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
Solvent Green is people
Shots witch one do you prefer comrade ?.
The one that you take, comrade..................
Indeed step into the trench first.
Exactly. And no doubt efficacy and side effect stats are made up and also manipulated. They want us dead so we can’t talk
Just plain ol’ “No”.
TRUST US. NOT!
I don’t know how long I wait. It took me 1 1/2 months to get over it and other issues from it.
I got sick for 2 weeks, then I needed antibiotics then I got costochondritis (inflammation in the tub cage) that was very painful for a month, and can still hurt after a long sneezing bout.
The costochondritis was horrible!
I’ll skip it this winter, but if I get another horrible bout I’ll probably take it.
Is there any indication that this is a conventional vaccine,
or,
is this another experimental "mRNA vaccine" injection ?
Any indication ?
I ask this question because the "mRNA vaccine" had serious adverse reactions, some of which were worse, and more fatal, than the covid disease itself.
“Among a subset of these clinical trial participants, the most commonly reported side effects by individuals who received Arexvy were injection site pain, fatigue, muscle pain, headache and joint stiffness/pain. Among all clinical trial participants, atrial fibrillation within 30 days of vaccination was reported in 10 participants who received Arexvy and 4 participants who received placebo.”
You have to look at the generic name for the medication. The tell is the last few letters in that name. For instance, if the last letters are “mab”, it is a monoclonal antibody shot. Last letters “vir” means it is an anti-viral med. Any use of the term “mir” in a generic name can mean “mRNA”.
Does it come with free clots?
“ They have broken my trust. I would not take so much as a tetanus shot from them today.”
Same.
They have lost me forever and they did so by their own actions. I feel the same way about my employer who instituted mandates. I’ll never trust them again either
Is there a contest for the dumbest Freeper that I’m not aware of? I don’t think you’ll win but you’ll certainly be in the running.
You have to look at the generic name for the medication. The tell is the last few letters in that name. For instance, if the last letters are “mab”, it is a monoclonal antibody shot. Last letters “vir” means it is an anti-viral med. I’ve seen other articles that say that any use of the term “mir” in a generic name can mean “mRNA”.
I’m not afraid of it. No spike proteins.
It’s in farm animal vaxes. Kids/Seniors next. The Flu shot will have it, and you know how brainwashed the public is on those, Shingles too.
I swore after the Bird Flu shot which was my first on, NEVER, EVER AGAIN. MADE ME SICK AS A DOG FOR 2 WEEKS, NEEDED A ER TRIP FOR A $700 IV.
BlueMondaySkipper wrote: “Is there a contest for the dumbest Freeper that I’m not aware of? I don’t think you’ll win but you’ll certainly be in the running.”
I would lose out in the first round to those who believe that COVID is a fraud and the vaccines are an attempt to depopulate the world.
The problem with you BS, is I believe in all vaccine with the exception of the MRNA “vaccine” because it doesn’t work. Heck, in the beginning of 2023 the MSM actually changed the title of articles to “Covid has now become the pandemic of the vaccinated”.
58% of Covid deaths were from those vaccinated——So you can blow your fake science up your azz. I have been vaccinated and will continue to be vaccinated with “tried and proven” vaccines. Not this MRNA left wing propaganda anti-science BS.
Seriously, does anyone really believe that the FDA, CDC, US Gov, really care about extending the life of Americans who are 60 and older. If so, then I have a bridge I’d like to sell to you.
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