Pharmaceutical company Pfizer said it is continuing trials of the COVID-19 vaccine for children between the ages of five and 11, and expects to make the vaccine available in the fall.
If studies show a good immune response and safety, it will start the vaccine for children from six months to five years.
“Once safety and immunogenicity are confirmed, and pending regulatory or regulatory approval, we hope to submit the Potential Emergency Permit (EUA) vaccine to the US Food and Drug Administration (FDA) sometime between September and October. for children 5-11, and shortly thereafter for 6 months to 5, ”the company said in a statement.
Pfizer has developed its vaccine in partnership with German biotechnology company BioNTech.
The drug manufacturer tests the vaccine at lower doses in three different age groups: five to 11 years, two to five years and six months to two years, to test the efficacy, safety and immunity of the vaccine.
The efficacy of the vaccine will be worked out by comparing the immune response of the participants with the “16-25-year-old population from the crucial phase 3 trial, as the efficacy of the vaccine was shown in this age group,” Pfizer said.
The children receive two injections of the vaccine or a placebo that is three weeks apart. Those who are five to 11 years old will receive 10 micrograms each, while the younger age group will receive three micrograms each.
About 4,500 children will be enrolled at clinical sites in the United States, Spain, Finland and Poland.
Pfizer also said that babies younger than six months can be considered for vaccination once an acceptable safety profile has been established.
While the trial is expected to last two years, Pfizer said all participants will be exposed during a six-month follow-up visit, or they will be told if they received the vaccine or a placebo. Those who originally received 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 it helps bring about herd immunity and possibly prevent children from developing a rare condition called multi-system inflammatory syndrome (MIS-C) that causes inflammation in various parts of the body, including the organs. This can occur several weeks to a month after exposure to the CCP virus (Chinese Communist Party), which causes COVID-19.
Doctors say parents should not be too worried about the rare condition.
“But this condition can be treated, and many children who develop MIS-C do not become critically ill or require intensive care,” said Dr. Christina Mikesell, a pediatrician, said in March, adding that the condition “affects two out of 100,000 children or less than 0.01 percent of the population.”
Some competitors and parents’ rush to vaccinate healthy children and adolescents without adequate safety data is important to some experts and parents, as severe COVID-19 disease is rare among this age group, and deaths due to the disease even more rare. Furthermore, young children are not the spreaders of the virus.
Dr. Cody Meissner, a 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 was concerned about the adverse effects of COVID-19 vaccines in children. Reports of myocarditis, an inflammation of the heart muscle, in adolescents who have received an injection of an mRNA vaccine are being investigated by the CDC.
‘The problem one has to deal with with any vaccine is whether any side effect of the vaccine outweighs the benefit of the disease being prevented? At present, there do not appear to be any deaths in the age group 12 to 17. The ethical mandate is not 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 jumps on it and it makes me a little nervous. It’s too fast. ”
Parent Janci Lindsay, a toxicologist and molecular biologist, said children should not be vaccinated with a FDA-approved COVID-19 vaccine that does not have long-term safety data.
“Multiple studies show that infants and children do not have a significant risk of disease or death from COVID-19,” Lindsay said in a public statement to the Vaccine Advisory Committee on May 12, adding that the infectious mortality rate (IFR) ) for the different age groups was small: “0.003 [percent] for the age group 0–4, 0.001 [percent] for the age group 5–9, 0.001 [percent] for the age group 10-14, and 0.003 [percent] for the age group 15–19 years. ”
The IFR estimates the number of deaths due to COVID-19 among all infected individuals.
Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, said parents could not make an informed decision without all the ‘sufficient scientific evidence’ about the safety and efficacy of the vaccine.
“The FDA said that ‘there is no information on co-administration of the Pfizer-BioNTech COVID-19 vaccine with other vaccines,’ but the CDC chose to accept safety,” Fisher said in an e-mail in May. mail told The Epoch Times. ‘They have given the green light to medical workers to administer Pfizer’s still experimental vaccine to adolescent children in combination with flu, meningococcal, HPV, Tdap and other CDC vaccinations recommended on the same day.
‘Why are parents placed in the position to play vaccination? Why do federal legislators allow the FDA and CDC to get away with simply adopting COVID vaccine safety rather than proving it? “