Pfizer Declares COVID Vaccine Safe For Children Ages 5 to 11: Here’s What You Should Know.
Following a clinical trial, Pfizer (PFE) and BioNTech (BNTX) announced Monday that their COVID-19 vaccine is now safe for children aged 5 to 11 and will be submitted for FDA approval as soon as feasible.
The vaccine was tested on 2,268 youngsters using a two-shot schedule of 10 microgram doses 21 days apart, according to the drugmakers — a third of the dose given to children aged 12 and up.
The 10 mg dose was “carefully chosen as the preferred dose for safety, tolerability, and immunogenicity,” according to Pfizer.
The businesses claimed that the shot elicited a “robust” reaction and was well tolerated, with side effects comparable to those reported in studies of people aged 16 to 25.
The COVID shot can cause fatigue, headaches, muscle soreness, chills, fever, and nausea, according to the Centers for Disease Control and Prevention.
Pfizer CEO Albert Bourla said in a statement, “We are excited to expand the protection given by the vaccine to this younger population, subject to regulatory permission, especially as we follow the emergence of the Delta form and the serious threat it poses to children.”
The FDA has cleared the Pfizer-BioNTech COVID vaccine for use in children aged 12 and up. Adults aged 18 and above are eligible to receive the Moderna and Johnson & Johnson vaccines.
On Friday, the Pfizer booster shot was also advised for anyone aged 65 and up. Adults with impaired immune systems can also get a booster shot from Pfizer or Moderna.
The businesses also stated that clinical trial data on their COVID vaccination on children aged six months to five years will be released in the fourth quarter of this year.
According to the CDC, about 220 million doses of the Pfizer-BioNTech COVID vaccination have been administered to far.
Pfizer’s stock was selling at $43.24, down 65 cents, or 1.48 percent, while BioNTech’s stock was trading at $341.31, down $17.87, or 4.98 percent, in Monday premarket hours.