Sunday, December 27, 2020

To Take or not to Take. That is the Question. The Pfizer Vaccine

 

 I have studied and blogged about the Covid pandemic since early February and I have followed treatment and vaccine development with interest since then recommending tiered approaches of prevention and management to friends and family. The first tier is to build up your natural immunity with diet, exercise and vitamins and supplements thought to be useful. I have scoured the world literature and media reports and one does need to maintain skepticism no matter the source. Early on the WHO and the CDC issued misleading and entirely wrong assessments and recommendations and I relied upon European and Asian studies early on. It does appear that Vitamin D in 5000 units/day along with selenium and zinc confers resistance to Covid but this is not well supported by properly constructed US studies. There is no downside to their use in moderate amounts. There are many companies rushing their vaccines to market utilizing some tried and true vaccine technologies while others are using revolutionary genetic sequencing methods. Most companies use either  injection of messenger RNA of the Spike protein of the sars covid-2 virus. Pfizer and Moderna’’s trials use this technique.  Messenger RNA is very fragile and these RNA chunks are encased within a protective fatty shell or nanoparticle. They then get into your body’s cells and instruct your protein making machinery of ribosomes to make copies of the virus spike proteins which allow the body to recognize the real Covid invaders spike protein and thereby mount an immune response firing up the various components of the immune system.  This is a new technology and may have risks to some in our population such as those with autoimmune diseases, a class of diseases poorly understood. The clinical trials were run by Pfizer and Moderna and were not large or lengthy. Only 95 cases of Covid occurred in the Moderna  trial and most were in the placebo group. The PCR test used did not mention how many”cycles” were used in the run which influences  positive results. Side effects were  said to be minimal. The vaccines were not administered to all age groups and duration of immunity is unknown. The immunity does appear to last at least two months which is when the results were released. The Oxford(UK) AstraZeneca vaccine uses an inactivated Chimpanzee cold virus bonded to the mRNA spike protein. Participant numbers were small and only vaccinating those between 18 and 55(Moderna) and there was some question of dosing regimens. The most widely distributed vaccine is the Chinese vaccine by Sinopharma using traditional methods of an inactivated corona virus which has been given to over a million people. Unfortunately data on the efficacy is sketchy and hampered by poor US/China relations.

The Russian Sputnik vaccine also uses a human adenovirus bonded to spike protein. Results and efficacy is anecdotal and there was nothing resembling anything like a Phase 3 trial.

Novovax is a US company using a wacky idea of selecting the baculovirus, an insect virus to get the spike protein into Moth(!) cells who then produce the proteins which are somehow captured. This technique is called “protein subunit” technology. Sanofi/GlaxoSmithKline are also using this protein subunit method.  Johnson and Johnson has a Phase 3 trial underway since September  and they have announced they are including Black, Hispanic and Native American as well as people with and without comorbidities . They also are offering it as a single dose injection.

  Here are my conclusions based upon preliminary reliable information. The trials are relatively small in extent and duration.  They are certainly RUSHED. The project is called Warp Speed. Duration and intensity of immunity is unknown. Not all age and racial groups both healthy and those with compromised health were tested nor were children, infants or pregnant women or patients on chemotherapy or immune rejection regimens. Could these RNA subunits provoke genetic mischief down the line?  Corona viruses are sturdy stable viruses but mutations in the spike protein or in the parent virus might  doom these vaccines requiring nimble  changes in their configuration. DNA is robust and RNA falls apart quickly so this is probably a safe new technology but there is no way to know for sure. One thing is certain. The companies are in it for the money. Billionaires are being minted daily under their roofs. These vaccines are not polio vaccines which were open source vaccines in the public realm. Unregulated profit driven proprietary vaccine development is problematic by its very structure. The US medical establishment is rushing new and expensive vaccines into distribution and not bothering to test inexpensive promising vaccines from other countries from non US companies. They are also not waiting on other vaccines from domestic companies. I plan on waiting.

UPDATE: Dec 28 2020): Since this initial post the Pfizer variety has been released and several million doses administered so far. There have been  some anaphylactoid and anaphylactic reactions  but to my knowledge no deaths. I have read that Pfizer will cost $40 for the 2 doses and both Moderna and AstraZeneca are considerably less.Astra Zeneca is said to cost $2 and  has waived obtaining a patent. Pfizer is patented. Duration of immunity remains unknown. Frontline medical people are prioritized as well as older people. People over 55 were not part of the Moderna Trials, nor were anyone under age 18 or people with comorbidities including pregnant women.Will the vaccine be effective or safe in these groups? It also appears dosing regimens in Moderna and AstraZeneca have been shifting to find the sweet spot.  If you are vaccinated can you still transmit the virus if you are infected? . Likely not, but still an unknown.  Now perhaps the most worrying factoid: Pfizer negotiated a "Heads I win. Tails you lose" contract with the US Government.  That means  no legal liability  with their Covid vaccine.   Do the American people know that if the vaccine is ineffective or dangerous that they will have no legal recourse to sue Pfizer? It would seem that this needs to be understood before anyone presents their bare shoulder. To take or not to take. ??  Once all or most of the US companies have had  their vaccines approved and released to significant numbers of people I will seriously consider joining the line of willing guinea pigs. Until then, I plan on waiting.