FDA authorizes Pfizer's COVID-19 booster dose for children ages 12 to 15

• FDA shortened the time between the second Pfizer dose and the booster shot to five months, down from six months

• New COVID-19 infections have hit a pandemic high in the U.S. as the highly contagious Omicron variant has ousted Delta as the dominant strain

U.S. Food and Drug Administration (FDA) on Monday authorized Pfizer Inc and BioNTech booster shots to children ages 12 to 15 years and the third vaccine for children ages 5 through 11 who have compromised immune systems.

The expanded eligibility announcement comes from the drug regulator, as school restarts after winter break amid a surge of Omicron strain of the coronavirus across the nation.

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U.S. Centers for Disease Control and Prevention (CDC) still has to sign off on expanded eligibility of booster shots for 12- to 15-year-old kids, and its expert advisory panel will meet on Wednesday.

“The recent rise in COVID-19 cases is concerning to all, and today’s decision by the FDA to further expand the Emergency Use Authorization of a booster dose of our vaccine is critical to help us ultimately defeat this pandemic,” Pfizer CEO Albert Bourla said in a statement.

Updated timeframe for booster shot

The FDA also narrowed the interval between the second Pfizer dose and the booster shot to five months, down from six months.

Moreover, anyone who received the Moderna vaccine is still supposed to get their booster at least six months after the second jab, while the person who opted for Johnson & Johnson’s single-dose vaccine will receive a booster at least two months after their shot.

“We continue to believe that broad use of boosters is essential to preserving a high level of protection against this disease and reducing the rate of hospitalizations,” Bourla said.

Data supporting booster for children

The FDA said no new safety concerns had emerged after assessing real-world data from Israel on 6,300 kids between 12 years and 15 who received a Pfizer booster dose.

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“Based on the FDA’s assessment of currently available data, a booster dose of the currently authorized vaccines may help provide better protection against both the Delta and Omicron variants,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said on Monday.

However, the FDA in the statement said kids ages 5 to 11 with normal immune systems do not need a third vaccine dose right now, and the agency will review emerging data and update its authorization if third shots are broadly required for that age group.

Concerns around Omicron

The Omicron variant is responsible for more than 70% of recent COVID-19 cases in the U.S., CDC data shows.

While the two-dose vaccine is about 35% effective against infection from the Omicron variant, but a booster dose restores effectiveness to 75%, according to the CDC, based on data from South Africa and the United Kingdom.

The FDA said peer-reviewed data from multiple laboratories demonstrate that Pfizer booster doses greatly improve an individual’s antibody response to the Omicron strain of the coronavirus.

More than 65% of people ages 5 and older are fully vaccinated in the nation, according to CDC data.

Children under the age of 5 are not yet eligible for vaccination.

Picture Credit: Reuters