by Dr. Sherri Tenpenny, DO, AOBNMM, ABHIM
In December 2020, the first vaccines for coronavirus disease were granted an EUA – Emergency Use Authorization – by the Food and Drug Administration (FDA) and recommended by the Advisory Committee on Immunization Practices (ACIP). Vaccine administration began immediately. Were you first in line? I hope you were not, and no one you care about was either.
What We Know About the COVID Vaccines
According to the Coronavirus Vaccine Tracker, as of Dec. 26, 2020, 83 vaccines are in Phase 1, 2 or 3 human and animal clinical trials, with 18 approaching the final stages of testing. Never before have so many companies tested so many different vaccines at the same time, against a virus that has not been isolated. Of those in the trials, five vaccines are now early use, with three vaccines approved for clinical use Pfizer, Moderna and AstraZeneca. Here’s what we have been told, so far:
Pfizer’s vaccine – given the tentative name Comirnaty – has been approved for persons 16 years of age and older. The mRNA vaccine consists of two doses (30mcg solution in 0.3cc) given intramuscularly 21 days apart. The vaccine must be stored at -94F (-70C). mRNA is an unstable molecule, which is why it needs to be wrapped in lipid nanoparticles for storage and transportation. But the lipid nanoparticle is exquisitely sensitive to temperature; hence the reason that the vaccine must be stored and transported at extraordinarily low temperatures.
The ingredients found in Pfizer’s vaccine include the following:
- ALC-0315 = (4-hydroxybutyl) azanediyl)bis (hexane-6,1-diyl)bis(2-hexyldecanoate)
- ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide
- potassium chloride
- potassium dihydrogen phosphate
- sodium chloride
- disodium hydrogen phosphate dihydrate
Note that none of the ingredients are listed with milligrams dosage. Look at the first three excipients. Not one of these has ever been used in a previously approved vaccine. Have they been tested for synergistic toxicity? Has there been stability testing for the breakdown of each ingredient when warmed to room temperature? And what about all those allergic reactions being reported? Have ANY of these chemicals been tested for allergic responses, in humans or even in animals?
While Pfizer and the FDA have no idea if this vaccine will prevent infection or even if the antibodies will persist long-term, Pfizer expects to manufacture over 1.3 billion doses worldwide by the end of 2021. For more on how this vaccine works, go here.
Like Pfizer’s vaccine, Moderna’s vaccine also uses mRNA as its vehicle for inducing antibody responses to the spike protein. Approved for those 18 years of age and older, the vaccine is given as two doses, (100 mcg in 0.5 cc intramuscular injection) with the second dose given one month (28 days) later, or as close to the recommended interval as possible. This vaccine can be stored up to six months at -4F (-20C) temperatures. Notably, the ingredients of this vaccine have not been released. Are you willing to be injected with something unknown? For more on how this vaccine works, go here.
Either of the currently authorized mRNA COVID-19 vaccines can be used when indicated; ACIP does not state a product preference. However, these two vaccines are not interchangeable and both doses of the series should be completed with the same product. However, if two doses of different mRNA COVID-19 vaccine products are inadvertently administered, no worries! Additional doses of either product are not recommended.
Remember that both vaccines are completely protected from all liability by the 2005 PREP Act. So, if the nurse gives you the wrong shot, and you have a serious reaction, even death, there will be no repercussions for the nurse and no compensation for you.
One more candidate: AstraZeneca (AZD1222) (ChAdOx1 nCoV-19)
AstraZeneca’s AZD1222 coronavirus vaccine candidate, formerly known as ChAdOx1 nCoV-19, is made from a weakened version of a common cold virus, hence its original name. While it can cause infection in chimpanzees, the virus was genetically changed so it cannot reproduce/replicate in humans.
This vaccine candidate is of interest because the clinical studies, done in collaboration with the University of Oxford, were widely publicized as the first and most promising vaccine. However, in May 2020, it was reported that all the vaccinated monkeys treated with the Oxford vaccine became infected when challenged. Then, why did the company press forward with the renamed, AZD1222 vaccine candidate? Because even though the vaccine did not protect the animals from infection, it did moderate the disease. Watch for this type of logic as the 80+ COVID vaccines try to make their way into the multi-trillion-dollar vaccine market.
But not to let all that research and money to go to waste, researchers now believe the shot will be effective against a new viral variant emerging in Britain. To find out more about how this vaccine works, to here.
For details on all of the current vaccines clinical trials, go to the Coronavirus Vaccine Tracker found here.