Preliminary results of phase II and III clinical trials of Pfizer’s COVID-19 vaccine have shown that it safely produces a “strong” antibody response in children aged 5 to 11.
Pfizer is now preparing to submit the findings of the trials to the US Food and Drug Administration (FDA) to seek Emergency Use Authorization (EUA) for the vaccine among the said age group. The FDA is expected to issue EUA in a few weeks once Pfizer officially applies for it.
According to details, 2,268 children between the ages of 5 and 11 participated in the highly anticipated trials. Two 10-microgram doses of Pfizer’s Coronavirus vaccine were administered to all the participants 21 days apart.
To determine the safety, tolerability, and immunogenicity 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 participants 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.
All participants showed a strong immune response without reporting any major side effects. It is worth mentioning here that Israeli researchers had linked Pfizer’s COVID-19 vaccine with myocarditis, inflammation of the heart muscle, last month.
Pfizer’s vaccine was initially approved for use in individuals aged 16 and above. Later, it was authorized for use among children aged 12 to 15. Now, it is being anticipated to be recommended for use in children aged 5 to 11 within a couple of weeks. Next, Pfizer aims to receive regulatory approval for the use of its Coronavirus vaccine among children as young as 6 months.