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.
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.”
“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.
“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.
“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.”
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."
McCullough said COVID-19 has become "progressively" milder through its progression of mutations and the Omicron variant caused much fewer hospitalizations or deaths.
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.