Pfizer officials state that the company’s Covid-19 vaccine for children from 5 to 11 years old is not only safe but shows what they call a “robust” antibody response, according to a statement issued on Monday.
At a time when the Delta variant of the virus continues to surge around the globe, and unvaccinated young children return to school in person, the pharmaceuticals giant stated that a Phase 2/3 trial demonstrated that its coronavirus vaccine was not only safe but also sparked a “robust” antibody response in children from the age of 5 to 11.
Although the data is brand-new and has not yet been peer-reviewed, the results come as extraordinarily welcome news as this age cohort has returned to school at a time when the Delta variant continues its march across the globe, causing spikes in hospitalizations and deaths around the world.
Officials from Pfizer said they plan to submit the results of the study to the US Food and Drug Administration soon. Like the adult vaccine, the inoculation for children will be used as emergency use authorization only until the final FDA approval of the drug can take place later.
Pfizer’s trial included a total of 2,268 children from age 5 to 11. Like adults, they received two doses of the vaccine, given to them 21 days apart. One crucial difference, however, is that each dose contained only 10 micrograms — fully one-third of the dose that is given to all those 12 and older.
Vaccine Dosage for Children One-Third That of Adult Version
The company stated in an announcement that “The 10 microgram dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age.”
Pfizer’s scientists analyzed the immune responses of the children taking part in the trials by studying neutralizing antibody levels in their blood. They then contrasted those levels to a control group, consisting of 16- to 25-year-old subjects, who had received two-doses of 30 micrograms each.
According to the research, the immunity levels were comparable to those in older individuals who had gotten the “adult-size” dose, showing that there indeed was what they termed a “strong immune response in this cohort of children one month after the second dose.”
Pfizer’s statement noted that “Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.”
Some parents have expressed worries that side effects would be particularly strong in such young children.
Responding to another concern, a spokesperson from the Pharma giant confirmed to the press that there had been no instances of myocarditis, a heart inflammation that has been linked with young people, especially boys, who had received mRNA vaccines.
Vaccine for Children Vital as School Resumes for 2021/2022
Pfizer added that all the information will be part of its submission, which it said will occur in the “near term” for the Emergency Use Authorization of the product for that age cohort. In addition, the firm will of course continue to assemble all pertinent data that will be needed to file for full FDA approval for all those between the ages of 5 and 11.
The Pfizer/BioNTech inoculation is already fully approved for all those age 16 and above and has been authorized for emergency use in teenagers 12 — 15 years of age.
While the vast majority of children do not suffer as heavily from the effects of Covid-19, the spike in the Delta mutation of the virus has caused widespread infections in all age groups, especially those who are unvaccinated — which includes all children under 12.
Just since July of 2021, the number of Covid-19 cases in children increased nearly 240%, according to Pfizer CEO Albert Bourla.
Most parents are not only eagerly waiting the emergency authorization of the 5-11 vaccine but also that which will eventually be administered to infants and children up to age 5. Studies in that age cohort are still ongoing with Pfizer officials saying that they expect trial data for this age group “as soon as the fourth quarter of this year.”
Bourla, the chairman and chief executive officer of Pfizer, said that “Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. — underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”
Dr. Scott Gottlieb, who is a former commissioner of the FDA and who is now a Pfizer board member, stated in the past that a coronavirus vaccine for children from age 5 to 11 could be available by October 31 of this year.
However, those who serve as part of the FDA will not issue such a timeline at present.
Dr. Janet Woodcock, who is the acting FDA Commissioner, and Dr. Peter Marks, the director of the Center for Biologics Research and Evaluation at the American drug regulator, said in a statement earlier in September that the agency would review vaccine data for this age cohort “as quickly as possible, likely in a matter of weeks rather than months,” as soon as it was submitted for emergency use authorization.
“However, the agency’s ability to review these submissions rapidly will depend in part on the quality and timeliness of the submissions by manufacturers,” the scientists emphasized.
The American Academy of Pediatrics issued a statement last week which said that coronavirus infections have increased “exponentially” in youngsters across the United States; they now make up almost 29% of all cases reported in the United States.
At the same time, scientists know that children are not just small adults — they have unique characteristics in a multitude of ways as they brains and the rest of their bodies are growing at a rapid rate.
Some express concern that those who are age 12 are being given the larger vaccine dose that is administered to adults.
Dr. Peter Marks of the FDA, stated in an interview hosted by the ResearchAmerica Alliance last week that “We don’t want children to have adverse effects. Granted, we want them to be able to get vaccinated as quickly as possible, but let’s do it right.
“There is a difference here because they’re not just getting the same-old, same-old dose as a 12 and up person will,” he added. “They have to get a reduced dose. And that’s why it’s not a good idea for doctors to take things in their own hands at this point.”