DORAL, FL – In a recent statement, Pfizer says its vaccine is safe for children 5 to 11 years of age. According to the pharmaceutical, if approved it could be available by Halloween.
Pfizer arrived to these conclusions after conducting a trial with 2,268 participants ages 5 to 11. The company administered a two-dose regimen of the vaccine within the group provided 21 days apart.
Unlike the vaccine aimed at those 12 and older, under this trial it was used a 10-microgram dose which is smaller than the 30-microgram dose used for those 12 and older.
“The 10 microgram dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age,” Pfizer said in a news release.
After analyzing the results of this trial, it was concluded its COVID-19 vaccine for this population generated a “robust” antibody response in them with side effects generally comparable to those observed in participants 16 to 25 years of age.
In addition, there weren’t signs of myocarditis, a type of heart inflammation that has been linked with mRNA vaccines.
Now, the plan is to submit the data to the US Food and Drug Administration to gain emergency use authorization. This could arrive in a matter of weeks.
Also, the company is expecting trial data for children as young as 6 months, which could be conducted during the fourth quarter of this year.
So far, the Pfizer/BioNTech vaccine against the coronavirus has only been approved for individuals 16 and older and authorized for use in children ages 12 to 15.
“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. — underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency,” Albert Bourla, chairman and chief executive officer of Pfizer, said in the statement.