The administration is recommending all Americans who got the Pfizer or Moderna vaccine receive a third booster dose about eight months after getting their second dose. Research on booster shots for those who received the Johnson & Johnson vaccine remains ongoing.
Booster shots are expected to be made available to all Americans starting the week of September 20.
Apparently the “booster” is just another dose of the existing vaccine that they’re throwing away in the South.
Fair Economist
Recommending boosters after mRNA vaccines but *not* J&J (yet) is totally backwards.
Hoodie
Need more microchips, I guess. IIRC, Pfizer and Moderna were working on modified vaccines directed more to delta, but I guess there’s not enough time to get those out, so just build up what we already have.
Joe Falco
The wasted doses just boil my blood. They all could have gone to the southern border to vaccinate not just those wanting to emigrate to the US but any person living in Mexico that wanted one too. What I wouldn’t give for a video of VP Harris at the border overlooking migrants being vaccinated. The RW media sphere would be tripping over themselves with all the bile they would spew.
jl
This is a big decision, so I hope CDC releases some good ‘The Data and The Science’ to back it up. Analysis of the Israeli data that seems to the reason for this decision gives results that are all over the map, some indicating need for a booster, some not. The analysis that says there is no need says the decay in vaccine protection is due to not separating the effect of the vaccines by age group.
Natalie E Dean’s twitter ( https://twitter.com/nataliexdean ) for Aug 16 has two threads giving the opposing views.
Media reporting is also not distinguishing vaccine performance against any, symptomatic or severe infection, hospitalization, etc. which makes it even more confusing. I think boosters for all has to be a serious need have higher priority than getting vaccines to rest of the world.
Four Seasons Total Landscaping mistermix
@Fair Economist:
I didn’t include this part but looks like a booster is coming soon.
jl
@Fair Economist: J&J protection seems to increase over time, and there should be results of a study out on its performance soon.
Another wrinkle is that longer time between first and second doses of mRNA vaccines gives far stronger and longer protection than what most got in US, which was exactly what was specified in RCT protocols.
But, important to remember that RCT protocols were designed to get answers to public health questions about vaccine performance, not to get the most information about the performance of the vaccine. We needed a vaccine quick that would be good enough to protect public health and medical system without endless severe, socially and economically ruinous shutdowns. So, dosing schedule was compressed to what was considered absolute minimum (edit: based on causal models of human immunology and experience with vaccines against similar coronaviruses) to get answers quick. Must less exploration of optimal dosing and interval between shots.
prostratedragon
@Hoodie: My chips are still working after 6 months. In the Garden Chat on Sunday we noted the mysterious occurrence of several Jackals cooking eggplant dishes. I expressed the opinion that caponata could go with anything, even something like sweet potatoes.
Yesterday I unloaded some groceries and there… in the bottom of a bag of Cottonelle … was an enormous sweet potato.
jeffreyw
I wonder if our Pfizer vax will get a J&J booster. Any guidance on that from CDC?
MJS
Can the CDC credibly claim that the booster is needed due to Delta, and Delta is a problem because of the high number of people who refused to get the vaccine? If they can, they should.
Cameron
I am confused. Is it after the first one or the second? I’ve seen references to both.
Gin & Tonic
@Joe Falco: May be tangential to your point, but a lot of Mexicans (those with the means, anyway) have traveled to Texas and Florida to get vaccinated.
Joe Falco
RW talking point coming soon: “Biden wants to give you a booster of an experimental drug but doesn’t want to give a booster to the people of Afghanistan.”
WereBear
I’m not due to think about it until Winter Solstice, so it’s moving down the priority list a bit. Should be more science to wrestle with then.
jl
@Joe Falco: Which is why the CDC needs to show its work and make an clear and concise case that the public will understand. Maybe that is being done right now. I hope so.
Dagaetch
I think I’ve seen some preliminary studies have indicated that mixing types (mRNA and adenovirus) actually increases immune response, maybe in one of AL’s morning roundups? Whatever, as a J&J recipient, I just hope I can get a booster on Sept 20.
jeffreyw
What Have the Romans Ever Done for Us?
@jeffreyw: I was wondering about the Novavax as a booster – that was the last one to go through clinical trials in the US and hence had the greatest exposure during trials to different variants. It showed about 90% effectiveness if memory serves.
jeffreyw
Another Scott
@jl: Also too, IIRC, Matt McIrvin pointed us to a thread that the Israel results might be an artifact (of mixing old and young populations with different breakthrough rates – Simpson’s Paradox).
https://twitter.com/CT_Bergstrom/status/1427767356600688646
Thanks.
Cheers,
Scott.
What Have the Romans Ever Done for Us?
I can see them erring on the side of caution and recommending boosters before a lot of folks may need them for one particular reason: front line health care workers were the first to get the shots. Maybe many of them don’t need a booster yet, but do we want to take that chance? Like, if a significant portion of the front line health care workers in the nation go down to Covid that would be…pretty bad.
Robert Sneddon
@jl:
There isn’t any work to show on booster doses of vaccine. There’s a number of on-the-fly reports from various places, numbers pulled out of ongoing vaccination efforts and the like, not far from anecdotal and too close to wishful thinking for my liking, personally speaking.
There are real systematic science-based trials of booster vaccinations going on, double-blinded even but they’re not complete and the data from them isn’t yet available to base decisions on booster vaccination programs. Give it another month or two and we’re going to have a better idea what works and what doesn’t or if boosters are actually any use at all but until then I’d ignore the Internet Research Bureau and its breathless pronouncements.
JMG
So it’d be about Thanksgiving for me. We will know a lot more, I hope, by that time.
VOR
Honestly not surprised. We get annual boosters for influenza and other vaccines need periodic boosters. This is a new disease where we lack the decades of case data available for an older disease like measles. I will take my place in line to get a booster when it is time.
My cynical side notes the pharmas were early in talking about this possibility. There is probably more money in boosters paid by US government and insurance than shipping doses off to less developed countries.
jl
@jeffreyw: Thanks, great link. I’ll read it closely when I have time later. It explains some of the complexities in understanding what the Israeli data really say about waning protection.
I don’t see a discussion of whether waning effectiveness (assuming that it exists) is due to a dosing interval that is shorter than optimal. UK used much longer intervals. It will be interesting to compare UK and Israel experience (though, mostly different vaccines, so that will be difficult too). Singapore is mostly Pfizer I think, so if they used a different interval, that might be a point of comparison.
jl
@Robert Sneddon: I agree. So if my comments suggest otherwise, then that is my sloppy writing. Edit: though for some issues, won’t be able to do rigorous RCT to get timely answers, I think. Will have to use observational data (vital stats and from stat analysis of samples) RCTs and close approximations, and cross check until we get a clear causal story.
Another Scott
@What Have the Romans Ever Done for Us?: NovaVax still hasn’t gotten their act together on manufacturing (from August 6). Being new to manufacturing, it’s not surprising that they’re having teething problems.
Cheers,
Scott.
debbie
@Joe Falco:
People aren’t being vaccinated after they enter the asylum process?
WendyBinFL
Longtime lurker, first time commenter here — a happy grandma retired in Florida. My superpower is Covid-19 immunity! Got my third dose of the Moderna vaccine this morning. I am eligible for the early booster because the Humira I take for Ankylosing Spondylitis suppresses my immune system. Went to the pharmacy where I get my prescription filled, completed the paperwork, got punctured. Nothing on my calendar for the next few days, so if I develop side effects I can simply chill. Stay safe, everyone!
Fair Economist
@jl: I think it’s pretty clear we’ll have to get regular boosters on *some* schedule, which makes the exact timing between the first two shots less important anyway.
I’d like to see more focus on intranasal vaccines to generate the IgA (secreted) antibody protection the injected vaccines don’t produce. Potentially that could provide enough protection to partially replace injected boosters, which would really help with compliance.
WhatsMyNym
@Joe Falco: Migrant workers are being vaccinated, with J&J if IIRC.
Matt McIrvin
My impression is that the CDC is getting a bit ahead of the data here, but it’s because they’re trying to be proactive. Giving everyone who’s vaccinated a booster will almost certainly do more good than harm for them; to me it’s just a question of whether this is really a wise use of resources.
germy
@Matt McIrvin:
Better use of resources than throwing away expired batches because of refuseniks.
Mary G
I scheduled a telephone appointment with my rheumatologist this morning to discuss timing for a third shot. I think it’s going to have to be before 9/20 so I don’t get stuck in the rush. It’s incredibly important that we get the rest of the world their first and second shots so we don’t get an Omicron variant and have to start all over.
germy
@WendyBinFL:
Welcome! And I hope your side effects are mild.
Another Scott
@WendyBinFL: Welcome, and thanks for the report. Good luck!
Cheers,
Scott.
Joe Falco
@WhatsMyNym:
I didn’t mean to imply they weren’t. My rant was directed toward the vaccine doses being wasted and a wish those doses could have instead gone into those that want them. The bit with VP Harris and migrants comes from the RW’s fear mongering and lies about “disease-ridden hordes” being responsible for the increasing COVID-19 cases in the US and their bitching about why VP Harris hasn’t been to the southern border yet.
MomSense
@Joe Falco: Then she went to the Southern Border and they called it a publicity stunt. Fuckers.
Roger Moore
@Four Seasons Total Landscaping mistermix:
It’s likely that they’ll recommend an mRNA booster for the adenovirus vaccines. The adenovirus vaccines have a problem that people can develop immunity against the viral package, so a second dose of the same vaccine may be ineffective.
jl
@Fair Economist: We’ll probably need some kind of booster. But suboptimal interval between first and second shot might make the difference between once a year or once every, say, seven years, at least what I read from ID docs (e.g., Monica Gandhi or Michael Mina). So if interval between first and second doses is suboptimal that could make a big difference.
I’m probably a small minority here, but I think the different results from different approaches to analyzing the Israeli data need to be reconciled before we’ll know whether boosters are needed regularly over long term, or even whether boosters soon for younger people with good immune systems are needed.
I think CDC announcement may be premature. Wouldn’t make much difference maybe if there were plenty of vaccines for globe, but there is a huge shortage.
Joe Falco
@MomSense: She did? And they called it a publicity stunt? Worthless sacks of flesh and space.
Jeffro
A couple of guys at the pool this morning were kidding a third guy (presumably, they were all docs or researchers or similar): “Hey Jerry, it looks like your microchips stop working after about six months or so”, yuk yuk yuk. I had to grin, and ‘Jerry’ seemed to take it in stride too.
Sign me up! Boost away! Let’s have at it!
jonas
I wonder if the bad reaction a lot of people (including me) had to the second Moderna shot wasn’t because it should have been spaced out more, say 2 months instead of 2 weeks? No idea, but I sure hope the booster isn’t anything like that second round because it knocked me on my ass for about 2 days.
rikyrah
Stretch Marks of the Beast (@KieseLaymon) tweeted at 5:53 PM on Tue, Aug 17, 2021:
Here’s what’s not being said about Mississippi. The system has already failed. When medical professionals call and beg you to keep your elderly family from needing the hospital because there is no staff and no rooms, the system has already failed. Literally left for dead.
(https://twitter.com/KieseLaymon/status/1427765431830450180?s=03)
germy
Eunicecycle
I’m sorry if someone already answered this (I skimmed pretty fast) but are you supposed to get the third shot of the same vaccine you had the first time? Or can you mix?
Roger Moore
@Another Scott:
Yeah, the manufacturing side is really hard. This is one of the things I find really frustrating about the story you hear a lot that big drug companies aren’t adding real value to the system because they just buy up the smaller companies that do the drug development. There’s some truth to that, but the big drug companies really do add a lot. Being able to manufacture drugs to rigorous cGMP standards at the scale needed to bring them to market is one of those things they add.
jl
@Eunicecycle: From what I read, some experts think enough evidence to mix with confidence you get better protection. Others don’t think enough evidence yet.
sab
@Eunicecycle: Nobody seems to know yet, except J&J should probably get something different.
MisterForkbeard
@Another Scott: My company is providing the Novavax vaccine to our Philippine employees. Originally that was supposed to happen in September – now it looks like December.
Most of them are getting their shots from their local authorities (mostly Sinovax, and a few have gotten Moderna)
What Have the Romans Ever Done for Us?
@Roger Moore: Yeah Novavax would have been wise to partner with another big pharm company, although J&J is big and they had manufacturing issues too. They got them ironed out pretty quickly though whereas Novavax has been struggling for months to meet the manufacturing standards and still hasn’t gotten it done.
Matt McIrvin
@jonas: I’d think that if anything, spacing them out more would increase the immune response, so you might get a stronger reaction. Who knows.
(As I mentioned, I had a much stronger reaction to the second shot of the shingles vaccine, and with that one, they space them out more–I had the shots about six months apart.)
germy
@sab:
Since September is only a few weeks away, they should have an update soon about mixing or matching previous vaccinations.
I hope…
What Have the Romans Ever Done for Us?
@Matt McIrvin: I had my shingles vax shots about 6 months apart and both knocked me back for a day. Better than shingles though. I think the Moderna vaccine might have a larger dose of the active agent than Pfizer (100 micrograms vs only 30), which might be why it had more side effects. It also might mean it produced a more robust immune response and is working better for longer.
Also the interval between the first and second shot of Moderna was slightly longer – 4 as opposed to 3 weeks.
Spanky
@Matt McIrvin:
Yeah, it’s important to remember that the oldest data available is only 8-10 months old.
WereBear
@WendyBinFL: you stay safe too!
Matt McIrvin
@What Have the Romans Ever Done for Us?: Yeah, I remember feeling like that 4-week interval between Moderna shots was endless–I was one of the last people in my circles to be fully vaccinated for COVID, since I wasn’t eligible to get the first shot until mid-April and the other vaccines involved shorter delays
So I got my second shot on May 20, and by the CDC’s timetable I guess that means that I’m supposed to get my booster in January.
Spanky
@rikyrah: Ya know, during yesterday’s thread about Chasten and Pete’s adoption, I was going to make a crack about how they’ll find a baby in some shithole, and in 20 years s/he will want to go back to Mississippi to find his/her biological family. Wish I had.
MisterForkbeard
@Spanky: Well, there’s a bit of data older than that – there were the vaccine trials for 4-5 months before that.
But the vast majority of our data with ‘normal’ dosage rates is really new, you’re right.
Mel
@WendyBinFL: Me, too. I’m on Cellcept and Decadron (immunosuppressants) for autoimmune conditions (plus having hyper-coagulable conditions – not good in the face of Covid’s tendency to cause clotting issues), and a surgery coming up, so I received the third shot yesterday.
With the first two doses, there were very few side effects. With this third dose, I had some of the expected side effects: low-grade fever, chills, a swollen arm, and muscle aches.
Although I know that there is no clear correlation demonstrated yet between side effects and actual antibody response, I’m still hopeful that this third dose will do the trick and create a stronger antibody response, as happened for some of the patients in the Johns Hopkins study who were also on CellCept.
Spanky
@Eunicecycle: GIMME THAT SPUTNIK V DOSE!
(said no one ever)
marcopolo
@jonas: On the positive side of your bad reaction, there is evidence that the worse your reaction to the second shot of the mRNA vaccine was, the more robust your overall immune response is. Those two days of feeling lousy were your body super gearing up to fight this stuff in the wild.
What Have the Romans Ever Done for Us?
@Matt McIrvin: Yeah I had to wait until late April to be eligible in Maryland. I got Pfizer just because that’s what they had at the Salisbury mass vaccination site. I was so anxious to get vaccinated that when I heard they were taking teenage walk ins at that location I jumped the line slightly (by like 3 days) and drove out there (3 hours one way) on a Monday I wasn’t working to get my shot. They were indeed taking walk ins of all ages (down to 16) there, with no questions asked about eligibility, so I didn’t feel like I was stealing a shot from someone who needed it more.
The interval between the first and second shot seemed endless so an extra week doesn’t seem like much in abstract, but in practice it probably seemed like a month. You’re getting the last laugh now though as it seems like indications are the Moderna vaccine is holding up better. Nobody knows for sure yet though.
Mel
@marcopolo: Could you post a link to that data? I appreciate it!
Michael Cain
I’m hoping that before long someone is going to say whether this will be from the CDC (advisory, no legal effect) or the FDA. And if the latter, will it be a matter of full license, off-label use under a full license, a modification of the EUA, or what.
Barbara
@Spanky: I think that they are looking at Israel and UK, which have higher vaccination rates than we do. If Israel and UK are having issues, it stands to reason that our experience will be worse. Although vaccine uptake does appear to be increasing due to mandates and Delta upsurge, it is unlikely to be enough to really stem the incidence of breakthrough infections.
Anyway
I don’t see anything in the data suggesting a booster is necessary for everyone … disappointed in CDC’s data evaluation and communication process.
Ohio Mom
@WendyBinFL: Welcome and congrats on your super power!
rikyrah
@WendyBinFL:
Don’t be a stranger!
Glad you got the booster!
We are pro-vaccine, pro-booster around here in these BJ streets :)
rikyrah
I’m still at the point that the no-good, lowdown muthaphucka is trying to block the attempts to protect others , by school boards and Democratically run cities, all the while, he phucking gets tested every damn day.
rikyrah
Can we mix and match boosters?
I am Team Pfizer. Can I get a booster from the House of Moderna?
rikyrah
Why 8 months?
Why not 6?
Roger Moore
@What Have the Romans Ever Done for Us?:
The big problems J&J had were with a subcontractor they were working with to expand their capacity, not with their own manufacturing. But yeah, the manufacturing side is really, really hard. It’s one of the big barriers to entry in the pharma field and is a major reason companies can jack up prices even for off-patent products. Even if someone sees a market opportunity there, it will take them a long time to get their own manufacturing to the point they can compete.
Michael Cain
@rikyrah:
See my question above. This was worse than useless. No one has enough information to make a decision about anything.
PST
I had an experience this weekend that drove home for me the power of lies endlessly repeated. We had a weekend visit from an intelligent, well educated relative. She is vaccinated, wears a mask when appropriate, and makes sure that her young children mask up as well. We talked trash about antivaxxer relatives and bemoaned all the harm people like Governors DeSantis and Abbott are doing. And yet, at one point she asked me if there is any truth to what she hears about Dr. Fauci being heavily invested in vaccine manufacturers! That and a few similar questions involved not half truths but total bullshit that it seems to me a child could recognize as such. Apparently when you are immersed in this kind of nonsense on Facebook and other social media it rubs off. I’ll bet she has neighbors and friends in her white suburb pushing this stuff too. And even though my cousin seemed to accept my dismissal of all this 100 percent, just the fact that she raised the questions indicates the damage done even with people you wouldn’t expect it to affect.
Anoniminous
As I have said many times: vaccinations are not panacea. It is very possible to be vaccinated and still get Covid.
Cutting through the ignorant hysteria being spread by our ignorant hick Infotainment Mediums …. the Israel study found 39 or 2.6% of 1,497 study population who claimed to have have fully vaccinated contracted Covid. Turning that around 1,458 people or 97.4% DID NOT GET THE DISEASE. But that doesn’t sell newspapers
So: follow proper Personal Protection Protocols & chill.
What Have the Romans Ever Done for Us?
@Roger Moore: I heard a guy from that facility in Baltimore on NPR on multiple occasions swear up and down that they were ready to roll out vaccines without a hitch…and then they had a hitch.
burnspbesq
@PST:
if any FDA, CDC, or NIH employee were into anything like that, they would be in deep, deep shit. They would need securities and criminal defense lawyers on speed-dial.
WaterGirl
@Eunicecycle: SAME
Elizabelle
@WendyBinFL: Yea WendyB. Let us know how it goes; whether you get any side effects.
Happy for you.
Betty Cracker
I’ve mentioned her here before, but I’ll hold up the example of my husband’s auntie again to underscore the importance of vaccinations. She’s 80-years-old, diabetic, and has been O2-dependent for a couple of years. She got vaxxed (Pfizer) as soon as she was able to here in FL.
She had shoulder surgery a couple of weeks ago, caught a breakthrough case of COVID in the rehab facility (almost certainly from some boneheaded unvaxxed employee — there was a facility-wide outbreak) and was admitted to the hospital’s COVID ICU with pneumonia about a week and a half ago.
We thought she was almost certainly done for, given her co-mobidities. But she’s doing great! She was released from the hospital back to a rehab facility a couple of days ago to work on her shoulder and expects to go home toward the end of the month.
I am convinced she’d be dead right now if she hadn’t been fully vaccinated.
What Have the Romans Ever Done for Us?
@burnspbesq: Yup. Federal employees are not allowed to invest in companies they regulate. He would have been fired long ago.
trollhattan
@PST:
Have not encountered that one personally, but can well believe it’s one of many spaghetti strands tossed against the right wing wall of lies, just to see if it sticks.
My easy response, not just about Fauci, is that if he were driven by money he would never have taken a government job and would instead be making 100X as much in the private sector. Folks confuse being in charge with getting rich, all the damn time.
How much would Obama have earned straight out of Harvard Law, where he edited the Review, if he’d have gone into a white shoe law firm and made partner? By now he’d be worth A LOT.
Kayla Rudbek
@Betty Cracker: oh, that’s good news, Betty! I’m debating whether or not I would be eligible for a booster; probably not in my opinion but if my doctors tell me otherwise, I’ll get it.
I’d rather have my crazy uncle get his full doses instead.
Old School
@Betty Cracker: That’s wonderful news! I saw the post when she first tested positive, but didn’t see any updates. So thanks for re-posting!
Jim, Foolish Literalist
I haven’t read this whole thread yet, but I consider Slavitt a solid source of information
Nicole
@Betty Cracker: I was just telling the story of your husband’s aunt to a friend of mine yesterday as we were discussing vaccinations- glad to hear she’s continuing to improve. Thank you for the update!
Betty Cracker
@Old School: It’s good news for sure! Not long after she was admitted, Auntie’s name came up on my phone, and my heart sank. I thought for sure it was someone in ICU calling us so Auntie could FaceTime goodbyes. But nope, it was Auntie herself, sounding just fine and wanting to know if we could bring her some stuff. These vaccinations are truly an amazing gift, and I just hope the selfish shit-stains among us don’t squander that gift (for everyone!) with their insistence on being mutation vectors.
Benw
@Betty Cracker: awesome!
Brachiator
@VOR:
Not a booster. The flu vaccine is formulated to deal with the most likely seasonal virus.
We have a pandemic. A worldwide virus. If we don’t get the entire world vaccinated, we increase the risk of new variants developing. And are we going to ban travel to and from countries that cannot get vaccinated?
WendyBinFL
Thanks for the warm welcome! Five hours post-injection now, feeling fine.
To Betty Cracker — another Floridian and a personal hero! — thanks for the inspiring story of your husband’s aunt! Go, Auntie, go!
Roger Moore
@What Have the Romans Ever Done for Us?:
One of the biggest problems the FDA identified in their inspection was that management overrode anyone who pointed out problems. If you want to do things right, you need to have an independent quality team that can step in and shut manufacturing down if they are doing things wrong. Their management didn’t let that happen; they pushed to keep manufacturing going even when there were known problems.
That lack of independent quality oversight is one of the worst problems you can have. Anyone can make mistakes. The essence of Good Manufacturing Practices is to catch mistakes and keep them from affecting the final product, and that requires an independent quality team. If you don’t have that, nothing you do can be trusted.
Brachiator
@Betty Cracker:
Fantastic news!
Betty Cracker
@WendyBinFL: Thank you! Hope you have zero booster shot side effects, and do chime in again when the spirit moves you! People outside our state need to see signs of intelligent life from time to time or they’ll write us all off. ;-)
rikyrah
@Jim, Foolish Literalist:
Slavitt is a go-to source of information for me too. I trust him.
hueyplong
@Betty Cracker: “People outside our state need to see signs of intelligent life from time to time or they’ll write us all off.”
While funny, also true.
smith
@Roger Moore: Probably just beating a dead horse here:
Dan B
@Spanky: What is your point? I can’t parse it out. Is it well off guys traveling to visit poor people in the south? Is it well off white guys “rescuing” a child from life in a “hellhole”? Is it the culture shock that a young adult raised by two gay guys would experience in the deep south?
Sorry if it seems obvious to you but not to me. I’m curious.
Spanky
@Dan B: It’s about Mississippi being a shithole, is all.
JAFD
Meself, I figure I see docs often enuf, if I should get booster they’ll tell me, so I’ll not worry. Anyway, ‘mychart’ – automated medical records / appointment tracker / message system, at Univ Hosp, sez I should get booster shots of MMR, Varicella, and DTAP/TDAP/TD vaccines. (Last one sounds like weird chord sequence…)
Have cardiologist’s appointment tomorrow, he thinks I oughta get a Catheter Ablation procedure to alleviate my Atrial Fibrillation. He’s probably right, but going to get second opinion first. Then Friday have dentist’s appointment, probably first of series to deal with all mouth problems. Fun fun fun.
Hope y’all are staying healthy, happy and hydrated.
Mel
@Betty Cracker: So glad that she is feeling better! Good news, indeed.
Roger Moore
@smith:
I would be very careful about reporting based on FDA inspection reports that isn’t written by someone very familiar with the inspection process. The primary goal of inspection is to help manufacturers find problems with their processes and fix them. That means an inspection report will almost always find something wrong, even things that sound really serious to someone who doesn’t know a lot about cGMP regulations. The reports are written in very official, threatening-sounding language that cites exactly what section of the FDCA is being violated. But that doesn’t necessarily mean the violations are serious. Unless the same problem shows up in several reports in a row, or if the report results in an “Official Action Indicated” conclusion, it’s relatively minor no matter how terrible it sounds.
geg6
I’ll be right there in December for my third jab, for sure. Just watched my sister, who had the J&J, spend two miserable weeks with a breakthrough infection. No, she wasn’t severely ill enough to be hospitalized, but she was feeling pretty damn bad. Luckily, her husband had the Moderna (like me!) and didn’t catch it. She didn’t realize until about 2 days in that it was COVID and a quick test confirmed. She also went to her doctor and he also confirmed. She thinks she was exposed three Wednesdays ago and finally tested negative on this past Saturday. She says the only symptom hanging on is fatigue, which for her is like torture because she’s usually an Energizer bunny. The idiot who exposed her is our good friend’s boyfriend who we all thought was vaccinated but was not. Our friend also had a mild case due to this idiot boyfriend (she had the Pfizer) due to him. The one I worry about is his 96 year-old-mother, with whom he lives!!! He made a big deal out of him taking her for her vaccine and we all assumed he had gotten one at the same time. Well, we have now all found out that he refused the shot that was offered at that time. What an asshole!
The good news is that it seems that the Moderna effects do not wear off as quickly, based on this purely anecdotal evidence.
Dan B
@PST: It doesn’t surprise me that your friend would be distracted by repeated lies and half truths. The Nazi’s understood this and used it effectively as has every authoritarian regime. With the advent of advanced imaging technologies like MRI and the understanding of neuroplasticity we can now see physical changes in the brain caused by repeated messaging. We are all susceptible. More worrying to me is these changes occur if you repeat the propaganda while declaring it to be false. Our minds seem to get molded to comprehend the logic of the lie and then rebut it. Part of the brain accepts the lie. Repeating the lie and rebutting it requires energy and puts us in stress. This makes for anxiety. Your friend needed reassurance from you that the lies were actually false.
There are ways to overcome this stress from social cues, from humor – hence why authoritarians and malignant narcissists hate jokes, and by getting the attention of the “fight or flight” base of the brain. All these require skill and practice.
Dan B
@Betty Cracker: Much worse than being written off for you is if we send Bugs Bunny.
Beware THE BUNNY!#×/*!!!
sab
@JAFD: I had SVT ( cousin of AFB) a few years ago, and had the cardiac ablation. Inconvenient but not the least bit painful. I haven’t had a fast ticker incident or fainted since, and I have been fainting on a fairly regular basis since childhood. (Why did no one notice, when my dad was a doctor?)
Dan B
@Spanky: Culture shock then? I have a feeling that South Bend was as bad as much of Mississippi. A good friend who went to Notre Dame in the 70’s would not go near downtown South Bend. Pete grew up with that. Having lived in Jim Crow Arkansas I would rather be in South Bend. South Bend wasn’t 95% hopeless, although Indiana was reputed to have had the largest Klan in the country.
smith
@Roger Moore: My point was more about the apparent conflict of interest than about the quality control issues. If the NYT is to be believed, those issues had been uncovered by multiple audits and inspections by a variety of parties over a period of time, not just by routine FDA audits.
Matt McIrvin
@rikyrah: My strong impression from what fragmentary data exists is that it probably doesn’t hurt to mix and match vaccines and may even be better. But everyone’s sort of working in the dark, and I don’t know if the CDC made any kind of recommendation here.
The reason they told everyone to get the same kind of shot both times, before, is that that’s what the field trials tested.
Citizen Alan
@Spanky: As I sit here in the Charlotte airport halfway to Queens, I can attest to the truth of this.
Cermet
I am suspicious that this is more ‘covering one’s ass’ by the CDC/Biden Admin than something we really need. First off, all vaccines wane in time yet we don’t generally need revaccination due to memory T-cells. Sure, breakthroughs occur for most all vaccines but that is rare simply because we have herd immunity established. Hence, waning vaccination doesn’t cause problems. That said, never have we had nearly half the population refusing critical vaccinations.
In any case, a third vaccination will prime everyone so breakthroughs for the rare person (that isn’t immune compromised) will be avoided preventing those rare events making the vaccine look better as well as the CDC. Is it a huge money maker for the vax companies – certainly. Is it cost effective … well, an ICU ward is expensive. But again, not sure (or is that Ideocracy … ?) Also, reactions occur and can be an issue so that too comes into play but apparently not enough to prevent a third round.
J R in WV
This morning I had a routine quarterly Dr appointment, with the family practice Dr we’ve been seeing for nearly 40 years. So I had a fistfull of prescriptions when I left for (first) a sandwich and (then) Krogers.
I dropped off the prescription I was most out of, went shopping for foods and such. When I went back to the pharmacy, and sat down to wait for my refill, a somewhat younger woman when to the counter and said “I have a 3 o’clock appointment.” …
“Yes, for a vaccine.”
They told her to have a seat, they would be right with her. I said “Thanks for getting vaccinated.” and she said “This is my third, a booster. My husband is a doctor with a heart condition, and our grandchildren can’t be vaccinated yet!”
So booster shots are happening RIGHT NOW HERE IN WV, and probably everywhere. She got a pfizer, asked what I had [Moderna], then she said they say pfizer dwindles sooner than Moderna.