Twenty-five members of Congress are asking U.S. drug regulators to explain why they cleared COVID-19 vaccine booster shots for 12- to 15-year-olds without consulting a panel of expert advisers.
They also asked for an explanation of why the panel was not convened before the “unusual decision,” including what factors were utilized and what scientific materials the FDA relied upon.
“We owe it to Americans to stand up against bureaucrat-driven policies that take away power and information from parents to make good choices for their children. The FDA’s unusual decision to bypass their normal committee approval process puts children at risk. The accumulation of mistaken federal policies carried out by executive fiat in response to the pandemic—from lockdowns, to perpetual masking, and rushed vaccine policies—deeply concern me,” Roy told The Epoch Times in an emailed statement.
“Democrats from [President] Joe Biden all the way down to county and city officials have spent the last two years trying to stop parents from choosing what’s best for their children by closing schools, imposing authoritarian mandates, and selectively enforcing lockdowns. These petty tyrants have shamefully vilified and persecuted the parents who dared to challenge them. Parents are right to stand up for the kids and demand answers and accountability, and I’m proud to fight for them,” Cruz added.
An FDA spokeswoman confirmed receipt of the missive and said the agency would respond directly to Congress.
All three COVID-19 vaccines authorized for use in the United States were originally declared highly effective against both infection and severe disease by federal officials, but their effectiveness, particularly against infection, was shown to wane considerably over time against the Delta virus variant, triggering a push for boosters.
Before the FDA and the Centers for Disease Control and Prevention (CDC) decided on whether to clear and recommend boosters, top Biden administration officials in the fall said boosters were needed for all 16 or older, citing the weakened protection.
Panel members didn’t see “a clear benefit” and were concerned about post-vaccination heart inflammation, Dr. Paul Offit, one of the members, told The Epoch Times in a recent interview.
The FDA agreed, but the agency in November decided to clear boosters of all three vaccines, only consulting the panel before clearing an additional dose of the Johnson & Johnson jab.
An FDA spokesperson told The Epoch Times previously that the agency’s review of data on boosters “does not raise questions that would benefit from additional discussion by the members of the committee.”
Regulators relied heavily on data from Israel when authorizing a Pfizer booster for kids as young as 12, alleging data from the country revealed “no new safety concerns in this population” because “there were no new cases of myocarditis or pericarditis reported to date in these individuals.”
However, an Israeli health official told a CDC meeting in early January that two cases of post-vaccination heart inflammation were detected out of some 41,610 booster doses administered to the age group.
The FDA’s data review also included trial data on 78 16- or 17-year-olds, some of whom received a placebo, and no trial data on how boosters affect children 12- to 15-years-old.
The decision to authorize boosters for teenagers “is misguided and not based on any science,” Dr. Paul Alexander, a former senior pandemic adviser to the U.S. Department of Health and Human Services, told The Epoch Times in an email last month.
“The FDA has a responsibility to work to protect our nation’s children by ensuring the data and science show this booster vaccine is safe for 12- to 15-year-olds,” they said. “Children are still growing and developing, and these are relevant factors for consideration to ensure that this additional vaccine dosage is appropriate, especially as early teens in the 12 to 15 age group are at extremely low-risk for death and hospitalization from COVID-19.”
