According to trial results disclosed Friday, kid-size doses of Pfizer’s COVID-19 vaccine appear safe and nearly 91% efficient at avoiding symptomatic infections in 5- to 11-year-olds, as the US contemplates expanding vaccines to that age group.
If the FDA grants the go-ahead, the shots may start as early as November, with the first children in line fully protected by Christmas.
The results of Pfizer’s investigation have been made public. The FDA is expected to release its independent review of the company’s safety and effectiveness data later on today.
Next week, FDA advisers will debate the evidence publicly. The Centers for Disease Control and Prevention will make the final choice on who should get the shots if the agency approves them.
For children 12 and older, full-strength Pfizer shots have already been authorized, but many parents and pediatricians are eagerly awaiting protection for younger children to prevent rising infections from the delta variant and help keep kids in school.
So far, more than 25,000 pediatricians and primary care doctors have signed up to help administer the vaccine to children.
According to reports, the Biden administration has purchased enough doses for the country’s estimated 28 million children aged 5 to 11.
Once the vaccine is approved, millions of doses would be delivered across the country.
During the study, at least 2,268 children were given two shots three weeks apart, one of a placebo and the other of a low-dose vaccination. The doses were about a 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% 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 children hit new highs last month.