Coronavirus

The Secret To Vaccinating Children: Off-Label Vaccinations

It’s legal for doctors to give kids the Pfizer vaccine, but Pfizer isn’t allowed to say so.

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With the Pfizer vaccine for COVID-19 granted full approval by the Food and Drug Administration (FDA) for use on anyone ages 12 and up*, pediatricians can actually now legally give it to patients under 12 years old, even though the drug is not yet technically approved for this age group. This is because once a drug is FDA approved, physicians can legally prescribe drugs off-label, beyond the scope of the drugs' initial approval, if they judge that it is medically appropriate. Yet while some parents have successfully scheduled vaccines for their younger children, pediatric vaccination is likely to remain unavailable to most families even as children return to school in communities that are facing a resurgence of COVID-19 cases and pediatric hospitalizations are on the rise.

Pediatric vaccination is unlikely to become widely available for two reasons. First, FDA marketing restrictions prevent manufacturers from publicizing information about off-label vaccination for kids younger than 12. Second, public health authorities at the FDA and the Centers for Disease Control and Prevention (CDC) are discouraging off-label prescribing, citing a lack of data regarding the safety and efficacy of vaccines for younger patients, and many parents and providers follow the guidance of those officials.

So, in essence, public health officials are censoring the information that would help people make an informed choice, and then saying that parents and pediatricians can't make an informed choice because they don't have enough information about off-label pediatric vaccination.

Off-label prescribing is very common for kids, since many drugs are not approved for pediatric prescribing. Pediatricians know that "off label is not synonymous with off evidence" and it's often worth it for doctors, parents, and patients to choose to use a drug in ways that differ from its approved use. But the FDA prohibits any drug marketing except for FDA-approved intended uses. This means that drug makers, like Pfizer, are prohibited from publicizing truthful information about the potential benefits of off-label prescribing, even when physicians and parents would benefit from knowing all of their options. 

Government restrictions on off-label marketing amount to content-based restrictions on speech that relates to lawful conduct. These restrictions are a form of government censorship that harms patients, physicians, and caregivers by keeping them in the dark about their medical options. With COVID-19, censoring information about off-label pediatric prescribing prevents parents and pediatricians from learning truthful information about the risks and benefits of vaccination from the people who are making the vaccines and running pediatric trials.

Off-label marketing restrictions are also plausibly unconstitutional. In the past decade, at least two federal courts have ruled that restrictions on non-misleading off-label promotion "run afoul of the First Amendment" and that this kind of marketing is not a form of misbranding. In both cases, the government did not appeal, allowing officials to avoid a Supreme Court case and thus leaving the current restrictions to remain largely unchallenged by risk-averse pharmaceutical companies. And while there is some indication that the government is no longer prosecuting people for providing truthful, non-misleading information, the government retains the right to do so and it has indicated that it will prosecute this kind of marketing if it poses a "public health concern."

For off-label pediatric vaccines, these restrictions mean manufacturers cannot market pediatric vaccines by publicizing the preliminary results of their vaccine trials for younger patients. Many parents and pediatricians would have a strong interest in seeing preliminary data from the 7,000 trial participants before making a decision about off-label vaccination for kids, even if the FDA wants more data before expanding emergency or final approval to children.

Not only are manufacturers prohibited from publicizing information about off-label vaccination, public health officials are actively discouraging parents from pursuing off-label vaccination for their younger patients. Officials at the FDA discouraged pediatricians and parents from seeking off-label vaccination for their children until the FDA grants an Emergency Use Authorization (EUA) for one of the available vaccines. This recommendation is based on a lack of information about the vaccines' risks to kids and optimal dosing. Yet parents and pediatricians lack this information and the people who have it are legally prohibited from publicizing it until the FDA grants an EUA.

Worse still, the CDC's provider agreement for health workers says that anyone providing off-label vaccinations to kids could lose access to vaccines and forfeit their legal immunity. This makes widespread pediatric off-label vaccination even less likely because off-label vaccine providers could face civil penalties associated with off-label vaccination and their patients may not be able to receive compensation from the federal government if they experience an adverse event associated with vaccination.

Some critics of off-label pediatric vaccination argue that the known risks of vaccines cannot justify off-label pediatric vaccination. Based on what we do know, there is some risk that vaccinating kids could slightly increase their risk of myocarditis, a rare heart condition. But this argument overlooks the risks of failing to vaccinate children. According to a recent study in the New England Journal of Medicine, COVID-19 puts children at an even higher risk of myocarditis.

Other critics of off-label pediatric vaccination argue that vaccines should be held to a higher standard of safety because they are given to children who are "perfectly healthy." But with kids going back to school while the delta variant is still surging and cases are still rising, children are just one back-to-school outbreak away from becoming unhealthy and contagious COVID-19 patients.

For these reasons, many parents reasonably think that the risks of off-label pediatric vaccination do not exceed the risks of pediatric COVID-19 infection. But public health officials are actively obscuring information about pediatric vaccine risks and won't let manufacturers publicize the information that pediatricians and parents need to make an informed choice.

Correction: This piece previously said the Pfizer vaccine was approved for use on anyone 13 and up. It was approved for those 12 and up.

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  1. Now do off label ivermectin.

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  2. The secret to vaccinating children: We don’t need to.

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    2. Don’t be so sure, it might be good if a child is in a risk-group.

  3. With the Pfizer vaccine for COVID-19 granted full approval by the Food and Drug Administration (FDA) for use on anyone ages 13 and up, pediatricians can actually now legally give it to patients under 12 years old

    Why do people hate 12 year old kids so much?

    1. Have you ever met one?

    2. That line is factually incorrect. It is approved for 16 and up. There is an EUA for 12-15 year olds to get it. This is because the younger teenage trials started later than the adult trials, so they do not yet have all the information they would normally be required prior to approval.

      1. Thanks — hadn’t expected any actual answers, but some surprises are good.

  4. “pediatric hospitalizations are on the rise”

    Well, when the previous number is almost zero, there’s no place to go but up. Any number above 1 is going to be a “record number.”

    BTW, as of two weeks ago, pediatric hospitalizations in the US hit a whopping 1900, nationwide.

    https://www.reuters.com/world/us/children-hospitalized-with-covid-19-us-hits-record-number-2021-08-14/

    1. It isn’t clear whether the Delta variant is making kids sicker than they would have been if infected with previous strains.

      10s of millions of cases of COVID classic every month for the last 18 mos. None of them 12 and under. Go CDC!

  5. Why is this totalitarian cunt being given a platform on a libertarian site? Wake, this is Reason so carry on situation normal.

    1. The Commies like her circle the drain in Lefty spheres of influence. They have banned all wrongthink from comments, social media, etc so these lunatics think they have most Americans on their side.

      The Lefties need to destroy Libertarian rally points, so the Commies at unreason obliged. Some Democrat who is questioning how Lefties have led them astray visits unreason and thinks these are libertarian positions. Its basic divide and conquer type stuff. destroy/prevent any organized resistance to tyranny.

  6. Advocating kids get an experimental vaccine for a virus that 99.9% of kids survive is evil.

    You Commies are traitors to everything America stands for.

  7. This is straight up child abuse

    1. Yeah but it’s child abuse being advocated by a professor of ethics and critical thinking!

  8. >>citing a lack of data regarding the safety and efficacy of vaccines

    if *they* don’t have the datas …

    1. See above. Untold thousands, at least, of cases of COVID among children and the CDC can’t tell if the delta variant is more deadly to them. Two years to flatten the curve… once we find it… if there is a curve…

      1. perpetual sine wave

        1. When do we get to the part with negative deaths?

          1. new Texas law helps.

  9. Further evidence that masks are effective (of course).
    Study with a sample size of 340,000, real world data with real control and randomization. There is no room for the politically motivated bullshit now.

    https://www.washingtonpost.com/world/2021/09/01/masks-study-covid-bangladesh/?utm_source=reddit.com

      1. How is this a reach? This is the most thorough study on the topic by far, and it is unequivocal: masks are effective.

        1. if you are over 50, and don’t use a cloth mask…

          seriously, under 50, no difference. cloth mask? no difference.

          Given the interventions mentioned, there’s a strong possiblity of confounders such as the social distancing that was also advised for the masking cohort.

        2. Well, you did reach all the way to Bangladesh.

          Some people have been arrested for allegedly spreading false information about the COVID-19 pandemic.[116] According to Human Rights Watch, “Since mid-March 2020, the authorities have apparently arrested at least a dozen people, including a doctor, opposition activists, and students, for their comments about coronavirus, most of them under the draconian Digital Security Act.”[117]

          But disinformation does not affect the whole of society equally, since women in this country are less likely to receive information about COVID-19 than men. The reasons that prevent women from being well informed about the pandemic are their difficulty in owning a mobile phone and accessing the Internet, as well as their low level of education. However, it is crucial that they have access to accurate and reliable information about the coronavirus, as they are the ones in charge of promoting hygiene in the household.

          Just stop posting under this handle. It’s an insult to real veterans and servicemembers.

        3. So, you can’t do your own simple statistical analysis?
          Even with decent data widely available?
          Maybe you have a thinking problem?
          Or maybe you just like gobbling bullshit?
          Here’s a hint:
          Masks don’t really work.
          Neither do lockdowns or any of the other stringency measures politicos love to promote.
          And vaccines?
          They’re also losing their efficacy.
          Ever wonder why you need a 3d vaccine shot if vaccines are so effective?
          The only thing that does seem to work is the Mark I Human Immune system.
          Despite all the claptrap “experts” try to sell.

    1. Right in the headline, it says this is for surgical masks. Given that 90+% of the masks that I see are cloth masks, I really don’t see how that study has much bearing on mask mandates.

    2. Eh, you maybe want to actually look at the study and not a summary. It’s hot garbage.

      Spoiler: There’s no ‘real control and randomization’.

      1. It’s real world data. This is it. There is nowhere left for the anti mask crowd to hide. You are denying a heavy weight of evidence against your politically motivated and stupid opinion.

        This is the real world study ya’ll have been claiming it would take to convince you. Of course, you can never intake new information or adjust your rigid and cult fed opinions once they are set.

        1. It is real world data for something that nobody is proposing. Every time people talk about masks, they mean any mask and the vast majority of those are unregulated cotton masks which your link is silent on (I assume…I am not giving money to NYT). If anyone is proposing that everyone should wear surgical masks, then fine, this is real world data for that proposal. Does the would have enough surgical masks to make such a proposal feasible?

      2. It’s heavily flawed, but the news media are already hyped up about it.

        And even taking everything at face value and pretending there are no confounders, what they found was 11% efficacy.

        ELEVEN.

        That doesn’t support universal mask mandates.

  10. Well, we know who has Pfizer stock in her portfolio and no soul.

  11. He didn’t want to eventually father children anyway.

  12. Why give kids a vaccine for a virus that has so little chance of causing them harm?

    Because left wing democrats want your obedience, and your dignity, and they want control over your kids.

  13. In fact, according to Dr. Robert Malone, the inventor of the mRNA platform, Pfizer’s ‘vaccine’ is still only EUA. He explains, “The product that’s licensed is the BioNTech product, which is substantially similar but not necessarily identical, called Comirnaty, and it’s not yet available. They haven’t started manufacturing it or labeling it. And that’s the one the liability waiver will no longer apply to. So, the one that’s actually licensed is not yet available, and when it does become available it will no longer have the liability shield. In the interim, the one that does have the liability shield is the Pfizer product and that is what is currently available and it’s still under emergency use authorization.” Games we play.

    1. He is not the inventor, and many of his colleagues say he hasn’t even contributed the most. Only he calls himself that. He is a kook, like the rest of them.

      1. I have had other people throw me under the bus for pointing out flaws in products that I designed. They too said I had nothing to do with the project, which was a lie. At this point the question is who do you believe. From my perspective I trust my intuition. I can’t see a single institutional source to trust.
        Nih – funded the wuflu
        Cdc – lies, admits to lying for political purpos
        FDA – now says clinical trials are not necessary. If this is true every drug on the market can make a takings claim against the fda for enforcing unnecessary burden
        Apa(American pediatric association) – face time with your baby is unimportant for development
        Jama (journal of American medicine) all studies involving race must come to the conclusion that systemic racism is the cause
        The list can go on forever.

    2. None of that makes any sense. The EUA was issued based on interim results from a clinical trial. The later results from the clinical trial were used for the approval. How could one clinical trial with one vaccine lead to approval/authorization for two different vaccines? That would imply that one of the two vaccines didn’t go through a clinical trial.

      The liability waiver applies to ALL vaccines, regardless of whether they are fully approved or EUA, so I’m not sure what “liability waiver no longer applies to” could possibly mean.

      Finally, it makes absolutely no sense in a Project Warp Speed world that the vaccine furthest along in development didn’t have any manufacturing facilities built in parallel with its approval process.

      1. I do not believe this is correct. For approved vaccines, one may petition for compensation for injury (bad side effect) in the United States under the Vaccine Injury Compensation Program (VICP). But VICP is not for the vaccines under EUA. Instead, their manufacturers received a broad indemnity to suit and, in place of the VICP, the US instituted the Countermeasures Injury Compensation Program (CICP) to cover problems arising from “pandemic countermeasures”, including the EUA vaccines.

  14. What happened to trusting the experts? Does that only apply if what they say feeds your hysteria?

  15. “The Secret To Vaccinating Children: Off-Label Vaccinations”

    The secret is they don’t need vaccinations Asshole.

  16. Vaccination is very necessary.

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    1. Shayari Panda is for Assholes that want hear crap.

  17. The parents of the first underage kid who develops a nasty myocarditis will sue because the jab he received would have been BNT162b2 (available, as before, under the EUA) and not Comirnaty (approved but not yet available; still in production).

    The FDA made it completely clear that legally these are separate entities. There is no legal “off-label use” of a drug authorised under EUA.

  18. While the ‘vaccines’ are apparently very, very effective personal insurance policies against serious disease from SARS-Cov-2 virus, recent data shows that they do NOT prevent the spread or the variants, or extinguish the virus. We need to use every tool available to do this, including broad spectrum antivirals and natural immunity. We are asked to ‘trust’ in a situation where there are perverse incentives, censorship, lots of questions and only one answer, “just do it”. Many of the comments here are accurate, (even if ‘anti-narrative’), and I am disappointed that Reason doesn’t work harder as journalists to explore the bigger picture.

  19. Thank you for sharing this secret it was helpful

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