Pfizer says its Covid vaccine is safe and generates robust immune response in kids ages 5 to 11

PUBLISHED: Mon, 20 Sep 2021 13:53:14 GMT
Berkeley Lovelace Jr.
CNBC
Share
Key Points
  • Pfizer and BioNTech’s Covid vaccine is safe and appears to generate a robust immune response in a clinical trial of kids ages 5 to 11, the drugmakers announced.
  • The companies tested a two-dose regimen of 10 micrograms – about a third the dosage used for teens and adults – administered three weeks apart.
  • They plan to submit the data to the FDA and other health regulators “as soon as possible.”
A teen gets a dose of Pfizer’s COVID-19 vaccine last month at Holtz Children’s Hospital in Miami. Nearly 7 million U.S. teens and preteens (ages 12 through 17) have received at least one dose of a COVID-19 vaccine so far, the CDC says.

Pfizer and BioNTech’s Covid-19 vaccine is safe and generates a “robust” immune response in a clinical trial of kids ages 5 to 11, the drugmakers announced in a press release Monday.

The companies tested a two-dose regimen of 10 micrograms — about a third the dosage used for teens and adults — administered three weeks apart. The shots were well tolerated and produced an immune response and side effects comparable to those seen in a study of people ages 16 to 25, they said.

Common side effects for teens and adults include fatigue, headache, muscle pain, chills, fever and nausea, according to the Centers for Disease Control and Prevention.

The data, which included more than 2,200 children, will be submitted to the Food and Drug Administration and other health regulators “as soon as possible,” the companies said.

“We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children,” Pfizer CEO Albert Bourla said in a release.

Read more: Sinovac to trial COVID-19 vaccine in South African children as part of global study

The new data comes as many parents say they are anxious to get their children vaccinated, especially as schools reopen and the highly contagious delta variant continues to spread. The strain has led to a surge in hospitalizations across the U.S., including among young kids who are currently ineligible to get the shots.

So far, the Pfizer-BioNTech coronavirus vaccine has been cleared by the FDA for people as young as 12, while Moderna’s and Johnson & Johnson’s vaccines have been authorized for adults.

The FDA is expected to issue a decision sometime this week on which groups are eligible to get a third dose, or booster shot, of the Pfizer vaccine. An FDA advisory committee on Friday unanimously recommended Pfizer booster shots to people age 65 and older and other vulnerable Americans.

Bourla said last week that Pfizer could submit data on children from ages 5 to 11 by the end of this month.

Additionally, Pfizer expects to release clinical trial data on how well its Covid vaccine works in children as young as 6-months-old to 5 years old as early as the end of October, he said.

Sign Up for Our Newsletter Daily Update
Get the best of CNBC Africa sent straight to your inbox with breaking business news, insights and updates from experts across the continent.
Get this delivered to your inbox, and more info about about our products and services. By signing up for newsletters, you are agreeing to our Terms of Use and Privacy Policy.