From a poster on Instapundit’s open thread tonight:
The November New England Journal published results from Pfizer’s pivotal mRNA influenza trial (AKA Pfizer trial C4781004, with Registered http://ClinicalTrials.gov number, NCT05540522). Trial was non-inferiority contest between currently licensed traditional quadrivalent vaccine control vs a new Pfizer mRNA quadrivalent. 18,000 aged 18 -64 randomized 1 to 1.
I intend to use this flu publication in NEJM to demonstrate how Pfizer is lying scum that people should never trust. You will also note that the NEJM has turned into pharma whores.
The CDC estimates that the mortality rate for flu is 32 per 100,000 in people over age 65. This elderly rate is MANY times higher than the rate observed in younger cohorts: age 0-4 = 1.4/100k, age 5-17 = 0.5/100k, age 18-49 = 1.9/100k, age 50-64 = 9/100k.
NEJM authors report the following efficacy: For the primary efficacy end point, the relative efficacy of the modRNA vaccine as compared with the control vaccine against a first episode of influenza-like illness occurring at least 14 days after vaccination was 34.5% (95% confidence interval [CI], 7.4 to 53.9), a finding that met the criteria for both noninferiority and superiority. END QUOTE (my emphasis)
NEJM authors report the following safety: “. . . recipients of the modRNA vaccine reported more local reactions and systemic events than control recipients (70.1% vs. 43.1% for local reactions and 65.8% vs. 48.7% for systemic events). Reactogenicity events were generally mild to moderate, with no clinically meaningful differences between groups in severe events. END QUOTE (my emphasis)
The quotes above are EXACTLY what Pfizer salesmen will highlight to physicians too busy to read and understand the NEJM article critically.
Pfizer is lying and NEJM is supporting their lies. This is not a small lie. Flu annual burden in the U.S. is approximately 30,000 deaths, 18 million OV’s, 450,000 hospitalizations.
Doctors are crazy busy, so Thecoldeye will ask the questions doctors should ask if they had time.
Question: Given the fact that flu kills people age 65+ at a rate SIXTEEN TIMES higher than people aged 18 -49, why is the Pfizer trial cutoff at age 64?
Answer: Well, um, gee wiz, the NCT05540522 trial published in NEJM actually DID enroll people over age 65. Pfizer very quietly posted the over age 65 results on the Federal trial website - - as Pfizer is required to do. Pfizer chose NOT to publish over 65 results in NEJM. When the NEJM says that they are publishing results from trial NCT05540522, NEJM really means they are publishing SOME of the results.
Question: Was Pfizer’s over age 65 cohort an “exploratory” or insignificant part of the trial?
Answer: No. The NEJM published data for 18 - 64 came from 18,000 enrollees. The UNpublished over 65 data came from 27,000 enrollees. The over 65 data was more powerful statistically and much more important medically because people over age 65 present a much higher disease burden to our healthcare system.
Question: What were the over 65 results for efficacy NOT published in the NEJM?
Answer: People given Pfizer’s mRNA vax had a 6% GREATER chance of getting the flu (95% CI NEGATIVE 47.2% TO 23.8%). MRNA had NEGATIVE efficacy.
Question: What were the over 65 results for safety NOT published in NEJM?
Answer: Twenty-two who received the mRNA shot were diagnosed with acute kidney injury, chronic kidney disease, or end-stage renal disease, compared to nine who received the standard shot. 17 who received mRNA suffered “acute respiratory failure,” compared to only six who received the standard flu shot.
Question: Why would Pfizer and NEJM lie like this?
Answer: Because mainstream media reporters are stupid and/or corrupt.
For the NEJM article, the NBC headline, for example, was “Pfizer’s mRNA flu shot outperforms standard flu vaccine in late-stage trial.” Now stupid people want to shoot Grandma with the mRNA flu vax because they read a headline on NBC. The TV docs on NBC (who are also too busy) are “brought to you by Pfizer” and gain nothing by biting the hand that feeds them.
Question: Does the data for young people prove the benefits of mRNA flu vax?
Answer: No, but that is the subject of a different email.
Question: Given the disease burden of flu and the widely acknowledged limitations on flu vax efficacy, shouldn’t “establishment medicine” (ie, the CDC, FDA, NIH, AMA etc, ) insist that trials like Pfizer’s include a third arm for placebo?
Answer: Obviously, the answer is yes. Establishment medicine is afraid that such data might not support the current recommendations of establishment medicine. Establishment medicine is anti science.
This scandal is under reported.