A key component of President Joe Biden’s recently revamped plan to end the COVID-19 pandemic involves providing booster shots to individuals once considered fully vaccinated — a plan that would require the approval of independent advisory panels for both the Food and Drug Administration (FDA) as well as the Centers for Disease Control and Prevention (CDC).
Unfortunately for Biden, a big wrench was just thrown into that plan. According to Fox News, the FDA advisory panel overwhelmingly rejected the idea of widely providing booster vaccinations to Americans age 16 and older, by a margin of 16–2.
Instead, the panel of independent advisors voted unanimously, 18–0, to only recommend authorization of booster vaccination shots for those age 65 and older, or who were otherwise considered to be a “high risk” of exposure or severe infection from the coronavirus.
Fox said the recommendations from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will now be forwarded to the broader agency for final approval, while the CDC’s own independent panel — the Advisory Committee on Immunization Practices (ACIP) — will hold a similar authorization vote next week.
“A serious concern”
According to NBC News, one of the main issues facing the FDA advisory panel ahead of the unexpected vote was the question of whether booster shots are effective or even necessary for otherwise healthy young adults and people between the ages of 16 and 65.
Citing insufficient evidence, panel members reportedly expressed skepticism about claims put forward by vaccine manufacturer Pfizer-BioNTech about the waning effectiveness, over time, of its initial two-dose vaccine.
Furthermore, some members of the panel expressed concern over evidence that side effects of the vaccine — such as myocarditis, an inflammation of the heart muscle — could prove more dangerous to young people than the virus itself.
“I have a serious concern about myocarditis and young people,” Dr. James Hildreth, a member of the panel and the CEO of Meharry Medical College in Nashville, said, according to NBC.
“The booster shots induce a very strong response that is going to amplify the risk for myocarditis in those individuals,” Hildreth said.
As noted, the ruling by the FDA panel puts a kink in President Biden’s six-pronged plan to combat the pandemic, which he first outlined in a speech Sept. 9.
Both in that talk as well as in a “Path out of the Pandemic” fact sheet released by the White House, it was noted that plans for widespread distribution of booster shots for COVID-19 would be contingent upon final approval by the FDA and CDC. Still, it seems the White House was expecting a yes; it said earlier this month that it would “be prepared” to begin rolling out the shots “starting the week of September 20th.”
Even as recently as Friday morning, Biden’s Surgeon General Vivek Murthy seemed confident that authorization would be granted, touting the fact that the White House had already prepared a substantial supply of booster doses ready to be administered imminently. To say the Biden administration was completely blindsided by the FDA panel’s decision would be an understatement.