[W]e don’t know if the vaccines are safe and effective. The rushed FDA action was based on extremely weak evidence. It’s one thing to show regulatory flexibility during an emergency. But for children, Covid isn’t an emergency. The FDA bent its standards to an unusual degree and brushed aside troubling evidence that warrants more investigation….
Only 209 kids between 6 months and 4 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.
Category: COVID-19 and Public Health
Why Don’t People Trust the CDC?
Consider the CDC studies on school mask mandates, which have uniformly claimed benefits. Two researchers at the University of Toronto and University of California, Davis recently sought to replicate a CDC study that found that pediatric Covid cases increased faster in U.S. counties that didn’t have school mask mandates compared with those that did….
As another example, recall the CDC’s widely cited studies last fall that purportedly found vaccines provide better protection than natural immunity from infection…. But a new study, published this month in the New England Journal of Medicine, finds that natural immunity provides more-durable and stronger protection than vaccines.
Pfizer’s View of its Own Vaccine
Turns out, it is very positive. But in a review of Pfizer CEO Albert Bourla’s book, Moonshot, Robert Kaplan asks:
How transparent has Pfizer been? In the book’s more than 200 pages, one topic is not explored in any real depth—side effects. Although the vaccine is generally regarded as safe, side effects do appear to be more common—and perhaps more severe—than for other widely used vaccines. In the 2020 clinical trial that provided the basis for FDA emergency-use authorization, more than 83% of 18- to 55-year-old participants (in comparison with 14% of those injected with a placebo) reported arm pain after their first shot, and approximately a third had a fever in reaction to their second (in contrast to less than 1% for a placebo).
FDA Looking to Modify Covid Vaccine for Omicron (Only a Year too Late)
On Tuesday, the Vaccines and Related Biological Products Advisory Committee of the U.S. Food and Drug Administration met to discuss the Covid-19 vaccine booster. The advisory committee was tasked to decide whether to recommend updating the Covid vaccine to contain an Omicron component for booster vaccines in the United States. Public health officials are concerned that the arrival of colder weather than keeps people indoors along with emerging variants could result in a sharp rise in Covid cases.