Pfizer Vaccine In Children: When Will It Be Approved In NJ?

NEW JERSEY — On Thursday, Pfizer-BioNTech asked the U.S. Food And Drug Administration (FDA) to permit the use of its two-dose COVID-19 vaccine in children between the ages of 5 to 11, marking a pivotal step in the process to vaccinate young Americans.

“We and @BioNTech_Group officially submitted our request to @US_FDA for Emergency Use Authorization (EUA) of our #COVID19 vaccine in children 5 to <12,” the drugmaker tweeted on Thursday.

The request follows single-dose COVID vaccine maker Johnson & Johnson asking the Food and Drug Administration to allow booster shots of its COVID-19 vaccine for those ages 18 and older. The federal government has already authorized a single booster dose of the Pfizer COVID-19 vaccine for those who received their second dose six months ago. Read more: Johnson & Johnson Asks FDA To Approve Booster Shot

Pfizer shots could get into the arms of children in a matter of weeks if approval is granted, according to the Associated Press. It would be the first COVID vaccine available to kids under 12 in the nation and could help protect over 28 million people in the nation, the New York Times reports.

UPDATE: We and @BioNTech_Group officially submitted our request to @US_FDA for Emergency Use Authorization (EUA) of our #COVID19 vaccine in children 5 to <12. pic.twitter.com/72Z2HXlkOx
— Pfizer Inc. (@pfizer) October 7, 2021

An independent review panel is slated to debate Pfizer’s evidence on Oct. 26. A decision is expected sometime between Halloween and Thanksgiving.

Pfizer has previously said that children between 5 and 11 are to relieve a third of the adult dose. Read more: Pfizer Says Low COVID Vaccine Dose Is Good For Kids 5 To 11

In total, Pfizer tested its COVID vaccine on 4,500 children worldwide, with 2,268 participants enrolled in the 5-11 age group.

The children demonstrated a strong immune response one month after the second dose, said Pfizer. Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years old.

"We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season," said Dr. Ugur Sahin, CEO and co-founder of BioNTech, in a statement. "The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose."

During a Wednesday afternoon news conference, Gov. Phil Murphy announced that 69 COVID-19 outbreaks were reported in the state since the beginning of the school year. This is up an additional 31 outbreaks since last week when only 38 outbreaks were reported at school districts across New Jersey.

The New Jersey Department of Health subsequently issued a directive requiring Wednesday all schools to report COVID-19 data to the department on a weekly basis.

Data reported back to the state will also include any COVID-19 testing, testing vendors, and cases reported to schools by parents, students, and staff.

"As schools begin testing this data it will provide information on the circulation of the virus among the school children and school staff. This data, however, is not a reflection of the in-school transmission, which is captured through the outbreak reports," said New Jersey Health Commissioner Judy Persichilli.

Schools will also be required to report vaccination data on students and staff.

Persichilli stressed the importance of school staff members getting vaccinated to protect school children as they cannot yet receive the jab.

"As you know children under 12 can not be vaccinated yet so we need strong vaccine coverage in these populations who come into contact with these young individuals in order to protect them," said Persichilli.

With reporting by Carly Baldwin and Alexis Tarazzi.