Posted on 05/04/2023 6:11:25 AM PDT by Red Badger
The Food and Drug Administration on Wednesday approved the world's first RSV vaccine: a shot for adults ages 60 and up, made by pharmaceutical giant GSK.
The milestone was decades in the making. Researchers first attempted to develop a vaccine for respiratory syncytial virus roughly 60 years ago.
In a late-stage clinical trial, the single-dose shot lowered the risk of symptomatic illness by 83% and of severe illness by 94%.
The Centers for Disease Control and Prevention must still recommend the vaccine before it becomes available to the public. A CDC advisory committee is scheduled to meet in June to discuss how the shot should be used.
Dr. Phil Dormitzer, GSK’s senior vice president and global head of vaccines research and development, said the company is already manufacturing doses of the vaccine, to be sold under the brand name Arexvy.
“The goal is to have shots available in the fall so that people can get them before the next RSV season coming up late fall and winter,” Dormitzer said, though he did not give specific production numbers.
RSV causes a lower respiratory illness that is typically mild for healthy adults. But in serious cases, the virus can lead to pneumonia or bronchiolitis, which inflames airways and clogs them with mucus. Older people and infants are particularly at risk: RSV kills up to 10,000 people ages 65 or older and up to 300 children under 5 every year in the U.S.
RSV cases typically peak between late December and mid-February, but cases last year started climbing in the summer as people left pandemic precautions behind.
As of late April, the rate of RSV hospitalizations for the current season was around 51 per 100,000 people, according to the CDC. That's up from 19 hospitalizations per 100,000 people by the same point in the prior season.
GSK’s trial showed that protection from its vaccine lasted at least six months.
"It’s not like you have to wait to the very last minute because it’s not going to last long enough," Dormitzer said. "We know from studies we have done that getting a vaccine — for example, in the fall — should cover you through the next RSV season."
Dormitzer said the company's data also suggests it is safe to administer the RSV vaccine at the same time as a standard flu shot. But GSK is still studying whether the vaccine can be administered alongside high-dose or adjuvanted flu vaccines (shots with an added ingredient to encourage a better immune response), which are the types the CDC recommends for older adults.
Monitoring for safety concerns
GSK’s trial is ongoing, so the company plans to keep collecting data over the next two RSV seasons. It will also monitor people who receive the newly approved shot.
So far, commonly reported side effects in the trial include injection site pain, fatigue and muscle pain.
The FDA noted a higher incidence of atrial fibrillation (irregular heart rhythm) among vaccine recipients relative to the control group, and it identified one case of Guillain-Barré syndrome — a rare neurological disorder that damages nerve cells and causes muscle weakness or paralysis — that was potentially related to the vaccine.
Dormitzer said it’s hard to know what to make of the Guillain-Barré case but added, “I would not say it’s a great concern at this point.”
A panel of FDA advisers in March voted 10-2 in favor of approving the vaccine based on its safety and unanimously recommended the vaccine based on its efficacy.
The future of RSV vaccines
A second RSV vaccine for older adults, from Pfizer, is up for FDA approval later this month. The FDA advisory panel voted 7-4 to recommend that shot based on its safety and efficacy.
Some members expressed concerns that not enough participants in Pfizer’s trial got infected with RSV to adequately assess the shot’s efficacy, and several worried about a potential association with Guillain-Barré. One man in Pfizer’s trial developed Guillain-Barré after he received the vaccine, and a woman developed Miller Fisher syndrome, a related, rare nerve disease.
The FDA has asked Pfizer to conduct a study on the risk of Guillain-Barré after its vaccine is approved.
Pfizer also tested a second application of its shot in pregnant people to help protect infants from RSV. The FDA is reviewing that data, with a decision likely in August.
Dormitzer said GSK doesn't have further plans to study its shot among pregnant people after a previous trial involving a slightly different version of the vaccine showed a higher preterm birth rate among some vaccine recipients.
However, GSK is studying its shot in people ages 50 to 59 — particularly those with underlying health issues. Dormitzer said that data should be available sometime after July.
Aria Bendix
“ I would lose out in the first round to those who believe that COVID is a fraud…”
Nope, you’re still in the running for the dumbest Freeper. You may have even taken the lead.
You see, nobody thinks COVID was a fraud. We think the RESPONSE to COVID was a fraud. Dumb people might not be able to grasp the difference, but it is important nonetheless.
This is like climate change. Dumb (and dishonest) people think we on the opposing side don’t believe climate change is real. We do of course. The climate has been changing for forever. What we think is a scam (it is) is that humans are the cause and that spending trillions of dollars will “solve” it. See the difference? Now apply that to your covid thinking.
You’ve moved on to the regionals
BlueMondaySkipper wrote: “You see, nobody thinks COVID was a fraud. We think the RESPONSE to COVID was a fraud. “
Multiple posters have alleged that COVID was a fraud, not just the response to covid but covid itself. In fact, at lease one poster has alleged that viruses don’t exist. None.
And, no, I’m not going back through months of posts to provide quotes.
You’re the one claiming that people here said covid didn’t exist. Either prove it or admit you’re lying.
Covid exists. It’s likely a strain of the common flu that mysteriously appeared during the covid scamdemic. It was made more deadly by Fauci and his band of criminals. The ONLY question is whether it escaping from the lab was an accident or intentional.
We’ve now seen proof of what we thinking people (not you of course ) knew all along. Masks didn’t work. Social distancing didn’t work. The jabs didn’t protect you from getting covid. The jabs didn’t protect you from spreading covid. The jab are dangerous. Shutting down the economy didn’t work. Shutting down the schools was way more harmful than keeping them open. Spending us further into debt was reckless.
The entire reason they inflated it and spent so much time scaring the rubes is to enact their vote stealing scheme which required mass mail-in voting. When you true believers keep defending it it’s reasonable to question exactly which side you are one.
I’m a big fan of Ivermectin and HCQ.
“The age range, “age 60 and up”, forebodes.”
Well obviously, they missed a lot of folks that were ‘not’ trapped in nursing homes. They’ll fix that with this new and improved version. Gotta make room and save SSN $$$ for all of those “NEW” voters and citizens, dontcha know.
“At this point I don’t trust big pharma enough to take an effing aspirin.”
At this point I don’t trust the entire medical industry. Too many pro-death ghouls. How do you really know what they’re injecting you with? I won’t be taking any vaccine unless or until I’m ok with dying and ready to do so.
Depressing thought. I think it’s a handful of reprobate men and women who sit in high places that think along those lines, not the workers at our level. Satan energizes them and “he was a murderer from the beginning” (Jesus, John 8:44).
I have a Veteran friend who was diagnosed with ALS, and from all the bad things I’ve heard about the VA I can say that none of them have been true in his case. One benefit after another, financial and material, has been poured out and all the medical staff have been wonderful (I’ve been with him at every appointment, in the room).
I’ve known many in the medical field and they only try to benefit others to the best of their ability.
“I’ve known many in the medical field and they only try to benefit others to the best of their ability.”
You’re lucky, then. My experience...specifically 13 years ago when my mother died in a hospital, with half a dozen medical staff standing around doing NOTHING to help her (she had signed a DNR, but had seemed fine the night before) and participating in Kabuki Theatre for my benefit. Ghouls, all. And please don’t underestimate how much worse it has gotten since then.
It’s 999% effective! TRUST US
BlueMondaySkipper wrote: “You’re the one claiming that people here said covid didn’t exist. Either prove it or admit you’re lying.”
Here’s a thread posted to FR which claims COVID is fake.
BlueMondaySkipper wrote: “Covid exists. It’s likely a strain of the common flu that mysteriously appeared during the covid scamdemic.”
When you ,call COVID a strain of the common flu, when you use the term ‘scamdemic’ you prove my point.
BlueMondaySkipper wrote: “We’ve now seen proof of what we thinking people (not you of course ) knew all along. Masks didn’t work. Social distancing didn’t work.”
I’ve never supported masking or social distancing.
BlueMondaySkipper wrote: “The jabs didn’t protect you from getting covid. The jabs didn’t protect you from spreading covid. The jab are dangerous.”
Name three vaccines that are 100% effecive, that never have breakthrough infections or that do not have side effects.
BlueMondaySkipper wrote: “The entire reason they inflated it and spent so much time scaring the rubes is to enact their vote stealing scheme which required mass mail-in voting. When you true believers keep defending it it’s reasonable ttion exactly which side you are one.”
There have been over a million Americans dead from COVID, over six million deaths world wide and you think it was so they could enact vote fraud?
Sheesh ...what did I do wrong with the formatting of that list I tried to post? Sorry....IVM has been a miracle drug for me. Cured my covid, GERD, gnarly toenail fungus/warts, arthritis, and lowered my blood pressure so much I’ve been able to reduce my hypertension med dose by 3/4. If we all had access to it, the MedPharma Borg would starve to death. (Just think what it would do to the Cancer Research/Treament Industry.)
BlueMondaySkipper wrote: “You’re the one claiming that people here said covid didn’t exist. Either prove it or admit you’re lying.’
Here’s another example:
https://freerepublic.com/focus/f-news/4152984/posts
You aren’t very bright for a shill.
For example, you said “ There have been over a million Americans dead from COVID, over six million deaths world wide and you think it was so they could enact vote fraud?”
First off,, that number is FAKE. Did you miss all the reporting that “with Covid” was presented as “from covid”? Literally people getting shot, testing positive for covid (high cycle counts with a bad test will do that by design) and then the death being counted as a covid death.
I initially had hope that you were simply misinformed, but now I thing your intentionally dishonest. Perhaps it pays well?
An honest and observant person would grasp that yes, the cabal (swamp) would indeed leverage an outbreak (that they caused!!), sensationalize it’s effect, game the numbers by rolling anything and everything into the body counts, make wild unsupported claims, and scare the bejesus out of everyone stupid enough to believe them to protect themselves from Trump and people like him.
Of course you are neither of those, so I’ll cut you some slack…
You see today how they made up the entire Russia collusion farce and knowingly spread it for years, right? You think this was above them? They would never do anything dishonest? C’mon man
BlueMondaySkipper wrote: “You aren’t very bright for a shill.”
If you were brighter, you would understand that hundreds of thousands lived for years with comorbidities and would have lived many more. Then, they contracted COVID which pushed them over the cliff.
If you pushed someone with comorbidities over a cliff, would you claim that anything other than the push was the proximate cause for their deaths.
Now, please provide evidence that the swamp caused the virus.
“ Now, please provide evidence that the swamp caused the virus.”
You aren’t even trying. What a weak shill you are. Oh, and Ukraine is involved in the biolab business as well. Of course you and your ilk will defend that as well.
https://theintercept.com/2021/09/09/covid-origins-gain-of-function-research/
#tryharder
BlueMondaySkipper wrote: “You aren’t even trying. What a weak shill you are. Oh, and Ukraine is involved in the biolab business as well. Of course you and your ilk will defend that as well.”
You’re the weak shill. I asked for proof and you provided a link. Your link disproved your allegation.
“Scientists unanimously told The Intercept that the experiment, which involved infecting genetically engineered mice with “chimeric” hybrid viruses, could not have directly sparked the pandemic. None of the viruses listed in the write-ups of the experiment are related to the virus that causes Covid-19,”
You need to #tryharder”
Nope. I posted the wrong link.
Try this one. Also not the date(s). The military was onto Fauci from the start.
I may have messed up a link but you missed the truth and still believe (defend even) the lie. It wasn’t organic and Fauci tried to cover it up. That’s because he was involved. How about working for the good guys for a change? DU kick you out?
Game
Set
March
Not just no, but F NO!
Another magical miracle cure for a disease I’ve never heard of.
BlueMondaySkipper wrote: “I may have messed up a link but you missed the truth and still believe (defend even) the lie. It wasn’t organic and Fauci tried to cover it up.”
Nice try but once again your link does not prove your allegation that the virus was caused by “the cabal (swamp)”. Quoting from you link: “This critique of Anderson et al.’s argument does not aim to show that SARS-CoV-2 originated in a laboratory, much less identify a specific laboratory source or to characterize the goals of research that could have generated the virus.”
That’s two links in a row that do not say the things you say they do.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.