say (Texas Tribune) | https://www.texastribune.org/2021/08/…
Health Care Crisis Protocol for the State of Nebraska (DHHS) | https://dhhs.ne.gov/Documents/NE-Cris…
All coronavirus updates are at MedCram.com (including more discussion on delta variant covid, COVID Delta, COVID children, natural immunity COVID 19, and more).
MedCram Update 46: https://youtu.be/EFRwnhfWXxo
MedCram Update 47: https://youtu.be/H1LHgyfPPQ8
MedCram Update 132: https://youtu.be/9OZZ6_M4OB0
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