The CDC approves vaccines for children under five: An advance, but with many limitations

Over the weekend, the Advisory Committee on Immunization Practices (ACIP) voted unanimously to approve the COVID vaccines for the youngest in the population. Based on these endorsements, the Centers for Disease Control and Prevention (CDC) recommended that children between six months and five years of age should be vaccinated with either Pfizer or Moderna’s COVID-19 vaccines.

Arihana Macias, 7, gets a compress after receiving the Pfizer COVID-19 vaccine for children five to 12 years at a Dallas County Health and Human vaccination site in Mesquite, Texas, Thursday, Nov. 4, 2021. [AP Photo/LM Otero]

There are 19.3 million in this age group for whom the COVID vaccines remained out of reach since the vaccines were first ushered in in December 2020. 

While the number of young children who have died from COVID has so far remained low, some 442 under the age of five according to the CDC, this figure is far greater than the death toll from influenza in the same age bracket. As the pediatric infectious disease specialist Dr. Yvonne Maldonado of Stanford University noted, “Children shouldn’t be dying of anything.” 

According to the American Academy of Pediatrics (AAP), children represented nearly 19 percent of all cumulative COVID cases in the US. However, seroprevalence data based on blood samples, published by the CDC, indicated that approximately 75 percent of all children 18 and under have been infected, far above the 60 percent figure for the whole population.

This means that children represent the most infected group, a point that should be contrasted with the incessant claims by capitalist politicians and the media bears that children were somehow immune to the ravages of the virus. 

Since the pandemic, AAP reported that over 90,000 children have been hospitalized for COVID, a number known to be a vast undercount. Per the CDC’s provisional count of COVID deaths, 1,257 children have died during the pandemic, 20 percent of them during the Omicron wave.

These figures might seem low compared to the horrifying death toll among the elderly and immunocompromised, but they are far greater than the toll in terms of hospitalizations and death from the flu among the same age group.

There were 42,386 pediatric hospitalizations during the 2017-2018 flu season, the worst in the last decade, as compared to the quarter million hospitalized in the first three months of this year due to COVID. 

There were also 110 deaths among the youngest and, in total, 526 children died that flu season compared to the over 1,200 who have been killed by SARS-CoV-2. In the current flu season, only 29 children have died, in large part to the limited mitigation measures in effect, including masking. In just the last month alone, almost 60 children died from COVID.

study released in preprint by the Imperial College of London, reviewing COVID deaths among children, found, “COVID was a leading cause of death in CYP [children and young people] aged 0-19 years in the US between March 2020 to April 2022, ranking #9 among all causes of deaths, #5 in disease-related causes of deaths (excluding accidents, assault and suicide), and #1 in deaths caused by infectious/respiratory disease.” Specifically, for those under the age of five, it ranked in the top five.

All these figures do not even address the broader issue of Long COVID and its unknown long-term impact on the health of children, who have much longer to live and develop symptoms than the elderly.

These realities make the approval of the Pfizer and Moderna vaccines a welcome step forward, albeit with significant limitations, as we shall see.

Both Pfizer and Moderna had presented their clinical-trial data to the Food and Drug Administration’s (FDA) advisory panel on June 15, highlighting that these vaccines are both safe and produce an antibody response that is similar to that in older children and adults. The panel recommended the vaccines unanimously by a 21-0 vote.

There are differences between the two pediatric version of the mRNA vaccines that are important to review.

Pfizer’s regimen consists of three shots, each containing three micrograms, or one-tenth of the adult dose. The second shot is given three weeks after the first and the third two months later, with a total of three months required to complete the series. 

The pediatric trials were small, with fewer than 1,000 participants. Only 10 children actually contracted COVID, seven in the placebo group and three in the vaccine group. Pfizer’s original two-dose regimen had not generated a sufficient immune response, leading the company to announce in December 2021 that it would add a third dose to its regimen.

As STAT News noted regarding Pfizer’s limited effectiveness data, “This was a result of the fact that the Pfizer shot was not effective enough as a two-dose vaccine to warrant authorization. The company, consulting with the FDA, decided to test a third dose, but there has simply not been enough time for cases of COVID to occur. FDA officials say they are confident the three-dose regimen protects as well as two doses in other age groups.”

It bears mentioning that the FDA’s confidence was based on the level of immune antibodies generated after participants had completed the vaccine series. As Pfizer noted in its review of the results for children aged 2-4 years and infants 6-23 months, “The antibody responses in both age groups were comparable to those recorded in people 16 to 25 years of age immunized with two 30-µg doses and met the pre-specified success criteria ...”

Moderna’s vaccine is a two-dose regimen, each containing 25 micrograms, or a quarter of an adult dose. The shots are given four weeks apart. Though children complete the vaccination series sooner with Moderna, the side effects, albeit transient, may be harsher. Whereas Pfizer’s were limited to pain at the injection site and some fatigue that resolved quickly, in the Moderna trial one child had a seizure presumably triggered by a high fever after vaccination.

An FDA panel member, who is a pediatric infectious-disease specialist from Washington University School of Medicine in St. Louis, Missouri, said, “Beyond one febrile seizure, there wasn’t anything that was highly concerning. That was very reassuring to me.”

Moderna’s trial was larger, at almost 5,000 participants. The efficacy against symptomatic infection ranged from around 37 to 51 percent with 265 children contracting COVID, making the data more robust and applicable. Additionally, in the Moderna trial more participants who received the active ingredient developed a fever after the second vaccine dose, while the adverse reactions among Pfizer recipients and the placebo arm had similar complaints.

Other side effects of the vaccines include loss of appetite, nausea or vomiting, irritability, fever, and pain at the site of injection. With Moderna, children can develop swollen lymph nodes in the inoculated arm. The trials were too small to evaluate for heart inflammation, which has occurred infrequently in adolescent boys. Questions about boosters have already been raised, as immune waning is rapid with the vaccines and the subvariants of the Omicron strain of SARS-CoV-2 are known to have significant immune evasion capacity.

As critical as it is to ensure all children have access to life-saving vaccines, the CDC and the Biden administration will use this advance to reinforce their claims that a vaccine-only approach is a viable response to the pandemic. They seek to justify the abandonment of all-inclusive public health measures to ensure mask mandates are in place, all COVID cases are tracked, and public health departments provide robust and accurate data that includes infections, hospitalizations and deaths.

More than 18 months into the era of COVID vaccines, the vaccine-only strategy has proven an abysmal failure. Breakthrough infections are very common, and vaccines have not alleviated the risks of Long COVID nor the impact on various organ systems. The campaign for Zero-COVID remains the only viable solution to a pandemic that continues to wreak havoc on the population of the working class across the globe.