FDA approves RSV vaccine (allergy, pain, infect, blood)
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The vaccine still needs approval from the US Centers for Disease Control and Prevention before it can be rolled out to the public.
Officials say the vaccine, named Arexvy by the manufacturer GSK, is a major breakthrough that will save many lives.It could be available to people over 60 within months, officials say.
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Wish this was available last year although having never heard of RSV I probably would not have taken it. But I've heard of it now. RSV re-ignited a nasal polyp problem that had been dormant for many many years, that is still giving me fits 6 months later and may end up needing surgery.
I will definitely get it when it is available.
If you look at the historical record with regards to vaccine production involving RSV and another virus called Rotavirus, one needs to be very cautious involving new vaccines being released. The other are carrier adenovirus vaccines. They say they overcame the problem with RSV and it took many years to do so but one needs solid ground safety evidence with problematic vaccines in the past.
If you look at the historical record with regards to vaccine production involving RSV and another virus called Rotavirus, one needs to be very cautious involving new vaccines being released. The other are carrier adenovirus vaccines. They say they overcame the problem with RSV and it took many years to do so but one needs solid ground safety evidence with problematic vaccines in the past.
I'm a test subject for the GSK vaccine, and have been for over two years. It's a double-blind study, so I don't know if I've received the vaccine or not. I do know that I've had two shots, and I'm in it for another year.
The research group is meticulous in their study, calling me every week for a month, then every other week. Twice yearly I go in for a physical and a blood draw. I ALSO have to go in whenever I call them to tell them I'm experience ANY upper respiratory illness symptoms other than my usual pollen allergy symptoms (which I have all year, and can easily tell the difference). When I have symptoms I have to write them down in a daily diary for the duration of the symptoms.
There's a lot of other stuff that goes on, interviews and discussion and insanely sterile surroundings (they wear a head-to-toe disposable plastic onesie plus a mask to examine me).
Obviously this isn't a "new" vaccine, it's been in test trials for almost three years (I started in a later batch of the study subjects).
If you look at the historical record with regards to vaccine production involving RSV and another virus called Rotavirus, one needs to be very cautious involving new vaccines being released. The other are carrier adenovirus vaccines. They say they overcame the problem with RSV and it took many years to do so but one needs solid ground safety evidence with problematic vaccines in the past.
What was "the problem" they overcame with RSV vaccine?
What was "the problem" they overcame with RSV vaccine?
"Vaccine development for RSV was derailed after a trial of a candidate in 1966 led to two deaths and the hospitalization of 80% of the infants who received the product, which contained an inactivated version of the entire virus."
I'm a test subject for the GSK vaccine, and have been for over two years. It's a double-blind study, so I don't know if I've received the vaccine or not. I do know that I've had two shots, and I'm in it for another year.
The research group is meticulous in their study, calling me every week for a month, then every other week. Twice yearly I go in for a physical and a blood draw. I ALSO have to go in whenever I call them to tell them I'm experience ANY upper respiratory illness symptoms other than my usual pollen allergy symptoms (which I have all year, and can easily tell the difference). When I have symptoms I have to write them down in a daily diary for the duration of the symptoms.
There's a lot of other stuff that goes on, interviews and discussion and insanely sterile surroundings (they wear a head-to-toe disposable plastic onesie plus a mask to examine me).
Obviously this isn't a "new" vaccine, it's been in test trials for almost three years (I started in a later batch of the study subjects).
Infants and children tend to be more susceptible to serious consequences for which death occurs. Good luck to you.
Infants and children tend to be more susceptible to serious consequences for which death occurs. Good luck to you.
So are seniors. I fall into that category. I've had no side effects from either shot. Not even pain near the injection site. I'm assuming I got the placebo.
As I said - it's been two years already. If I were to experience negative side effects from either shot I would've experienced them by now.
I don't need luck. I need efficient and safe monitoring and testing.
You quoted a snippet about something that happened in 1966 that involved a vaccine that used a whole live virus. That's over 50 years ago. Science has evolved in the past 50+ years, they know better what NOT to do, and their processes are more efficient. They also have easy access to computers now, which were not readily available to - anyone at all, in 1966.
So are seniors. I fall into that category. I've had no side effects from either shot. Not even pain near the injection site. I'm assuming I got the placebo.
As I said - it's been two years already. If I were to experience negative side effects from either shot I would've experienced them by now.
I don't need luck. I need efficient and safe monitoring and testing.
You quoted a snippet about something that happened in 1966 that involved a vaccine that used a whole live virus. That's over 50 years ago. Science has evolved in the past 50+ years, they know better what NOT to do, and their processes are more efficient. They also have easy access to computers now, which were not readily available to - anyone at all, in 1966.
Basic immunology has been around for centuries. People have died through mistakes. Infants and children are more susceptible because children are protected from large studies and last to be tested but just because adults have been tested children are not small adults. The comments I made were inclusive of the population and not just your status.
This is from 1999 and withdrawal of a vaccine that was tested and approved for release yet caused deaths.
Monitoring of participants does not prevent adverse events. They detect them. There is no way to predict who will develop Guillain-Barré syndrome and despite all the years and technology most modern day vaccines still produce GBS. There is risk in being in a trial for any medical study. "If I were to experience negative side effects from either shot I would've experienced them by now." So why are you still being followed and monitored? Why are they testing you?
The message I am trying to convey is that anything new may be potentially dangerous in select populations because of testing bias in clinical trials. Testing usually involves healthy people rather than people with chronic conditions. One needs to be critical of new vaccines of old infectious agents that have had past historical vaccine failures and safety issues. Vaccines try to mimic a part of the virus that in itself can cause an immune response that may be good or bad. We learn through mistakes but it is wrong to assume just because with have the advanced technology that we won't have safety failures or efficacy failures.
I tell everybody good luck because I wish them good luck when the future is uncertain.
Anything new may be potentially dangerous in select populations.
Anything new may also be potentially life-saving in select populations.
Since science has been working on the RSV vaccine all the way back from 1966 to the present, I'm confident that the current iteration of it has already had all the -previous- bugs worked out. Might there be new ones? Sure. Of course. The same is true whenever you buy the latest of ANYTHING.
The newest cell phone might have a defective battery that blows up and burns you. The newest flavor of Pepsi might be made with an ingredient you didn't even know you were allergic to, until you tried it for the first time, and then you die.
The newest car might have airbags that randomly pop open while you're in the middle of the highway.
The newest clothes washing machine might have a bad switch that results in flooding your basement.
There are risks to everything in life. The risk of danger when participating in a clinical trial, has the potential to save lives other than my own. So I'll look at the phase of the trial - if it's already at phase 3, that means it's already been proven safe for phase 1 and phase 2 participants. The RSV vaccine trial I'm in is a phase 3 trial. My risk of death or serious illness is more or less the same as the risk of death or serious illness if I caught RSV without a vaccine at all.
So all things being equal, I'm fine risking it for the chance at saving lives down the line.
Anything new may be potentially dangerous in select populations.
Anything new may also be potentially life-saving in select populations.
Since science has been working on the RSV vaccine all the way back from 1966 to the present, I'm confident that the current iteration of it has already had all the -previous- bugs worked out. Might there be new ones? Sure. Of course. The same is true whenever you buy the latest of ANYTHING.
The newest cell phone might have a defective battery that blows up and burns you. The newest flavor of Pepsi might be made with an ingredient you didn't even know you were allergic to, until you tried it for the first time, and then you die.
The newest car might have airbags that randomly pop open while you're in the middle of the highway.
The newest clothes washing machine might have a bad switch that results in flooding your basement.
There are risks to everything in life. The risk of danger when participating in a clinical trial, has the potential to save lives other than my own. So I'll look at the phase of the trial - if it's already at phase 3, that means it's already been proven safe for phase 1 and phase 2 participants. The RSV vaccine trial I'm in is a phase 3 trial. My risk of death or serious illness is more or less the same as the risk of death or serious illness if I caught RSV without a vaccine at all.
So all things being equal, I'm fine risking it for the chance at saving lives down the line.
Plus, I get paid.
The easier vaccines against old known agents are pretty much over with. All the low hanging fruit has been taken. What is left are all old known agents that have either problems with safety or efficacy. Since they are old and problematic one needs to be cautious. I am glad that you are confident but it should be based on studies for which you are still involved with. There are pre-clinical studies and post release studies.
I am biased and come from an empirical science based background with experience in many new things being presented meant to replace old ways of doing things. There is many monetary incentives and scientific incentives in doing so. I have never been naive in simply accepting what manufacturers say. When the newest cell phone comes out nobody, especially not the manufacturer, is going to tell you that the battery blows up. That was found via experience. You need to be skeptical of representations being made about anything new. That is my conclusion based on my experience in evaluating many new testing kits, instruments and equipment used in the medical laboratory and actually comparing each to one another and trying to choose. This RSV is the first. Nothing to compare it to. Look at the diversity of the COVID vaccines.
Again all I am saying is that one needs to be skeptical and cautious when coming to any conclusions in dealing with vaccines that have been problematic for a reason in the past inclusive of the malaria vaccine.
"Mosquirix, the world’s first licensed malaria vaccine, was positively reviewed by the European Medicines Agency, but its use is being limited to pilot implementation, in part to evaluate outstanding safety concerns that emerged from previous clinical trials.
These were a rate of meningitis in those receiving Mosquirix 10 times that of those who did not, increased cerebral malaria cases, and a doubling in the risk of death (from any cause) in girls.
WHO says the study is a “pilot introduction” and not a “research activity” - and that those children living in areas randomised to receive the new vaccine will do so as part of each country’s routine vaccination schedule and that consent is “implied.”
An implied consent process means that recipients of the vaccine are not being informed that they are in a study."
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