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
mikelets456 wrote: “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.”
the total number (or percentage) isn’t as important as the rates (#/100,000).
GSK’s Arexvy is a fRespiratory syncytial virus vaccine, adjuvanted, contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01E adjuvant.
trials continue to evaluate an annual revaccination schedule and protection/immunogenicity over multiple seasons following one dose of the RSV vaccine.
yet, another damn annual vaccine with a secret-sauce adjuvant, which is a chemical designed to hyperstimulate the immune system because the basic vaccine is too weak to work without it ...
and of course, the super efficacy claimed in the trials will likely drop to a fraction of those claims in real life, if this vaccine follows the pattern of influenza and covid vaccines ...
worse, though, both pfizer and moderna have mRNA RSV vaccines they’re trying to get accelerated approval for ...
all of this for an illness that knocks off 6,000-14,000 old folks each year like me who have a shitpile of comorbidities ...
we had RSV blow through my area a few months ago and awhole bunch of gave it to each other (it’s highly communicable), and it did in fact go down into our lungs and we were very ill, but no one that i know died from it ... unfortunately, immunity from subsequent infection only lasts a year or so like influenza ... though i don’t know if the immunity wanes or the virus mutates ...
Probably both...................
no. see my post 82 ...
Thanks.
For now anyway, tetanus vaxes are still old school. I have had few, usually after getting poked by a rusty nail or after a deep cut in the field.
I was reading an early covid study that suggested that tetanus vaccines offered cross-over covid risk reduction of 25%-30%.
Better than long term mRNA vax protection.
apparently, immunity isn’t long-lasting due to rapid mutation of the RSV virus, AND it may be that annual vax would be necessary with a NEW and DIFFERENT vax each year, as is the case with influenza vax ... and then wonders if the vax makers will be any more successful in dealing with the mutation issue than the influenza vax makers have been ...
https://news.vumc.org/2023/03/09/study-finds-rsv-may-evade-vaccines-via-rapid-mutation
Excuse my ignorance, but what the hell is RSV?
Respiratory Syncytial Virus.
It can be deadly....................
Thanks, Red. Never heard of it before.
Is this something they’ve been working on for awhile, fully tested long term, or did they just pull it out of their asses like the last vaccine?
HA
They have been working on it for long time.
But the FDA is accelerating its approval.................
It’s a respiratory virus that is the leading cause of death of infants in our country. It can also be bad for the elderly
My twins were very sick from it when they were 6 weeks old. One was on a ventilator for a month. They thought she was going die, but a last ditch effort with a blood transfusion turned things around. She’s 26 now, and RSV still flares up her asthma.
My other daughter was on a ventilator for a week,but she got a brain injury as a side effect of it.
Premature babies are especially at risk. Elderly and babies that get asthma from respiratory viruses are also at risk.
It kicked my butt this year. I’ll be looking at this vaccine pretty seriously, especially as I get older. I could see RSV killing me as I get older.
They’ve been working on a vaccine since my girls were babies, and they are 26.
LoL!!
Sick. Accurate but sick.
Gosh, since the quoted quoted is a quote from Dugaway Duke, he must be among the anti-vaxxers. Either that, or rhetorical repartee is not a part of his skill set.
I know your, but what am I?
Worldtraveler once upon a time wrote: “Gosh, since the quoted quoted is a quote from Dugaway Duke, he must be among the anti-vaxxers. Either that, or rhetorical repartee is not a part of his skill set.”
You should realize the tag line is nothing more than a statement of confirmation bias. It applies to myself and it apples to everyone posting in this forum.
From 2019...
https://ndc.services.cdc.gov/case-definitions/respiratory-syncytial-virus-associated-mortality-2019/
Note this bit...
“...A more accurate assessment of RSV-associated deaths is important for establishing a baseline level of mortality ahead of the potential licensures of vaccines, immunoprophylaxis products, and anti-viral therapies...”
So we’ve got that now...?
If not, WTH are we doing?!
Not getting shot up with this one either.
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