According to trial results disclosed Friday, kid-size doses of Pfizer’s COVID-19 vaccine appear safe and nearly 91 percent efficient at avoiding symptomatic infections in 5- to 11-year-olds, as the US contemplates expanding vaccines to that age group.
If authorities grant the go-ahead, the shots may start as early as November, with the first youngsters in line fully protected by Christmas.
The findings of Pfizer’s investigation were made public. Later in the day, the FDA was due to release its independent review of the company’s safety and effectiveness data.
Next week, FDA advisers will debate the evidence in public. The Centers for Disease Control and Prevention will make the final choice on who should get the shots if the agency approves them.
Pediatricians and many parents are eagerly awaiting protection for younger children to stem rising infections from the extra-contagious delta variant and help keep kids in school. Full-strength Pfizer shots are already authorized for anyone 12 and older, but pediatricians and many parents are anxiously awaiting protection for younger children to stem rising infections from the extra-contagious delta variant and help keep kids in school.
More than 25,000 physicians and primary care professionals have already joined up to help get the vaccines into the hands of children.
The Biden administration has ordered enough pediatric doses — in unique orange-capped vials to distinguish them from adult vaccine — for the country’s estimated 28 million children aged 5 to 11. If the vaccine is approved, millions of doses, as well as kid-size needles, will be sent around the country as soon as possible.
In a Pfizer research, 2,268 children in that age range were given two shots three weeks apart, one of a placebo and the other of the low-dose vaccination. Each dose was one-third of what teens and adults were given.
Based on 16 COVID-19 cases in children given fake shots vs three cases among vaccinated children, researchers concluded that the low-dose vaccine was roughly 91 percent effective. There were no serious infections reported among the children, but those who had been vaccinated had considerably milder symptoms than those who had not been inoculated.
Furthermore, young children who received low-dose vaccines produced coronavirus-fighting antibody levels that were comparable to those of teens and young adults who received regular-strength vaccinations.
This is crucial information given that hospitalizations of predominantly unvaccinated youngsters hit new highs last month.
Even as the delta mutant spread between June and September, the CDC revealed earlier this week that Pfizer immunizations were 93 percent successful in preventing hospitalizations among 12- to 18-year-olds.
The low-dose shots were found to be safe in a study of younger children, with transitory side effects similar to or less than those experienced by teens, such as aching arms, fever, or achiness.
The study’s sample size is insufficient to detect any exceedingly unusual side effects, such as cardiac inflammation, which happens sometimes after the second dose and is mostly seen in young males.
COVID-19 has killed more than 630 Americans aged 18 and under, according to the CDC, despite the fact that children have a reduced risk of serious illness or death than adults. According to the American Academy of Pediatrics, about 6.2 million children have been infected with the coronavirus, with more than 1.1 million afflicted in the previous six weeks as the delta mutant spread.
Moderna is also testing its COVID-19 shots on children in elementary school. Even younger children, as early as six months old, are being studied by Pfizer and Moderna. The results will be available later this year.