More troubling, vaccinated toddlers in Pfizer’s trial were more likely to get severely ill with Covid than those who received a placebo.
COVID has never been an emergency for toddlers. the FDA bent its standards, and Pfizer and Moderna vaccines met standards for adults but not toddlers. Abandoning all standards and spewing misinformation and disinformation has cost irreparable harm to trust in the medical community.
An article by a Wall Street Journal Editorial Board member has some very troubling facts that people should know.
In case you don’t have a subscription to the Wall Street Journal, which is behind a paywall, here are some excerpts:
Only 209 kids between six months and four years old have died from Covid—about 0.02% of all virus deaths in the U.S.
About half as many toddlers were hospitalized with Covid between October 2020 and September 2021 as were hospitalized with the flu during the previous winter.
More children were hospitalized during the Omicron wave last winter, but hospitalization rates were still roughly in line with the 2019-20 flu season.
None of the 5,400 or so toddlers in Moderna’s trial were hospitalized for Covid. Yet, at least 15 were hospitalized for non-Covid infections.
The two children in Pfizer’s trial who got sickest with Covid also tested positive for other viruses. It’s possible that many hospitalizations attributed to Covid this winter were actually instigated or exacerbated by other viruses. Doctors had warned that more “immunologically naive” children were likely to get sick once schools reopened and lockdowns were lifted.
At least Moderna’s trial showed modest efficacy against symptomatic Omicron infection—37% among 2- to 5-year-olds and 51% for those 6 months to 2 years old. Pfizer claimed its vaccine was 80% effective, but this is misleading.
For one, Pfizer contravened numerous clinical-trial conventions. Its initial protocol involved only two doses, but this failed to generate the antibody levels required for FDA approval. So Pfizer added a third dose, which the FDA generously allowed. Usually, the agency won’t let drugmakers make a course correction when a trial ends in failure.
Pfizer then planned to track at least 21 cases to establish a bare-bones measure of efficacy. By comparison, Moderna tracked more than 250 cases. Yet Pfizer truncated its data collection on April 29—the day after Moderna announced it had submitted its application for emergency-use authorization—even though a mere 10 cases had been recorded after the third dose. It’s hard not to conclude that Pfizer cut corners to avoid getting beaten by Moderna.
But as a result too few cases were documented to measure with any degree of confidence Pfizer’s vaccine efficacy. Pfizer nonetheless proclaimed its vaccine was 80% effective. Moderna scientists must be seething. A Pfizer spokesperson says the FDA was more interested in vaccine “immunogenicity” data than efficacy among toddlers and will do another efficacy analysis after more cases accrue.
More troubling, vaccinated toddlers in Pfizer’s trial were more likely to get severely ill with Covid than those who received a placebo. Pfizer claimed most severe cases weren’t “clinically significant,” whatever that means, but this was all the more reason that the FDA should have required a longer follow-up before authorizing the vaccine.
Also worrisome: Most kids who developed multiple infections during the trial were vaccinated. This warranted more investigation since experimental vaccines for other diseases sometimes increases susceptibility to infection.
Bold is mine.