FDA authorizes use of Pfizer's Covid vaccine for 5- to 11-year-olds | Hacker News Reader

FDA authorizes use of Pfizer's Covid vaccine for 5- to 11-year-olds

npr.org

29 pointsEastOfTruth27 comments

In the clinical trial underlying the decision there were ZERO severe covid cases or deaths in vaccinated or unvaccinated 5-11 kids. There were a grand total of 19 covid cases altogether out of 1,450 treatment and 736 control groups, over 6 months.

What exactly is the claimed health benefit?!

"The evaluable efficacy population included 1,450 participants randomized to BNT162b2 and 736 participants randomized to placebo."

"All cases of COVID-19 occurred in children without prior history of infection. None of these cases met the criteria for severe infection. Most of the cases occurred in July-August 2021. Comorbidities at baseline (including obesity) were present in total of 20.1% of cases"

https://www.fda.gov/media/153447/download

Just look at the pediatric hospitalization/ICU and death rate over the pandemic. These are all unvaccinated kids. We know the same vaccine formulations at higher doses reduce hospitalization/death in older populations. It's not hard to see the benefit.

That's a bit of an odd argument, as no kids are vaccinated to compare, and especially no kids are vaccinated a year ago to see how well VE holds over time.

The point is the Pfizer's own trials failed to prove vaccine health benefits in kids, mainly because covid in kids is a minor health risk, and the trial was too small to capture any severe case. Odd that the FDA went with it, no wonder that some FDA officials are choosing to resign than to partake in the charade.

I agree that it is a little strange - usually approval of a drug relies on direct evidence from a trial of the health benefit, rather than an indirect estimation. The FDA has estimated the health benefit from observational data for hospitalization and compared it to the health risk the riskiest side-effect, myocarditis This risk also had to be estimated from observational studies in older children.

From the link above:

"FDA conducted a quantitative benefit-risk analysis to evaluate predicted numbers of symptomatic COVID-19 cases, hospitalizations, ICU admissions, and deaths that would be prevented per million fully vaccinated children 5-11 years of age over a 6-month period, as compared with predicted numbers of vaccine-associated excess myocarditis cases, hospitalizations, ICU admissions and deaths per million fully vaccinated children 5-11 years of age. The model conservatively assumed that the risk of myocarditis/pericarditis associated with the 10 µg dose in children 5-11 years of age would the same as the estimated risk associated with the 30 µg dose in adolescents 12-15 years of age from Optum healthcare claims data. While benefits of vaccination were highly dependent on COVID-19 incidence, the overall analysis predicted that the numbers of clinically significant COVID-19-related outcomes prevented would clearly outweigh the numbers of vaccine-associated excess myocarditis cases over a range of assumptions for COVID-19 incidence. At the lowest evaluated COVID-19 incidence (corresponding to the June 2021 nadir), the predicted number of vaccine-associated myocarditis cases was greater than the predicted number of COVID-19 hospitalizations prevented for males and for both sexes combined. However, in consideration of the different clinical implications of hospitalization for COVID-19 versus hospitalization for vaccineassociated myocarditis, and benefits related to prevention of non-hospitalized cases of COVID19 with significant morbidity, the overall benefits of the vaccine may still outweigh the risks under this low incidence scenario. If the myocarditis/pericarditis risk in this age group is lower than the conservative assumption used in the model, the benefit-risk balance would be even more favorable."

It’s not odd at all. And the vaccine is safe. Your only plausible argument would be that it’s useless, which we know is not true generally.

> And the vaccine is safe.

Are you willing to stake liability on that? Is anyone willing to stake their liability on that point?

The answer is no. No one has liability, which means theirs no incentives for honesty, accuracy, or transparency. Without the threat of lawsuits and bankruptcy, why would a vaccine company be more transparent and honest, than say Microsoft?

Huh? I don’t get your point? No vaccine provider has ever taken liability which is why we have the vaccine National Vaccine Injury Compensation Program. The threat of lawsuits is not the only nor the best way to enforce quality. In fact we have regulations and the FDA for this reason.

Liability isn't something to take. A liability exists as the nature that there is a cost that someone else is responsible for. E.g. if I start a fire in my kitchen, even unintentially, and it spreads to another's home (or apartment), I'm liable for the damaged of that fire to those affected by the fire.

I can't just say "oh, you can't sue me. I don't take liability". But I can lobby the government to say "you can't sue him" which is what these vaccine companies did and continue to do.

Liability is defined by the law.

Liability is a concept. If the vaccines cause you harm, then the vaccine company is liable.

And as with all concepts, yes - they are defined by laws and statues so that society can function and the rules of the game can be determined. Vaccine companies changed their rules so they don't play the liability game like everyone else. Maybe fast food restaurants shouldn't be liable when they poison people too?

Can you share these numbers? I just checked - in my own country (The Netherlands), there have been 0 deaths in the age-group 5-9. I actually think no approval will be given here for this age group based on this data. That would lead to the same situation as the flu-vaccine - recommended for everyone by the CDC, but only to 65+ and people with underlying health conditions in the Netherlands

Why don’t you check other countries data? It’s not hard.

The link you provided explains it pretty well:

“ Regulatory precedent with other preventive vaccines provides a basis for inference of vaccine effectiveness in pediatric populations based on immunobridging to a young adult population in which clinical disease endpoint vaccine efficacy has been demonstrated for the same prototype vaccine. The immune marker(s) used for immunobridging do not need to be scientifically established to predict protection but should be clinically relevant to the disease. […] A secondary objective is to evaluate efficacy of BNT162b2 against laboratory-confirmed symptomatic COVID-19 occurring from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection and in participants with or without evidence of prior SARS-CoV-2 infection. A descriptive analysis was conducted once 19 confirmed cases had accrued.“

The 19 confirmed cases were part of a secondary analysis. The primary plan was to compare immune markers and verify the vaccine was working similarity to the adult one which has been repeatedly proven to work.

Rofl. From the paragraph you just quoted: "The immune marker(s) used for immunobridging do not need to be scientifically established".

What is the health benefit they are claiming for kids? Look at table 14: assuming we buy all their assumptions, maybe 1:1,000,000 deaths. How about vaccine adverse effects (by their own projections 1:10,000 excess miocarditis) and long term OAS risks?

What about the higher risks of viral myocarditis, MIS-C, hospitalization to the children?

Not to mention the quarantines and loss of school / social life that happen when you are sick with covid because you’re a danger to others.

What about them? It's Pfizer's job to quantify how their vaccine prevents these in kids, not mine. Perhaps redo the trials with a larger population?

One more note. The vaccines effectiveness agains infection fades over time, going even in negative territory. There is the US veteran 6 months study (55% Pfizer, -3% J&J). There is the UK PHE data showing negative VE against infection (up to -50% for certain age groups), but there were some arguments about the denominator. A preprint of a Swedish total population study just dropped, and VE against symptomatic infection after 9 months is in negative territory (-15%). Everybody that quotes VE against infection is quoting outdated data, either original trials or studies with a cutoff <6 months since vaccination. Worse, VE against severe disease also significantly drops over time, the Swedish study looks bad :(

(Not happy about any of this, btw)

https://www.medrxiv.org/content/10.1101/2021.10.13.21264966v...

https://assets.publishing.service.gov.uk/government/uploads/...

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3949410

Errata: The Sweden study only breaks down VE against severe infection in <80 and >=80 age groups. VE in <80 holds at 82% at 6 months point, no data for 9 months in the respective table.

> What about them? It's Pfizer's job to quantify how their vaccine prevents these in kids, not mine. Perhaps redo the trials with a larger population?

It’s not their job to do that, though. They have passed the standards of the FDA. It sounds like what you actually want is for the FDA to increase their standards and require more than they have for past vaccines.

There are multiple studies from outside Pfizer showing MIS-C, hospitalization, and illness in general affecting children as a result of COVID-19. If the vaccine can reasonably be believed to prevent illness then it follows that it will prevent or reduce all three of those.

Vaccine waning is a bit of a different story, but keep in mind the studies you’ve linked are only part of the picture. Other studies claim the vaccines remain effective at some % after 6 months. Personally, I just got a booster to deal with the issue.

OK, so you brought in some unquantified covid effects that you then said are irrelevant. I agree, they are irrelevant because they are too rare.

Can you please quote a single VE longitudinal study with at least 6 months duration that shows stable VE? Even VE against severe infection is declining by about 10% around from 92% to 82%. UK PHE VE reports, which is as close to a real-time VE indicator as we'll ever have (short of FDA/CDC actually doing their jobs) show a steady decline week after week. The trouble is that VE against symptomatic infection drops off a cliff around the 6 months point, so it's entirely rational to wonder if VE against severe infection doesn't also fall off a cliff, only a few months delayed. We don't have data at 9/12/etc months, so we have to wait. Looks like you are indeed concerned about this very problem and decided to boost. Good for you. Myself, I really wish the vaccines perform well over time. But can't help notice that the (meager) data we have so far doesn't support the wish, and being faced with medicine that lost its effectiveness over a long period of time earlier in life to the point of being a wash, I'm less enthused about boosting on a regular basis.

In the context of kid vaccinations though, the whole situation is ridiculous. Covid health risks for kids are minimal. Pfizer own admitted unscientific application (aka we can p-hack whatever metrics we want to prop our side of the argument) estimates they might save only one life in a million, and hospitalization in low hundreds in a million, same order of magnitude as myocarditis adverse effects. That means one million kids need to be jabbed to see any positive effect. Given that there are longterm risks with any novel intervention that we don't know about yet, this is an entirely unnecessary medical intervention that borders on criminal negligence.

As a philosophic note, life has risks, even for kids: https://www.vox.com/22699019/covid-19-children-kids-risk-hos... We fundamentally can't eliminate all risk, we have to learn to live with risk. What other risks than myocarditis, you may ask. An excerpt from a 2011 paper summarizing why dengue vaccines failed:

"Original antigenic sin has the advantage that a response can be rapidly mobilized from memory. However, the downside is that in some cases, such as dengue, the response is dominated by inferior-quality antibody. In influenza, original antigenic sin has been shown to reduce the effectiveness of vaccination (13, 34, 51). In dengue, the effect of original antigenic sin has considerable bearing on vaccine strategies. Once a response has been established, it is unlikely that repeat boosting will be able to change its scope, meaning that balanced responses against the four virus serotypes will need to be established with the first vaccine dose."

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3014204

PS. Whomever feels the urge to retort that kids taking the vaccines somehow saves grandma, please stop. Besides being creepy (we don't put kids at risk to save elders, ever) and nasty (quite the guilt load on young shoulders being thrown around), it doesn't. By now there is multiple evidence showing that VE against infection fading to irrelevancy after 6-9 months. Unless there is a credible longitudinal study showing the contrary, this particular matter is closed.

> OK, so you brought in some unquantified covid effects that you then said are irrelevant. I agree, they are irrelevant because they are too rare.

I didn’t say they were irrelevant. They’re relevant to your argument that vaccination has only downsides. Pfizer doesn’t need to do independent research on this, the committee was already aware and discussing the known risks of covid to children as part of their evaluation of this application.

The rest of your post seems to be mostly speculation about VE against severe infection waning relatively rapidly in the future despite it not having done so yet.

> being faced with medicine that lost its effectiveness over a long period of time earlier in life to the point of being a wash, I'm less enthused about boosting on a regular basis.

Meanwhile I’ve got a flu shot every year for a decade. No side effects and I’ve been protected from flu without issue. So far it’s looking like we won’t need such frequent boosters for coronavirus though.

Danger to whom? The adults have their vaccine and the kids aren’t susceptible

Many adults in USA have refused the vaccine due to anti-vax propaganda. It’s far from a safe assumption, without something like a vaccine passport scheme in place, that every or even most adults a sick child meets would be vaccinated.

Perhaps some ethical systems would argue that anti vax adults have made their choice and should be exposed to the virus without care though. Personally if I was sick with covid I wouldn’t take that approach and would stay home though…

Please correct if I am wrong but schools can start to require them similar to immunizations. Won’t help now but years later we have basically everyone vaccinated.

Years later the vaccinations effect will be long gone. Unless you are suggesting we implement a 2-3 times per year immunization cycle for our children to attend school, that certainly is unprecedented.

>What exactly is the claimed health benefit?!

Easing parental anxiety.

"We conducted a covid clinical trial for kids ages 5-11. Nobody got seriously ill. Send Johny out to play with his friends."

Who am I kidding.

Should authorize and mandate it for dead people too.

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