In Reversal, FDA Puts Brakes On COVID Shots For Kids Under 5

The FDA is reviewing data for Pfizer's COVID-19 vaccine for children under five. Initially, the FDA asked Pfizer to apply for approval before completing its study due to the Omicron variant's impact. However, Pfizer and BioNTech decided to wait for more data on a third dose's efficacy, delaying the process. The FDA postponed a meeting to review trial data, affecting the anticipated vaccine rollout by Presidents Day. The CDC had planned to distribute 10 million doses, with some orders already placed. Approval would relieve families, and the CDC is coordinating with healthcare providers to ensure vaccine availability. Pfizer aims to provide more protection with a three-dose regimen.

What was the main reason for the FDA's delay in authorizing Pfizer's vaccine for children under five?

• Impact of the Omicron variant

• High demand for adult vaccines

• Concerns about side effects

• Lack of sufficient trial data

Why did Pfizer decide to wait until at least April before authorizing the vaccine for young children?

• To address manufacturing issues

• To focus on adult vaccinations

• To gather data on a third dose

• To conduct more trials

What was the tentative plan for the vaccine rollout for children under five?

• Distribute 5 million doses

• Roll out 10 million child-sized doses

• Provide vaccines only in hospitals

• Delay the rollout until summer

How is the CDC preparing for the vaccine distribution once approved?

• By collaborating with pediatricians and pharmacies

• By setting up new vaccination centers

• By increasing vaccine production

• By training new healthcare workers

What is the expected benefit of the three-dose regimen for young children?

• Lower cost

• Increased protection

• Reduced side effects

• Faster immunity development