At a Glance:
- The U.S. regulators are reviewing the COVID-19 vaccine for the age group under 5.
- A committee of expert advisers will meet on 15th Feb to discuss the authorization of the vaccine.
- The U.S. has approved the use of available vaccination in younger population aged 5 and older.
We might soon get out hands on the first COVID-19 vaccine for children for the age group under 5. The U.S. regulators are inspecting the Pfizer Inc. and BioNTech SE vaccine.
Pfizer and Biotech submitted the data for using the vaccine as emergency authorization—even though it failed to meet the key target in the clinical trial of 2 to 4-year-olds. The data is has been submitted at the request of the US Food and Drug Administration to address the rising concerns of public health needs for that age group.
COVID-19 vaccination for Younger Children
Under the rising concerns of COVID variant Omicron, it has become a priority to work on a safe and effective vaccine for the younger age group. Similarly, the FDA will be assigning an outside committee of expert advisers to confirm the authorization of the vaccine. The meeting will commence on Feb 15th to discuss the authorization.
If the committee approves the vaccines, it will need further clearance from the U.S. Center for Disease Control and Prevention on how the vaccination will be implemented. The meeting of U.S. regulators will take place one week after the FDA decision.
Omicron surge and Booster Vaccination
The available vaccine has been approved by the FDA and U.S. regulators for the young age group (up to 5) while fully-approved for adults. The FDA has authorized the third dose or booster shot of Pfizer/BioNTech vaccination for the adults, also for age 12 and above. The vaccination is authorized for two-dose among the children aged between 5-11.
Even after the approval, it is unclear if the parents will be comfortable in vaccinating the younger age group. The U.S. already has reported fewer numbers in the vaccinated younger population. For ages 5-11 only 22% have received the two shots, since the campaign in November.
