Science

FDA Vaccine Approval Delays Are Deadly

The vaccines seem to be working well, but the FDA isn't.

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In August, as COVID-19 cases began rising again throughout the country, Rochelle Walensky, the director of the Centers for Disease Control and Prevention, had a simple message for Americans: Get vaccinated. "Our vaccines are working exceptionally well," she said on CNN. "They continue to work well for [the delta variant] with regard to severe illness and death. They prevent it."

That message was reiterated by Anthony Fauci, President Joe Biden's top medical adviser, who has even expressed support for requiring public school teachers to be vaccinated. And it was echoed by the Food and Drug Administration (FDA), which regulates vaccines and must sign off on their use before widespread deployment.

"Getting more of our population vaccinated is critical to moving forward and past this pandemic," said Janet Woodcock, the FDA's acting commissioner. Woodcock also has emphasized that the FDA conducted thorough reviews of the vaccines, finding them safe and effective.

Yet for most of the year, that message was undermined by the regulatory reality. As of mid-August, the FDA still had not granted formal approval to any of the COVID-19 vaccines. Instead, they were administered under "emergency use authorizations," a provisional status suggesting that the FDA still wasn't sure about them.

Officially, the FDA was still collecting safety data. But given that Woodcock had clearly stated the vaccines were safe and effective, it seemed the agency's real priority was hewing to its slow, laborious drug approval process, even if that meant sending mixed signals to the public in the midst of a pandemic, confusing people and perhaps costing lives by discouraging vaccination.

In late August, the FDA fully approved a vaccine made by Pfizer. But two others are still only authorized for emergency use, and emergency authorization to vaccinate young children is still likely months away.

In 2020, the FDA waited weeks to provisionally approve the first vaccines after the results of clinical trials were submitted for review. Faster action could have stemmed the deadly winter wave, likely saving many lives in the process. The vaccines, in other words, seem to be working well. But the FDA isn't.

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  2. The current Pfizer shot is not FDA approved. Comirnaty is approved, but it won’t be on the market until late 2022 at the earliest. And it’s a different product from the Pfizer jab currently available.

    1. What are the differences between the Pfizer vaccine available under emergency use authorization and Comirnaty? I’m curious and am interested in details. Links to information would be greatly appreciated.

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    2. It is the exact same drug, made in exactly the same way. Otherwise, the FDA would be mandating new clinical trials. As the Pfizer EUA fact sheet states, Comirnaty is interchangable with the Pfizer vaccine released under EUA, it is just a legal distinction. News articles indicate that the only difference is the label on the bottle.

      Keep in mind that drug companies are prohibited from marketing under an EUA. So, it doesn’t make sense to give them a brand name. One fully approved though, it is time to slap a new label on the bottle with your fancy new name. Doesn’t mean anything about the drug itself.

      1. There are some minor differences, apparently. They probably produce the same mRNA in the same way (though there might be some changes in some of the codon optimization), but the other ingredients differ some.

        The legal difference probably is the more substantial difference anyways. The Pfizer drug is still on full EUA, while the BioNTech Comirnanity has both full approval and EUA but is not available. The likely reason for this is legal – EUA comes with tremendous liability protections and almost no mechanism for recourse (largely due to the PREP act). Full approval has a more limited liability; VICP does not apply under most conditions, and PREP protections become more limited. This places the product only under the most general liability protections. Once a product is part of a childhood vaccination schedule, or is recognized in some equivalent way, VICP comes into play and the protections once again increase.

        What we are seeing is probably legal gymnastics to limit liability while still legitimizing the product – full approval for an unavailable but purportedly equivalent product may quiet some of the hesitancy and can pave the way for further legal advancement of the product, while not introducing any additional liability because the product is actually provided in the form of a substitute which is still entirely under EUA. This also explains all the push for approval in children and pregnant women, despite their exponentially reduced risk from natural infection. Opening up these two groups introduces VICP protections.

        It’s better to examine the substantial claims made in the approval rather than to try and accept the approval process as some non-legal scientific statement in and of itself. IMO the compromise of the control group and un-blinding of the study reduces power to detect and introduces bias, enough so that I don’t put any stock in the approval. We also still don’t have most of the documentation or data, and the approval was never subject to public discussion of data. The whole thing is intentionally weird, opaque, and confusing. If you’ve never seen an FDA approval letter, I suggest you look one up and compare to what they issued for Comirnanity.

  3. Jab, jab, jab, jab, Body Blow!

  4. FDA doubts feed the paranoid doubts of the anti-vackers-wackers crowd… If it MIGHT not be PERFECT enough for the FDA, it ain’t perfect enough for Precious Perfect MEEEEE!!!

    Thank You Government Almighty; may I have another!

    https://www.stardem.com/news/national/survey-20-of-americans-32-of-republicans-worry-covid-vaccines-are-part-of-government-microchip/article_a8f34620-d6c1-5eba-8000-1215d552c235.html

    Survey: 20% of Americans, 32% of Republicans worry COVID vaccines are part of government microchip plot

    When will the FDA just go right ahead and ADMIT some shit about these dastardly plots?

    1. Next time they should get a sample larger than your inbred family, uncledaddy.

      1. Dizzle-fizzle’s brain has fizzled a LONG time ago, by now!

    2. For dim-witted troglodyte rethugglicans, my point was that a significant percentage of “R” party fans are a bit on the dull and credulous side. Fizzled-brain just helped to prove my point, by being a dim-witted grade-school-level poop-slinger, instead of refuting my point.

      1. That number is so high, it almost certainly means the survey takers are being trolled.

    3. Bless your heart…

  5. It’s almost like there were several promising medicines that turned out to have nasty side effects years down the road, and the FDA thought they should require long term studies in the future.
    To save one child.

    1. Thalidomide babies applaud with their flippers.

      1. As do cancer patients who had their progression slowed by thalidomide (it’s still an FDA approved drug).

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    2. I look forward to all the ads from attorneys: “ Have you or someone in your family taken the Covid vaccine “?

      1. The vaccine is so safe, the pharmaceutical companies are shielded from lawsuits.

        1. This is true of all vaccines BTW. Because they are given to everyone, even a 0.0001% chance of serious side effect would be unmanageable legal mess, even though the vaccine might be preventing a disease with orders of magnitude greater chance of serious complications. As a result, the government (which after all, recommended the vaccine) takes in responsibility.

          1. Many other products are similarly widespread and have to deal with more normalized liability structures. Many other medicines, in fact, operate under more normalized liability structures. Vaccines in the past even had to do so. If you really wanted to make it easier then we would just cover vaccine damages under health insurance, and then the health insurance providers would pursue compensation from the vaccine manufacturers. This would even have the benefit of dramatically improving actuarial data regarding vaccine risks and damages.

            The spirit and reasoning behind this argument in favor of vaccine industry liability protections is basically the same argument that props up qualified immunity in policing.

  6. I think it’s pretty clear that this particular libertarian/deregulatory stance has no political traction in either party.

    1. Yeah. Talking up lack of FDA approval as an excuse for vaccine hesitancy or slagging on “horse paste” is a blinking red light that the speaker in question doesn’t have a properly libertarian spirit.

  7. If there is an emergency order allowing people to use the vaccine, then we don’t need to speed up the approval process. As the only thing speeding up the approval process will get us is legal cover to forcible vaccinate people against their will. From a libertarian perspective, having this vaccine authorized on a emergency basis is the ideal situation, and we should really be looking at how we could allow similar legal situations be allowed for more medicine that is in testing. Giving people the right to use something if they want, but preventing the USG and companies from forcing people to do so.

    1. What is this “allowing people” to choose for themselves? They might deviate from the tribal norms and defy the gods, bringing devastation down on the whole village. Science tells us how to try these heretics and keep holy the revealed word.

      1. Vaccine for the vaccine gods!

    2. The libertarian position, of course, is to rush the approval of drugs developed through public-private partnerships where the government pays for the development while the drug company receives 100% of the revenue and is shielded completely from any liability whatsoever resulting from the use of their drug, and then force people to take said drug regardless of their personal, religious, philosophical or moral reservations. Forget about a “right to try” experimental drugs, now you have the legal obligation. Everything which is not forbidden is compulsory.

  8. OT Post:

    https://reason.com/2021/10/05/-aww-shoot/

    ___ _______ ___ .===. (
    / ) ( __ ) / ) | | )
    / /) | | ( ) | / /) | | | (
    / (_) (_ | | / | / (_) (_ | | )
    (____ _)| (/ /) |(____ _) | \*/
    ) ( | / | | ) ( ,’ //.
    | | | (__) | | | :~~~~~//~~;
    (_) (_______) (_) `. // .’
    `——-‘
    What’s so good about a 420 error? I have a 420 error… I don’t have enough weed to smoke!

    1. It means the feds are investigating you.

    2. sarcasmic is living proof that while weed cannot kill you, you can still smoke yourself stupid.

  9. If the FDA hurries then they’re killing people with experimental medicine, and if they don’t then they’re killing people by delaying good medicine.

    1. Tomato, tomahto.

    2. The latter number is harder to quantify, so they always defer to delaying.

    3. It’s almost like the FDA is a worthless piece of shit that gives cover to politically-connected pharmaceutical companies while failing to protect consumers; that this has been well known for decades; and that therefore using the FDA’s approval or lack thereof as a cudgel to beat people over the head with is an incredibly stupid thing to do and only engaged in by radical left wing pieces of shit trying to rationalize forcibly injecting people with experimental drugs against their will.

      For the thousandth or so time now, we went from having to fight the government for a “right to try” experimental drugs to being legally obligated to take experimental drugs. And radical left wing sacks of shit like sarcasmic think nobody will notice when they deliberately conflate the two to advance their radical left wing agenda.

  10. Three years ago the FDA held a news conference celebrating the fact that they had just approved a drug that would save about 30,000 lives every year. The approval process had taken 10 years.
    Not one reported asked if that meant that 300,000 lives had been lost during that time.

  11. Speeding the approval of vaccines by the FDA is nothing more than a means of legitimizing mandates. I do think that the government should make it possible for anyone who wants it to get the vaccine. So they should EUA as many of the vaccines as possible. But the only thing standing in the way between mandates for children is the lack of full FDA approval.

    By any conventional methodology, the FDA would never approve this drug for general use among children, because the COVID Vaccine is unnecessary for children. 4 children per million in the united states will die of this virus in a year. 34 kids out of A MILLION will be hospitalized. Children do not need this vaccine, let alone require mandates to get it administered.

    I do not like the FDA, but at least they can be consistent. I do believe that they stand in the way of innovation and people seeking hail mary cures. But right now, there is a mechanism for getting kids the vaccine if they need it, by way of the EUA. The very few at risk children should be able to get the vaccine, and we should leave it at that. Approving the vaccine for general use among kids is nothing but a pathway to mandates in a direct contravention of previous precedent.

    1. If only there were some kind of other option, like having no government approval process for drugs and letting third party laboratories and investigators to test new drugs, provide information to the public, and let them make their own choices what they do or do not put into their bodies.

    2. It isn’t even per year. Once you are exposed, you get immunity. While there are no guarantees, chances are very high immunity (natural or vaccine) will last at least through childhood.

  12. >>seem to be working well

    somebody has been fast forwarding through the Tracey Morgan commercials.

  13. Forcing everyone to take the same drug is also deadly.

    1. If everyone would just take it, they wouldn’t need to be forced to take it.

  14. This article aged spectacularly.

    https://apnews.com/article/coronavirus-pandemic-business-denmark-public-health-health-453163d8f93618fde90c06d3474921a0

    A single dose is kicking the increase in myocarditis off, how much will there be 5 years and 10 doses down the line one wonders. Heart transplants for everyone!

  15. Wrong again. All mRNA injection approvals are deadly. Get your facts straight for once.

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