If regulators approve, the shots could start in November with the first child in line fully protected by Christmas.
Pfizer posted details of its study online. Later in the day, the Food and Drug Administration would post its independent review on the company’s safety and efficacy data.
Next week, FDA advisors will debate the evidence in public. The final decision about who should get them will be made by the Centers for Disease Control and Prevention if the agency approves.
Pfizer full-strength shots are already approved for those 12 and older. However, many parents and pediatricians are anxiously waiting for protection for their children as they face rising infection from the extra-contagious delta variant.
Already, more than 25,000 primary care providers and pediatricians have signed up for the shot.
The Biden administration purchased enough doses in kid-size vials, with special orange caps to differentiate them from the adult vaccine. This will be sufficient for approximately 28 million children aged 5-11 years old. Millions of doses, as well as kid-size needles, will be shipped out to the nation if the vaccine is approved.
Pfizer studied 2,268 children in this age group, who received two doses of the low-dose vaccine or a placebo three weeks apart. Each dose was equal to one-third of the dose given to adults and teens.
Based on 16 COVID-19 cases from children who received dummy shots, researchers calculated that the low-dose vaccine was almost 91% effective. This is compared to three cases for vaccinated kids. None of the children suffered from severe illness, but the vaccines produced milder symptoms than those who were not vaccinated.
Additionally, the coronavirus-fighting antibodies levels of young children who received low-dose shots were just as strong than those of teens and young adults who had regular-strength vaccines.
This is important information, considering the record-breaking hospitalizations of unvaccinated children last month.
The CDC reported this week that Pfizer vaccines were 93% effective in preventing hospitalizations among 12- and 18-year-olds, despite the rise of the delta mutant between June and September.
Pfizer’s study on younger children found that low-dose shots were safe and had similar or fewer temporary side effect like fever, sore arms, or achiness as teens.
Although the study was small enough to detect rare side effects such as heart inflammation, which can sometimes occur after the second dose, it is not large enough for young men.
According to the CDC, children are at lower risk of serious illness and death than those who are older than them. However, COVID-19 has claimed the lives of more than 630 Americans aged 18 or under. The American Academy of Pediatrics reports that nearly 6.2 million children have been infected by the coronavirus. This is in addition to more than 1.1million who were infected in the six weeks since the rise in the delta mutant.
Moderna is also studying COVID-19 shots with elementary-school-aged children. Moderna and Pfizer are also studying children as young as 6 months old. More information will be available later in the year.
