Posted on 12/17/2017 3:49:50 PM PST by Morgana
July 11, 2017 CoG for Life
http://www.fiercepharma.com/vaccines/eager-for-marketing-approval-gsk-s-shingrix-passes-revaccination-test
With GlaxoSmithKline eager for marketing approval, Shingrix passes revaccination test
Awaiting a potential FDA approval, GlaxoSmithKline’s much-anticipated shingles vaccine Shingrix met its goal in a phase 3 study examining whether it can protect older adults who have previously received Merck’s Zostavax. If approved, CDC officials said they’re likely to recommend the GSK vaccine over Merck’s shot.
In the revaccination study, investigators found that Glaxo’s shot induces a strong immune response in people 50 and older who received Zostavax a minimum of 5 years before their Shingrix vaccination. Since previous studies have shown Zostavax’s protection wanes over time, the results could mean a new option for those who’ve already received the Merck vaccine, should Shingrix win FDA approval.
The data were presented at the CDC’s Advisory Committee on Immunization Practices (ACIP) meeting Wednesday, where members said the FDA is set to act on the GSK shot in the coming months. Apart from the U.S., GSK has also submitted its vaccine to authorities in Europe and Canada.
At the meeting, CDC medical epidemiologist Dr. Kathleen Dooling said a majority of members of a herpes zoster work group would recommend a preference for GSK’s Shingrix over the current vaccine, Merck’s Zostavax. That’s based on currently available data, Dooling cautioned, adding that the group is awaiting the GSK vaccine’s final price and a cost effectiveness analysis.
Experts at the ACIP meeting noted that should the FDA approve Shingrix by their October gathering, the group could choose whether to recommend the shot for national vaccination guidelines. A preference for GSK’s shot could gravely hurt Merck’s Zostavax sales, which totaled $685 million last year.
Just this week, life science commercial intelligence firm Evaluate predicted that Shingrix would climb to more than $1 billion in sales by 2022. The analysts found that Shingrix is the most valuable vaccine R&D project in the industry.
For their part, Glaxo executives have said the vaccine represents a big opportunity as it would steal market share and also drive uptake. GSK CEO Emma Walmsley recently told analysts the company’s “immediate focus” is to “deliver excellent commercial execution” on three drug launches, Shingrix among them.
This is coming soon, am going to assume the one on the market contains fetal cells.
hmmmm.
Does immunity from having the shingles wane over time too?
This site? They were the ones who caught was Pepsi was up to before anyone else. We will have to wait and see.
I am going to assume that $$ is the only reason for halting or moving forward on distribution of this and any other drug..
Pretty sad especially where life saving cases are involved.
Pressure from pro lifers, oh we can be a pain in the ass.
Whatever they say, don't believe them.
I have had chicken pox multiple times. I know someone who has had it 6 times. Yet, many docs say you only get it once. That's because they don't read the literature.
You prefer socialist medicine?
LJ when I was a little every runt had chickpox. You got it once and if you got it good you never got it again. At least this is what the Old Ones told us. It built up your immunity.
Now they don’t want kids getting that? Now vaccines for chicken pox? Nope sorry, I believe the Old Ones.
Back in 2016 my 84 year old father, who had stage 4 COPD was moved to a nursing home to live out his final months. After a week in the nursing home he came down with shingles. He went from lucid, oxygen on 2 and only taking morphine when needed to fully sedated with the oxygen turned all the way up. The last thing he said was he was in terrible pain and needed a shot. As soon as he fell asleep from the morphine we knew he was never waking up. 4 days later he was dead.
My suggestion for the nursing home was every new resident should have a shingles vaccination.
No offense but I seriously doubt your claim........
However, if you're telling the truth then not only you but especially your friend are true anomalies of nature and belong in a secret research facility where they perform all sorts of horrendous tests on you and your friend to determine why you've never developed an immunity to that virus...........LOL!
“You prefer socialist medicine?
I don’t prefer socialist medicine, nor crony capitalism.
Both suck and pervert markets and healthcare.
My suggestion is never go to a nursing home! Get a full time nurse and stay in your own home! Is what we did for our granny!
Have known people to get chicken pox more than once! The Old Ones always told us it was because they did not get it good the first time and they did not build up their immunity up to it. For some reason LJ just did not build up her immunity to it.
I prefer rational human beings
Must be nice to be wealthy
Don’t know the answer to your question but here are a few details to add that I do know. I was just in an immunization clinic on Thursday to pick up some typhoid pills for an upcoming overseas trip when I was asked whether I ever had the shingles vaccine… I said “no but tell me about it.” What I was told is that the current vaccine is a one shot deal that is approximately 60% effective (not sure how ‘effectiveness’ is determined). Shingrex is due to come out in January and it is supposed to be approximately 95% effective. It’s a two shot deal… didn’t say how far apart the two shots are. The cost of it will be about 80% more than the current vaccine.
Didn’t say how far apart the two shots are.
Im only 5 9 I hope thats far enough
For those without that option, there are now nursing homes and retirement communities in more peaceful parts of northern Mexico. Their biggest advantages are that they cost a fraction of US care, and have a much better caregiver to patient ratio. A lot of their caregivers and doctors and nurses speak English, their pharma and surgical costs are much lower, and the places look good.
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