According to the New York Times (NYT), the FDA asked Pfizer and Moderna to expand their COVID-19 vaccine trials. It specifically requested that the vaccine trials include at least 3,000 children aged five to 11 years old. The expanded trials would help regulators better understand the potential side effects from the two companies' mRNA vaccines in younger populations, the report added.
The NYT report also said Pfizer is also in talks to include younger children in its vaccine trials. A spokesperson for the company said it has no updates to its previous trial timelines or details. The New York-based drug firm earlier announced its plan to enroll around 4,500 children between six months and 11 years old at more than 90 clinical trial sites. However, the size of the group aged five to 11 years old remained unclear.
Meanwhile, a Moderna spokesperson told The Washington Post that the company is "actively discussing a proposal" with the FDA to expand its vaccine trial. The proposal strived to "enroll a larger safety database which increases the likelihood of detecting rarer events." The spokesperson for the Massachusetts-based firm added that a final number for the trial's size has yet to be determined.
The FDA added a warning to both the Pfizer and Moderna vaccines in June 2021 about the risk of cardiac inflammations – myocarditis and pericarditis in particular. Myocarditis involved the inflammation of the heart muscle, while pericarditis involved the inflammation of the heart's lining. The June 25 updates to both the vaccines' fact sheets cited "increased risks of myocarditis and pericarditis, particularly following the second dose."
Making children guinea pigs for the experimental vaccines
The Centers for Disease Control and Prevention (CDC) said that as of July 19, health officials confirmed 674 reports of myocarditis and pericarditis among vaccinated people aged 30 and younger. The public health agency added that most who reported cardiac inflammation received mRNA vaccines. Because of this, the CDC said it is investigating the reports "to assess whether [they have] a relationship to COVID-19 vaccination" alongside its partners.
In spite of the concerning number of cardiac inflammation cases following vaccination, the CDC insisted that these side effects were rare. It defended vaccines as "safe and effective" and recommended Americans aged 12 and older to "get vaccinated as soon as possible." (Related: Heart inflammation reported in teens following Moderna and Pfizer vaccine.)
However, the expanded COVID-19 vaccine trials appeared to be a demand to experiment on more children. Many studies have shown that children have an extremely low risk of dying from or catching severe COVID-19. If anything, forcing dangerous vaccines on children that have a very high chance of recovering from SARS-CoV-2 infection constituted a crime against humanity.
Because of this, nonprofit group America's Frontline Doctors (AFLDS) filed a motion on July 19 in the U.S. District Court for the Northern District of Alabama. The motion asked the court to stop the use of COVID-19 vaccines granted emergency use authorization (EUA) by the FDA. Both the two-dose mRNA vaccines by Pfizer and Moderna, alongside the single-dose Johnson & Johnson vaccine, received emergency approval in the United States.
AFLDS's suit called to immediately stop vaccinations for three particular groups of Americans. People aged 18 years old and below were among the three groups named by AFLDS. "Human children are not experiments," the nonprofit organization said in a press release. (Related: America's Frontline Doctors sue HHS to revoke emergency use authorization for covid vaccines.)
According to AFLDS, children were "at statistically zero percent risk of death" from COVID-19. On the other hand, expert studies revealed that COVID-19 vaccine deaths numbered "into the tens of thousands" and vaccine injuries amounted to "well into the hundreds of thousands." AFLDS Communications Director Dr. Teryn Clarke said: "Children are one third of our population and all of our future. Children are never the experiment."
Mother-of-two Deborah Sobczak, who was among the motion's plaintiffs, said: "My [children] will not be [subjects] of an experiment. Perfectly healthy children have developed heart inflammation, brain bleeding and even died. I am not sacrificing my [children] so a pharmaceutical company can experiment on [them.]"
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