Moderna has requested the U.S. Food and Drug Administration (FDA) to grant an emergency use authorization (EUA) for its COVID-19 vaccine for children as young as 6 months. However, according to Dr. Peter McCullough, such authorization shouldn’t be granted because there’s almost no clinical benefit for children that young.
Pfizer is also working on data for a three-dose regimen after the FDA postponed its decision in February on whether to authorize its COVID-19 vaccine for this age group.
“I think for children that age, it’s a non-starter,” McCullough told NTD’s “Capitol Report” program on April 30.
McCullough said a recent study from New York State showed the efficacy of Pfizer’s COVID-19 vaccine in young children was so low that “it looks like they don’t work.”
The study (pdf) analyzed the Pfizer vaccine’s effectiveness in over 1.2 million fully vaccinated children in New York state from Dec. 13, 2021, to Jan. 30, 2022. Among those vaccinated children, over 852,000 were aged 12–17, and over 365,000 were aged 5–11.
“In the papers by [Vajeera] Dorabawila and colleagues from New York state, over a couple hundred thousand children aged 5 to 11, [had] virtually no clinical benefit, no vaccine efficacy. All the vaccine efficacy was less than 25 percent,” said McCullough, a renowned cardiologist and epidemiologist.
The study found that the vaccine effectiveness against infection declined from 66 percent to 51 percent for 12 to 17-year-olds and from 68 percent to 12 percent for 5 to 11-year-olds in about one and a half months.
The Pfizer vaccine is the only one currently being administered to children in this age group.
The FDA has said that vaccines should be at least 50 percent effective in preventing infection or decreasing disease severity to receive emergency authorization. The World Health Organization says vaccines are required to be 50 percent effective or better to receive clearance.
According to Moderna’s data, the vaccine was just 43.7 percent effective in the youngest group and 37.5 percent effective in the other children during the Omicron wave. Both were below the 50 percent bar. Some doctors and experts questioned that the trial result was not strong enough to warrant a EUA.
“That’s not acceptable by the FDA’s own standards,” Dr. Steven Hatfill, a virologist who advised the Trump administration, told The Epoch Times last month.
The FDA said it would thoroughly review Moderna’s request after additional data was provided.
“We have received a request from Moderna for a EUA for its COVID-19 vaccine for children 6 months to 6 years of age. As the company has acknowledged, they still need to submit additional data to complete its request. FDA cannot reach a decision on any vaccine without a completed EUA request, which allows us to do a thorough review, which includes, among other things, a comprehensive review of all of the adverse events and replication of the key analyses,” an FDA spokesperson told The Epoch Times in an email last week.
Some experts said it doesn’t make sense for young children to receive COVID-19 vaccines, as they are at low risk for severe disease and death from the CCP (Chinese Communist Party) virus, and the possible severe side effects are a big concern.
“Parents should think twice about vaccinating their child,” Dr. Robert Malone previously told The Epoch Times, adding that serious adverse events can occur, and most “are irreversible.”
Malone is a key contributor to mRNA vaccines, and his website includes a list of peer-reviewed studies related to COVID-19 vaccine adverse events in children, the main one being myocarditis.
In March, Florida’s top health official issued guidance, saying healthy children may not benefit from receiving current COVID-19 vaccines.
“Based on currently available data, the risks of administering COVID-19 vaccination among healthy children may outweigh the benefits,” Florida Surgeon General Dr. said in a statement. “That is why these decisions should be made on an individual basis and never mandated.”
The Centers for Disease Control and Prevention (CDC) has been saying that COVID-19 vaccines are safe and effective, and severe side effects are rare. The agency also says that all children aged 5 and older should get Pfizer’s vaccine, and all children between the ages of 12 and 17 should get a booster.
However, recent studies have found that Pfizer’s COVID-19 vaccine doesn’t do well in preventing infection against the Omicron variant for children 5 to 15 years old.
McCullough pointed out that it would be unnecessary to get young children vaccinated because most of them have already contracted the virus.
“We’ve heard reports recently from the CDC that roughly 75 percent of children have already had COVID. So for them, it’s too late for any hope of a vaccine. The vaccine can’t help once somebody’s already had COVID,” McCullough said, adding that if a vaccine doesn’t have at least 50 percent coverage, it would be considered “nonviable.”
On April 26, an early release of CDC’s Morbidity and Mortality Weekly Report said that about 75 percent of children and adolescents had already developed antibodies against the disease.
CDC recommends people who were infected to still receive the vaccine, saying it would provide “added protection against COVID-19.”
McCullough said COVID-19 has become “progressively” milder through its progression of mutations and the Omicron variant caused much fewer hospitalizations or deaths.
A number of studies have found that the clinical severity of infection is much lower for Omicron than for the Delta variant. In March, a peer-reviewed study published in Lancet is the largest one to date, which analyzed data from 1.51 million COVID-infected people in England between November 2021 and January 2022. Among them, over 1.06 million were infected by Omicron.
The study found that the overall risk of hospitalization within the 14 days after a positive test was 1.64 percent with Delta and 0.9 percent with Omicron. The mortality risk in the 28 days after a positive test was 0.27 percent after Delta, falling to 0.11 percent after Omicron.
“I can tell you, we have studies now, large studies on Omicron, where there’s close to zero hospitalizations or deaths,” said McCullough. “It’s essentially a common cold.”
The Epoch Times has contacted FDA, Moderna, and Pfizer for comments.
Zachary Stieber and Mimi Nguyen Ly contributed to this report.