FDA Endorses Pfizer Jab for Children 5-11, Formal Decision Expected Soon

An FDA panel has endorsed an emergency use of a lower dose of the Pfizer vaccine for use in the youngest population yet, for five to 11 year olds. 

The US Food and Drug Administration (FDA)’s Vaccine and Related Biological Products Advisory Committee, which is a panel of independent advisors, voted 17-1 to recommend the use for children of this age. The one vote that was not in favor was in abstention. 

The vaccine dose for children 5-11 will be one third of the dose that adults receive. Children would then receive a second dose of the vaccine at least 21 days after the first dose.

This is not the final formal decision on the use of the vaccine in this age group. This approval is part of an extension of the emergency use authorization of the vaccine. The formal decision is expected in the coming days, and it is expected that the FDA will fully approve it. The FDA typically approves the advice of its expert panels, but it is not bound to do so. 

If and when the FDA officially approves the vaccine for this age group, it then gets referred to the Centers for Disease Control and Prevention (CDC). The CDC vaccine advisory group will meet to further discuss and make their own recommendations on the matter, and construct their own guidelines for use among this age. 

Moderna also plans to submit its vaccine to the FDA for approval in younger children. This comes following trials that showed a positive, strong response in children aged six to 11 years old. 

If it is officially approved, an estimated 15 million doses will be sent to pediatric offices, children’s hospitals and pharmacies across the U.S. 

Research and data has shown that a child’s dose of the vaccine was found both to be safe, and 90 percent effective, in children of this age. 

Dr. Anthony Fauci has urged parents to vaccinate their children. The top infectious disease expert said that while he understands parents may be hesitant, he has emphasized the importance of immunizations for children because they are especially important to prevent additional strains of the virus. 

If approved, tens of millions of children would be eligible for the vaccine. Of children aged 12-15 — currently the youngest eligible — an estimated 47 percent have received the first vaccine dose. 

Be the first to comment

Leave a Reply

Your email address will not be published.