The ACIP has spoken. Tired of Merck reps telling doctors how great their shingles vaccine is. If it were so great why is there such little utilization of it? Shingrix has been approved by the FDA and now has Preferential Recommendation by ACIP for 50+. Managed Care has been waiting for this news and is poised to act quickly. Sorry! Your run with your terrible vaccine is soon to be over
Bye bye Zostavax!!
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"The Advisory Committee on Immunization Practices (ACIP) provides advice and guidance to the Director of the CDC regarding use of vaccines and related agents for control of vaccine-preventable diseases in the civilian population of the United States. Recommendations made by the ACIP are reviewed by the CDC Director and, if adopted, are published as official CDC/HHS recommendations in the Morbidity and Mortality Weekly Report (MMWR)."
"The Advisory Committee on Immunization Practices (ACIP) provides advice and guidance to the Director of the CDC regarding use of vaccines and related agents for control of vaccine-preventable diseases in the civilian population of the United States. Recommendations made by the ACIP are reviewed by the CDC Director and, if adopted, are published as official CDC/HHS recommendations in the Morbidity and Mortality Weekly Report (MMWR)."
Very informative! But it doesn’t change their vote today. Sorry Not Sorry! The MMWR will reflect the results of the vote today.
Has the newer vaccine been approved yet? My doctor recommended that I take the shingles vaccine and I wanted to wait and see which vaccine would be better. Is there an advantage to either vaccine? Are they both the same?
Are you kidding? It has been all over the news. Shingrix has been approved for adults 50+, for naive or previously vaccinated with Zostavax, Shingrix 97 % efficacy vs Zostavax 70%, with Shingrix being preferred by ACIP.
I love this shat, Merck is going to hell in a handbasket, every day this shat hole company gets bad news. Vaccine cuts are next! They can't even but their way out of problems now, there are 7 pharma-bio companies with more cash on hand than Smerck. Some as much as 15-30 billion more than this shat hole. This is awesome!!
Okay, retired vaccine person here and wanted to offer some perspective and context.
What the ACIP did with this vote is unprecedented and reflective of the 8-7 vote. For the sake of the patients who will get this new vaccine, I hope there are no rare side affects that become visible with real world usages. Additionally, I hope all get the two doses needed to benefit from the efficacy demonstrated in the clinical trials. The big question is how many people will actually come back for the second dose after they experience a grade 3 AE...and how many doctors will want to continue to offer this vaccine after they get patients complaining about the grade 3 AEs. Only time will tell...
Even when the ACIP was assessing Gardasil vs Cervarix, they DID NOT put forth a preferential recommendation...they carefully crafted the recommendation to say “if you want to prevent cervical cancer” you can use with HPV2 or HPV4. But “if you want to also prevent genital warts” you should use HPV4. At that point the marketplace decided and eventually Cervarix market share went to zero. In this week’s vote, the ACIP is in effect telling all providers to use Shingrix for all patients (thereby resulting in Zostavax share going to zero).
This will be one big public health experiment...of patients get harmed, they will need to look no further than the ACIP, CDC, GSK and Raphael H.
What the ACIP did with this vote is unprecedented and reflective of the 8-7 vote. For the sake of the patients who will get this new vaccine, I hope there are no rare side affects that become visible with real world usages. Additionally, I hope all get the two doses needed to benefit from the efficacy demonstrated in the clinical trials. The big question is how many people will actually come back for the second dose after they experience a grade 3 AE...and how many doctors will want to continue to offer this vaccine after they get patients complaining about the grade 3 AEs. Only time will tell...
Even when the ACIP was assessing Gardasil vs Cervarix, they DID NOT put forth a preferential recommendation...they carefully crafted the recommendation to say “if you want to prevent cervical cancer” you can use with HPV2 or HPV4. But “if you want to also prevent genital warts” you should use HPV4. At that point the marketplace decided and eventually Cervarix market share went to zero. In this week’s vote, the ACIP is in effect telling all providers to use Shingrix for all patients (thereby resulting in Zostavax share going to zero).
This will be one big public health experiment...of patients get harmed, they will need to look no further than the ACIP, CDC, GSK and Raphael H.
What drug/vaccine isn't a big public health experiment? What did we learn about Zotavax over time???
Zostavax has roughly 50% seroprotection----it's a very crappy vaccine.
Gardisil has a tendency to hurt young girls worse than any other vaccine in world history. I wouldn't give that poison to anyone.
Goodbye, Vaccine Reps.
Gardisil has a tendency to hurt young girls worse than any other vaccine in world history. I wouldn't give that poison to anyone.
Goodbye, Vaccine Reps.
So the best answer to the question of what did we learn is to look at the Kaiser Real World study by Baxter, et. al. (1.4 million patients). Basically the study confirmed what was shown in the clinical trials - similar efficacy, similar safety and similar low AE rates. The other fascinating finding was that approximately 1% of patients who received Zostavax went on the get shingles (this is not how efficacy is calculated), but it is how doctors experience Zostavax. Each doctor that used Zostavax will hve very few patients that were vaccinated and went on to get shingles. One could call this a vaccine failure, but given this vaccine was designed as a booster vaccine for a virus that the patient had dormant in their body, doctors and patients were aware that this was possible. Again, consistent with the clinical trials, this Kaiser study showed that these “vaccine failures” had a milder cases of shingles that placebo matched patients (less PHN). And all of this was delivered with a single dose, well-tolerated vaccine used in over 30 million patients since approval.
A naive GSK rep will think this will be a “walk in the park”...the savy GSK rep will realize this will be hard - hard to deal with Medicare Psrt D and two co-pays due to two doses, hard because Shingrix has serious injection site AE issues that doctors, pharmacists and patients will find challenging. Doctors and pharmacists are too busy to deal with these issues for a disease (shingles) that will not kill anyone.
....it’s going to be a fascinating experiment.
For Merck, Zostavax was never a blockbuster vaccine, and for many was really more of a distraction. In the end, this will be a blessing for them as they will be able to focus on the segment where they dominate - Pediatrics.
Let it go! You lost the fight!! Yet you keep bashing the competition that is much better. Do you think the ACIP is going to reverse their decision because you don’t agree? Grow up! Move on!!!!!
You’re right, ACIP will not change their recommendation.
I have no horse in this race and I am just a curious bystander waiting to the train wreck coming down the tracks...if you, and everyone else at GSK associated with this vaccine does not have an exceptional plan to manage the injection site AEs, and the 2 part D co-pays, thisnis going to be a train wreck!
If, however, you all exceptionally plan and execute around this, it could be a billion dolla brand within a year...
You keep mentioning 2 copays. However, weren’t you running around saying there was no copay for Zostavax for 60-64 yr old patients because the Affordable Care Act requires first dollar coverage on ACIP recommended vaccines? So wouldn’t that be the same for 50-64 yr olds with Shingrix? Over 65 you struggled with Medicare coverage because your efficacy is terrible and Medicare didn’t want to cover it. With 97% efficacy with Shingrix it is in the best interest of Medicare to provide coverage. I get that you are scared, angry, and in denial. Move on! Let Shingrix show how well it can help prevent Shingles. As for your safety concerns, perhaps you need to read the Shingrix PI that was approved by the FDA. Pretty good AE profile. Good luck with your job when Pneumovax sales drop. Your company will walk away from Adult vaccinations completely. You already can’t provide Hep A or B for adults. Soon Zostavax will be pulled once MMWR is official. Pneumovax 23 sales are lower than Merck would like. If sales don’t improve you will be focused completely on Pediatrics. Hence, your territories will drastically get bigger and your sales force will have significant cuts. Stop being bitter and just enjoy your day.
Thank you for the well wishes
. I am retired and loving life!I spent many years in the vaccine space and know a lot about Zostavax....before the HQ folks at GSK set a crazy sales objective and convince the sales Force minions that this will be a slam dunk, head then following warnings
1. VERY few people under 60 got Zostavax and most of them do not feel they are at risk for shingles - too busy with life (look at flu coverage rates for this population as a proxy)
2. About 25% of the Zostavax business came from 60-64 year olds and they do have first dollars coverage per ACA (as will shingrix for 50-64).
3. About 75% of the business for Zostavax came from 65+ (and many of the 60-64 have now aged in to this population. Medicare Part D plans HAVE to cover shingles vaccine, but they have the option of what copay tier it should be placed..
4 about 50% of the eligible 65+ year olds have received Zostavax (flu coverage rates among this population is about 70%). For the ones that have not yet gotten Zostavax it’s mAinly because of the copay or they don’t like vaccines - this will also apply to Shingrix.
5. The “easiest” target are people who already go Zostavax because they show evidence on wanting to be protected from shingles. Since most of them are over 65, you will need to content with 2 co-pays for Part D and the grade 3 AEs thst somenwill get...people who don’t get bad I jest ion site reaction will not say anything, but those who do will tell everyone and that is what the doctor and pharmacist will remember the most.
Shingrix is clearly an effective vaccine, but you all have some big hurdles to overcome to make this a blockbuster...Don’t drink the “kool aid” from HQ that this Ian going to be a lay up.