Hi Bills,
I am like any bladder cancer patient just trying to understand things as my urologist is so busy and has no time or interest in explaining to me "why"? But, mostly I get information from the internet like many others. I try to comsume the information before I post it.
1. mRNA vaccine
Though this is the first time that the FDA had approved mRNA based vaccine and it is still for emergency use, mRNA based drugs are not new. Both Moderna and Biontech have been working on mRNA based drugs over 10 years. Moderna had been working on mRNA based drug for rare disease but also as vaccine for such as Zika virus, Flu and even cancer vaccine partnering with MERCK - the manufacturer of immunotherapy drug keytruda. Biontech who partnered with Pfizer to manufacture mRNA based vaccine for COVID-19 has been focusing on individualized cancer vaccine which is also based upon mRNA. So, I tend to believe that those companies who are very familiar with cancer will not produce cancer causing vaccine. Also FDA and WHO are there as gatekeepers to check the safety especially when the vaccines are to be used by everyone in the world. mRNA is a biological instruction set ( a series of nucleotides which a ribosome enzyme reads to produce protein inside cytoplasm in our cell. Then the protein goes outside of the cell though some stay in the cell, but it will not come into the nucleus where DNAs are stored. For the vaccine, after various studies, they determined that the spike protein of the virus causes high response of antibodies to prevent the infection and t cells to kill the virus infected cells. So, mRNA vaccine contains mRNAs for ribosomes to produce copies of the spike protein of the virus. mRNA vaccines by Pfizer-Biotech and Moderna use a little fat bubble ( called nanolipid) to wrap around mRNA and uses it as the transporter to deliver the spike protein mRA into the cytoplasm of the cell ( likely the muscle cells where the vaccine is jabbed). Once the vaccine produced spike proteins come out of the cell, our immune system detects as pathogen and produces various immunities such as antibodies, B memory cells, T helper cells and T killer cells. The antibodies will be circulating in out body through blood vessels. So, when the virus actually comes into our body, the antibodies are ready to to stop the virus to infect by sticking to the spike protein and preventing the virus from coming inside the lung cells. For the virus which the antibody missed and infect the lung cell, the T killer cell will be dispatched readily to kill the virus infected lung cell to prevent us from becoming severely ill.
I have followed Medcram from early on to understand COVID-19 Sars 2 virus. Medcram is for students who are studying medicine but sometimes medical professional. Dr. Roger Seheult, MD himself is an Associate Clinical Professor at the University of Caifornia,Riverside School of Medicine and he is a board-certified in internal medicine, pulmonary diseases and critical care medicine. So he has been treating COVID-19 patients often in ICU from the beginning of the pandemic. He had been explaining almost every day about COVID-19 based on published study papers such as in New England Journals, The Lancer, Nature comparing the data he gets with his experience in seeing the patients every day and providing various treatments to his patients. There are a few episodes about the vaccine for COVID-19 in his youtube channel. Also sometimes they invite guests. One guest relating to the vaccine was Professor Shane Crotty of Critty lab of La Jolla Institute for immunology. Professor Shane Crotty is a virologist and professor in the vaccine discovery division at La Jolla Institute for immunology. His team’s early studies on the immune activities in Covid-19 patients gave encouraging prospects of the vaccine. Dr. Crotty and the other co-counder of Medcram Kyle Allred gave a webinar of explaining about the vaccine for COVID-19. So, I list the link to the webinar. Also, Dr. Seheult of UCR explains mRNA vaccines in a bit more technical but easily understandable. Your dad may understand better due to his background.
by Prof. Critty of La Jolla Institute for immunology.
by Dr. Sehult of UCR
I am not sure availability of mRNA vaccines there,. I have read that people in some area are getting COVIDShield vaccine. COVIDShield vaccine is actually Astrazenaca-Oxford vaccine. Astrazenaca-Oxford licensed SII in India to manufacture the vaccine. So, Covidshield vaccine uses adenovirus as its delivery system of DNA for spike protein to the cells to produce spike protein and subsequently antibodies and T cells for the virus just the same as mRNA based vaccine. Adenovirus is usually common cold virus but engineered to be non toxic. Covidshield chose DNA rather than mRNA to be delivered to cells. Below is the New York times explaining how adenovirus covid-19 vaccine works. Dr. Sehult of Medcram also explains the difference between Astrazenca-Oxford vaccine which is the same as COVIDShied.
www.nytimes.com/interactive/2020/health/oxford-astrazeneca-covid-19-vaccine.html
2. Dr, Kamat
I have notice that Dr. Kamat has empathy and vesting interest in well being of people near birth place.
But I think he is bound by code of conducts as a medical doctor and by policy of MD Anderson. In NA, also mitigating professional liability may also prevent a doctor giving any advise unless it is to his or her patient. I would rather communicate to Dr. Michael O'Donnell of University of Iowa, but not by you directly but rather by your urologist if he or she thinks it necessary because that is what Dr. O'Donnell in 2013 webinar which I had referred previously.
3.CFU
I have looked at a few studies about the efficacy and the side effects of reduced dose of BCG, but none of them described about qualifying CFU of BCG vials they used for the study.
Do you think your cousin can find out if each vial of BCG has information of lot or batch, and if the prescription label on the vial says CFU? If CFU is not described on the label, can CFU in the vial be traced back by presenting the lot number to the BCG manufacturer, i.e. SII?
I have sent an email to Dr. Lamm asking if CFU on the label or the production lot should be used as a measure for dose reduction rather than just say 1/3 dose reduction, which I think often understood as 1/3 of a vial. Lets see if Dr. Lamm will respond.
4. Is 3 years of BCG maintenance necessary for high risk nmibc (any HG except single,<3 cm TaHG), CIS)
AUA guideline for high risk nmibc classifies BCG treatment into Strongly recommended, Moderate recommended, and Conditional recommendation. Strongly recommended means that net benefits (benefits vs risk/burden) is substantial. Moderate recommendation means that Net benefit is modest. The guide line says a six -week induction course is Strongly recommended for newly diagnosed high risk nmibc, and a clinician should . The guideline also says in high-risk patient who completely responds to induction BCG, a clinician should continue maintenance BCG for three years, as tolerated. ( Moderate recommendation). Incidentally, recently FDA and urologists community came up a term BCG un-response, which does not apply to your dad. BCG unresponsive means that high risk nmibc has recurred after a certain period after the adequate BCG treatment. They also defined that the adequate BCG treatment is the induction treatment of 5 or 6 and the 1st maintenance of 2-3 weeks. So, your dad had the adequate BCG treatment though there was a delay for the maintenance due to waiting for healing the side effects. I know Allan and I think Sara too had 6 weeks induction course and followed by another 6 weeks treatment, and the cancer had not recurred for many years.
Urologists often say that they do not fully understand yet how BCG works for bladder cancer even BCG treatment for bladder cancer was introduced 40 years ago. They say they use it because it has worked. BCG therapy utilizes our own immune responses. But not all have the same immune responses and tumor can be different even between T1HG and T1HG. I know a patient who has autoimmune disease -Rheumatoid arthritis. In his case had to halt after 4th BCG in the initial 6 weeks course because of severe side effects. The same patient had severe reaction to the 2nd dose of covid-19 vaccine, which put the patient in in the hospital for 10 days. So, it seems that many things affect BCG treatment so it needs to be cared personally for each patient, which I think you, urologist and oncologist are providing.
www.auanet.org/guidelines/guidelines/bladder-cancer-non-muscle-invasive-guideline
best