I would say it’s a bit late to be putting this in place. I see the call for bids was placed in October. An adverse event might not be actually related to the medicine - it’s something that has happened when someone has been taking the medicine, and therefore needs investigating - while a side effect is definitely related to the medicine.
No reason normally. Small market and historically a higher evidence threshold than most other regulators as I understand it.
Seemed right to me, although to be a pedant, I think you're obliged to report on AEs you hear about for any drug, not just those related to your own shop.
Just reading a little further. You talk about adverse events, but the link I posted earlier refers to Adverse Drug Reactions (ADR). It seems that the language is specific and important. I read this from a BMJ article... What is an adverse drug reaction? Medicines have unintended side effects, and if any of these is harmful, the patient has an adverse drug reaction.2 The European Medicines Agency (EMA) defines an adverse drug reaction as “a response to a medicinal product which is noxious and unintended.”3 ...then this from pharmacologyeducation.org.... An adverse drug reaction (ADR) is an unwanted or harmful reaction experienced following the administration of a drug or combination of drugs under normal conditions of use and is suspected to be related to the drug. An ADR will usually require the drug to be discontinued or the dose reduced. Noxious, unintended, unwanted and harmful... will require the stud to be discontinued or dose reduced. Given that they are expecting a high volume of ADR’s, this sounds a little worrying and seems quite definitely linked to the medicine received rather than coincidental sickness. I’m not intending to take any vaccine, as I wouldn’t for flu, but I know my old man will and I want him to consider all information, which is difficult when his world view is based on the bbc.
If 30 million people take a vaccine, and 0.1% have an ADR that’s 30,000 people. Statins are one of the most commonly prescribed drugs, with about 8 million people on them, but that number has been built up over many years not a few months, so it’s volume related, they need a system to track and act if worrying patterns do arise. Every day thousands of people stop taking drugs or have their dose changed because they find them hard to tolerate. Seems like you have made your mind up on the vaccine, and I assume you extend that to all medicines because they all have risks.
I’ll take a neurofen for a headache, but I honestly can’t remember the last time I even went to the doctor. Should the need arise, I’d almost certainly take a course of medicine, but definitely not something preventative like this, where the risk to my health is low to negligible. I understand your first paragraph, it just seems different somehow with a shot or two in the arm vs a course of medication that can be monitored and adjusted, but I acknowledge my understanding is almost nil.
So many many moons ago I was on a trial taking folic acid during pregnancy...I took 3 tablets a day Twice ( funny enough) after eating pizza, I was crippled with severe abdominal pain, once taken to hospital. I was taken off the trial and my symptoms were reported to the trial bosses who were very concerned. Serious adverse effects, in a pregnant woman. The trial I was on ( a small one at that time) was stopped. But after extensive investigation, it appeared I had underlying gallstones. Eating fatty foods had precipitated the attacks...it was nothing to do with the folic acid at all...The trial was restarted and millions of women now take folic acid supplementation, with no ill effects. But everything has to be recorded, checked and double checked. It is a very difficult and time consuming process.
I also acknowledge that my feelings about this vaccination programme may be clouded by my mistrust of the government and media, the proportion of their response to this virus, the lack of meaningful scientific debate, the use of the PCR test, the talk of coercive measures regard the vaccine and all the other things I’ve been banging on about for some time.
Blimey the side effects of neurofen are 1:100 ...sounds a risky drug to me. Common side effects The common side effects of ibuprofen taken by mouth happen in more than 1 in 100 people. Talk to your doctor or pharmacist if these side effects bother you or don't go away: headaches feeling dizzy feeling sick (nausea) being sick (vomiting) wind indigestion Serious side effects Call a doctor straight away if you have: black poo or blood in your vomit – these can be signs of bleeding in your stomach swollen ankles, blood in your pee or not peeing at all – these can be signs of a kidney problem severe chest or stomach pain – these can be signs of a hole in your stomach or gut difficulty breathing, or asthma symptoms that become worse
Wind is the only thing on that list that I may be suffering from, but it could equally be the beans I had for dinner.
Ibruprofen (neurofen) has a range of side effects including not being great for kidneys, so I don’t take them. I opt for paracetamol, which isn’t too hot for your liver. Swings and roundabouts. Of course you may have a low risk from a serious bout of COVID due to age and overall fitness but taking the vaccine doesn’t just protect you it protects the people you come into contact with, including those who may be much more vulnerable than you.
I have no idea why there is such mistrust. Most of you will have had more than 10- 20 vaccination in your life time. Chicken pox, tetanus, diptheria, polio, MMR, TB some will have hepatitis vaccines, some encephalitis, some of your children will have had vaccination against cervical cancer. Some will have had flu vaccination. These vaccination have saved millions of lives. Sorry I do not understand the mistrust
I heard the opposite, certainly about the Moderna vaccine, that it may not stop the vaccinated individual being able to transmit to others, meaning it purely protects that one individual. Widely reported, unless I misunderstood.
I’ve had tetanus, yellow fever and whooping cough that I know of. Never got the bcg at school for some reason. I think the mistrust comes from the speed of the rollout and the fact that whilst most people are protected as intended by certain vaccines, many have been seriously injured. Also the indemnity against liability of the producers of the vaccine and the talk of coercive measures against those who choose not to take it.
Seems that everyone has the wrong idea about this. It doesn't stop you getting infected. If some one sneezes Covid into your face...You are going to get a lung full of virus, and they are going to replicate. If you are unprotected or niave, the virus will multiple and spread before your immune system, which have never seen the buggers, before get their act together to make a response....and you get symptoms. However if you are vaccinated ...the immune system is like a loaded and half-cocked gun. It is ready to go...and stops the virus before it has gone very far.. So if you look at it in a different way..unprotected you may have 10-15 days with a high vial load in your breath, sneeze cough. Protected you may have a small viral load in your sneeze or cough for 1-2 days. So it protects you from getting seriously ill...and because when you are infectious it is a short time and very low levels..it protects those around. And if you sneeze with your low levels of virus into the face of another vaccinatef person...the levels they get will be subdued even faster. Simples
Understood. I think it was the chief medical officer of Moderna who said they don’t yet know if vaccinated people can still carry and transmit, or maybe they just haven’t collected that data yet. What about immunity? If people who have had it or have cross immunity from other Coronaviruses, what does that mean? Can they be tested for T cell immunity? If new, viruses, unrecognised by the immune system multiply quicker than we can defeat them, how did we ever develop an immune system, given that we had to come into contact with every virus for the first time at some point?