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
Jeez, talk about prejudice.
The trouble is, mRNA "vaccine"s don't walk like a duck. Any rational person knows the mRNA concoction doesn't walk like a duck, doesn't quack like a duck, and doesn't perform like a duck. It's not a "vaccine" just because the suits in marketing say so. If Pfizer et al were proud of its performance, they wouldn't even want to associate it with vaccines. They'd say "it's new!, it's different!, it's a revolution in medicine!, this isn't simply an old-fashioned "vaccine", it's a remarkable, historical departure and a novel approach to medicine, all for the betterment of humanity! It's the mRNA miracle!"
Instead, since they can't sell it as something that will safely stand alone or be of great benefit, they have to piggyback onto something that the general public trusts: "vaccines". Only then can they push their snake oil out the door (for "free") to a gullible public, and that's only possible since they've planted their agents in the regulatory agencies, then greased the palms of the people's elected representatives, conning them into using public funds to pay for just about all of it. It must be nice.
Cool! Good to know. Obviously, I have, we have(?), trust issues with FedGov, and as of late the CDC & FDA for obvious reasons.
Yep. Before COVID, I would have been thrilled by the news. Now, I’m cautiously hopeful. I really hope there is a vaccine for babies before my kids have kids. My daughter is getting married in less than a month
Fauci said the mRNA was so successful it would be used in all vaccines going forward. :(
“GSK’s trial showed that protection from its vaccine lasted at least six months. “
Still redefining what the word ‘vaccine’ means....
Tellurian wrote: “Instead, since they can’t sell it as something that will safely stand alone or be of great benefit, they have to piggyback onto something that the general public trusts: “vaccines”.”
Now, why would the pharmaceutical companies do that?
Why would the regulators participate in that scheme?
Why would hundred of thousands of medical professionals play along?
Why would the politicians provide the billions of dollars to develop and pay for the vaccines?
Why hasn’t the media jumped all over this?
And, it wasn’t the marketing suits that called it a vaccine. It was the entire medical profession. mRNA techology has been in development for at least 20 years.
I’m gonna get one.
Not really.
Why would the regulators participate in that scheme? Money.
Why would hundred of thousands of medical professionals play along? Money.
Why would the politicians provide the billions of dollars to develop and pay for the vaccines? Money.
Why hasn’t the media jumped all over this? Money.
“Safe and effective”
In case nobody knew already, we are the carbon that they want to reduce. Just say no to everything this government offers.
Also, I’ve never heard of RSV. Sounds like a trim package on a 4WD Audi.
already had my pneumonia shot, not getting this one ever
Tellurian wrote: “Money.”
You’re overlooking one very big thing. You are essentially accusing the pharmaceuticals, the regulators, all the medical professionals of fraud, a criminal expense. And accussing them of medical malpractice bordering upon homicide. Do you really think you’re local doctor would go to jail to protect Fauci, et al?
Thank you for reminding yourself as well as us all that you have your confirmed biases. Yup. Nothing like admitting all your biases posted as comments to others are biases. We can now move from discussing issues to "apples," as you so cleverly wrote.
You are amusing. How about them apples?
Yes. They were either pulled aside into the swamp, or of their own volition they waded into the swamp. The swamp offered plausible deniability and lucrative compensation for their cooperation. Even with that, many objected or even said no, but they were stymied with protocols that they were prohibited from violating, threatened with ostracism, or sanctioned.
Worldtraveler once upon a time wrote: “You are amusing. How about them apples?”
Do you get paid for being a spell checker?
Unlike other posters, I recognize confirmation bias. Too bad those who spend hours scouring the web for anti-vaxxer propaganda don’t recognize their biases.
HELL NO!!!!
But the theme is not a simple pro-vax or anti-vax, given that not all vaccines are similar, not all definitions of vaccines are identical and not changed in the last decades, and when an official from Bayer identifies the mRNA injections as "vaccines" which are “cell and gene therapy,” obviously there are those who disagree with your simplistic and sometimes pejorative style of breaking the “vaccine” discussion into two simple pieces like a good little amateur Hegelian, even though somewhat emotional at times.
As to "scouring" the internet, a previous post of yours shows you and I can"scour" too. You wrote "What is misleading is to imply that these vaccines are gene therapy."
One reads: "Ultimately the mRNA vaccines are an example for that — cell and gene therapy — I always like to say that if we had surveyed two years ago in the public, 'would you be willing to take a gene or cell therapy and inject it into your body' — we would have had probably a 95% refusal rate."
So there's bias aplenty, and you are as mired in it as you say others are.
Perhaps you need to "scour" the internet. There might be some way through all that bias, including yours.
Worldtraveler once upon a time wrote: “an official from Bayer identifies the mRNA injections as “vaccines” which are “cell and gene therapy,”
Not so:
"For us, therefore, we're really taking that leap — us as company, Bayer, in cell and gene therapy, which to me is one of these examples where really we're going to make a difference, hopefully, moving forward. Ultimately the mRNA vaccines are an example for that — cell and gene therapy — I always like to say that if we had surveyed two years ago in the public, 'would you be willing to take a gene or cell therapy and inject it into your body' — we would have had probably a 95% refusal rate. I think this pandemic has also opened many people's eyes to innovation in a way that was maybe not possible before."
The end of the "fact check," which you citing shows that you too can "scour" the internet, states "So, the claim circulating now is just a retread of an already debunked falsehood about the vaccines, which have proven to be both safe and effective."
Now re-read to discover that indeed the quote is verbatim: "Ultimately the mRNA vaccines are an example for that — cell and gene therapy — ...."
So I quoted "cell and gene therapy," and clever you manages to say "not so."
Yup, "cell and gene therapy."
Bias showing, dearie. You are embarrassing yourself.
Prayers for you and your own.
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