Yesterday, Friday Dec 11, The Food and Drug Administration issued an emergency authorization for a COVID-19 vaccine developed by Pfizer and their German partner company BioNTech.
This means that US vaccinations can begin in a matter of days for individuals age 16 or older. This is not an FDA approval, but is an emergency authorization which is part of WARP SPEED PROGRAM to fight COVID-19.
In less than one week, another vaccine developed by Moderna, a biotech company, will request emergency use authorization as well. The Moderna vaccine is based on the same messenger RNA technology, and it is expected to be authorized quickly as well.
Is the Vaccine Safe?
This is the question. And the answer is… not for everyone.
Not everyone will be a candidate for these new vaccines developed during “Operation Warp Speed”.
FDA noted that the vaccine
should not be given to anyone with a history of any allergic reactions to
any component. This advice comes as 3 reports of
anaphylactic reactions requiring emergency care following receipt of the
vaccine in Europe earlier last week.
In clinical trials, common side effects included pain at the injection site, fatigue, fever and chills. Less common and more serious reactions included Bell’s palsy (a temporary paralysis), swelling of the lymph nodes, and transverse myelitis, a neurological disorder that involves inflammation of the spinal cord resulting in weakness of the arms and legs, loss of bladder and bowel control, and pain.
The vaccine has not been tested in women who are pregnant and breastfeeding or in children under the age of 16. So, until further testing is conducted, the vaccine is not currently approved for use in these populations.
One major oversight is that none of the clinical trials included people with known autoimmune conditions. Unfortunately, those with autoimmune conditions were excluded from the clinical trials, so there has not been enough time elapsed to see if the otherwise healthy trial participants end up developing an autoimmune condition over the next 12-24 months as a result of the vaccine.
24 million Americans currently suffer from one or more autoimmune
conditions. This number does not include those living with undiagnosed
autoimmunity. This is potentially concerning due to the fact that the
mechanism of the mRNA vaccine is to instruct the body to manufacture the
spike protein of the SARS-COV2 virus (the virus that causes
The idea is that the presence of this protein inside the cell would trigger inflammation and a resulting immune response, attacking the protein and enabling the immune system to create memory cells for that protein. This way, should the body encounter this protein again, it would be able to quickly fight it.
The problem is that the creation of these spike proteins could be a trigger for autoimmune conditions to start or flare. Since autoimmune conditions like Rheumatoid arthritis, Systemic lupus erythematosus (lupus), Inflammatory bowel disease (IBD), Multiple sclerosis (MS), Diabetes, and Hashimotos can take many months or even years after a triggering event to show symptoms, much longer testing would be needed to ensure this mRNA vaccine is safe for these populations.
In a paper in Nature Reviews Drug Discovery, Drew Weissman, MD, PhD, of the University of Pennsylvania in Philadelphia and an early pioneer of mRNA technology stated “A possible concern could be that some mRNA-based vaccine platforms induce potent type I interferon responses, which have been associated not only with inflammation but also potentially with autoimmunity,"... "Thus, identification of individuals at an increased risk of autoimmune reactions before mRNA vaccination may allow reasonable precautions to be taken.”
Nearly 7 percent of the US population is diagnosed with autoimmunity and that number is growing rapidly. There are more than 80 known autoimmune diseases. Several factors contribute to the development of an autoimmune condition. These include a genetic propensity, impaired barrier function, and a triggering event. All three factors must be present for the autoimmune condition to develop. It is possible to have a genetic propensity and not develop an autoimmune condition, as long as barrier function integrity is retained and triggering events are avoided.
Those with autoimmune conditions or with a genetic propensity for autoimmunity should give some extra thought and perhaps wait a while before raising their hand to get the new fast tracked COVID-19 vaccine.
Understanding your potential risks can be life changing when it comes to vaccines.