On June 15, 2022 the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the U.S. Food and Drug Administration (FDA) unanimously advised the FDA staff to grant Moderna and Pfizer/BioNTech an Emergency Use Authorization (EUA) amendment to allow their mRNA COVID vaccines to be given to children under age five and as young as six months.1 2 3 Within 48 hours, the FDA approved the EUA amendment followed by a June 17-18 meeting of the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC) that ended with a unanimous recommendation for both COVID vaccines to be given to all children in the six-month to five-year-old age group, which was immediately approved by the CDC’s director.4 5
National rollout of the reduced dose vaccines is underway this week and, with it, the U.S. becomes the first country to give COVID vaccine to children under age two.6
Natural immunity from SARS-CoV-2 infection has been documented to be robust and long lasting,7 8 9 and the CDC estimated in April that about 75 percent of children ages 0 to 11 years old in the U.S. already had been infected.10 After the CDC admitted in March that pediatric deaths from COVID were initially over-estimated,11 a June 15 FDA briefing document stated that, “According to death certificate data, 202 deaths have been attributed to COVID-19 among children 6 months to 4 years of age through May 11, 2022.”12
The FDA briefing document confirmed that “many persons” with COVID are “presenting with asymptomatic or mild disease,” noting that symptoms in children are “generally milder” and as many as 50 percent of infections in children are asymptomatic. The agency said that about half of the children four years old or younger, who were hospitalized with COVID, had one or more underlying health conditions.13
Weak mRNA COVID Vaccine Efficacy for Young Children
FDA summary documents for both Moderna and Pfizer vaccines show weak efficacy, especially when considering that the FDA did not require COVID-19 vaccine manufacturers to demonstrate their vaccines prevent infection and transmission of the SARS-CoV-2 virus to obtain an EUA.14 The companies were only required to demonstrate a minimum 50 percent efficacy in preventing severe COVID disease leading to hospitalization and death before the FDA granted an EUA to both companies in December 2020.
As the SARS-CoV-2 virus has evolved and created different variants over the past two years, COVID disease has been reported in a growing number of vaccinated people with quickly waning immunity, who are able to transmit the virus to others even though they are vaccinated.15 16 On June 15, 2022, the Washington State Department of Health reported that, between Jan. 17, 2021 and June 4, 2022, over 500,000 reported COVID cases occurred in vaccinated persons in that state, with 17 percent of vaccinated persons reporting symptoms, two percent being hospitalized and 0.4 percent dying of COVID-related illness.17
The clinical trial data from Pfizer and Moderna that the FDA used to green light administering mRNA COVID vaccines to very young children revealed that the efficacy of two 25 microgram doses (one quarter of the adult dose) of the Moderna COVID vaccine given about a month apart to children six months to five years old, who had not been previously infected with SARS-CoV-2, was 50.6 percent in preventing symptomatic COVID-19 in a six to 23 month old age group and 36.8 percent effective in a two to five year old age group. The Pfizer COVID vaccine, which is given in three doses containing three micrograms (one tenth the adult dose) with three weeks between the first and second dose and two months between the second and third dose, was tested in children aged six months to five years old. Although Pfizer reported 80 percent efficacy after the third dose in children under five, the numbers of children evaluated were so tiny that the FDA staff simply commented in its June 15 briefing paper for VRBPAC that, “In these FDA analyses, the immune response to the vaccine for both age groups of children was comparable to the immune response of the older participants.”18
mRNA COVID Vaccines for Young Children: Safety Last…
Continue reading the full story [icon name=”arrow-right” prefix=”fas”] Source: U.S. Becomes First Country to Give mRNA COVID Vaccine to Babies – The Vaccine Reaction