Pfizer has published the detailed results of the clinical trials of its COVID-19 vaccine among children aged 5 to 11, suggesting the vaccine produces a ‘safe’ and ‘strong’ immune response in the age group.
According to details, Pfizer’s COVID-19 vaccine offers 90.7% protection against symptomatic Coronavirus infection to children aged 5 to 11.
The New York-based pharmaceutical company had enrolled 2,268 children between the ages of 5 and 11 in the highly anticipated clinical trials. Two 10-microgram doses of Pfizer’s Coronavirus vaccine were administered to all the participants 21 days apart.
To determine the safety and efficacy of its vaccine in children aged 5 to 11, Pfizer carefully opted for a 10-microgram dose in these trials as it had previously administered a 30-microgram dose during the clinical trials of children aged 12 to 15.
The immune responses of all 2,268 children were measured by first observing the levels of neutralizing antibodies in their blood and then comparing those levels to a control group aged between 16 and 25 years who had received the two doses larger than 30-microgram.
Pfizer initially received assent for use in individuals aged 16 and above. Later, it got authorization for use among children aged 12 to 15. Now, it is aiming to receive regulatory approval for use in children aged 5 to 11. Next, Pfizer aims to seek authorization for the use of its Coronavirus vaccine among children as young as 6 months.
On the other hand, the US Food and Drug Administration (FDA) is set to meet on Tuesday to decide whether to grant Emergency Use Authorization (EUA) to Pfizer’s vaccine for children aged 5 to 11. FDA will announce its decision next Friday.
If FDA issues EUA to Pfizer’s vaccine for children aged 5 to 11 on Friday, U.S. Centers for Disease Control and Prevention (CDC) will meet on 2-3 November to make recommendations to the FDA on how the vaccine should be administered in the said age group. It is because most US states wait for CDC’s recommendations to the FDA before administering any vaccine to their populations.