Pfizer data - kids' vaccines have terrible efficacy

Does inflation exceed the vaccine's efficacy numbers?

Pfizer and Moderna are back at it, pleading with the FDA for an expansion of their Emergency Use Authorizations (EUA) for their COVID-19 vaccines. Moderna is requesting an EUA for (1) kids aged 6 through 17; and (2) kids aged 6 months through 5. Pfizer is asking for an EUA to include the administration of its vaccine for kids aged 6 months through 4 years. (Dr. Anthony Fauci has been promoting these vaccines for children since last year.)

Prediction: the FDA will approve these EUAs for COVID-19 vaccines these kids don’t need. (Update: On June 15, 2022, FDA advisors recommended the Moderna vaccine be approved for kids aged 6 months - 5 years, and the Pfizer vaccine for kids aged 6 months through 4 years.)

For reference, this is the same FDA that granted an EUA to the Pfizer vaccine for kids aged 5-11 while admitting it didn’t know the long-term risks – or short-term risks – of that vaccine. In fact, one of the FDA voting members justified his vote by stating: “We're never gonna learn about how safe the vaccine is until we start giving it.”

Techno Fog @Techno_Fog

FDA Voting Member: "We're never gonna learn about how safe the vaccine is until we start giving it." 🤷‍♂️ Video HT @politicalwilli

As an aside - what is a vaccine, anyway? According to CDC documents we obtained, the definition of “vaccine” needed to be changed because “Right-wing covid-19 deniers are using your ‘vaccine’ definition to argue that mRNA vaccines are not vaccines…”

Anyway, that comment proved prescient in its own ignorant way, as we really are starting to find out “how safe the vaccine is.” This presentation, which provides an update on myocarditis following MRNA vaccination (which I highly encourage you to review) is being reviewed at the current FDA meetings.

Here’s the data on post-Pfizer vaccination on myocarditis in kids aged 5-17.

For Moderna and Pfizer, here’s more data on myocarditis in adults – with Moderna coming out worse.

Adding to this, we previously wrote about how Pfizer gamed the COVID-19 “clinical study” of kids aged 5-11, observing the long-term risks – and long-term effectiveness of the vaccine – were both unknown. In that same article, we observed why vaccination of children was unnecessary.

Now we’re seeing a repeat of the same game. For the kids aged 6 months through 4 years, let’s take a look at Pfizer’s data, available here.

Some general observations on the latest information:

• This was a short-term study (no surprise), with an average follow-up time was “2.1 months after Dose 3.”

• Lymphadenopathy (swelling of the lymph nodes) was observed in the vaccinated group; no cases appeared in the placebo group.

• Pfizer conceded its vaccines issues in fighting against infection from the Omicron variant, stating: “Observed estimates of vaccine effectiveness against symptomatic disease due to the Omicron variant include the following: 8.8% (95% CI, 7.0 to 10.5) at 25 or more weeks since primary vaccination in adults; 59.5% among adolescents 12 to 15 years of age 2 to 4 weeks after dose 2, 16.6% during month 2 after the second dose, and 9.6% during month 3 after the second dose.; and 60.1% for children 5 to 11 years of age 2 to 4 weeks after dose 2, and 28.9% during month 2 after dose 2.”

• The means of measuring outcomes for the youngest was flawed from the outset.

Marty Makary MD, MPH @MartyMakary

Table 73: “Vaccine effectiveness in participants ages 6-23 mo. was inferred through immunobridging to the young adult data in Study P301 using the co-primary endpoints of GMC ratio and difference in SRRs at 28 days post-Dose 2 (Day 57).” This violates basic scientific principles

• Pfizer also admitted that its COVID-19 vaccine is ineffective in preventing hospitalization due to the Omicron variant: “In one observational study among adolescents 12 to 18 years of age (median interval since vaccination, 162 days) during the Omicron-predominant period, primary series vaccine effectiveness was 40% (95% CI, 9 to 60) against hospitalization for COVID-19.”

• The highest reports of myocarditis and pericarditis after vaccination “have been in males 12 through 17.” There is no information about the long-term “outcomes in affected individuals.”

• For ages 2-4, the number of severe COVID-19 cases in the vaccinated group exceeded those in the placebo group: “Seven cases in participants 2-4 years of age met the criteria for severe COVID-19: 6 in the BNT162b2 group, of which 2 cases occurred post unblinding, and 1 in the placebo group.”

• Kids in the vaccinated group developed more than one confirmed case of COVID-19: “Six participants 2-4 years of age (5 BNT162b2 recipients and 1 placebo recipient) developed more than one virologically and clinically confirmed episode of symptomatic COVID-19 disease.”

• And here’s the worst of it. The vaccine efficacy is terrible, with the “vaccinated” group having in some cases more COVID-19 cases when compared to the placebo group. For some groups, the placebo outperformed the vaccine.

Here’s Pfizer’s data per the FDA, showing disastrous efficacy numbers for its 2-dose vaccine for kids 6-23 months and kids 2-5 years.

Finally, when we talk about “gamed” clinical studies, here’s what we mean. Due to the study’s cut-off date, Pfizer prevented itself from making conclusions on the vaccine’s “efficacy post-Dose 3 as compared to efficacy post-Dose-2.”

How can the FDA approve a 3-dose Pfizer regiment if there isn’t sufficient data to determine efficacy after the third dose??

Then there’s something else that’s important in that paragraph: Pfizer’s admission that its vaccine, for many of these children, offers only “modest protection against COVID-19.”

One FDA advisor who voted in favor of recommending the FDA grant the Pfizer EUA for children observed Pfizer’s 2-shot data was “surprisingly poor” and speculated kids would eventually need 4 doses of the Pfizer vaccine:

Another voting member (who also voted to recommend approval) expressed concerns about the purported efficacy rate, stating “I do not have any idea” what the final efficacy number “will end up being.”

As to Moderna, its 2-dose COVID-19 vaccine for kids aged 6 months through 5 years has poor efficacy numbers similar to Pfizer’s:

Despite there being no official FDA decision on these vaccines (FDA advisors recommended approval on June 15), and despite this troubling data, the Biden Administration knows FDA authorization is a certainty. It has been planning a “COVID-19 vaccine rollout plan for children under 5” for weeks, with the first vaccines to start as early as June 20. Pfizer and Moderna are already taking orders of vaccines for kids under 5, with “5 million doses available for pre-order pending FDA authorization.”

The effectiveness data doesn’t matter - the dollars are too big. And for a desperate Biden Administration, the COVID-19 vaccine rollout for children will, at least for a short time, shift the public’s focus from raising interest rates and near-double digit inflation. (35% - is that energy’s inflation rate, or is it Pfizer’s efficacy?)