Pfizer and BioNTech asked the Food and Drug Administration on Tuesday to grant emergency use authorization to administer its COVID-19 vaccine to children younger than 5 years old.
The FDA already has granted emergency use authorization for children between the ages of 5 and 11 despite members of FDA and CDC advisory panels expressing concern that safety data for children regarding Pfizer’s COVID vaccine is lacking. And further, children have a nearly 100% survival rate from infection while the current omicron variant generally is producing mild symptoms.
Last week, White House coronavirus adviser Dr. Anthony Fauci said children younger than 4 years old likely will receive three doses of the Pfizer COVID-19 when it’s approved after clinical trials showed two doses were ineffective.
Some members of an FDA panel said they reluctantly approved the shots for children 5-11 because they wanted high-risk children to have access. Panel member Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine, said: “We’re never going to learn about how safe the vaccine is unless we start giving it. That’s just the way it goes.”
Robert F. Kennedy Jr.’s non-profit Children’s Health Defense has filed a lawsuit against the FDA charging the agency’s emergency use authorization of COVID vaccines for children 5-11 violated federal law. The complaint contends the move was arbitrary and capricious since the agency didn’t follow its own guidelines in granting “authorization for medical products for use in emergencies.”
The argument is that the law allows for EUA designation only when “there is no adequate, approved and available alternative to the product for diagnosing, preventing or treating such disease or condition.”
The lawsuit contends the FDA ignored reports of deaths and serious injuries, and there are other, safer options for treating COVID-19.
“Vaccinating young children against a virus that poses no harm to them is unethical and dangerous,” said CHD president and general counsel Mary Holland. “It does, however, bring Pharma closer to its ultimate goal of getting COVID shots added to the recommended childhood vaccine schedule, which means Pfizer and other COVID vaccine manufacturers will have a captive market in perpetuity and likely never be held accountable for harm or even death to young children caused by their products.”
CHD cited a Johns Hopkins study showing a COVID mortality rate of zero among 48,000 children without preexisting conditions. And a major study in Germany found the case fatality rate among children is three out of a million. And zero deaths occurred in children under 5.
Former FDA commissioner Scott Gottlieb said Sunday the vaccine might be authorized for children under 5 as soon as March.
Pfizer found in clinical trials, with a shot administered at one-tenth the strength of the adult shot, that two doses did not produce an immune response in children ages 2-5. That prompted regulators to urge the administering of a third shot at least two months after the second dose.
Young children are far less likely than adults to die or develop serious complications from COVID-19.
One month ago, Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, warned that children were being hospitalized “at their highest rate compared to any prior point in the pandemic.
But the CDC and other officials are now acknowledging that a substantial percentage were admitted for other reasons and tested positive while in the hospital.
The the World Health Organization’s chief scientist said last week that healthy children and adolescents don’t need COVID-19 vaccine booster doses.
“There is no evidence right now that healthy children or healthy adolescents need boosters. No evidence at all,” said Soumya Swaminathan at a news briefing Tuesday.
Last month, Dr. Robert Malone, the leader inventor of the mRNA technology behind the Pfizer and Moderna vaccines, issued a video statement explaining why more than 15,000 physicians and medical scientists around the world have signed a declaration that healthy children should not be vaccinated for COVID-19.
Malone said there is “no benefit for your children or your family to be vaccinating your children against the small risks of the virus, given the known health risks of the vaccine that as a parent, you and your children may have to live with for the rest of their lives.”
Pfizer CEO Albert Bourla acknowledged earlier this month that two doses of his vaccine “offer very limited protection, if any” against omicron. And he said the mRNA vaccines “don’t have the safety profile that we hoped we can achieve with this technology.” Pfizer is working on a new vaccine to target omicron that he hopes will be ready by March.
Earlier this month, the European Union’s top health agency warned that getting boosted every four months could harm the immune system’s ability to fight off the disease. The European Medicines Agency advised countries instead to mirror the seasonal influenza vaccination strategy tied to the onset of the cold season. And the WHO said in a statement last week that a vaccination strategy based on repeated booster doses of the original COVID-19 vaccines is unlikely to be appropriate or sustainable.