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Thread: Vaccine thread - part 2

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    Senior Member dneal's Avatar
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    Default Vaccine thread - part 2

    Waiting to see what the latest 80,000 page Pfizer data dump reveals, but this WSJ article popped up in my news feed:

    FDA Limits Authorized Use of J&J's Covid-19 Vaccine
    Agency makes the change after confirming nine deaths tied to a clotting condition among those who received the one-dose shot

    The Food and Drug Administration limited the use of the Covid-19 vaccine from Johnson & Johnson after reviewing the risk of life-threatening blood clots.

    The agency said Thursday that the J&J shot’s authorization was now only for adults for whom other shots aren’t available or medically appropriate, or who won’t take another vaccine.

    The FDA said it was making the move after confirming a total of 60 cases, including nine deaths, of the clotting condition known as thrombosis with thrombocytopenia syndrome, or TTS, among the millions of people who got the J&J shot.

    The change will likely sharply scale back use of a vaccine that health authorities had once hoped would be a convenient option for many people, but has become a third choice for most people because of the emergence of the risk for the rare but life-threatening side effect.

    In the U.S., roughly 17 million people have gotten the J&J vaccine, compared with more than 202 million who received two doses of the authorized Covid-19 vaccines from Pfizer Inc. and partner BioNTech SE and from Moderna Inc., according to the Centers for Disease Control and Prevention.

    Because of the risk for the clotting condition, the CDC in December recommended that patients opt for one of the other vaccines over the Johnson & Johnson shot.
    “Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals,” said Peter Marks, who leads the FDA division responsible for regulating vaccines.
    Maybe adhoc was justified in his concern. It's a shame that reasonable discussion can't be had on this topic because of certain partisan posters.
    Last edited by dneal; May 5th, 2022 at 06:58 PM. Reason: fixed link

    Finish every day, and be done with it.
    You have done what you could - some blunders and absurdities no doubt crept in, forget them as fast as you can, tomorrow is a new day.
    You shall begin it well and serenly, and with too high a spirit to be cumbered with your old nonsense.

    Emerson

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    Senior Member Lloyd's Avatar
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    Default Re: Vaccine thread - part 2

    60 cases in millions of cases? How rare is the condition in those never given the J&J vaccine?

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    M: No it isn't!

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    Default Re: Vaccine thread - part 2

    I'm not sure what you're asking. How often clotting happens absent the J&J vaccine?

    The point remains that the CDC and FDA identified enough risk to change policy recommendations.

    Finish every day, and be done with it.
    You have done what you could - some blunders and absurdities no doubt crept in, forget them as fast as you can, tomorrow is a new day.
    You shall begin it well and serenly, and with too high a spirit to be cumbered with your old nonsense.

    Emerson

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    Senior Member Lloyd's Avatar
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    Default Re: Vaccine thread - part 2

    Quote Originally Posted by dneal View Post
    I'm not sure what you're asking. How often clotting happens absent the J&J vaccine?

    The point remains that the CDC and FDA identified enough risk to change policy recommendations.
    I'm curious if this winds up as a temporary change while more analysis is performed, or if it's a final decision.

    Sent from my SM-G991U using Tapatalk
    M: I came here for a good argument.
    A: No you didn't; no, you came here for an argument.
    M: An argument isn't just contradiction.
    A: It can be.
    M: No it can't. An argument is a connected series of statements intended to establish a proposition.
    A: No it isn't.
    M: Yes it is! It's not just contradiction.
    A: Look, if I argue with you, I must take up a contrary position.
    M: Yes, but that's not just saying 'No it isn't.'
    A: Yes it is!
    M: No it isn't!

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    Senior Member Lloyd's Avatar
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    Default Re: Vaccine thread - part 2

    https://www.hematology.org/covid-19/...rombocytopenia

    Sent from my SM-G991U using Tapatalk
    M: I came here for a good argument.
    A: No you didn't; no, you came here for an argument.
    M: An argument isn't just contradiction.
    A: It can be.
    M: No it can't. An argument is a connected series of statements intended to establish a proposition.
    A: No it isn't.
    M: Yes it is! It's not just contradiction.
    A: Look, if I argue with you, I must take up a contrary position.
    M: Yes, but that's not just saying 'No it isn't.'
    A: Yes it is!
    M: No it isn't!

  6. #6
    Senior Member dneal's Avatar
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    Default Re: Vaccine thread - part 2

    Quote Originally Posted by Lloyd View Post
    Quote Originally Posted by dneal View Post
    I'm not sure what you're asking. How often clotting happens absent the J&J vaccine?

    The point remains that the CDC and FDA identified enough risk to change policy recommendations.
    I'm curious if this winds up as a temporary change while more analysis is performed, or if it's a final decision.

    Sent from my SM-G991U using Tapatalk
    The analysis is still being performed - behind closed doors.

    From the British Medical Journal:

    In the pages of The BMJ a decade ago, in the middle of a different pandemic, it came to light that governments around the world had spent billions stockpiling antivirals for influenza that had not been shown to reduce the risk of complications, hospital admissions, or death. The majority of trials that underpinned regulatory approval and government stockpiling of oseltamivir (Tamiflu) were sponsored by the manufacturer; most were unpublished, those that were published were ghostwritten by writers paid by the manufacturer, the people listed as principal authors lacked access to the raw data, and academics who requested access to the data for independent analysis were denied.

    The Tamiflu saga heralded a decade of unprecedented attention to the importance of sharing clinical trial data. Public battles for drug company data, transparency campaigns with thousands of signatures, strengthened journal data sharing requirements, explicit commitments from companies to share data, new data access website portals, and landmark transparency policies from medicines regulators all promised a new era in data transparency.

    Progress was made, but clearly not enough. The errors of the last pandemic are being repeated. Memories are short. Today, despite the global rollout of covid-19 vaccines and treatments, the anonymised participant level data underlying the trials for these new products remain inaccessible to doctors, researchers, and the public—and are likely to remain that way for years to come. This is morally indefensible for all trials, but especially for those involving major public health interventions.

    Unacceptable delay

    Pfizer’s pivotal covid vaccine trial was funded by the company and designed, run, analysed, and authored by Pfizer employees. The company and the contract research organisations that carried out the trial hold all the data. And Pfizer has indicated that it will not begin entertaining requests for trial data until May 2025, 24 months after the primary study completion date, which is listed on ClinicalTrials.gov as 15 May 2023 (NCT04368728).

    The lack of access to data is consistent across vaccine manufacturers. Moderna says data “may be available ... with publication of the final study results in 2022.” Datasets will be available “upon request and subject to review once the trial is complete,” which has an estimated primary completion date of 27 October 2022 (NCT04470427).

    As of 31 December 2021, AstraZeneca may be ready to entertain requests for data from several of its large phase III trials. But actually obtaining data could be slow going. As its website explains, “timelines vary per request and can take up to a year upon full submission of the request.”

    Underlying data for covid-19 therapeutics are similarly hard to find. Published reports of Regeneron’s phase III trial of its monoclonal antibody therapy REGEN-COV flatly state that participant level data will not be made available to others. Should the drug be approved (and not just emergency authorised), sharing “will be considered.” For remdesivir, the US National Institutes of Health, which funded the trial, created a new portal to share data (https://accessclinicaldata.niaid.nih.gov/), but the dataset on offer is limited. An accompanying document explains: “The longitudinal data set only contains a small subset of the protocol and statistical analysis plan objectives.”

    We are left with publications but no access to the underlying data on reasonable request. This is worrying for trial participants, researchers, clinicians, journal editors, policy makers, and the public. The journals that have published these primary studies may argue that they faced an awkward dilemma, caught between making the summary findings available quickly and upholding the best ethical values that support timely access to underlying data. In our view, there is no dilemma; the anonymised individual participant data from clinical trials must be made available for independent scrutiny.

    Journal editors, systematic reviewers, and the writers of clinical practice guideline generally obtain little beyond a journal publication, but regulatory agencies receive far more granular data as part of the regulatory review process. In the words of the European Medicine Agency’s former executive director and senior medical officer, “relying solely on the publications of clinical trials in scientific journals as the basis of healthcare decisions is not a good idea ... Drug regulators have been aware of this limitation for a long time and routinely obtain and assess the full documentation (rather than just publications).”

    Among regulators, the US Food and Drug Administration is believed to receive the most raw data but does not proactively release them. After a freedom of information request to the agency for Pfizer’s vaccine data, the FDA offered to release 500 pages a month, a process that would take decades to complete, arguing in court that publicly releasing data was slow owing to the need to first redact sensitive information. This month, however, a judge rejected the FDA’s offer and ordered the data be released at a rate of 55 000 pages a month. The data are to be made available on the requesting organisation’s website (https://phmpt.org/).

    In releasing thousands of pages of clinical trial documents, Health Canada and the EMA have also provided a degree of transparency that deserves acknowledgment. Until recently, however, the data remained of limited utility, with copious redactions aimed at protecting trial blinding. But study reports with fewer redactions have been available since September 2021, and missing appendices may be accessible through freedom of information requests.

    Even so, anyone looking for participant level datasets may be disappointed because Health Canada and the EMA do not receive or analyse these data, and it remains to be seen how the FDA responds to the court order. Moreover, the FDA is producing data only for Pfizer’s vaccine; other manufacturers’ data cannot be requested until the vaccines are approved, which the Moderna and Johnson & Johnson vaccines are not. Industry, which holds the raw data, is not legally required to honour requests for access from independent researchers.

    Like the FDA, and unlike its Canadian and European counterparts, the UK’s regulator—the Medicines and Healthcare Products Regulatory Agency—does not proactively release clinical trial documents, and it has also become delayed in posting information released in response to freedom of information requests on its website.

    Transparency and trust

    As well as access to the underlying data, transparent decision making is essential. Regulators and public health bodies could release details such as why vaccine trials were not designed to test efficacy against infection and spread of SARS-CoV-2. Had regulators insisted on this outcome, countries would have learnt sooner about the effect of vaccines on transmission and been able to plan accordingly.

    Big pharma is the least trusted industry. At least three of the many companies making covid-19 vaccines have past criminal and civil settlements costing them billions of dollars.31 One pleaded guilty to fraud. Other companies have no pre-covid track record. Now the covid pandemic has minted many new pharma billionaires, and vaccine manufacturers have reported tens of billions in revenue.

    The BMJ supports vaccination policies based on sound evidence. As the global vaccine rollout continues, it cannot be justifiable or in the best interests of patients and the public that we are left to just trust “in the system,” with the distant hope that the underlying data may become available for independent scrutiny at some point in the future. The same applies to treatments for covid-19. Transparency is the key to building trust and an important route to answering people’s legitimate questions about the efficacy and safety of vaccines and treatments and the clinical and public health policies established for their use.

    Twelve years ago we called for the immediate release of raw data from clinical trials. We reiterate that call now. Data must be available when trial results are announced, published, or used to justify regulatory decisions. There is no place for wholesale exemptions from good practice during a pandemic. The public has paid for covid-19 vaccines through vast public funding of research, and it is the public that takes on the balance of benefits and harms that accompany vaccination. The public, therefore, has a right and entitlement to those data, as well as to the interrogation of those data by experts.

    Pharmaceutical companies are reaping vast profits without adequate independent scrutiny of their scientific claims. The purpose of regulators is not to dance to the tune of rich global corporations and enrich them further; it is to protect the health of their populations. We need complete data transparency for all studies, we need it in the public interest, and we need it now.
    We're admonished to "trust the science", but scientists aren't allowed to review the "science".

    Finish every day, and be done with it.
    You have done what you could - some blunders and absurdities no doubt crept in, forget them as fast as you can, tomorrow is a new day.
    You shall begin it well and serenly, and with too high a spirit to be cumbered with your old nonsense.

    Emerson

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    Senior Member Lloyd's Avatar
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    Default Re: Vaccine thread - part 2

    drneal: That's just an editorial from the BMJ. Note-
    Competing interests: We have read and understood BMJ policy on dedaration of interests and declare
    that The BMis a co-founder of the AlITrials campaign. PD was one of the Cochrane reviewers studying
    influenza antivirals beginning in 2009, who campaigned for access to data. He also helped organise
    the Coalition Advocating for Adequately Licensed Medicines (CAALM), which formally petitioned the
    FDA to refrain from fully approving any covid-19 vaccine this year
    (docket FDA-2021-P-0786). PD is
    also a member of Public Health and Medical Professionals for Transparency, which has sued the FDA
    to obtain the Pfizer covid-19 vaccine data. The views and opinions do not necessarily reflect the official
    policy or position of the University of Maryland.
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    M: I came here for a good argument.
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    M: An argument isn't just contradiction.
    A: It can be.
    M: No it can't. An argument is a connected series of statements intended to establish a proposition.
    A: No it isn't.
    M: Yes it is! It's not just contradiction.
    A: Look, if I argue with you, I must take up a contrary position.
    M: Yes, but that's not just saying 'No it isn't.'
    A: Yes it is!
    M: No it isn't!

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    Default Re: Vaccine thread - part 2

    Yes, it is an editorial. But it passed the editorial board of the BMJ. Is it untrue? The .pdf linked includes the footnotes and references.

    This isn't a pro or anti-vax dichotomy issue our hyper-partisan society makes it out to be. This is an issue of transparency and ethics. Correct me if I'm wrong, but it seems that you are dismissing the article simply because "it is an editorial" and because they petitioned the FDA from formally approving any covid vaccine (as opposed to emergency authorization).

    Is it not reasonable to advocate not fully approving something that is still under study by the maker?

    Finish every day, and be done with it.
    You have done what you could - some blunders and absurdities no doubt crept in, forget them as fast as you can, tomorrow is a new day.
    You shall begin it well and serenly, and with too high a spirit to be cumbered with your old nonsense.

    Emerson

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    Senior Member Lloyd's Avatar
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    Default Re: Vaccine thread - part 2

    Medicines often remain under study long after release- often as long as they're on the market. Many miss that vaccines and masking aren't stressed to protect individuals, but to protect society. It's public health. If you don't want a vaccine or to wear a mask, stay out of social settings.

    Sent from my SM-G991U using Tapatalk
    M: I came here for a good argument.
    A: No you didn't; no, you came here for an argument.
    M: An argument isn't just contradiction.
    A: It can be.
    M: No it can't. An argument is a connected series of statements intended to establish a proposition.
    A: No it isn't.
    M: Yes it is! It's not just contradiction.
    A: Look, if I argue with you, I must take up a contrary position.
    M: Yes, but that's not just saying 'No it isn't.'
    A: Yes it is!
    M: No it isn't!

  10. #10
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    Default Re: Vaccine thread - part 2

    That's not the issue. Do you think it is ethical to withhold trial data, requiring a judge to order its release to the larger scientific community? How does peer review happen if the data is not reviewed?

    Finish every day, and be done with it.
    You have done what you could - some blunders and absurdities no doubt crept in, forget them as fast as you can, tomorrow is a new day.
    You shall begin it well and serenly, and with too high a spirit to be cumbered with your old nonsense.

    Emerson

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    Senior Member Lloyd's Avatar
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    Default Re: Vaccine thread - part 2

    It depends on the circumstances. It doesn't take a large community to analyze this type of data. It's more important to curtail the spread of a plague at the expense of a small population than slow up the process by every Tom, Dick, and Harry stepping forth. Sadly, statistics can be easily misused. If every alternative thinker can tinker with the numbers, no vaccine would be released, especially with any support. Look at the results of releasing climate data. Most grad schools separate statistics from mathematics - the latter being non-contentious. Statistics don't "lie" any more than a calculator, but people can easily use them to support a fallacy.

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    Last edited by Lloyd; May 6th, 2022 at 03:40 PM.
    M: I came here for a good argument.
    A: No you didn't; no, you came here for an argument.
    M: An argument isn't just contradiction.
    A: It can be.
    M: No it can't. An argument is a connected series of statements intended to establish a proposition.
    A: No it isn't.
    M: Yes it is! It's not just contradiction.
    A: Look, if I argue with you, I must take up a contrary position.
    M: Yes, but that's not just saying 'No it isn't.'
    A: Yes it is!
    M: No it isn't!

  12. #12
    Senior Member dneal's Avatar
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    Default Re: Vaccine thread - part 2

    Lots in there that also isn't the issue.

    Let me ask more simply: Should the data for scientific claims be made available to fellow scientists to peer review?

    Finish every day, and be done with it.
    You have done what you could - some blunders and absurdities no doubt crept in, forget them as fast as you can, tomorrow is a new day.
    You shall begin it well and serenly, and with too high a spirit to be cumbered with your old nonsense.

    Emerson

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    Senior Member Lloyd's Avatar
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    Default Re: Vaccine thread - part 2

    Quote Originally Posted by dneal View Post
    Lots in there that also isn't the issue.

    Let me ask more simply: Should the data for scientific claims be made available to fellow scientists to peer review?
    Yes but not ALL fellow scientists in every instance.

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    A: No you didn't; no, you came here for an argument.
    M: An argument isn't just contradiction.
    A: It can be.
    M: No it can't. An argument is a connected series of statements intended to establish a proposition.
    A: No it isn't.
    M: Yes it is! It's not just contradiction.
    A: Look, if I argue with you, I must take up a contrary position.
    M: Yes, but that's not just saying 'No it isn't.'
    A: Yes it is!
    M: No it isn't!

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    Senior Member Lloyd's Avatar
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    Default Re: Vaccine thread - part 2

    Does every public transportation system wait to be constructed until every single engineer and architect has looked over the blueprints, materials list, billing statements, design calculations, Etc?

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    M: I came here for a good argument.
    A: No you didn't; no, you came here for an argument.
    M: An argument isn't just contradiction.
    A: It can be.
    M: No it can't. An argument is a connected series of statements intended to establish a proposition.
    A: No it isn't.
    M: Yes it is! It's not just contradiction.
    A: Look, if I argue with you, I must take up a contrary position.
    M: Yes, but that's not just saying 'No it isn't.'
    A: Yes it is!
    M: No it isn't!

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    Default Re: Vaccine thread - part 2

    No one is asserting anything has to wait until every person of a particular discipline reviews something. I don't know why you're introducing that.

    I'm simply talking about common scientific standards of scrutiny and peer review. If data is withheld, no real scrutiny can take place. It becomes something one must take on faith. We don't need a few select high-priests of science, holed up in some metaphorical Vatican of science, pronouncing truth - particularly when there is money involved.

    That's how people end up with gold slippers and funny hats. Who wants that?

    Finish every day, and be done with it.
    You have done what you could - some blunders and absurdities no doubt crept in, forget them as fast as you can, tomorrow is a new day.
    You shall begin it well and serenly, and with too high a spirit to be cumbered with your old nonsense.

    Emerson

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    Senior Member Lloyd's Avatar
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    Default Re: Vaccine thread - part 2

    During the time of a Public Health crisis, we do need that. Otherwise, nothing would ever happen. Have you looked at our democracy? We can't even have an election without controversy.

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    M: I came here for a good argument.
    A: No you didn't; no, you came here for an argument.
    M: An argument isn't just contradiction.
    A: It can be.
    M: No it can't. An argument is a connected series of statements intended to establish a proposition.
    A: No it isn't.
    M: Yes it is! It's not just contradiction.
    A: Look, if I argue with you, I must take up a contrary position.
    M: Yes, but that's not just saying 'No it isn't.'
    A: Yes it is!
    M: No it isn't!

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    Senior Member Lloyd's Avatar
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    Default Re: Vaccine thread - part 2

    As I stated in mentioning the writers of that opinion piece, they didn't want any vaccine put out throughout the year.

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    A: No you didn't; no, you came here for an argument.
    M: An argument isn't just contradiction.
    A: It can be.
    M: No it can't. An argument is a connected series of statements intended to establish a proposition.
    A: No it isn't.
    M: Yes it is! It's not just contradiction.
    A: Look, if I argue with you, I must take up a contrary position.
    M: Yes, but that's not just saying 'No it isn't.'
    A: Yes it is!
    M: No it isn't!

  18. #18
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    Default Re: Vaccine thread - part 2

    Tend to agree with Lloyd on this. Some people will always complain about an aspect of peer review such that it supports their own argument. Other scientists looking at the data - are they the right scientists? Are there enough scientists? Are they scientists I personally approve of? And on and on. Shifting the goalposts to make a point that doesn't really exist.


    Is it ethical to withhold trial data? That depends entirely on the context in which the data is collected, AND with the precise nature and conditions of the ethical approval under which that data is sought.

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    Default Re: Vaccine thread - part 2

    Recall, in the beginning (and middle) stages, hospitals couldn't keep up, and this was viewed figuratively as a war. When a country is considering going into a war, does every political scientist in the country get to look at all the top secret reasons we need to get involved prior to the involvement?

    Sent from my SM-G991U using Tapatalk
    M: I came here for a good argument.
    A: No you didn't; no, you came here for an argument.
    M: An argument isn't just contradiction.
    A: It can be.
    M: No it can't. An argument is a connected series of statements intended to establish a proposition.
    A: No it isn't.
    M: Yes it is! It's not just contradiction.
    A: Look, if I argue with you, I must take up a contrary position.
    M: Yes, but that's not just saying 'No it isn't.'
    A: Yes it is!
    M: No it isn't!

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  22. #20
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    Default Re: Vaccine thread - part 2

    Quote Originally Posted by Lloyd View Post
    During the time of a Public Health crisis, we do need that. Otherwise, nothing would ever happen. Have you looked at our democracy? We can't even have an election without controversy.
    Again, you're setting up a false dichotomy. Your assertion isn't the case, and the problems with our democracy hinge on false narratives being put forth from each side (among other things)

    Quote Originally Posted by Lloyd View Post
    As I stated in mentioning the writers of that opinion piece, they didn't want any vaccine put out throughout the year.
    Were that true, I would be in agreement, but it is not true. They petitioned that the vaccines shouldn't be fully approved - as opposed to emergency use. See links below.

    Quote Originally Posted by Lloyd View Post
    Recall, in the beginning (and middle) stages, hospitals couldn't keep up, and this was viewed figuratively as a war. When a country is considering going into a war, does every political scientist in the country get to look at all the top secret reasons we need to get involved prior to the involvement?
    Once more you perpetuate this all or none argument. No one is arguing that every scientist must review the data, only that the data should be made available for review.

    Also recall that there were no treatment protocols. If you tested positive, you went home until you got better or had to go to the emergency room. Any attempt at treatment was ridiculed, and doctors were being threatened for using their best medical judgement to save lives. Medicine got politicized because of irrational hatred for Trump.

    and for EOC: A member of your beloved Cochrane institute was one of the petitioners.

    The link for the petition is HERE
    The FDA's response is HERE

    This petition for administrative action is submitted on behalf of CAALM, the Coalition Advocating for Adequately Licensed Medicines (“Petitioner”) pursuant to 21 C.F.R. § 10.30 and related relevant provisions of the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act to request that the Commissioner of Food and Drugs (the “Commissioner”) require that the vaccine manufacturers provide the FDA with the data outlined in the “Actions Requested” section below before approval of any COVID-19 vaccine.

    The Food and Drug Administration (FDA) has granted Emergency Use Authorizations (EUAs) to three COVID-19 vaccines, enabling rapid, and widespread vaccine rollout across the United States. These EUAs do not have any built-in expiration date, and therefore vaccines can continue to be lawfully distributed under EUA even after a future date when a public health emergency no longer exists.

    Approximately seven months have passed since the first EUAs were granted, and two vaccine manufacturers now seek licensure (approval) and have submitted Biologics License Applications (BLAs). Other manufacturers have indicated similar intentions, as well as intentions for EUAs for additional pediatric populations.

    We believe the FDA should not prematurely grant a license to any COVID-19 vaccine until all necessary efficacy and safety studies are completed and substantial evidence demonstrates the benefits of an individual COVID-19 vaccine product outweigh the harms for the indicated, recipient population. We are concerned that the premature licensure of a COVID-19 vaccine can seriously undermine public confidence in regulatory authorities, particularly if long-term safety issues were to emerge following licensure.
    That seems perfectly reasonable.

    Finish every day, and be done with it.
    You have done what you could - some blunders and absurdities no doubt crept in, forget them as fast as you can, tomorrow is a new day.
    You shall begin it well and serenly, and with too high a spirit to be cumbered with your old nonsense.

    Emerson

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