Moderna has asked the US Food and Drug Administration (FDA) to approve emergency use (EUA) for its COVID-19 vaccine for 6-month-old children. However, according to Dr. Peter McCullough, such approval should not be given because there is almost no clinical benefit for such young children.
Pfizer is also working on data for a three-dose regimen after the FDA postponed its decision in February on whether to approve its COVID-19 vaccine for this age group.
“I don’t think it’s a beginner for kids that age,” McCullough told NTD’s April 30 Capitol Report program.
McCullough said a recent study from New York State found that the effectiveness of Pfizer’s COVID-19 vaccine in young children was so low that it “doesn’t seem to work.”
The study (pdf) analyzed the effectiveness of Pfizer in more than 1.2 million fully vaccinated children in New York State from December 13, 2021 to January 30, 2022. Among those vaccinated children, over 852,000 were aged 12 to 17 years and more 365,000 were aged 5 to 11 years.
“In the newspaper since [Vajeera] Dorabawila and colleagues from New York State, over several hundred thousand children aged 5 to 11, [had] there is virtually no clinical benefit, no vaccine efficacy. The overall effectiveness of the vaccine was less than 25 percent, ”said McCullough, a renowned cardiologist and epidemiologist.
The study found that the effectiveness of the vaccine against the infection dropped from 66 percent to 51 percent for 12- to 17-year-olds and from 68 percent to 12 percent for 5-11-year-olds in about a month and a half.
The Pfizer vaccine is the only one currently used in children in this age group.
The FDA said vaccines should be at least 50 percent effective in preventing infection or reducing the severity of the disease to get an emergency permit. The World Health Organization says vaccines must be 50 percent effective or better to get approval.
According to Modern data, the vaccine was only 43.7 percent effective in the youngest group and 37.5 percent in other children during the Omicron wave. Both were below the 50 percent limit. Some doctors and experts have questioned that the test result is not strong enough to justify the EUA.
“It’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 consider Modern’s request once additional information is provided.
“We received a request from Moderna for the EUA for the vaccine against COVID-19 for children from 6 months to 6 years of age. As the company acknowledged, they still need to provide additional information to meet their request. The FDA cannot decide on any vaccine without meeting the EUA’s requirements, which allows us to conduct a thorough audit, which includes, among other things, a comprehensive review of all adverse events and replication of key analyzes, “an FDA spokesman told The Epoch Times in an email. last week.
Some experts say it makes no sense for young children to receive COVID-19 vaccines because they are at low risk of serious illness and death from the CCP (Chinese Communist Party) virus, and possible serious side effects are a major concern.
“Parents should think twice about vaccinating their child,” Dr. Robert Malone told the Epoch Times, adding that serious adverse events can occur, and most of them are “irreversible.”
Malone is a key contributor to the mRNA vaccine, and his website includes a list of peer-reviewed studies related to the side effects of the COVID-19 vaccine in children, the main one being myocarditis.
In March, a top Florida health official issued guidelines, saying healthy children may not benefit from receiving current COVID-19 vaccines.
“Based on currently available data, the risks of vaccination against COVID-19 in healthy children may outweigh the benefits,” Florida’s chief surgeon said in a statement. . ”
The Centers for Disease Control and Prevention (CDC) declares that vaccines against COVID-19 are safe and effective, and that serious side effects are rare. The agency also says that all children aged 5 and over should receive the Pfizer vaccine, and all children aged 12 to 17 should receive the supplementary vaccine.
However, recent studies have found that Pfizer’s vaccine against COVID-19 does not work well in preventing infection against the Omicron variant for children aged 5 to 15 years.
McCullough pointed out that it would be unnecessary to vaccinate young children because most of them are already infected with the virus.
“We recently heard CDC reports that approximately 75 percent of children already had COVID. So it is too late for them to have any hope of a vaccine. The vaccine cannot help after someone has already had COVID, ”McCullough said, adding that if the vaccine does not have at least 50 percent coverage, it will be considered“ unsustainable ”.
On April 26, an early edition of the CDC’s Weekly Morbidity and Mortality Report said about 75 percent of children and adolescents had already developed antibodies to the disease.
The CDC recommends that those who have been infected continue to receive the vaccine, saying it will provide “additional protection against COVID-19.”
McCullough said COVID-19 became “progressively” milder through the progression of mutations and that the Omicron variant caused far fewer hospitalizations or deaths.
Numerous studies have found that the clinical severity of the infection is much lower for Omicron than for the Delta variant. In March, a peer-reviewed study published in the Lancet was the largest to date, analyzing data from 1.51 million people infected with COVID in England between November 2021 and January 2022. Among them, more than 1.06 million were infected with Omicron.
The study found that the overall risk of hospitalization within 14 days after a positive test was 1.64 percent in Delta and 0.9 percent in Omicron. The risk of mortality at 28 days after a positive test was 0.27 percent after Delta, and dropped to 0.11 percent after Omicron.
“I can tell you, we now have studies, big studies on Omicron, where there are almost zero hospitalizations or deaths,” McCullough said. “It’s basically a common cold.”
The Epoch Times contacted the FDA, Modern and Pfizer for comment.
Zachary Stieber and Mimi Nguyen Ly contributed to this report.