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Related: Editorials & Other Articles, Issue Forums, Alliance Forums, Region ForumsTop federal health officials warn that booster shots initially may be limited to Pfizer recipients
Janet Woodcock, acting commissioner of the Food and Drug Administration, and Rochelle Walensky, director of the Centers for Disease Control and Prevention, told White House coronavirus coordinator Jeff Zients on Thursday that their agencies may not be able to approve a more expansive coronavirus booster plan that they, along with other top doctors across the administration, endorsed last month.
Woodcock and Walensky told Zients that, by the end of this month, they may be able to approve and recommend booster shots only for people who received the Pfizer-BioNTech vaccine. Some officials said Friday that reviews of the other vaccines boosters could take an additional few weeks, though they cautioned it depends on the data. . . .
Now, Woodcock and Walensky, who have faced criticism for endorsing a plan before their agencies completed their reviews, have warned that staff may need more time to make a determination about boosters for people who received the Moderna vaccine. The FDA has only partial data on Moderna and Johnson & Johnson boosters. Pfizer and BioNTech submitted late-stage booster data late last month.
https://www.washingtonpost.com/health/2021/09/03/booster-shot-delay-pfizer-first/
Haggard Celine
(16,844 posts)Both the Moderna and the Pfizer boosters have been available around here for people who meet certain criteria. I just looked at my vaccine card and it says I've had 3 Moderna shots. Did they give me a shot that wasn't approved by the FDA? This is weird!
Elessar Zappa
(13,964 posts)I received my Moderna booster two weeks ago at WalMart.
Haggard Celine
(16,844 posts)I guess we're part of an experiment. Hope we don't grow another head or turn into lizard people.
LisaL
(44,973 posts)use half a dose for a booster, not the full dose.
FDA wants them to submit dat on full dose.
LisaL
(44,973 posts)But not yet for general population.
Haggard Celine
(16,844 posts)I assume they did that in order to give some added protection to those of us with immune system issues.
iemanja
(53,031 posts)And it does seem odd. It seems that providers may be acting without proper guidelines, based on the recent CDC announcement about boosters after 8 months.
helpisontheway
(5,007 posts)people were getting their boosters. I assumed in those cases the benefit outweighs any possible risks. However, I dont think there are any risks to it. Other countries have been doing boosters for awhile. Im beginning to wonder if they are trying to make sure they have enough doses for every person that wants a booster. Plus they will need to have doses (although lower dose) on hand for when younger kids are approved for emergency use.
BumRushDaShow
(128,857 posts)"Supply" is not the issue. I think they are trying to make sure they have enough efficacy and safety data banked in case you start getting litigation-crazy Americans "suing" if something goes "wrong" with them.
Because this global pandemic has been so extreme, everyone is literally try to find some way to knock the spread down as fast as they can, and the vaccines are a good way to do that - but they need to ensure there are no long-term after effects. This is also why the wanted the vaccine makers to expand the size of the trials for children so they could capture any "signal", even if "tiny", of any possible issues, and then be able to better quantitate the smallest of risks to compare with the benefits.
iemanja
(53,031 posts)From the CDC and the Biden administration is that people shouldn't get a third dose 8 months after their second. This article suggests that may be more complicated.
boston bean
(36,221 posts)On Israels data. Israel has used Pfizer exclusively. The greatest country in the world decided they didnt need to do data themselves on breakthrough cases that didnt require hospitalization.
LisaL
(44,973 posts)and is giving boosters to everyone who wants them.
BumRushDaShow
(128,857 posts)It's actually because Pfizer submitted their data to the health agencies (FDA & CDC) first - for the EUA, for final approval, and for a booster.
One of the things probably running in the back of their minds regarding Israel's data is the faster efficacy drop for Pfizer vs others like Moderna. But Pfizer/BioNTec literally had all their resources brought to bear to get their data submissions in quick.
Several months ago, Pfizer alerted to the booster possibility -
Published Thu, Apr 15 2021 1:23 PM EDT | Updated Thu, Apr 15 2021 3:13 PM EDT
Berkeley Lovelace Jr.
@BerkeleyJr
(snip)
Pfizer CEO Albert Bourla said people will likely need a booster dose of a Covid-19 vaccine within 12 months of getting fully vaccinated. His comments were made public Thursday but were taped April 1. Bourla said its possible people will need to get vaccinated against the coronavirus annually.
A likely scenario is that there will be likely a need for a third dose, somewhere between six and 12 months and then from there, there will be an annual revaccination, but all of that needs to be confirmed. And again, the variants will play a key role, he told CNBCs Bertha Coombs during an event with CVS Health. It is extremely important to suppress the pool of people that can be susceptible to the virus, Bourla said.
The comment comes after Johnson & Johnson CEO Alex Gorsky told CNBC in February that people may need to get vaccinated against Covid-19 annually, just like seasonal flu shots. Researchers still dont know how long protection against the virus lasts once someone has been fully vaccinated.
Pfizer said earlier this month that its Covid-19 vaccine was more than 91% effective at protecting against the coronavirus and more than 95% effective against severe disease up to six months after the second dose. Modernas vaccine, which uses technology similar to Pfizers, was also shown to be highly effective at six months. Pfizers data was based on more than 12,000 vaccinated participants. However, researchers say more data is still needed to determine whether protection lasts after six months.
https://www.cnbc.com/2021/04/15/pfizer-ceo-says-third-covid-vaccine-dose-likely-needed-within-12-months.html
-and was initially smacked down.
June 23, 2021, 5:42 PM EDT
By Sara G. Miller
Theres no evidence yet to suggest that a Covid-19 vaccine booster shot is needed, a working group for the Centers for Disease Control and Prevention said Wednesday.
That could change as the pandemic evolves, however, and public health officials will continue to monitor the virus to determine if additional shots are warranted in the future.
Members of an independent group of advisers to the CDC, called the Advisory Committee on Immunization Practices, agreed with the working groups conclusion.
https://www.nbcnews.com/health/health-news/no-evidence-yet-suggest-covid-vaccine-booster-needed-cdc-group-n1272197
boston bean
(36,221 posts)BumRushDaShow
(128,857 posts)They're just a bigger, seasoned vaccine provider and had all their ducks in a row before Moderna and Janssen (J&J). And those "ducks" are including a massive manufacturing capacity to provide many times more vials than their nearest competitors. So Pfizer/BioNTec shots are the majority of what was dished out in the U.S.
This is the approx. global distribution by manufacturer and for various countries -
Doses ordered (as of March) -
boston bean
(36,221 posts)My point stands.
BumRushDaShow
(128,857 posts)These companies have to submit data FIRST in order to get the various approvals. I have been watching both the CDC ACIP and FDA VRBPAC review/approval meetings since coming up on a year ago (and these go on all day) and what Israel provided is just one piece of the puzzle. But it is not the sole thing. CDC changed its masking requirements due to data outside of Israel that happened over the summer that I have posted about multiple times dealing with Delta and breakthroughs including in OPs and posts in other threads. E.g. -
https://www.democraticunderground.com/10142776000
https://www.democraticunderground.com/10142777706
So they have started correlating state data with efficacy drop and variant changes.
And as a note - THIS is Pfizer's too so soon we'll see ads like this from them for the COVID-19 vaccine -
boston bean
(36,221 posts)It was barely critical. But it is the truth. And a true explanation.
BumRushDaShow
(128,857 posts)and posted about the latest here - https://www.democraticunderground.com/?com=view_post&forum=1014&pid=2793245
(reproduced below)
(I have it on a little convertible laptop that I have used to stream them in the past and when they were done, I would just stop the stream and just minimize that browser window... And interestingly, when they have their next meeting, the new stream suddenly auto-starts the stream in that browser window, so out of nowhere I'll suddenly start hearing people talking while the laptop is on the lockscreen and am like WTF? )
Anyway - the have a biggy going on right now that started at 10 am EDT (must be at least 50 people on it, including liason reps from HHS OPDIVs, the Vaccine-related Committee members, a pile of independent hospital/medical organization reps, a bunch of medical/pharmaceutical industry reps - all on this telecon) - https://www.ustream.tv/channel/VWBXKBR8af4
The agenda is to look at the data pre-post Pfizer full approval and apparently discuss the boosters.
One of the working group slide decks they presented at the beginning of the meeting included this slide (relevant to the OP) -
I think that slide says it all regarding the vaccines. It's not saying the people who are vaccinated aren't contracting it nor does it say that some are not being hospitalized, but it is stark about who IS being hospitalized to a very high degree.
The axis is X = time (since availability of the vaccine) and Y = rate of hospitalizations per 100,000.
That slide was (taken as a snapshot) from here - https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-08-30/01-COVID-Daley-508.pdf (PDF)
Link to all the slide decks that will be presented today - https://www.cdc.gov/vaccines/acip/meetings/slides-2021-08-30.html
The slide decks with the agenda for that big meeting, might be helpful for you. THAT is how the "process" works and are "the facts".
boston bean
(36,221 posts)Is there more for Pfizer. Yep because Israel tracked properly for the vaccine they use. US is using Israels data.
There is a huge segment of US who received Moderna in the US. Did the US decide not to track and identify these issues. Why yes they did.
I just finished watching CNN where they have essentially said the same thing.
Will Moderna get approval for booster for population who received it prior, yes. It will be later for the reasons stated above.
BumRushDaShow
(128,857 posts)There are 14 different links to "studies" including Israel, UK, and the U.S. that are going into the decision.
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-08-30/09-COVID-Oliver-508.pdf (PDF)
THAT is the document that the Committees are using for their review for boosters. They expect to have another meeting coming up "about mid month" they said, and I just found per this - https://www.npr.org/sections/coronavirus-live-updates/2021/09/01/1033474298/moderna-fda-covid-19-booster-shot that the Committees will meet again on September 17. So that will be a "must watch" meeting.
And what you just wrote is what I said. Pfizer came in "first" with their stuff, then Moderna, then Janssen (J&J). Others like GSK/Sanofi bowed out completely after their vaccine attempt failed and Novavax might end up bowing out of the U.S. market altogether (although they applied in the UK I believe).
And as a note, I am a Moderna recipient and don't have a problem with the "timing". There was a recent story that Moderna was looking at various booster doses - https://time.com/6046405/moderna-covid-19-vaccine-booster-study/ and I think that may also be what has to be evaluated considering their active ingredient dosage of mRNA was at least twice that of Pfizer's.
boston bean
(36,221 posts)However CDC hasnt even given moderna full fda approval. What is going on there? I would have expected to see it by now. Since moderna submitted approx a month after Pfizer.
Also CDC decided in early spring they would not track data on break through infections. Which is crucial. They were wrong. On so many levels wrong!
They are now heavily relying on another nations data. Fine, but we are or were the good standard. What the hell is going on with the CDC and the FDA.
Pfizer will naturally come first because there is more data. But why are we relying on that. We should have been doing the work ourselves. And rest assured we are relying heavily on Israels data. Is it the best data we have. But why?? Again, we are just failing ourselves,on every level
From the covidiots up the chain to those in power. We could be doing much better and mistakes have been made. Like go ahead vaccinated unmask and live, putting the unvaxed on an honor system, knowing delta was around the corner and Israel was at the time was beginning a new wave of delta. And then decide not to track breakthroughs. And then all the sudden vaxed were spreading the virus.
It is ridiculous.
Do I believe them that a booster is needed. Yes. But its because a different country proved it. Not our own government. Which makes me extremely angry with those who are suppose to be doing this work.
BumRushDaShow
(128,857 posts)I don't disagree with much of what you just wrote.
Moderna submitted their "full approval" package less than 2 weeks ago -
By Carolyn Crist
Aug. 26, 2021 -- Moderna has completed its submission to the FDA for full approval of its COVID-19 vaccine for ages 18 and older, the company announced on Wednesday.
Moderna began submitting data for the biologics license application, or BLA, in June. As part of the completed submission, the company has requested priority review from the FDA.
This BLA submission for our COVID-19 vaccine is an important milestone in our battle against COVID-19 and for Moderna, as this is the first BLA submission in our companys history, Stephane Bancel, CEO of Moderna, said in a statement.
In a final analysis of late-stage clinical trial data, the Moderna vaccine showed 93% efficacy, the company announced. The efficacy remained high through 6 months after the second dose.
https://www.webmd.com/vaccines/covid-19-vaccine/news/20210826/moderna-requests-full-fda-approval-covid-vaccine
Pfizer submitted theirs back in May -
By Alexa Lardieri | May 7, 2021, at 8:15 a.m.
U.S. News & World Report
Granting full approval of the vaccine could also boost the publics confidence in it and encourage more people to get vaccinated.(JEAN-FRANCOIS MONIER/AFP via Getty Images)
Pfizer and BioNTech on Friday became the first companies to apply to the Food and Drug Administration for full approval of their coronavirus vaccine.
The companies announced they had initiated a rolling submission of a biologics license application with the FDA for the approval of their vaccine in people aged 16 and older. The companies will submit supporting data on a rolling basis for consideration in the coming weeks, with a request for priority review.
Pfizer and BioNTech have submitted their clinical data to the FDA, which includes six months of information on the vaccine's safety and efficacy. They will continue to submit more data, including information about the manufacturing of the vaccine, in the coming future.
https://www.usnews.com/news/health-news/articles/2021-05-07/pfizer-applies-for-full-fda-approval-of-coronavirus-vaccine
So that's almost 4 months difference (although they had been doing "rolling submissions" of their data all along). It took 3 months of an expedited review to get Pfizer fully approved last month. If they spent the same amount of time, that might mean November for Moderna.
I have had issues with CDC for some time in terms of "lag" and what has been the messaging that was far to extreme and "definitive", and then that got magnified by the media, who added their own spin, thus making them look like fools when things changed. It essentially forced Fauci (who is not even part of CDC but is in NIH as director of NIAID) to go out on the media circuit to "smooth over" the mess.
However note that U.S. studies are always going on whether CDC explicitly "tracks them" or not. Meaning that all CDC has to do is to do a search and tap into what has been done right here in the U.S., which is what they have finally done, and add that to their knowledge base.
One of the problems we are going to have with these Committees however (as a heads-up) is that several members have objected to use of the term "booster" (which I sortof agree with) because they consider such shots as basically "3rd in a series", with "booster" having a different meaning.
Another problem is that some on the Committees still don't see a need for this and would prefer to have a "priority" to "vaccinate the unvaccinated", which IMHO this late in the vaccine rollout, is now a fool's errand.
boston bean
(36,221 posts)Should never have been that long. It undermined all of the vaccines.
They need to also understand human behavior as well as science. It is making me so upset!
BumRushDaShow
(128,857 posts)And I think they thought they had a good thing because it is so much easier to do a single shot and be done, and they were using a more "traditional, tried and true" method for vaccine development (which is what AstraZeneca also did).
But in this case, COVID-19, as a freaky novel coronavirus, really screwed their pooches. Those spikes on it are nasty and I think both Janssen and AstraZeneca saw what was happening early on and had to get a handle on who their vaccines were impacting (a narrow demographic apparently).
So that "delay" was not just because of what they were finding here, but for what was being found with AstraZeneca's vaccine world-wide, because theirs was the bulk of what has been used outside of the U.S. and they had a ton of data points to go by. In that case, they were able to still utilize the vaccine but direct it away from certain populations.
What they have all done in general is remarkable and is a culmination of work that many of them started way back in 2003 with SARS CoV-1. So they had been testing out their various technologies for a long time, and it was now a matter of finding the best "candidate" entity to use for trials and final rollout.
THAT is mainly why they were able to move so fast with getting their vaccines out. The normal vaccine approval process takes several years.
boston bean
(36,221 posts)Understanding people and actions you take have consequences. They problem was what was identified on the day they made the decision to suspend was exactly what they knew day ten. They waited ten days to give ok with a warning. Way too long.
It scared me because my son had just gotten it the day before they suspended. It created a lot of doubt not reassurance. And I am sure it reinforced in the covidiots that you cant trust it or any vaccine.
A couple day suspension but 10 days to say what you knew on day one. Way too long.
You may disagree.
Science is important. Most important. But they have been wrong a bunch of times on masking especially from the beginning. And they screwed the pooch with it with a final deadly blow late spring.
Again, understanding human behavior and having some common sense about it would go a long way.
BumRushDaShow
(128,857 posts)and both of them (the FDA one and the CDC one) are large. They needed to quickly schedule get together, assess the data, and then make a decision. They had apparently seen the reports and had to formalize the "why" for a "pause".
The Committee members belong to and/or work for hospitals and hospital systems, medical research institutions, and university epidemiology departments, so the actual members who work in the relevant Centers/Offices of their federal agencies, are just a handful in comparison.
Whenever a decision is communicated by CDC or FDA, it is supposedly based on actual votes that these Committees hold (and they literally "vote" on statements and/or approval language). CDC and FDA then take those Committee decisions under advisement and concur or don't concur.
The problem here, just like I have posted about regarding a whole different subject - marking up legislation in Congress - is that the American public is unfortunately seeing the "sausage-making" that goes on behind the scenes - whether it is for vaccines or legislation. This is "normal" and typical. But generally, vaccines are "boring" and don't garner much attention. But COVID-19 changed that view, at least for now.
It can be even more awful because the media then takes "sound bites" from the Committees and the agencies and rus with them. That's why I calmly (and thankfully being retired I can do that) just listen to the discussions when they are streaming their meetings.
You were correct to be concerned about your son but again, you should also need to be concerned about the process and reasons why things happen the way they do - it's so that the advice on THAT particular vaccine could be properly calibrated and tailored. The same thing is going on behind the scenes with checking on the trials for children (both infants - 4 and 5 - 11), because there are possible cases of them experiencing some adverse reactions that adults might not experience since their little immune systems are still developing.
And for me, as an ACS-certified chemist, I don't give a shit about the jackass covidiots. Many of them may not even be above ground by the end of the year. You just have to make sure that you are aware of the pros and cons and risks and benefits so you can make an informed decision.
It can be difficult with all the conflicting info out there because what people are now also seeing is that scientists can and DO "disagree" - not so much about the "facts", but what the facts mean, so we all have to navigate around that too.
boston bean
(36,221 posts)Appeasing committees should have been last on their list. And they should have worked every second to get that vaccine off hold..
BumRushDaShow
(128,857 posts)https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/vaccine-development-101
It's the same approval process that happens with other types of biologics, for drugs, cosmetics, and medical devices. There's no "appeasing". It's as they say, "regular order" and is codified as standard procedures that were created by mandate from the various public health laws passed by Congress since the early 1900s (with subsequent revisions).
Neither Woodcock (who had originally headed up FDA/CDER) and Wallensky (for CDC), "unilaterally" review. They rely on the experts - generally people who are not part of the federal government, and who will look at the clinical data and then decide on courses of action. Those experts work with a handful of designated agency experts (who work in the related agency Centers/Offices), to discuss the data and any concerns. They then summarize their findings, vote on their recommendations for next steps, and then present that to the respective agency heads.
Again, its' a shame that this process was completely unknown to the general public but it is what it is and has been for many many years.
ETA - here are the members of the 2 Committees -
CDC ACIP - https://www.cdc.gov/vaccines/acip/members/index.html
FDA VRBPAC - https://www.fda.gov/advisory-committees/vaccines-and-related-biological-products-advisory-committee/roster-vaccines-and-related-biological-products-advisory-committee
boston bean
(36,221 posts)This is not something where a pause that long should have taken place.
BumRushDaShow
(128,857 posts)they were way ahead of Janssen in terms of dates for data submission, approvals overseas, and use there (and they are not approved in the U.S. by the way), but their vaccine vectors were obviously not 'identical".
The Oxford-AstraZeneca vaccine was still being "paused" - e.g., by Canada - https://apnews.com/article/canada-panel-astrazeneca-vaccine-pause-under-55-06dde56d2db78d72c5bb9bcb97be4d5a as late as the end of March with stipulations added for use where Janssen's vaccine had only been given EUA approval at the end of February, and was just coming into the vaccine stream... Within a month, issues were popping up with it so they instituted the pause.
The "issues" were strictly MEDICAL. I.e., if any physician ran into a case where there was an adverse reaction that might have been related to the vaccine, then the agencies want to get info disseminated out to the medical community on how to TREAT that. I.e., this could NOT be treated with a standard therapy -
https://www.ajmc.com/view/pause-of-j-j-vaccine-to-continue-acip-to-reconvene-after-more-data-collected
You are just fussin'.
boston bean
(36,221 posts)No way.
We really suck here in the US.
BumRushDaShow
(128,857 posts)And their media briefing -
Sometimes it's useful to actually hear how things go on "behind the scenes".
boston bean
(36,221 posts)would be helpful.
They certainly we not telling us for the ten days that they were trying to alert health professionals how to treat if they ran across this.
BumRushDaShow
(128,857 posts)is that the "geeks" and "nerds" have been thrust into the public sphere and few are as dynamic as this guy -
or this guy -
There is a lot of "medical-speak" and "scientist-speak" that they are accustomed to using in their normal discourse and what they really need is some "interface" person who can better communicate some of this stuff.
I know in the past some had locked onto people like Dr. Sanjay Gupta to distill it all down, but I think they have all been relying on poor Fauci to "translate" what has essentially been gibberish to the average person, into something "tangible".
iemanja
(53,031 posts)by a vaccine called Sputnik.
BumRushDaShow
(128,857 posts)https://www.dw.com/en/between-sputnik-v-and-biontech-caught-in-vaccine-limbo/a-58915981
I still don't think they are approved in the EU yet and obviously not here, but apparently India is becoming a big distributor of it.
LisaL
(44,973 posts)"JERUSALEM, Sept 5 (Reuters) - Israel this month will present data from an extensive rollout of COVID-19 vaccine booster shots to the U.S. Food and Drug Administration, which is weighing White House plans to begin a booster drive in the United States."
https://www.reuters.com/world/middle-east/israel-present-covid-19-booster-shot-data-fda-experts-2021-09-05/
Celerity
(43,321 posts)The science and methodologies and other factors behind it make it far less than ideal to base decisions off of.
https://www.democraticunderground.com/100215820078
Also:
Israeli study claims major drop in vaccine protection; experts dont believe it
https://www.timesofisrael.com/israeli-study-claims-major-drop-in-vaccine-protection-experts-dont-believe-it/
Also, people who push Israel's data as the be all and end all are partially playing right into anti-vaxxer hands.
https://www.washingtonpost.com/politics/2021/07/19/vaccine-skeptics-zero-israel-again-some-reason/
Also
https://www.jpost.com/health-science/anti-vaxxers-hijacking-israels-covid-data-heres-why-they-are-wrong-674444
boston bean
(36,221 posts)FakeNoose
(32,633 posts)It's something like 80% of those vaccinated have received the Pfizer vaccine.
The other 20% are split between the other 2, with Moderna being a larger share than J & J.
I'll try to find that DU post and post it here. In the meantime, my guess is that the Pfizer vaccine got preference because it affects more Americans and because they were the first to file their data.
LisaL
(44,973 posts)NT
dalton99a
(81,454 posts)FakeNoose
(32,633 posts)Was this posted on DU?
I'm still trying to find the article I read the other day.
Response to dalton99a (Reply #29)
MichMan This message was self-deleted by its author.