The expert panel advising the Food and Drug Administration has finally recommended authorization for Pfizer-BioNTech’s COVID-19 vaccine for children ages 5 to 11, a much hoped for and major development for millions of families and children in the United States.
This step toward even more widespread inoculations to the deadly respiratory virus that has killed more than 749,000 Americans is expected to be joined by a full authorization for use from the FDA.
From there, the next step is for the Centers for Disease Control and Prevention to approve the guidance as well—and they are expected to—and then, some 28 million children according to estimates by the White House will finally be eligible for immunization.
FDA acting commissioner Janet Woodcock lauded the development.
“As a mother and physician, I know that parents, caregivers, school staff and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” Woodcock said. “Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parent and guardians that this vaccine meets our high standards.”
According to the FDA, in test groups, the response to the vaccine in children 5 to 11 was comparable to the response found in young adults ages 16 through 25. Pfizer’s vaccine was reported as 90.7% effective and as far as safety Is concerned, the regulatory body highlights that among the 3,100 children age 5 to 11 years old that were part of an ongoing study, “no serious side effects have been detected.”
The most commonly reported side effects during trials included redness at the injection site and soreness. Symptoms such as headaches, chills, nausea and muscle and joint pain were also reported and like many adults have experienced over the last several months, most side effects were reported after the second dose of vaccine was administered.
“Side effects were generally mild to moderate in severity and occurred within two days after vaccination and most went away within one to two days,” the FDA said in a statement Friday.
The FDA’s advisory panel voted 17-0 to approve the recommendation for use with one abstention, according to The New York Times.
Slightly diluted in strength but not efficacy, the Pfizer dose for this age group will be just one-third as strong as the vaccine delivered to individuals age 12 and up.
This July, primary care pediatrician Claire McCarthy wrote for Harvard Health that roughly 1,000 cases of myocarditis, or inflammation of the heart muscles, or pericarditis, which is inflammation of the tissue forming a sac around the heart, were recorded in adolescent and adult vaccine recipients.
“Millions of doses of COVID-19 vaccine have been given, and there have only been 1,000 cases of heart inflammation. Doing the math, the Centers for Disease Control and Prevention (CDC) notes that every million doses given, there have been 67 cases of heart inflammation in boys 12 to 17 (nine in girls of that age group), 56 in those aged 18 to 24 (six in girls), and 20 in males 25 to 29 (three in girls). That means the risk is quite low,” McCarthy wrote.
In a tweet, Colorado Democratic Rep. Diana DeGette summed up the development succinctly.
“This is a huge milestone in our fight to end this pandemic,” she wrote. “Once the CDC signs off, shots could be available to this important age group in the coming days.”
In addition to the recommendation for use in young children, the FDA also announced Friday that it has authorized a change for how the vaccine is manufactured. A different “buffer” will be used in the vaccine that helps maintain the drug’s pH levels. This will aid greater stability.
“This new formulation is more stable at refrigerated temperatures for longer periods of time, permitting greater flexibility for vaccination providers,” the FDA said.
The buffer is used commonly in many other FDA-approved vaccines and that includes products intended for consumption by children. It also presented zero safety concerns to experts at the agency.
This step toward even more widespread inoculations to the deadly respiratory virus that has killed more than 749,000 Americans is expected to be joined by a full authorization for use from the FDA.
From there, the next step is for the Centers for Disease Control and Prevention to approve the guidance as well—and they are expected to—and then, some 28 million children according to estimates by the White House will finally be eligible for immunization.
FDA acting commissioner Janet Woodcock lauded the development.
“As a mother and physician, I know that parents, caregivers, school staff and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” Woodcock said. “Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parent and guardians that this vaccine meets our high standards.”
According to the FDA, in test groups, the response to the vaccine in children 5 to 11 was comparable to the response found in young adults ages 16 through 25. Pfizer’s vaccine was reported as 90.7% effective and as far as safety Is concerned, the regulatory body highlights that among the 3,100 children age 5 to 11 years old that were part of an ongoing study, “no serious side effects have been detected.”
The most commonly reported side effects during trials included redness at the injection site and soreness. Symptoms such as headaches, chills, nausea and muscle and joint pain were also reported and like many adults have experienced over the last several months, most side effects were reported after the second dose of vaccine was administered.
“Side effects were generally mild to moderate in severity and occurred within two days after vaccination and most went away within one to two days,” the FDA said in a statement Friday.
The FDA’s advisory panel voted 17-0 to approve the recommendation for use with one abstention, according to The New York Times.
Slightly diluted in strength but not efficacy, the Pfizer dose for this age group will be just one-third as strong as the vaccine delivered to individuals age 12 and up.
This July, primary care pediatrician Claire McCarthy wrote for Harvard Health that roughly 1,000 cases of myocarditis, or inflammation of the heart muscles, or pericarditis, which is inflammation of the tissue forming a sac around the heart, were recorded in adolescent and adult vaccine recipients.
“Millions of doses of COVID-19 vaccine have been given, and there have only been 1,000 cases of heart inflammation. Doing the math, the Centers for Disease Control and Prevention (CDC) notes that every million doses given, there have been 67 cases of heart inflammation in boys 12 to 17 (nine in girls of that age group), 56 in those aged 18 to 24 (six in girls), and 20 in males 25 to 29 (three in girls). That means the risk is quite low,” McCarthy wrote.
In a tweet, Colorado Democratic Rep. Diana DeGette summed up the development succinctly.
“This is a huge milestone in our fight to end this pandemic,” she wrote. “Once the CDC signs off, shots could be available to this important age group in the coming days.”
In addition to the recommendation for use in young children, the FDA also announced Friday that it has authorized a change for how the vaccine is manufactured. A different “buffer” will be used in the vaccine that helps maintain the drug’s pH levels. This will aid greater stability.
“This new formulation is more stable at refrigerated temperatures for longer periods of time, permitting greater flexibility for vaccination providers,” the FDA said.
The buffer is used commonly in many other FDA-approved vaccines and that includes products intended for consumption by children. It also presented zero safety concerns to experts at the agency.