The Pfizer COVID-19 vaccine appears to be effective in young children, according to the FDA.
As the United States considers starting vaccines in children, federal health regulators said late Friday that kid-size doses of Pfizer’s COVID-19 vaccine appear to be extremely successful at avoiding symptomatic infections in elementary school children and have produced no unforeseen safety issues.
The FDA published its review of Pfizer’s data ahead of a public meeting next week to discuss whether the vaccines are ready for the country’s roughly 28 million youngsters aged 5 to 11. The agency will put the subject to a panel of outside vaccination experts for a vote.
According to FDA scientists, the vaccine’s effectiveness in decreasing COVID-19 hospitalizations and deaths outweighs any major potential side effects in children in almost every situation. However, agency evaluators stopped short of recommending that Pfizer’s injection be approved.
Next Tuesday, the agency will present that question to its panel of independent advisers, who will weigh in on their recommendations before making a final decision.
If the FDA approves the shots, the Centers for Disease Control and Prevention will make additional recommendations in the first week of November about who should get them. Children might start getting vaccines as early as next month, with the first in line expected to be fully protected by Christmas.
Pfizer’s full-strength vaccines are already recommended for anybody aged 12 and up, but pediatricians and many parents are waiting for protection for younger children to help prevent infections from the extra-contagious delta form and keep kids in school.
The FDA’s evaluation confirmed Pfizer’s earlier-released findings that the two-dose shot was nearly 91 percent effective in avoiding symptomatic infection in young children. The figure was obtained based on 16 COVID-19 cases in children who received fake shots against three cases in children who had been immunized. 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.
The majority of the data for the study was obtained in the United States in August and September, when the delta variation had overtaken COVID-19 as the prevalent strain.
The FDA discovered no new or unexpected negative effects during its investigation. Sore arms, fever, and achiness were the most common symptoms.
The trial, however, was not large enough to discover exceedingly rare side effects such as myocarditis, a form of heart inflammation that can occur after the second dose, according to FDA investigators.
The CDC employed statistical modeling to estimate how many COVID-19-related hospitalizations and deaths the vaccine might avoid versus the number of probable heart side effects. In four pandemic scenarios, the vaccine certainly saved more hospitalizations than the cardiac side effect would have predicted. The vaccination may only cause more hospitalizations than it prevented if virus cases were exceedingly low. However, officials came to the conclusion that the vaccine’s preventive benefits “clearly outweigh” its hazards.
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 last six weeks as the delta version spread.
The Biden administration has acquired enough vaccination for the country’s 5- to 11-year-olds, packaged in unique orange-capped vials to distinguish them from adult vaccine. If the vaccine is approved, millions of doses, as well as kid-size needles, will be sent around the country as soon as possible.
More than 25,000 physicians and primary care professionals have already joined up to help get the vaccines into the hands of children.