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What you need to know: Pfizer and BioNTech's Vaccine

Updates on COVID-19 that I want to share with you today is that first daily new cases of COVID -19 are on the rise throughout the United States and we now have over 200,000 new cases a day here in the United States which is like having a whole city like Des Moine, Iowa at 216,000 people getting COVID every day of the week.  Death rates are starting to increase in some states like Montana.  Secondly, you may have heard in the news is the Pfizer BioNtech messenger RNA SARS –COV2 vaccine has been doing well in phase 3 trials with 90% efficacy in preventing SARS COV-2. We will go into this vaccine briefly and for the next few weeks give you more information on other top 3 vaccine candidates.

The patient Pfizer BioNtech vaccine is not a vaccine in the traditional sense of a vaccine like the flu vaccine which either have heat killed viral particles or live weakened virus for your immune system to respond to. Rather, it delivers a messenger RNA surrounded by lipid bilayer or fat droplet into your bloodstream to get incorporated into your cells. This messenger RNA is an “executable” genetic instruction code. If you want to think of DNA as being the mircofilmed library or database that needs to be “pulled off the shelf” then messenger RNA as a “paper photocopy” of that information in a form that can be read or utilized. Viruses gets its messenger RNA which is the factory blueprint into our cells and hijacks our cellular factory to make of itself releasing these copies to infect other cells and repeat the process. The SARS COv2 virus as we know have spike proteins surrounding itself in a circular manner and thus the coronavirus name and the messenger RNA that was modified has the instruction code to make the spike protein in the fully assembled configuration which would attach to the ACE 2 receptors. Interestingly, this is not the normal preassembly spike protein so that in theory it wouldn’t fit in the normal assembly of a whole virus. The fully assembled extracellular configured spike protein then triggers a wide range of immune reactions from B cells making antibodies, to CD4 T4 helper cells and even CD8 immune cells as shown by earlier studies in Rhesus Monkeys before the phase 3 human trials. This may account for the 90% immune response as reported by BIoNtech but of course, will need third party verification.  The vaccine needs to given in 2 doses with the second dose given 21 days or 3 weeks after the first dose. Because of the lipid bilayer or fat droplet delivery system the vaccine needs to be stored at least minus 80 to minus 94 degrees Fahrenheit.

The BioNtech press release reads as follows: Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis.  Analysis evaluated 94 confirmed cases of COVID-19 in trial participants Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; safety and additional efficacy data continue to be collected Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints.

Based on supply projections, we expect to supply globally up to 50 million vaccine doses in 2020 and manufacture up to 1.3 billion doses in 2021. Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication

Next week we look at one of the other vaccines and keep you posted on any other updates.

Author
Jeffrey Mark, M.D. Helping clients with compassionate and comprehensive medical care for over 25 years with 4 board certifications in functional medicine, gastroenterology, internal medicine, and anti-aging/ regenerative medicine . IFMCP, ABIM Gastroenterology, NPAS Internal Medicine, ABAARM.

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