The FDA approves boosters for minors – without testing boosters on minors - Age group testing? Zero.
Late last week, on December 9, the FDA approved the Emergency Use Authorization (EUA) for the Pfizer COVID-19 vaccine, “authorizing the use of a single booster dose for administration to individuals 16 and 17 years of age.” The booster is to be given at least 6 months after vaccination.
Before we get to the data the FDA cited in the booster for kids aged 16-17, let’s go through the facts:
COVID-19 is not a threat to teenagers aged 16-17. On October 25, we warned that the FDA was about to approve an experimental COVID-19 vaccine for children. It seemed unnecessary to give the EUA Pfizer vaccine to minors, as CDC data showed that for children aged 5-11 years-old, there have been 1.8 million COVID-19 cases and only 138 deaths. Even the CDC concedes that “children are less likely to develop severe illness or die from COVID-19.”
The Pfizer vaccine is particularly dangerous for young men aged 16-17. As we observed back in October, teenage boys are especially at risk for heart problems – like myocarditis – after getting the Pfizer vaccine:
“Boys between 16 and 19 years of age had the highest incidence of myocarditis after the second dose . . . The risk of heart problems in boys of that age was about nine times higher than in unvaccinated boys of the same age.” New York Times.
The risk of myocarditis for boys 16 – 19 years old is higher after the Pfizer second dose. What happens after the third dose??
That’s a good question.
One would rightly assume that the third dose might present more danger of heart problems than the second dose. But FDA doesn’t have the answer to this question. And why doesn’t it have the answer?
Because the FDA didn’t look.
Because the FDA conducted ZERO tests in this age bracket before approving the latest Pfizer booster for this age bracket.
Instead, the FDA relied on prior (old) data from only “200 participants, 18 through 55 years of age.” Instead of looking at long-term data for the efficacy of the Pfizer booster shot, the FDA reviewed “the antibody response against the SARS-CoV-2 virus one month after a booster dose of the vaccine.”
That’s it. That’s the data. Given the FDA’s self-imposed and purposeful limitations on its own information, it has the audacity to conclude:
“The benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Comirnaty outweigh the risks of myocarditis and pericarditis in individuals 16 and 17 years of age to provide continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death.”
This is the FDA making a cost/benefit calculation without knowing the costs or benefits.
If it sounds familiar, it is because the Government did the same thing when recommending the COVID-19 vaccines for “people who are pregnant.”
 |  |  |
You’re a free subscriber to The Reactionary. For the full experience, become a paid subscriber.
Comments
Post a Comment