By Zachary Stieber
The U.S. Food and Drug Administration (FDA) abused and is continuing to abuse its power by granting emergency authorization for COVID-19 vaccines for children and keeping the emergency clearance in place even after the COVID emergency ended, a federal court heard on Jan. 10.
The FDA has authorized the Moderna and Pfizer COVID-19 vaccines for children as young as 6 months of age despite insufficient evidence, mislabeling the gene therapy products as vaccines, and making false statements about their safety and efficacy, plaintiffs in the case say.
They asked a U.S. court in 2022 to stop the FDA from marketing the shots to many children and to order the FDA to revisit its decision to issue the emergency use authorizations (EUAs).
The nonprofit Children’s Health Defense (CHD) and several parents brought the case.
A federal judge dismissed the case, finding that neither the nonprofit nor the parents met the bar for standing, which includes showing that they have suffered an injury and that their requested judicial relief would likely redress the injury.
That prompted an appeal. CHD and the government presented their positions during oral arguments in front of the U.S. Court of Appeals for the Fifth Circuit on Wednesday.
“If you’re bringing a claim on behalf of a third-party, standing can be difficult. But if you’re bringing it when you are the object of the agency action then typically you do have standing. That was the case here,” Robert Barnes, a lawyer representing CHD, told the court.
One judge questioned why the case was still relevant, considering how the pandemic has receded.
“Now we are in the endemic whatever, it’s not a pandemic anymore, but it’s kind of going to be with us forever,” she said. “What is the FDA doing now, that is of any relevance to you all, besides having the COVID vaccine available for kids?”
“They’re still promoting it, they’re still marketing it, they’re still suppressing information that’s relevant to the parents being able to make an informed consent decision, they’re still suppressing Children’s Health Defense,” which is blocked from multiple social media networks, Mr. Barnes said.
The FDA has, since the suit was filed in 2022, granted emergency authorization to two more rounds of shots from vaccine manufacturers, most recently in the fall of 2023. The Pfizer and Moderna vaccines have emergency clearance for children aged 6 months through 11 years of age, while Novavax’s shot has emergency authorization for individuals 12 years of age and older. That’s despite President Joe Biden declaring an end to the COVID-19 emergency in May 2023.
Emergency authorization has a lower standard than approval. It can be given if the FDA believes a product may be effective and there is no alternative. Approval historically involves much more data, including clinical data, though approval has been given to some of the COVID-19 shots without clinical data.
The case, if the appeal is granted, could result in the rescinding of the emergency authorizations for children aged 6 months through 11 years.
“If in fact it’s unsafe and ineffective for kids, absolutely,” Mr. Barnes said. “And we intend to prove that,” if the case is revived.
Another option is changing the labeling so it’s accurate, he said.
“We don’t want to wait until 15 years from now, and we have a different epidemic on our hands,” he added later. “Like what happened with the 1978 swine flu vaccine, where two years later we figured out, ‘Oh, the FDA rushed it, they shouldn’t have rushed it.’”
Sean Janda, a government lawyer representing the FDA, focused on the standing argument, telling the judges that neither CHD nor the parents have standing to sue.
“To the extent they think that we’ve screwed up the science, I don’t think that’s injury to them,” he said.
The parents said they have standing because guidance in Texas, their home state, allows vaccination of minors if there is “no known parental objection.”
CHD says it had to divert resources to respond to the FDA’s actions, including to filing a citizen petition for the first time, which constitutes an injury.
CHD says “that they had to do all sorts of contortions novel to their organization,” one of the judges said. “Doesn’t that seem to fall into the category of unusual activity, oppositional activity that yields standing?”
“No, your honor,” Mr. Janda said. “Nothing in the EUA requires the organization to do anything, or regulates them in any way. … The fact that FDA has done something that the organization disagrees with is not the basis for standing.”
He also said that the plaintiffs’ children are not “subject to a vaccine.”
In a written brief, government lawyers said that even if an injury was demonstrated, it would not be traceable to the FDA’s conduct.
“Plaintiffs fail to demonstrate that any of FDA’s actions in issuing the COVID-19 vaccine EUAs had any such determinative or coercive effect on the third parties that plaintiffs assert may vaccinate their children or harass or propagandize to them,” they wrote. “To the contrary, any such third parties are exercising their own discretion in choosing how to interact with unvaccinated individuals, and any harm they may choose to cause is not directly traceable to FDA’s challenged actions.”