FDA Approves Booster Shot for People with Weakened Immune Systems

[Aerides]

I am quite sure that if, some months down the road, the vaccine makers come up with a new version for new variants, anyone will be able to get it. "No, you had a booster last November!" will be the last thing anyone wants to say.

Sure, they'll have priority orders, but it won't be like the initial roll out. I will roll up my sleeve on Day 1, every time I'm eligible. So far nothing but sore arms here.

And I don't care if it offers no protection from infection. It's quite clear that if I get it, my chances of a barely-there case are way higher than they would be sans jabs. So the "doesn't stop you from getting it" argument is quite stupid.

 

[skyking1]

I sort of played my odds, and did not push to get boostered on day 1. I was going for a little longer window of protection. I doubt it makes any difference. As you say, if/when another vaccine comes down I will be right there.
Many of us may have indeed been infected but did not get ill from it. I will be taking my first test next week, but DW has had blood draws for her arthritis many times and each time her blood was screened for antibodies.

 

[Chuckanut]

The link below will take you to a podcast of an interview with Dr. Gottlieb. Unlike the 5 minute quickies of the TV news shows, this an an hour long and lets the doctor go into the details behind his views. But, it's not medical tech talk.

Among the surprises, in the first few minutes Gottlieb explains why he and others got it wrong about the current course of the Pandemic. It seems that Omicron has been hiding out for about a year, mutating until it got just-right for infecting humans. Sneaky Devil!

https://unlocked.fm/episodes/how-om...ntific-community-with-scott-gottlieb-AL3F9qLx

 

[ExFlyBoy5]

It is appropriate to have shingles and the vaccine in here IMO. Whereas you may have a mild or asymptomatic case of Covid, I have never seen a situation with shingles that was not just miserable, debilitating and long lasting.

This. I have had 3 relatives have flare ups (2 of them under the age of 50) and they all were absolutely miserable. One of them (SIL) had one during Christmas a few years ago and we honestly almost called 911 because she was discussing suicide. I have NEVER seen anyone is so much pain before. I will most certainly be getting shingles vax when I can...no doubt it.

 

[harllee]

This. I have had 3 relatives have flare ups (2 of them under the age of 50) and they all were absolutely miserable. One of them (SIL) had one during Christmas a few years ago and we honestly almost called 911 because she was discussing suicide. I have NEVER seen anyone is so much pain before. I will most certainly be getting shingles vax when I can...no doubt it.

Not sure how old you are but if you are age 50 or older you can and should get the Shingrix vaccine even if you have to pay for it. I had shingles at age 50 and it was the worst health related thing to ever happen to me. Now at age 70 I still have pain from it and it negatively affects my life.

 

[fh2000]

We got our 2 shingrix vaccine shots, and I believe neither of us had chickenpox before. I am very clueless as to how shingles virus spread. So I looked up CDC site for the explanation:

https://www.cdc.gov/shingles/about/transmission.html

"If you have shingles, direct contact with the fluid from your rash blisters can spread VZV to people who have never had chickenpox or never received the chickenpox vaccine. If they get infected, they will develop chickenpox, not shingles. They could then develop shingles later in life."

I assume the shringix shots we received will protect us from getting chickenpox in the first place, right?

 

[Gumby]

I assume the shringix shots we received will protect us from getting chickenpox in the first place, right?

That's what my doctor told me. He said it is like a really strong chicken pox vaccine.

 

[Mark1]

The link below will take you to a podcast of an interview with Dr. Gottlieb. Unlike the 5 minute quickies of the TV news shows, this an an hour long and lets the doctor go into the details behind his views. But, it's not medical tech talk.

Among the surprises, in the first few minutes Gottlieb explains why he and others got it wrong about the current course of the Pandemic. It seems that Omicron has been hiding out for about a year, mutating until it got just-right for infecting humans. Sneaky Devil!

https://unlocked.fm/episodes/how-om...ntific-community-with-scott-gottlieb-AL3F9qLx

Thanks for posting the link.

Below is a link of a recent interview with Paul Offit on booster shots. As some folks may know, he is still opposed to boosters for all younger adults. I was a little disappointed with the interview as I really want to hear someone knowledgeable talk about OAS (Original Antigen Sin), but I did hear a few things that interested me.

At 20:48 thru ~27:00 he makes the case that two doses should be sufficient to protect many adults against serious illness, including the omicron variant.

At 45:45 thru 48:00 he give his opinion on what age range(s) he believe 3 doses probably make sense.
https://www.microbe.tv/twiv/twiv-844/

 

[audreyh1]

I may eventually but saying no to the one shot shingles vaccine proved to be a smart move as it proved to be completely useless.

It wasn’t completely useless. It provided some protection certainly for limiting illness and it provided me that protection for a few years while I waited for the better vaccine to become readily available.

 

[pacergal]

Son and daughter got their third covid vaccine, SIL scheduled for his tomorrow

 

[tmm99]

The link below will take you to a podcast of an interview with Dr. Gottlieb. Unlike the 5 minute quickies of the TV news shows, this an an hour long and lets the doctor go into the details behind his views. But, it's not medical tech talk.

Among the surprises, in the first few minutes Gottlieb explains why he and others got it wrong about the current course of the Pandemic. It seems that Omicron has been hiding out for about a year, mutating until it got just-right for infecting humans. Sneaky Devil!

https://unlocked.fm/episodes/how-om...ntific-community-with-scott-gottlieb-AL3F9qLx

Good link. Thanks! It definitely was more in-depth than those TV show interviews. I thought his explanations in the end about what WHO is, how CDC is set up and why they're so bad at certain things was interesting.

 

[anethum]

I may eventually but saying no to the one shot shingles vaccine proved to be a smart move as it proved to be completely useless. The same can be said about the J&J vaccine that so many so called experts were pushing despite the 66% efficacy which in reality turned out to be much lower.

You made a lot of blanket and inaccurate statements. The Zostovax vaccine was hardly useless, though its initial efficacy was lower than the later introduced Shingrix vaccine. Furthermore, a Kaiser study of its vast Northern California patient population showed that Zostovax's efficacy didn't wane as quickly as had been expected when it was approved.

As for the JnJ vaccine, all of the efficacy figures in the trials were based on whatever variants of the virus were circulating during the trial. The JnJ vaccine is still showing good protection against severe Covid, so that's hardly "useless".

The District of Columbia posts excellent weekly data regarding infections based on vaccination status as well as individual vaccines. In the most recent reporting week when there was presumably significant omicron presence already, an unvaccinated DC resident was 250% more likely to test positive for Covid than someone who got the JnJ shot. Moderna and Pfizer recipients fared even better, however.

You've got to click on various links within the site below to get to more specific data:
https://coronavirus.dc.gov/data/vaccination

 

[explanade]

Israel is rolling out a second booster shot (4th Pfizer) for health care workers and people over 60 who've had their first booster at least 4 months ago.

An expert panel made the recommendation, but they said there isn't specific data indicating that the first booster needs to be augmented.

However, they are seeing an uptick in cases and they're shooting first, asking questions later.

More than three months on, Israeli health officials say the data is clear: Booster shots helped bring down the fourth wave of the virus that swept the country in August and September.

However, three doses appear to not be enough, with Tuesday's announcement marking the throes of a fifth wave.

The total number of new Covid cases in Israel topped 1,300 on Monday, a figure not reached since the middle of October.

Meanwhile, the country's R coefficient -- the number of people infected by each person with Covid-19 -- jumped to 1.28, its highest level since early August, when Israel was in the height of the fourth wave.

https://www.cnn.com/2021/12/21/middleeast/israel-fourth-covid-vaccine-booster-intl/index.html

 

[Freedom56]

You made a lot of blanket and inaccurate statements. The Zostovax vaccine was hardly useless, though its initial efficacy was lower than the later introduced Shingrix vaccine. Furthermore, a Kaiser study of its vast Northern California patient population showed that Zostovax's efficacy didn't wane as quickly as had been expected when it was approved.

As for the JnJ vaccine, all of the efficacy figures in the trials were based on whatever variants of the virus were circulating during the trial. The JnJ vaccine is still showing good protection against severe Covid, so that's hardly "useless".

The District of Columbia posts excellent weekly data regarding infections based on vaccination status as well as individual vaccines. In the most recent reporting week when there was presumably significant omicron presence already, an unvaccinated DC resident was 250% more likely to test positive for Covid than someone who got the JnJ shot. Moderna and Pfizer recipients fared even better, however.

You've got to click on various links within the site below to get to more specific data:
https://coronavirus.dc.gov/data/vaccination

Zostovax was a disaster from the start. Merck is facing a number of lawsuits for failing to warn patients the drug actually can cause shingles and other more serious side effects. Based on reports to the FDA Vaccine Adverse Events Reporting System, there were over 1,100 serious reactions to the vaccine – more than 8 percent of which caused the patient's death. In 2014, the FDA updated the Zostavax warning label, adding shingles as one of the possible side effects. In 2017, the CDC began recommending that doctors use Shingrix instead of Zostavax. Why would the CDC do that if it was safe and effective?

As for the J&J vaccine, it was a tragedy from the beginning as documented here:

https://www.statnews.com/2021/12/17/the-tragedy-of-johnson-johnsons-covid-vaccine/

 

[Aerides]

As for the J&J vaccine, it was a tragedy from the beginning as documented here:

https://www.statnews.com/2021/12/17/the-tragedy-of-johnson-johnsons-covid-vaccine/

That's the title - but the story in the article points to more of an issue with being late to market, with trying to meet a goal of "one dose", with losing public confidence on rare issues, and a fair amount of bad luck. Overall it doesn't consider the vaccine itself a failure, but it's an interesting look at how the public picks a winner and never cares much for the also-rans, even if they aren't as bad as we might all now have heard. Still, at this point, with no production impacts for P/M jabs, no reason not to go with them.

 

[Freedom56]

That's the title - but the story in the article points to more of an issue with being late to market, with trying to meet a goal of "one dose", with losing public confidence on rare issues, and a fair amount of bad luck. Overall it doesn't consider the vaccine itself a failure, but it's an interesting look at how the public picks a winner and never cares much for the also-rans, even if they aren't as bad as we might all now have heard. Still, at this point, with no production impacts for P/M jabs, no reason not to go with them.

When the CDC and public health officials are expecting the population to accept a vaccine under EUA, it's not surprising that loser is one with 66% efficacy and has serious but rare side effects such as blood clots. Now those same people that approved the once shot J&J vaccine are now publicly stating that based on the data, it should have been a two shot regimen at the initial approval.

 

[Aerides]

When the CDC and public health officials are expecting the population to accept a vaccine under EUA, it's not surprising that loser is one with 66% efficacy and has serious but rare side effects such as blood clots. Now those same people that approved the once shot J&J vaccine are now publicly stating that based on the data, it should have been a two shot regimen at the initial approval.

Yes I read the whole piece. It's not a bad "tragic" vaccine, but a botched implementation. Had they gone 2 shot from the start, perhaps things would be quite different, but they were trying to meet the 1-shot demand. It was an interesting read.

 

[explanade]

IIRC the adenovirus vector has been successfully used on other types of vaccines.

A few months back, there was a story that NovaVax was still struggling to scale up production.

They showed good efficacy at the time, against I believe Alpha variant. There was also a belief that it would be a good alternative to mRNA, using an adjuvant.

Also cheap to make so attractive to developing world.

Novavax has never successfully shipped a product in volume but they were hoping, since they're so late, to compete in the booster market≥

The EU just granted EUA to Novavax so maybe we'll hear more.


Meanwhile, Army announced they've made progress on a universal vaccine for beta coronaviruses. They've had animal trials and are analyzing phase 1 human trial results.

They could have something by the end of the year.

 

[Koolau]

Zostovax was a disaster from the start. Merck is facing a number of lawsuits for failing to warn patients the drug actually can cause shingles and other more serious side effects. Based on reports to the FDA Vaccine Adverse Events Reporting System, there were over 1,100 serious reactions to the vaccine – more than 8 percent of which caused the patient's death. In 2014, the FDA updated the Zostavax warning label, adding shingles as one of the possible side effects. In 2017, the CDC began recommending that doctors use Shingrix instead of Zostavax. Why would the CDC do that if it was safe and effective?

As for the J&J vaccine, it was a tragedy from the beginning as documented here:

https://www.statnews.com/2021/12/17/the-tragedy-of-johnson-johnsons-covid-vaccine/

Interesting. I, of course, took the Zostavax shot back in the day and do not recall ANY issues with it, unlike the Shingrix which (2nd shot) caused me problems for 2 weeks. YMMV

 

[anethum]

Zostovax was a disaster from the start. Merck is facing a number of lawsuits for failing to warn patients the drug actually can cause shingles and other more serious side effects. Based on reports to the FDA Vaccine Adverse Events Reporting System, there were over 1,100 serious reactions to the vaccine – more than 8 percent of which caused the patient's death. In 2014, the FDA updated the Zostavax warning label, adding shingles as one of the possible side effects. In 2017, the CDC began recommending that doctors use Shingrix instead of Zostavax. Why would the CDC do that if it was safe and effective?

As for the J&J vaccine, it was a tragedy from the beginning as documented here:

https://www.statnews.com/2021/12/17/the-tragedy-of-johnson-johnsons-covid-vaccine/

You might want to refrain from using such hyperbolic language like "disaster" and "useless".

The VAERS reporting system has over 51,000 adverse events reported for the Shingrix vaccine. One of those entries is mine, under one of the "deafness" categories in the database. (Both Zostovax & Shingrix have had disproportionate numbers of deafness cases attributed to them.) There are 55 entries for "death" which claim to be attributed to Shingrix. I suspect it's just a matter of time before the lawsuits start for Shingrix, if they haven't already.

The JnJ vaccine has prevented tens of thousands of Covid cases in the US alone, and kept thousands of infections from becoming severe Covid cases. That's hardly "useless". The article you linked to used the word "tragedy" as Aerides described it, that is, pertaining to its implementation, not as you used it, pertaining to the vaccine itself. You also omitted the JnJ 2 dose testing results showing efficacy improved to 90%. There is also evidence that the JnJ vaccine doesn't wane to the same degree as the mRNA vaccines. The jury is still out as to whether it will significantly prevent severe infections from omicron. It could well be that for omicron, JnJ has limited usefulness. But there is no doubt that up to this point, it proved very useful for millions of people around the world.

For the record, I received 3 doses of Pfizer.

 

[Gumby]

You might want to refrain from using ... hyperbolic language ....

Wise advice for posting on any topic.

 

[Koolau]

You might want to refrain from using such hyperbolic language like "disaster" and "useless".

The VAERS reporting system has over 51,000 adverse events reported for the Shingrix vaccine. One of those entries is mine, under one of the "deafness" categories in the database. (Both Zostovax & Shingrix have had disproportionate numbers of deafness cases attributed to them.) There are 55 entries for "death" which claim to be attributed to Shingrix. I suspect it's just a matter of time before the lawsuits start for Shingrix, if they haven't already.

The JnJ vaccine has prevented tens of thousands of Covid cases in the US alone, and kept thousands of infections from becoming severe Covid cases. That's hardly "useless". The article you linked to used the word "tragedy" as Aerides described it, that is, pertaining to its implementation, not as you used it, pertaining to the vaccine itself. You also omitted the JnJ 2 dose testing results showing efficacy improved to 90%. There is also evidence that the JnJ vaccine doesn't wane to the same degree as the mRNA vaccines. The jury is still out as to whether it will significantly prevent severe infections from omicron. It could well be that for omicron, JnJ has limited usefulness. But there is no doubt that up to this point, it proved very useful for millions of people around the world.

For the record, I received 3 doses of Pfizer.

Yes, the best I've heard on the subject of pharmaceuticals is: Show me a drug without side effects and I'll show you a drug without effect. YMMV

 

[RetMD21]

I know people who were afraid of mRNA but did accept the JNJ. I think it's a good vaccine competing against 2 outstanding vaccines.

 

[Turbo29]

Interesting. I, of course, took the Zostavax shot back in the day and do not recall ANY issues with it, unlike the Shingrix which (2nd shot) caused me problems for 2 weeks. YMMV

I had no problems (except for a sore arm for a day or so) with Zostavax either.

 

[Alan]

IIRC the adenovirus vector has been successfully used on other types of vaccines.

A few months back, there was a story that NovaVax was still struggling to scale up production.

They showed good efficacy at the time, against I believe Alpha variant. There was also a belief that it would be a good alternative to mRNA, using an adjuvant.

Also cheap to make so attractive to developing world.

Novavax has never successfully shipped a product in volume but they were hoping, since they're so late, to compete in the booster market≥

The EU just granted EUA to Novavax so maybe we'll hear more.


Meanwhile, Army announced they've made progress on a universal vaccine for beta coronaviruses. They've had animal trials and are analyzing phase 1 human trial results.

They could have something by the end of the year.

The Serum Institute of India started shipping doses of Novavax to Indonesia Dec 1st once it was approved for use, and a local production plant not far from me has already made 60m doses and is now producing another 200m to fulfill an order for the EU. Production issues is certainly what has delayed the approval for many months.

https://www.reuters.com/world/india...-first-novavax-shot-through-covax-2021-12-01/

I think it will be very welcome in many countries as it has proven to be very effective in trials against Alpha, has no cold chain for transportation and storage, is very cheap to manufacture and appears to have the fewest side effects of any of the current Covid vaccines.

Tests have also shown it triggers an immune response against the omicron variant.

https://www.reuters.com/business/he...e-boosts-response-omicron-variant-2021-12-22/