If studies show a good immune response and safety, it will then launch the vaccine for children aged six months to five.
“If safety and immunogenicity is confirmed, and pending authorization or approval from regulators, we hope to submit the vaccine for potential Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) sometime in September–October timeframe for children 5–11, and soon after for 6 months to 5,” the company said in a statement.
Pfizer developed its vaccine in partnership with German biotechnology company BioNTech.
The drugmaker is testing its vaccine at lower doses in three different age groups: five to 11 years, two to five years, and six months to two years, to examine vaccine efficacy, safety, and immunity.
The vaccine’s effectiveness will be worked out by comparing the participants’ immune responses to the “16–25-year-old population from the pivotal Phase 3 trial, as vaccine efficacy has been demonstrated in this age group,” Pfizer said.
The children will be given two injections of either the vaccine or a placebo spaced three weeks apart. Those aged five to 11 will receive 10 micrograms each, while the younger age group will get three micrograms each.
Around 4,500 children will be enrolled at clinical sites in the United States, Spain, Finland, and Poland.
Pfizer also said that infants younger than six months may be considered for vaccination “once an acceptable safety profile has been established.”
While the trial is expected to last for two years, Pfizer said that all the participants will be unblinded, or told whether they received the vaccine or a placebo, at a six-month follow-up visit. Those who originally got the placebo will be offered the vaccine.
The FDA expanded the use of Pfizer’s vaccine to 12- to 15-year-olds on May 10, with the Centers for Disease Control and Prevention (CDC) issuing a recommendation two days later.
Proponents of vaccinating children say that it will help in achieving herd immunity and possibly prevent children from developing a rare condition called multi-system inflammatory syndrome (MIS-C) that causes inflammation in different parts of the body, including the organs. It may occur several weeks to a month after exposure to the CCP (Chinese Communist Party) virus, which causes COVID-19.
Doctors say parents shouldn’t be too alarmed about the rare condition.
“But this condition can be treated, and many children who develop MIS-C don’t get critically ill or require intensive care,” Dr. Christina Mikesell, a pediatrician, said in March, adding that the condition occurs “in two out of 100,000 children or less than .01 percent of the population.”
The rush by health officials and the government to vaccinate healthy children and adolescents without adequate safety data is concerning to some experts and parents, as severe COVID-19 illness is rare among this age group, and deaths from the disease even rarer. Furthermore, young children aren’t super-spreaders of the virus.
Dr. Cody Meissner, professor of pediatrics at Tufts University School of Medicine and a former member of the CDC’s vaccine advisory committee, told USA Today that he’s worried about the adverse effects of the COVID-19 vaccines in children. Reports of myocarditis, an inflammation of the heart muscle, in adolescents who received an injection of an mRNA vaccine are being investigated by the CDC.
“The issue that one has to address with any vaccine is, does any side effect from the vaccine outweigh a benefit from the disease that’s being prevented … at the present time, there doesn’t seem to be deaths in the 12 to 17 age group. The ethical mandate isn’t to get our children and adolescents vaccinated, the ethical mandate is to do no harm,” Meissner said.
“There’s a train leaving the station, and everyone is jumping on it and it makes me a little bit nervous. It’s too fast.”
Parent Janci Lindsay, a toxicologist and molecular biologist, said that children shouldn’t be inoculated with a COVID-19 vaccine that isn’t FDA-approved and lacks long-term safety data.
“Multiple studies show that infants and children are not at significant risk for morbidity or mortality from COVID-19,” Lindsay said in a public comment to the vaccine advisory committee on May 12, adding that the infection fatality ratio (IFR) for the different age groups were minuscule: “0.003 [percent] for the 0–4 age group, 0.001 [percent] for the 5–9 age group, 0.001 [percent] for the 10–14 age group, and 0.003 [percent] for the 15–19 age group.”
The IFR estimates the number of deaths from COVID-19 among all infected individuals.
Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, said parents aren’t able to make an informed decision without all of the “adequate scientific evidence” on the safety and efficacy of the vaccine.
“The FDA has stated that ‘there is no information on the co-administration on the Pfizer-BioNTech COVID-19 vaccine with other vaccines,’ but the CDC has chosen to assume safety,” Fisher told The Epoch Times via email in May. “They have given the green light for medical workers to administer Pfizer’s still experimental vaccine to adolescent children in combination with influenza, meningococcal, HPV, Tdap, and other CDC recommended vaccines on the same day.
“Why are parents being put in the position of playing vaccine roulette? Why are federal lawmakers allowing the FDA and CDC to get away with simply assuming COVID vaccine safety rather than proving it?”