The motion filed in the U.S. District Court for the Northern District of Alabama named the HHS and Health Secretary Xavier Becerra as defendants. It also named a number of HHS sub-agencies as defendants, such as the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health.
Aside from Becerra and the sub-agencies, the motion also named HHS Acting Assistant Secretary for Preparedness and Response Nikki Bratcher-Bowman and the FDA's Vaccines and Related Biological Products Advisory Committee as co-defendants.
AFLDS Pediatric Medical Director Dr. Angelina Farella said in a statement: "The rotavirus vaccine was pulled [from the market] for 15 cases of non-lethal side effects. [The] swine flu vaccine was pulled for 25 deaths. But now, by the CDC's own data, we are seeing a 12,000 percent increase in deaths with these vaccines – and they're still talking about giving this to our kids."
Farella added that children are at "statistically zero risk" for COVID-19 based on CDC data. The same data show that COVID-19 patients below 20 years old have a 99.997 percent chance of surviving the disease. Thus, any move to expand the emergency use authorization (EUA) for COVID-19 vaccines to include younger people is medically unnecessary as well as ethically irresponsibe.
"Our children should never be the experiment," Farella said.
Attorney Lowell H. Becraft Jr. said: "There is no public interest in subjecting children to an inoculation program in order to protect them from a disease that simply does not threaten them."
The plaintiffs' leading attorney added: "Children are inherently incapable of providing informed content. Neither the children nor their parents can possibly give informed consent to these vaccines, since the [HHS] Secretary has failed to make … even the minimum statutory disclosures regarding risks and alternative treatments."
The May 19 suit filed by AFLDS and the parents followed the FDA's decision to expand the EUA for the Pfizer/BioNTech vaccine. A May 10 statement by the FDA said the two-dose mRNA vaccine can now be administered to children 12 to 15 years old. Its original authorization in December of last year permitted its use on individuals aged 16 years and above.
Acting FDA Commissioner Dr. Janet Woodcock said: "The FDA's expansion of the [EUA] for the Pfizer/BioNTech COVID-19 [vaccine] to include adolescents 12 [to] 15 years of age is a significant step in the fight against the … pandemic." She assured parents and guardians that the FDA performed a "rigorous and thorough review of all available data" before expanding the EUA.
Two days later, the CDC's Advisory Committee on Immunization Practices unanimously voted to approve the Pfizer/BioNTech vaccine for children 12 to 15 years old. CDC Director Dr. Rochelle Walensky signed the committee's May 12 recommendation and defended the move. "For vaccination to do its job, we must do our critical part. That means vaccinating as many [eligible] people as possible," she said.
Meanwhile, Pfizer lauded the FDA's decision to amend its vaccine's initial EUA. In a May 10 statement, Pfizer Chairman and CEO Albert Bourla said the regulator's move "represents a significant step forward in helping the U.S. government broaden its vaccination program and … protect adolescents before the start of the next school year."
The New York-based drug company added that it is evaluating the safety of its COVID-19 vaccine for children six months to 11 years old. Furthermore, it announced future plans to seek emergency authorization for two cohorts – children aged two to five and children aged five to 11 years old.
But not everyone shares the same opinion as Bourla. Plaintiff Matt Schweder expressed concerns about how the vaccine EUAs were handled and disagreed with the government pressuring young people to get vaccinated.
"I've done my research and know that there is essentially zero percent risk for young people dying of COVID-19," he said. Schweder – who is a parent of minor-aged children – added: "[I] fiercely oppose the use of an untested product that has not been fully approved for use in healthy children."
Ultimately, AFLDS Executive Communications Director Dr. Teryn Clarke said: "We all would like to put COVID-19 behind us, but we must be responsible about it as physicians, [as] parents and as a nation. People are being misled here, and we need to ensure that we don't rob our children of their future – because of a rush to administer a vaccine that has not been fully tested and approved."