FDA Expands Booster Shot Authorization To 12-15-Year-Olds

The Food and Drug Administration has expanded the eligibility for Covid-19 booster shots. It authorized this expansion on Monday, and will now allow boosters for 12-15-year-olds and for certain immunocompromised 5-11-year-olds. Additionally, it has shortened the time for all adults to receive the booster, from six months after their previous dose to five months.

Peter Marks, a top FDA vaccine official, said of the expansion, “The FDA has extended the range of individuals eligible to receive a booster, shortened the length of time between the completion of the Pfizer primary series for individuals to receive a booster and is authorizing a third protective vaccine dose for some of our youngest and most vulnerable individuals.”

This authorization comes in the wake of the surge in Covid-19’s delta and omicron variants. While all vaccinations provide essential protection against acquiring the virus and experiencing severe symptoms, the rise in variants has led to the importance of booster shots to increase protection.

Marks explained, “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. In particular, the omicron variant appears to be slightly more resistant to the antibody levels produced in response to the primary series doses from the current vaccines.”

The agency said it based its decision on boosters for 12-15 year-olds on data from 6,300 people in Israel.

“These additional data enabled the FDA to reassess the benefits and risks of the use of a booster in the younger adolescent population in the setting of the current surge in COVID-19 cases,” the FDA said. “The data shows there are no new safety concerns following a booster in this population.”

In the past few months, more children are returning to school nationwide. A high emphasis has been placed on the goal for children to return to in-person schooling due to the increased quality of education and social development.

Recently, there has been a surge in Covid-19 cases, including many breakthrough cases for vaccinated individuals. However, officials say that the number of hospitalizations is a more important measure of vaccine protection and Covid-19 danger than the number of overall cases. Vaccination significantly reduces the risk of severe illness. In addition, emerging evidence provides hope that the omicron variant might cause a lower average number of severe illnesses.

The Centers for Disease Control and Prevention must approve the recent FDA authorization before it take effect.