I want to share a few insights that I have gained on the SARS-CoV-2 vaccine’s emergency use authorization (EUA) for those over 16. I have learned much from many sources including watching the full CDC & FDA live meeting last week and relevant medical literature.
Also, I wish to direct you to what background resources exist and what to expect as you anticipate your vaccine timing. This blog by no means covers every aspect of the vaccine news.
First and foremost it is an Emergency Use Authorization– not a complete safety endorsement – what that means is if you are at high-risk of death the vaccine benefits outweigh vaccine risks. At present, in the general population who catch COVID-19, there is a 1/200 of being hospitalized and a 1/1000 risk of dying. Note: There have only been 2 months of follow-up in Pfizer Phase 3 volunteers, after receiving the second booster inoculation. I heard at FDA advisory committee meeting Pfizer is watching safety and effectiveness in the elderly while also fertile and pregnant women. This group should take the vaccine at their own risk. The company reported in testimony there were 4 cases of Bells Palsy in vaccine recipients vs. the placebo group. This is a neurological side effect unexplained to date.
Logistic realities are the Pfizer vaccine requires storage below (-) 70-degree (5-10 lbs. of dry ice needs to be changed every 24hours) once defrosted the vaccine survives 5 days in the refrigerator and once reconstituted survives 6 hrs before degradation. A 2nd (booster) dose 21 days later. If accidentally defrosted losses effectiveness and possibly bacterial growth will occur.
As we await the second mRNA vaccine – ‘Moderna’ as media calls it- approval, you should be learning as much as possible about them. No matter how far down the priority list you are to get the vaccine, you must be learning. We are awaiting the more traditional vaccines from Johnson and Johnson and Oxford Univ. These and others are similar to the flu vaccine and do not require special handling. No word on the likely date for completion of studies and submission of these vaccines.
A worthwhile link you may find is this video.